general notice no 1739 of 2007 - gov...staatskoerant, 14 desember 2007 no. 30525 3 notice 1739 of...
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STAATSKOERANT, 14 DESEMBER 2007 No. 30525 3
NOTICE 1739 O F 2007
MEDICINES CONTROL COUNCIL
CONDITIONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONS OF SECTION 15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT No. 101 OF 1965)
The applicant shall ensure that the medicine is manufactured and controlled in terms of current Good Manufacturing Practices as determined by Council.
The manufacture of this medicine is subject to regular investigation and inspections by the inspectors appointed in terms of Section 26 of the Act, to assess compliance with current Good Manufacturing Practices.
The information in the package insert shall be updated on a regular basis to conform to the package insert recently approved by Council.
The applicant must comply with all the legal requirements of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965).
The registration of this medicine shall be subject to regular review regarding its quality, safety and'efficacy, and the registration of this medicine may be varied subject to issues Council may deem fit.
The first two production batches must be fully validated in terms of the detailed process validation protocol submitted at the time of application for registration, and the validation report must be submitted within a month after completion of the validation.
The registration dossier is subject to review at intervals as determined by Council.
A post-registration inspection must be conducted in the first production batch of the locally manufactured product.
A post-registration inspection must be conducted on the first production batch manufactured by each local manufacturer.
A post-registration inspection must be conducted on the first production batch of the imported product.
Marketing of the product may only commence following a satisfactory post-registration inspection report.
One sample of every batch, together with four copies of the protocol for testing of the bulk lot and filling lot, and six copies of the certificate of release issued by a competent authority in the country in which the product was manufactured, must be submitted to the Council for lot release purposes.
The expiry date allocated shall be modified by adding a statement that the virus strains are currently recommended for South African usage in the specific year.
The strains of the master seed viruses must be approved by the Department of Health for each year.
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
3712
6104
65
BIA
ST
OLE
M R
U 1
0 m
g
INJE
CT
ION
EA
CH
VlA
L C
ON
TA
INS
: C
ISP
IAT
IN
10,O
mg
1, 2
, 3,4
, 5, 6
KE
Y O
NC
OLO
GIC
S (P
TY
) LT
D
LEM
ER
Y S
A d
e C
V, M
EX
ICO
LEM
ER
Y S
A d
e C
V, M
EX
ICO
LEM
ER
Y S
A d
e C
V, M
EX
ICO
IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE. R
SA
KE
Y O
NC
OLO
GIC
S, S
AN
DT
ON
, R
SA
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
3712
6104
66
Nam
e of
med
icin
e:
BIA
ST
OL
EM
RU
50
mg
~o
sa
~e
fo
rm:
INJE
CT
ION
Act
ive
ingr
edie
nts:
E
AC
H V
IAL
CO
NT
AIN
S:
CIS
PIA
TIN
50
,O m
g
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3,
4,
5, 6
App
lican
t: K
EY
ON
CO
LOG
ICS
(P
TY
) LT
D
Man
ufac
ture
r:
LEM
ER
Y S
A d
e C
V, M
EX
ICO
Pac
ker:
LE
ME
RY
SA
de
CV
, ME
XIC
O
Labo
rato
ry:
FP
RC
: LE
ME
RY
SA
de
CV
, ME
XIC
O
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
, S
ILV
ER
TO
ND
ALE
, R
SA
FP
RR
: K
EY
ON
CO
LOG
ICS
, S
AN
DT
ON
, R
SA
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
3817
.1.3
1012
1
Nam
e of
med
icin
e:
CO
VE
RT
EX
8 m
g
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
PE
RIN
DO
PR
IL, T
ER
T-B
UT
YLA
MIN
E
8,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4,
5, 6
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
BIO
GA
RA
N S
OU
TH
AF
RIC
A (
PT
Y) L
TD
LES
LA
BO
RA
TO
IRE
S S
ER
VIE
R IN
DU
ST
RIE
, GID
Y
FR
AN
CE
S
ER
VIE
R IR
ELA
ND
IND
US
TR
IES
, WIC
KLO
W,
IRE
LAN
D
LES
LA
BO
RA
TO
IRE
S S
ER
VIE
R IN
DU
ST
RIE
, GlD
Y
FR
AN
CE
S
ER
VIE
R IR
ELA
ND
IND
US
TR
IES
, WIC
KLO
W,
IRE
LAN
D
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S, R
OB
ER
TV
ILLE
, F
LOR
IDA
, RS
A
FP
RC
: LE
S IA
BO
RA
TO
IRE
S S
ER
VlE
R I
ND
US
TR
IE, G
lDY
F
RA
NC
E
SE
RV
IER
IRE
LAN
D IN
DU
ST
RIE
S. W
ICK
LOW
, IR
ELA
ND
M
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
, OR
MO
ND
E,
JOH
AN
NE
SB
UR
G, R
SA
FP
RR
: B
IOG
AR
AN
S.A
., R
IVO
NIA
, RS
A
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
ictr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
38/2
4/02
58
TH
ALl
DO
MlD
E P
HA
RM
ION
50
mg
CA
PS
ULE
S
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
TH
ALl
DO
MlD
E
50,O
mg
1, 2
, 3, 4, 5
, 6
KE
Y O
NC
OLO
GIC
S (
PN
) LT
D
PE
NN
PH
AR
MA
CE
UT
ICA
LS,
GW
EN
T,
UK
PE
NN
PH
AR
MA
CE
UT
ICA
LS,
GW
EN
T,
UK
Labo
rato
ry:
FP
RC
: P
EN
N P
HA
RM
AC
EU
TIC
ALS
, G
WE
NT
, U
K
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
, S
ILV
ER
TO
ND
ALE
, R
SA
FP
RR
: K
EY
ON
CO
LOG
ICS
, S
AN
DT
ON
, R
SA
She
lf-lif
e:
36 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
ME
PR
OP
AY
NE
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: P
AR
AC
ET
AM
OL
320,
O m
g
CO
DE
INE
PH
OS
PH
AT
E
8,O
mg
CA
FF
EIN
E
32,O
mg
M
EP
RO
BA
MA
TE
15
0,O
mg
MR
F 1
5
MD
I cc
PH
AR
MA
NO
VA
(PV
T)
LTD
, HA
RA
RE
, ZIM
BA
BW
E
PH
AR
MA
NO
VA
(PV
T)
LTD
, HA
RA
RE
, ZIM
BA
BW
E
PH
AR
MA
NO
VA
(PV
T)
LTD
, HA
RA
RE
, ZIM
BA
BW
E
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE, B
OK
SB
UR
G, R
SA
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
MD
I cc,
ME
NLO
PA
RK
, PR
ET
OR
IA, R
SA
24 m
onth
s
5 O
CT
BO
BE
R 2
007
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A39
/21.
2/00
27
GLU
CO
PH
AG
E X
R
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: M
ET
FO
RM
IN H
YD
RO
CH
LOR
IDE
50
0,O
mg
1, 2
, 3, 4
, 5,
6
ME
RC
K (
PT
Y)
LTD
ME
RC
K S
AN
TE
, CE
DE
X,
FR
AN
CE
ME
RC
K S
AN
TE
, CE
DE
X,
FR
AN
CE
M
ER
CK
PH
AR
MA
CE
UT
ICA
L M
AN
UF
AC
TU
RIN
G, W
AD
EV
ILLE
, G
ER
MIS
TO
N
ME
RC
K S
AN
TE
, CE
DE
X, F
RA
NC
E
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
, W
AD
EV
ILLE
, G
ER
MIS
TO
N
ME
RC
K,
MO
DD
ER
FO
NT
EIN
, RS
A
24 m
onth
s
5 O
CT
OB
ER
200
7
Reg
istr
atio
n nu
mbe
r:
A39
11 0
.2.1
101 5
4
Nam
e of
med
icin
e:
AS
PE
N S
ALB
UT
AM
OL
100
ug
Dos
age
form
: IN
HA
LER
Act
ive
ingr
edie
nts:
E
AC
H M
ET
ER
ED
DO
SE
CO
NT
AIN
S:
SA
LBU
TA
MO
L S
ULP
HA
TE
EQ
UIV
ALE
NT
TO
S
ALB
UT
AM
OL
100,
O u
g
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5,
6
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
PH
AR
MA
CA
RE
LIM
ITE
D
App
lican
t:
LAB
OR
AT
OR
IO A
LDO
-UN
ION
, B
AR
CE
LON
A,
Man
ufac
ture
r:
SP
AIN
LAB
OR
AT
OR
IO A
LDO
-UN
ION
, B
AR
CE
LON
A,
Pac
ker:
S
PA
IN
FP
RC
: LA
BO
RA
TO
RIO
ALD
O-U
NIO
N, B
AR
CE
LON
A,
Labo
rato
ry:
S P
A1 N
R
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L P
HA
RM
AC
Y, N
OR
TH
-WE
ST
UN
IVE
RS
ITY
, P
OT
CH
EF
ST
RO
OM
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
A
SP
EN
PH
AR
MA
CA
RE
, WIL
SO
NIA
, E
AS
T
LON
DO
N
FP
RC
IFP
RR
: P
HA
RM
AC
AR
E L
TD
, KO
RS
TE
N, P
OR
T E
LIZ
AB
ET
H
PH
AR
MA
CA
RE
LT
D, W
OO
DM
EA
D,
SA
ND
TO
N
FP
RC
:
FP
RR
:
She
lf-lif
e:
36 m
onth
s S
helf-
life:
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7 D
ate
of r
egis
trat
ion:
MR
F 1
5 M
RF
15
-
A39
11 5
.410
202
ALP
HA
GA
N P
UR
ITE
SO
LUT
ION
EA
CH
1,O
ml S
OLU
TIO
N C
ON
TA
INS
: B
RIM
ON
IDIN
E T
AR
TR
AT
E
1,5
mg
1, 2
, 3,
4,
5, 6
ALL
ER
GA
N P
HA
RM
AC
EU
TIC
ALS
(P
TY
) LT
D
ALL
ER
GA
N I
NC
, WA
CO
, TE
XA
S,
US
A
ALL
ER
GA
N I
NC
, WA
CO
. TE
XA
S.
US
A
ALL
ER
GA
N I
NC
, WA
CO
, TE
XA
S,
US
A
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
, S
ILV
ER
TO
ND
ALE
, R
SA
ALL
ER
GA
N P
HA
RM
AC
EU
TIC
ALS
, H
ALF
WA
Y
HO
US
E,
RS
A
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
OX
ALl
WlN
50
rngl
lO m
l
INF
US
ION
EA
CH
1,O
ml S
OLU
TIO
N C
ON
TA
INS
: O
XA
LlP
LAT
lN
5,0
mg
SA
NO
FI-S
YN
TH
ELA
BO
(P
TY
) LT
D
TH
ISS
EN
LA
BO
RA
TO
RIE
S, B
RA
lN L
'ALL
EU
D
BE
LGIU
M
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C, B
ED
FO
RD
, O
HIO
, US
A
TH
ISS
EN
LA
BO
RA
TO
RIE
S, B
RA
lN L
'ALL
EU
D,
BE
LGIU
M
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C, B
ED
FO
RD
, O
HIO
, US
A
GLA
XO
WE
LLC
OM
E P
RO
DU
CT
ION
CO
, N
OT
RE
D
AM
E D
E B
ON
DE
VIL
LE, F
RA
NC
E
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O,
PR
ET
OR
IA
TH
ISS
EN
LA
BO
RA
TO
RIE
S, B
RA
lN L
'ALL
EU
D,
BE
LGIU
M
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C, B
ED
FO
RD
, O
HIO
, US
A
GLA
XO
WE
LLC
OM
E P
RO
DU
CT
ION
CO
, N
OT
RE
D
AM
E D
E B
ON
DE
VIL
LE, F
RA
NC
E
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O,
PR
ET
OR
IA
SA
NO
FI-
SY
NT
HE
LAB
O, M
IDR
AN
D, R
SA
36 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
OX
ALl
WlN
100
mg1
20 m
l
INF
US
ION
EA
CH
1,O
rnl S
OLU
TIO
N C
ON
TA
INS
: O
XA
LI P
LAT
I N
50
rng
SA
NO
FI-
SY
NT
HE
LAB
O (
PP
I) L
TD
TH
ISS
EN
LA
BO
RA
TO
RIE
S, B
RA
lN
L'A
LLE
UD
BE
LGIU
M
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C,
BE
DF
OR
D, O
HIO
, U
SA
TH
ISS
EN
LA
BO
RA
TO
RIE
S, B
RA
lN
L'A
LLE
UD
, BE
LGIU
M
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C,
BE
DF
OR
D, O
HIO
, U
SA
G
LAX
O W
ELL
CO
ME
PR
OD
UC
TIO
N C
O,
NO
TR
E D
AM
E D
E B
ON
DE
VIL
LE, F
RA
NC
E
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O,
PR
ET
OR
IA
TH
ISS
EN
LA
BO
RA
TO
RIE
S, B
RA
lN
L'A
LLE
UD
, BE
LGIU
M
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C,
BE
DF
OR
D, O
HIO
, U
SA
G
LAX
O W
ELL
CO
ME
PR
OD
UC
TIO
N C
O,
NO
TR
E D
AM
E D
E B
ON
DE
VIL
LE, F
RA
NC
E
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S,
OR
MO
ND
E, J
OH
AN
NE
SB
UR
G
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O,
PR
ET
OR
IA
SA
NO
FI-
SY
NT
HE
LAB
O, M
IDR
AN
D, R
SA
36 m
onth
s
5 O
CT
OB
ER
200
7
15
trat
ion
num
ber:
of m
edic
ine:
le fo
rm:
ingr
edie
nts:
tions
of
regi
stra
tion:
ant:
'act
urer
:
ator
y:
FP
RC
:
FP
RC
IFP
RR
:
FP
RR
life:
)f re
gist
ratio
n:
OX
ALl
WlN
50
mg
llO m
l RT
U
INF
US
ION
EA
CH
1,O
ml S
OLU
TIO
N C
ON
TA
INS
: O
XA
LlP
LAT
lN
50
mg
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C, B
ED
FO
RD
, OH
IO,
US
A
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C, B
ED
FO
RD
, OH
IO,
US
A
GLA
XO
WE
LLC
OM
E P
RO
DU
CT
ION
CO
, NO
TR
E
DA
ME
DE
BO
ND
EV
ILLE
, FR
AN
CE
S
AN
OF
I WIN
TH
RO
P I
ND
US
TR
IE, Q
UE
TIG
NY
, F
RA
NC
E
AV
EN
TIS
PH
AR
MA
, DA
GE
NH
AM
, ES
SW
,UK
W
lNT
HR
OP
PH
AR
MA
CE
UT
ICA
LS, W
ALT
LOO
, P
RE
TO
RIA
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C, B
ED
FO
RD
, OH
IO,
US
A
GLA
XO
WE
LLC
OM
E P
RO
DU
CT
ION
CO
, NO
TR
E
DA
ME
DE
BO
ND
EV
ILLE
, FR
AN
CE
M
BL
LAB
OR
AT
OR
Y S
ER
VIC
ES
, OR
MO
ND
E,
JOH
AN
NE
SB
UR
G
SA
NO
FI W
INT
HR
OP
IND
US
TR
IE, Q
UE
TIG
NY
, F
RA
NC
E
AV
EN
TIS
PH
AR
MA
, DA
GE
NH
AM
, ES
SE
X,U
K
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
, WA
LTLO
O,
PR
ET
OR
IA
WIN
TH
RO
P P
HA
RM
AC
EU
TIC
ALS
, MID
RA
ND
36 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A39
1261
0522
Nam
e of
med
icin
e:
OX
ALl
WlN
100
mg1
20 m
l RT
U
Dos
age
form
: IN
FU
SIO
N
Act
ive
ingr
edie
nts:
E
AC
H 1
,O rn
l SO
LUT
ION
CO
NT
AIN
S:
OX
ALl
PLA
TlN
5,
0 m
g
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
, 3,4
, 5,
6
App
lican
t: W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS (P
TY
) LT
D
Man
ufac
ture
r:
Pac
ker:
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C, B
ED
FO
RD
, OH
IO,
US
A
BE
N V
EN
UE
LA
BO
RA
TO
RIE
S IN
C, B
ED
FO
RD
, OH
IO,
US
A
GLA
XO
WE
LLC
OM
E P
RO
DU
CT
ION
CO
, N
OT
RE
DA
ME
D
E B
ON
DE
VIL
LE, F
RA
NC
E
SA
NO
FI W
INT
HR
OP
IND
US
TR
IE, Q
UE
TIG
NY
, FR
AN
CE
A
VE
NT
IS P
HA
RM
A, D
AG
EN
HA
M, E
SS
EX
,UK
W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS, W
ALT
LOO
, P
RE
TO
RIA
Labo
rato
ry:
FP
RC
: B
EN
VE
NU
E L
AB
OR
AT
OR
IES
INC
. BE
DF
OR
D, O
HIO
, U
SA
G
LAX
O W
ELL
CO
ME
PR
OD
UC
TIO
N C
O, N
OT
RE
DA
ME
D
E B
ON
DE
VIL
LE, F
RA
NC
E
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
S
AN
OF
I WIN
TH
RO
P IN
DU
ST
RIE
, QU
ET
IGN
Y, F
RA
NC
E
AV
EN
TIS
PH
AR
MA
, DA
GE
NH
AM
, ES
SE
X,U
K
FP
RC
IFP
RR
: W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS, W
ALT
LOO
, P
RE
TO
RIA
FP
RR
: W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS, M
IDR
AN
D
She
lf-lif
e:
36 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
LAN
SO
PR
AZ
OLE
-WIN
TH
RO
P 1
5
CA
PS
ULE
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
LAN
SO
PR
AZ
OLE
15
.0 m
g
AV
EN
TIS
PH
AR
MA
(PT
Y)
LTD
TA
KE
DA
IR
ELA
ND
LT
D, W
ICK
LOW
, IR
ELA
ND
A
VE
NT
IS P
HA
RM
A S
PE
CIA
LIT
ES
, CO
MP
IEG
NE
, F
RA
NC
E
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O, P
RE
TO
RIA
PR
ET
OR
IA A
VE
NT
IS P
HA
RM
A S
PE
CIA
LIT
ES
, C
OM
PIE
GN
E, F
RA
NC
E
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O, P
RE
TO
RIA
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
A39
11 1
.4.3
1055
3
LAN
SO
PR
AZ
OLE
-WIN
TH
RO
P 3
0
CA
PS
ULE
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
LAN
SO
PR
AZ
OLE
30
,O m
g
1, 2
, 3,
4,
5, 6
AV
EN
TIS
PH
AR
MA
(P
TY
) LT
D
TA
KE
DA
IR
ELA
ND
LT
D, W
ICK
LOW
, IR
ELA
ND
A
VE
NT
IS P
HA
RM
A S
PE
CIA
LIT
ES
, C
OM
PIE
GN
E,
FR
AN
CE
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O,
PR
ET
OR
IA
AV
EN
TIS
PH
AR
MA
SP
EC
IALI
TE
S,
CO
MP
IEG
NE
, F
RA
NC
E
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
. P
RE
TO
RIA
FP
RC
IFP
RR
: A
VE
NT
IS P
HA
RM
A, W
ALT
LOO
, P
RE
TO
RIA
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
: FP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
RA
N-Q
UIN
AP
RIL
PLU
S
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: Q
UlN
AP
RlL
HY
DR
OC
HLO
RID
E E
QU
IVA
LEN
T T
O
QU
lNA
PR
lL
10,O
mg
HY
DR
OC
HLO
RO
TH
IAZ
IDE
1
25
mg
RA
NB
AX
Y S
.A. (
PT
Y) L
TD
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D. R
SA
RA
NB
AX
Y, C
EN
TU
RIO
N, R
SA
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5.
Reg
istr
atio
n nu
mbe
r:
A39
17.1
,310
56 1
Nam
e of
med
icin
e:
RA
N-Q
UIN
AP
RIL
FO
RT
E P
LUS
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
QU
INA
PR
IL H
YD
RO
CH
LOR
IDE
EQ
UIV
ALE
NT
TO
Q
UlN
AP
RlL
20
,O m
g H
YD
RO
CH
LOR
OT
HIA
ZID
E
12,5
rng
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4,
5, 6
App
lican
t: R
AN
BA
XY
S.A
. (P
TY
) LT
D
Man
ufac
ture
r:
Pac
ker
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
Labo
rato
ry:
FP
RC
R
AN
BA
XY
LA
BO
RA
TO
RIE
S L
TD
, DE
WA
S,
MA
DH
YA
PR
AD
ES
H, I
ND
IA
KH
ULU
LEK
AN
I LA
BO
RA
TO
RY
SE
RV
ICE
S,
MID
RA
ND
. RS
A
FP
RR
R
AN
BA
XY
(S.A
.), C
EN
TU
RIO
N, R
SA
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A39
17.1
.310
562
Nam
e of
med
icin
e:
QU
INP
RE
N P
LUS
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
QU
lNA
PR
lL H
YD
RO
CH
LOR
IDE
EQ
UIV
ALE
NT
TO
Q
UlN
AP
RlL
10
,O m
g
HY
DR
OC
HLO
RO
TH
IAZ
IDE
1
25
mg
Con
ditio
ns o
f re
gist
ratio
n:
I, 2,
3, 4
, 5, 6
App
lican
t: R
AN
BA
XY
S.A
. (P
TY
) LT
D
Man
ufac
ture
r:
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
Pac
ker:
R
AN
BA
XY
LA
BO
RA
TO
RIE
S L
TD
, DE
WA
S,
MA
DH
YA
PR
AD
ES
H, I
ND
IA
Labo
rato
ry:
FP
RC
: R
AN
BA
XY
LA
BO
RA
TO
RIE
S L
TD
. D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D. R
SA
FP
RR
: R
AN
BA
XY
(S.A
.), C
EN
TU
RIO
N, R
SA
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
A39
17.1
.310
563
QU
INP
RE
N F
OR
TE
PLU
S
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: Q
UlN
AP
RlL
HY
DR
OC
HLO
RID
E
EQ
UIV
ALE
NT
TO
Q
UlN
AP
RlL
20
,O m
g H
Y D
RO
CH
LOR
OT
HIA
ZID
E
12,5
mg
1, 2
, 3, 4
, 5,
6
RA
NB
AX
Y S
.A. (
PT
Y)
LTD
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D,
RS
A
FP
RR
: R
AN
BA
XY
(S
.A.)
, CE
NT
UR
ION
, RS
A
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A401
1 5.
4100
09
RE
TA
AN
E
SU
SP
EN
SIO
N F
OR
DE
PO
T IN
JEC
TIO
N
EA
CH
0,5
ml S
US
PE
NS
ION
CO
NT
AIN
S:
AN
EC
OR
TA
VE
AC
ET
AT
E
15,O
mg
1, 2
, 3,4
, 5,
6
ALC
ON
LA
BO
RA
TO
RIE
S (S
A)
(PN
) LT
D
ALC
ON
MA
NU
FA
CT
UR
ING
LT
D, F
OR
T W
OR
TH
, T
EX
AS
, US
A
ALC
ON
MA
NU
FA
CT
UR
ING
LT
D, F
OR
T W
OR
TH
, T
EX
AS
, US
A
ALC
ON
MA
NU
FA
CT
UR
ING
LT
D. F
OR
T W
OR
TH
, T
EX
AS
, US
A
ALC
ON
LA
BO
RA
TO
RIE
S, B
RY
AN
ST
ON
, RS
A
36 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A40
1261
005 1
Nam
e of
med
icin
e:
PLA
TO
SIN
10
mg
llO m
l
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H 1
0,O
ml V
IAL
CO
NT
AIN
S:
CIS
PLA
TIN
10
,O m
g
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3,
4,
5, 6
App
lican
t: P
HA
RM
AC
HE
MIE
(P
N)
LTD
Man
ufac
ture
r
Pac
ker
PH
AR
MA
CH
EM
IE B
.V.,
HA
AR
LEM
, TH
E
NE
TH
ER
LAN
DS
PH
AR
MA
CH
EM
IE B
.V.,
HA
AR
LEM
, TH
E
NE
TH
ER
LAN
DS
Labo
rato
ry:
FP
RC
: P
HA
RM
AC
HE
MIE
B.V
., H
AA
RLE
M, T
HE
N
ET
HE
RLA
ND
S
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,A
TLA
SV
ILLE
, BO
KS
BU
RG
FP
RR
: P
HA
RM
AC
HE
MIE
, R
UIM
SIG
, RO
OD
EP
OO
RT
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry
FP
RC
.
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
1261
0052
PLA
TO
SIN
50
mg1
50 m
l
INJE
CT
ION
EA
CH
50,
O m
l VIA
L C
ON
TA
INS
: C
ISP
LAT
IN
50,O
mg
PH
AR
MA
CH
EM
IE (P
TY
) LT
D
PH
AR
MA
CH
EM
IE B
.V.,
HA
AR
LEM
, TH
E
NE
TH
ER
LAN
DS
PH
AR
MA
CH
EM
IE B
.V.,
HA
AR
LEM
, TH
E
NE
TH
ER
LAN
DS
PH
AR
MA
CH
EM
IE B
.V.,
HA
AR
LEM
, TH
E
NE
TH
ER
LAN
DS
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, BO
KS
BU
RG
PH
AR
MA
CH
EM
IE, R
UIM
SIG
. RO
OD
EP
OO
RT
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
.Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
120.
1.21
0088
CLA
ME
NT
IN 1
000
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: A
MO
XY
ClL
LlN
TR
IHY
DR
AT
E E
QU
IVA
LEN
T
TO
A
MO
XY
ClL
LlN
87
5,O
mg
PO
TA
SS
IUM
CLA
VU
LAN
AT
E E
QU
IVA
LEN
T
TO
C
LAV
ULA
NIC
AC
ID
125,
O m
g
1, 2
, 3
,4, 5
, 6
ME
RC
K G
EN
ER
ICS
RS
A (P
TY
) LT
D
SA
ND
OZ
Gm
bH, K
UN
DL,
AU
ST
RIA
SA
ND
OZ
Gm
bH, K
UN
DL,
AU
ST
RIA
SA
ND
OZ
Gm
bH, K
UN
DL,
AU
ST
RIA
G
EN
ER
ICS
UK
, ST
AT
ION
CLO
SE
, H
ER
TF
OR
DS
HIR
E, U
K
GE
RA
RD
LA
BO
RA
TO
RIE
S, D
UB
LIN
, IR
ELA
ND
M
ER
CK
PH
AR
MA
CE
UT
ICA
L M
AN
UF
AC
TU
RIN
G, W
AD
EV
ILLE
, G
ER
MIS
TO
N
RE
SE
AR
CH
INS
TIT
UT
E F
OR
IND
US
TR
IAL
PH
AR
MA
CY
, NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M
ME
RC
K G
EN
ER
ICS
RS
A, M
OD
DE
RF
ON
TE
IN
24 M
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
ZO
XA
N E
YE
DR
OP
S
SO
LUT
ION
EA
CH
1,O
ml S
OLU
TIO
N C
ON
TA
INS
: C
IPR
OF
LOX
AC
IN H
YD
RO
CH
LOR
IDE
EQ
UIV
ALE
NT
T
O C
IPR
OF
LOX
AC
IN
3,0
mg
PH
AR
MA
CA
RE
LIM
ITE
D
FD
C L
TD
, WA
LUJ,
AU
RA
NG
AB
AD
, IN
DIA
FD
C L
TD
, WA
LUJ,
AU
RA
NG
AB
AD
, IN
DIA
P
HA
RM
AC
AR
E L
TD
, KO
RS
TE
N, P
OR
T E
LIZ
AB
ET
H
AS
PE
N P
HA
RM
AC
AR
E, W
ILS
ON
IA,
EA
ST
LO
ND
ON
FD
C L
TD
, WA
LUJ,
AU
RA
NG
AB
AD
, IN
DIA
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
R
ES
EA
RC
H IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
ALS
S
ER
VIC
ES
, NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M
MB
L LA
BO
RA
TO
RY
SE
RV
ICE
S, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
A
SP
EN
PH
AR
MA
CA
RE
, WIL
SO
NIA
, E
AS
T L
ON
DO
N
PH
AR
MA
CA
RE
LT
D, W
OO
DM
EA
D, S
AN
DT
ON
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A40
12.5
1011
8
Nam
e of
med
icin
e:
SA
ND
OZ
TO
PIR
AM
AT
E 2
5
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
TO
PIR
AM
AT
E
25
0 m
g
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4,
5, 6
App
lican
t: S
AN
DO
Z S
.A. (
PT
Y)
LTD
Man
ufac
ture
r:
Pac
ker:
SA
ND
OZ
PV
T L
TD
, NA
Vl M
UM
BA
I, IN
DIA
SA
ND
OZ
PV
T L
TD
, NA
Vl M
UM
BA
I, IN
DIA
S
AN
DO
Z S
.A.,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
Labo
rato
ry:
FP
RC
: S
AN
DO
Z P
VT
LT
D, N
AV
I MU
MB
AI,
IND
IA
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
. P
RE
TO
RIA
FP
RC
IFP
RR
: S
AN
DO
Z S
.A, S
PA
RT
AN
, K
EM
PT
ON
PA
RK
She
lf-lif
e:
24 m
onth
s (p
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
12.5
1011
9
SA
ND
OZ
TO
PIR
AM
AT
E 5
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: T
OP
IRA
MA
TE
50
,O m
g
1,2
, 3, 4
, 5,
6
SA
ND
OZ
S.A
. (P
TY
) LT
D
SA
ND
OZ
PW
LT
D, N
AV
l MU
MB
AI,
IND
IA
SA
ND
OZ
PV
T L
TD
, NA
Vl M
UM
BA
I, IN
DIA
S
AN
DO
Z S
.A.,
SP
AR
TA
N,
KE
MP
TO
N P
AR
K
SA
ND
OZ
PW
LTD
, NA
Vl M
UM
BA
I, IN
DIA
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
SA
ND
OZ
S.A
., S
PA
RT
AN
, K
EM
PT
ON
PA
RK
24 m
onth
s (p
rovi
sion
al)
5 O
CT
OB
ER
200
7
Reg
istr
atio
n nu
mbe
r
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
A40
12.5
1012
0
SA
ND
OZ
TO
PIR
AM
AT
E 1
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: T
OP
IRA
MA
TE
10
0,O
rng
1,2
,3,4
, 5,6
SA
ND
OZ
S.A
. (P
TY
) LT
D
SA
ND
OZ
PV
T L
TD
, NA
Vl M
UM
BA
I, IN
DIA
SA
ND
OZ
PV
T L
TD
, NA
Vl M
UM
BA
I, IN
DIA
S
AN
DO
Z S
.A.,
SP
AR
TA
N,
KE
MP
TO
N P
AR
K
SA
ND
OZ
PV
T L
TD
, NA
Vl M
UM
BA
I, IN
DIA
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
FP
RC
IFP
RR
: S
AN
DO
Z S
.A.,
SP
AR
TA
N.
KE
MP
TO
N P
AR
K
She
lf-lif
e:
24 m
onth
s (p
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5 M
RF
15
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
12.5
1012
1
SA
ND
OZ
TO
PIR
AM
AT
E 2
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: T
OP
IRA
MA
TE
20
0,O
mg
1, 2
, 3
,4,5
,6
SA
ND
OZ
S.A
. (P
TY
) LT
D
SA
ND
OZ
PV
T L
TD
, NA
Vl M
UM
BA
I, IN
DIA
SA
ND
OZ
PV
T L
TD, N
AV
l MU
MB
AI,
IND
IA
SA
ND
OZ
S.A
., S
PA
RT
AN
, KE
MP
TO
N P
AR
K
SA
ND
OZ
PV
T L
TD
, NA
Vl M
UM
BA
I, IN
DIA
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
SA
ND
OZ
S.A
., S
PA
RT
AN
, KE
MP
TO
N P
AR
K
24 m
onth
s (p
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
ME
DA
XO
NE
I g
INJE
CT
ION
E
AC
H V
IAL
CO
NT
AIN
S:
CE
FT
RIA
XO
NE
SO
DIU
M E
QU
IVA
LEN
T T
O
CE
FT
RIA
XO
NE
1
,og
SP
EC
PH
AR
M (
PT
Y)
LTD
ME
DO
CH
EM
IE L
TD
, LIM
AS
SO
L, C
YP
RU
S
ME
DO
CH
EM
IE L
TD
, LIM
AS
SO
L, C
YP
RU
S
ME
DO
CH
EM
IE L
TD
, LIM
AS
SO
L, C
YP
RU
S
AN
ALY
TIC
ON
, TE
RE
NU
RE
, KE
MP
TO
N P
AR
K
SP
EC
PH
AR
M, H
ALF
WA
Y H
OU
SE
, MID
RA
ND
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7 -
MR
F 1
5 M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e o
f med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
La
bo
rato
ry
She
lf-lif
e:
FP
RC
:
FP
RR
:
Dat
e of
reg
istr
atio
n:
A40
120.
1. lI
Ol9
9
ME
DA
XO
NE
250
mg
INJE
CT
ION
EA
CH
VlA
L C
ON
TA
INS
: C
EF
TR
IAX
ON
E S
OD
IUM
EQ
UIV
ALE
NT
TO
C
EF
TR
IAX
ON
E
250,
O m
g
1, 2
, 3,4
, 5, 6
Reg
istr
atio
n nu
mbe
r:
A40
120.
1.11
0200
Nam
e of
med
icin
e:
ME
DA
XO
NE
500
rng
Dos
age
form
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H V
IAL
CO
NT
AIN
S:
CE
FT
RIA
XO
NE
SO
DIU
M E
QU
IVA
LEN
T T
O
CE
FT
RIA
XO
NE
50
0,O
mg
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
, 3,
4,
56
SP
EC
PH
AR
M (
PW
) LT
D
App
lican
t:
ME
DO
CH
EM
IE L
TD
, LIM
AS
SO
L, C
YP
RU
S
Man
ufac
ture
r:
ME
DO
CH
EM
IE L
TD
, LI
MA
SS
OL,
CY
PR
US
P
acke
r:
ME
DO
CH
EM
IE L
TD
, LIM
AS
SO
L, C
YP
RU
S
Labo
rato
ry:
AN
ALY
TIC
ON
, TE
RE
NU
RE
, K
EM
PT
ON
PA
RK
SP
EC
PH
AR
M, H
ALF
WA
Y H
OU
SE
, MID
RA
ND
24 m
onth
s (P
rovi
sion
al)
SP
EC
PH
AR
M (
PT
Y)
LTD
ME
DO
CH
EM
IE L
TD
, LIM
AS
SO
L, C
YP
RU
S
ME
DO
CH
EM
IE L
TD
, LIM
AS
SO
L, C
YP
RU
S
FP
RC
: M
ED
OC
HE
MIE
LT
D, L
IMA
SS
OL,
CY
PR
US
A
NA
LYT
ICO
N,
TE
RE
NU
RE
, KE
MP
TO
N P
AR
K
FP
RR
: S
PE
CP
HA
RM
, HA
LFW
AY
HO
US
E, M
IDR
AN
D
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7 D
ate
of r
egis
trat
ion:
5
OC
TO
BE
R 2
007
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40/2.9/0388
AU
ST
ELL
-TR
AM
AD
OL 50 m
g
CA
PS
ULE
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
TR
AM
AD
OL
HY
DR
OC
HLO
RID
E
50,O m
g
1, 2, 3, 4, 5, 6
AU
ST
ELL
LA
BO
RA
TO
RIE
S (P
TY
) LT
D
IPC
A L
AB
OR
AT
OR
IES
, SIL
VA
SS
A,
DA
DR
A &
N
AG
AR
HA
VE
LI, I
ND
IA
IPC
A L
AB
OR
AT
OR
IES
, SIL
VA
SS
A,
DA
DR
A &
N
AG
AR
HA
VE
LI, I
ND
IA
IPC
A L
AB
OR
AT
OR
IES
, SIL
VA
SS
A, D
AD
RA
&
NA
GA
R H
AV
ELI
, IN
DIA
M
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
, OR
MO
ND
E,
JOH
AN
NE
SB
UR
G
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
, S
ILV
ER
TO
ND
ALE
, R
SA
AU
ST
ELL
LA
BO
RA
TO
RIE
S, S
PR
ING
FIE
LD,
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
2007
MR
F I5
Reg
istr
atio
n nu
mbe
r:
A40/20.1.1/0393
Nam
e of
med
icin
e:
ST
RID
ES
-CE
FO
TA
MA
X
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
INJE
CT
ION
EA
CH
VIA
L C
ON
TA
INS
: C
EF
OT
AX
IME
SO
DIU
M E
QU
IVA
LEN
T T
O
CE
FO
TA
XIM
E
1,o g
1, 2, 3, 4, 5, 6
ST
RID
ES
S.A
. PH
AR
MA
CE
UT
ICA
LS (P
TY
) LT
D
ST
RID
ES
AR
CO
LAB
LT
D, B
ILE
KA
HA
LLI,
BA
NG
ALO
RE
, IN
DIA
ST
RID
ES
AR
CO
LAB
LT
D, B
ILE
KA
HA
LLI,
BA
NG
ALO
RE
, IN
DIA
ST
RID
ES
AR
CO
LAB
LT
D, B
ILE
KA
HA
LLI,
BA
NG
ALO
RE
, IN
DIA
C
OLU
MB
IA P
HA
RM
AC
EU
TIC
ALS
, B
AR
DE
NE
, B
OK
SB
UR
G
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
, S
ILV
ER
TO
ND
ALE
N
OV
AR
TIS
SA
, SP
AR
TA
N, K
EM
PT
ON
PA
RK
ST
RID
ES
SA
PH
AR
MA
CE
UT
ICA
LS,
AR
CA
DIA
, P
RE
TO
RIA
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
2007
? 2 0
m
N
P
N I
MR
F 1
5 M
RF
15
0
Reg
istr
atio
n nu
mbe
r
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
110.
2.11
0413
FO
RA
TE
C H
FA
INH
ALE
R
EA
CH
AC
TU
AT
ION
DE
LIV
ER
S:
FO
RM
OT
ER
OL
FU
MA
RA
TE
12
,O u
g
1, 2
, 3, 4
, 5,
6
ClP
lA M
ED
PR
O (P
TY
) LT
D
ClP
lA L
TD
, (U
NIT
II),
VE
RN
A,
GO
A, I
ND
IA
ClP
lA L
TD
, (U
NIT
II),
VE
RN
A, G
OA
, IN
DIA
ClP
lA L
TD
, (U
NIT
II)
, VE
RN
A,
GO
A, I
ND
IA
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
A40
110.
2.11
0414
CIP
lA-F
OR
MO
TE
RO
L F
UM
AR
AT
E H
FA
INH
ALE
R
EA
CH
AC
TU
AT
ION
DE
LIV
ER
S:
FO
RM
OT
ER
OL
FU
MA
RA
TE
12
,O u
g
1, 2
, 3,4
, 5,
6
ClP
lA L
lFE
SC
IEN
CE
S (
PT
Y)
LTD
ClP
lA L
TD
, (U
NIT
II),
VE
RN
A,
GO
A, I
ND
IA
ClP
lA L
TD
, (U
NIT
II),
VE
RN
A.
GO
A, I
ND
IA
ClP
lA L
TD
, (U
NIT
II),
VE
RN
A,
GO
A,
IND
IA
ClP
lA M
ED
PR
O, R
OS
EN
PA
RK
, BE
LLV
ILLE
F
PR
R:
ClP
lA L
IFE
SC
IEN
CE
S,
RO
SE
NP
AR
K,
BE
LLV
ILLE
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7 D
ate
of r
egis
trat
ion:
5
OC
TO
BE
R 2
007
cn 5' 3 cn ii 0
rn n >
Z
-4
A
P O
rn
cn
rn 5 rn n ril 0 0
A
Z
? W 0
m
ril
m 2
h)
h) z ? W 0
Cn
til Cn
G) 2 rn
n z z rn
z -I G) 9
N
rn 3 rn
A
P 0 a m
rn
n til 0
0
4
MR
F 1
5 M
RF
15
Reg
istr
atio
n nu
mbe
r
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Reg
istr
atio
n nu
mbe
r:
A40
17.5
1047
4
GU
LF R
AN
lTlD
lNE
300
N
ame
of m
edic
ine:
R
AN
-PR
AV
AS
TA
TIN
10
TAB
LET
Dos
age
form
: T
AB
LET
EA
CH
TA
BLE
T C
ON
TA
INS
: R
AN
lTlD
lNE
HY
DR
OC
HLO
RID
E E
QU
IVA
LEN
T T
O
RA
NIT
IDIN
E
300,
O m
g
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
PR
AV
AS
TA
TIN
SO
DIU
M
10,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Con
ditio
ns o
f reg
istr
atio
n:
1,2
, 3,4
, 5, 6
GU
LF D
RU
G C
OM
PA
NY
(PT
Y)
LTD
A
pplic
ant:
RA
NB
AX
Y (S
.A.)
(PT
Y)
LTD
ALE
MB
IC L
TD
, PA
NC
HM
AH
ALS
, GU
JAR
AT
, IN
DIA
M
anuf
actu
rer
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LTD
, PA
ON
TA
S
AH
IB, H
IMA
CH
AL
PR
AD
ES
H,
IND
IA
Pac
ker:
A
LEM
BIC
LT
D, P
AN
CH
MA
HA
LS, G
UJA
RA
T, I
ND
IA
Pac
ker:
R
AN
BA
XY
LA
BO
RA
TO
RIE
S L
TD
, PA
ON
TA
S
AH
IB, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
Labo
rato
ry:
FP
RC
: A
LEM
BIC
LT
D, P
AN
CH
MA
HA
LS, G
UJA
RA
T, I
ND
IA
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, B
OK
SB
UR
G
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
C
ON
SU
LTIN
G M
ICR
OB
IOLO
GIC
AL
LAB
OR
AT
OR
Y,
MO
RE
HIL
L, B
EN
ON
I P
HA
RM
A-Q
, IN
DU
ST
RIA
-WE
ST
, JO
HA
NN
ES
BU
RG
Labo
rato
ry:
FP
RC
: R
AN
BA
XY
LA
BO
RA
TO
RIE
S L
TD
, PA
ON
TA
S
AH
IB,
HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D, R
SA
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
. BO
KS
BU
RG
FP
RR
: G
ULF
DR
UG
CO
MP
AN
Y, M
OU
NT
ED
GE
CO
MB
E,
DU
RB
AN
, RS
A
FP
RR
: R
AN
BA
XY
, CE
NT
UR
ION
, RS
A
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7 5
OC
TO
BE
R 2
007
MR
F 1
5 M
RF
15
Reg
istr
atio
n nu
mbe
r
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts,
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
RA
N-P
RA
VA
ST
AT
IN 2
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: P
RA
VA
ST
AT
IN S
OD
IUM
20
,O m
g
RA
NB
AX
Y (S
.A.)
(PT
Y)
LTD
WN
BA
XY
LA
BO
RA
TO
RIE
S L
TD
, PA
ON
TA
SA
HIB
, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A S
AH
IB,
HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A S
AH
IB,
HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D, R
SA
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, BO
KS
BU
RG
RA
NB
AX
Y, C
EN
TU
RIO
N,
RS
A
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
RA
N-P
RA
VA
ST
AT
IN 4
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: P
RA
VA
ST
AT
IN S
OD
IUM
40
,O m
g
RA
NB
AX
Y (S
.A.)
(PT
Y)
LTD
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A
SA
HIB
, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A
SA
HIB
, H
IMA
CH
AL
PR
AD
ES
H,
IND
IA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A
SA
HIB
, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
KH
ULU
LEK
AN
I LA
BO
RA
TO
RY
SE
RV
ICE
S,
MID
RA
ND
, R
SA
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, B
OK
SB
UR
G
RA
NB
AX
Y, C
EN
TU
RIO
N,
RS
A
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A40
11.2
1048
3
Nam
e of
med
icin
e:
ZO
SE
RT
50
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
SE
RT
RA
LIN
E H
YD
RO
CH
LOR
IDE
EQ
UIV
ALE
NT
TO
S
ER
TR
ALI
NE
50
,O m
g
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3,
4, 5
, 6
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
PH
AR
MA
PIA
N (P
TY
) LT
D
SU
N P
HA
RM
AC
EU
TIC
AL
IND
US
TR
IES
, D
AD
RA
&
NA
GA
R H
AV
ELI
, IN
DIA
SU
N P
HA
RM
AC
EU
TIC
AL
IND
US
TR
IES
, D
AD
RA
&
NA
GA
R H
AV
ELI
, IN
DIA
FP
RC
: S
UN
PH
AR
MA
CE
UT
ICA
L IN
DU
ST
RIE
S,
DA
DR
A &
N
AG
AR
HA
VE
LI, I
ND
IA
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE,
BO
KS
BU
RG
FP
RR
: P
HA
RM
AP
IAN
, M
IDR
AN
D, R
SA
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A40
11.2
1049
1
Nam
e of
med
icin
e:
VE
NLA
FA
XIN
E-H
EX
AL
150
mg
XL
Dos
age
form
: C
AP
SU
LE
Act
ive
ingr
edie
nts:
E
AC
H C
AP
SU
LE C
ON
TA
INS
: V
EN
IAF
AX
INE
HY
DR
OC
HLO
RID
E
EQ
UIV
ALE
NT
TO
VE
NLA
FA
XIN
E
I50,
O m
g
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5, 6
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
SA
ND
OZ
S.A
. (P
TY
) LT
D
SA
ND
OZ
PR
IVA
TE
LT
D, K
ALW
E, N
AV
l M
UM
BA
I, IN
DIA
SA
ND
OZ
PR
IVA
TE
LT
D, K
ALW
E, N
AV
l M
UM
BA
I, IN
DIA
S
AN
DO
Z S
.A.,
SP
AR
TA
N,
KE
MP
TO
N P
AR
K
FP
RC
: S
AN
DO
Z P
RIV
AT
E L
TD
, KA
LWE
, NA
Vl
MU
MB
AI,
IND
IA
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
AN
ALY
TIC
ON
, TE
RE
NU
RE
, K
EM
PT
ON
PA
RK
FP
RC
IFP
RR
: S
AN
DO
Z S
.A.,
SP
AR
TA
N,
KE
MP
TO
N P
AR
K
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A40
11.2
1049
2
Nam
e of
med
icin
e:
SA
ND
OZ
VE
NIA
FA
XIN
E X
L 1
50
Dos
age
form
: C
AP
SU
LE
Act
ive
ingr
edie
nts:
E
AC
H C
AP
SU
LE C
ON
TA
INS
: V
EN
LAF
AX
INE
HY
DR
OC
HLO
RID
E E
QU
IVA
LEN
T
TO
VE
NLA
FA
XIN
E
150,
O m
g
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5,
6
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
SA
ND
OZ
S.A
. (P
TY
) LT
D
SA
ND
OZ
PR
IVA
TE
LT
D, K
ALW
E, N
AV
l MU
MB
AI,
IND
IA
SA
ND
OZ
PR
IVA
TE
LT
D, K
ALW
E, N
AV
l MU
MB
AI,
IND
IA
SA
ND
OZ
S.A
., S
PA
RT
AN
, KE
MP
TO
N P
AR
K
FP
RC
: S
AN
DO
Z P
RIV
AT
E L
TD
, KA
LWE
, NA
Vl M
UM
BA
I, IN
DIA
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
A
NA
LYT
ICO
N, T
ER
EN
UR
E, K
EM
PT
ON
PA
RK
FP
RC
IFP
RR
. S
AN
DO
Z S
.A.,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A40
11.2
1049
3
Nam
e of
med
icin
e:
VE
NLA
FA
XIN
E-H
EX
AL
75
mg
XL
Dos
age
form
: C
AP
SU
LE
Act
ive
ingr
edie
nts:
E
AC
H C
AP
SU
LE C
ON
TA
INS
: V
EN
LAF
AX
INE
HY
DR
OC
HLO
RID
E
EQ
UIV
ALE
NT
TO
VE
NLA
FA
XIN
E
75,O
mg
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
, 3,
4,
5, 6
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
SA
ND
OZ
S.A
. (P
TY
) LT
D
SA
ND
OZ
PR
IVA
TE
LT
D, K
ALW
E, N
AV
l M
UM
BA
I, IN
DIA
SA
ND
OZ
PR
IVA
TE
LT
D, K
ALW
E, N
AV
l M
UM
BA
I, IN
DIA
S
AN
DO
Z S
.A.,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
FP
RC
: S
AN
DO
Z P
RIV
AT
E L
TD
, KA
LWE
, NA
Vl
MU
MB
AI,
IND
IA
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
AN
ALY
TIC
ON
, TE
RE
NU
RE
, KE
MP
TO
N P
AR
K
FP
RC
IFP
RR
: S
AN
DO
Z S
.A.,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
(I) d 3 (I) x % n > Z
rl
A
P u rn
(I) a m
rn n N
0
0
A
Z
P W
0
ul
N
ul
h)
UI
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
A401
1 20
49
4
SA
ND
OZ
VE
NLA
FA
XIN
E X
L 75
CA
PS
ULE
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
VE
NLA
FA
XIN
E H
YD
RO
CH
LOR
IDE
EQ
UIV
ALE
NT
T
O V
EN
LAF
AX
INE
75
,O m
g
1, 2
, 3, 4
, 5, 6
SA
ND
OZ
S.A
. (P
TY
) LT
D
SA
ND
OZ
PR
IVA
TE
LT
D, K
ALW
E, N
AV
l MU
MB
AI,
IND
IA
SA
ND
OZ
PR
IVA
TE
LT
D, K
ALW
E, N
AV
l MU
MB
AI,
IND
IA
SA
ND
OZ
S.A
., S
PA
RT
AN
, KE
MP
TO
N P
AR
K
SA
ND
OZ
PR
IVA
TE
LT
D, K
ALW
E, N
AV
l MU
MB
AI,
IND
IA
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
AN
ALY
TIC
ON
, TE
RE
NU
RE
, KE
MP
TO
N P
AR
K
FP
RC
IFP
RR
: S
AN
DO
Z S
.A.,
SP
AR
TA
N, K
EM
PT
ON
PA
RK
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
/20.
2.8/
0507
SO
NK
E-E
FA
VIR
EN
Z 2
00
CA
PS
ULE
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
EF
AV
IRE
NZ
20
0,O
mg
1, 2
, 3,
4,
5, 6
RA
NB
AX
Y (S
.A.)
(P
TY
) LT
D
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A
SA
HIB
, H
IMA
CH
AL
PR
AD
ES
H, I
ND
IA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A
SA
HIB
, HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A
SA
HIB
, HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D, R
SA
C
EN
TR
E F
OR
QU
ALI
TY
AS
SU
RA
NC
E O
F
ME
DIC
INE
S, N
OR
TH
-WE
ST
UN
IVE
RS
ITY
, P
OT
CH
EF
ST
RO
OM
RA
NB
AX
Y, C
EN
TU
RIO
N,
RS
A
24 m
onth
s (p
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
FP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
/20.
2.8/
0508
SO
NK
E-E
FA
VIR
EN
Z 6
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: E
FA
VIR
EN
Z
600,
1, 2
, 3, 4
, 5, 6
RA
NB
AX
Y (
S.A
.) (P
TY
) LT
D
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A S
AH
IB,
HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A S
AH
IB,
HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, P
AO
NT
A
SA
HIB
,HIM
AC
HA
L P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D, R
SA
C
EN
TR
E F
OR
QU
ALI
TY
AS
SU
RA
NC
E O
F
ME
DIC
INE
S, N
OR
TH
-WE
ST
UN
IVE
RS
ITY
, P
OT
CH
EF
ST
RO
OM
RA
NB
AX
Y, C
EN
TU
RIO
N, R
SA
24 m
onth
s (p
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
A40
/1.2
/065
2
AU
RO
MlR
TA
ZA
PlN
E 1
5 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: M
lRT
AZ
AP
lNE
15
,O m
g
1, 2
, 3, 4
, 5,
6
AU
RO
BIN
DO
PH
AR
MA
(P
TY
) LT
D
AU
RO
BIN
DO
PH
AR
MA
LT
D,
QU
TH
UB
ULL
AP
UR
MA
ND
AL,
AN
DH
RA
P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LT
D,
QU
TH
UB
ULL
AP
UR
MA
ND
AL,
AN
DH
RA
P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LT
D,
QU
TH
UB
ULL
AP
UR
MA
ND
AL,
AN
DH
RA
P
RA
DE
SH
, IN
DIA
FP
RR
: A
UR
OB
IND
O P
HA
RM
A, R
OS
EB
AN
K,
JOH
AN
NE
SB
UR
G
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A40
/1.2
/065
3
Nam
e of
med
icin
e:
AU
RO
MIR
TA
ZA
PIN
E 3
0 m
g
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
MIR
TA
ZA
PIN
E
30,O
mg
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
, 3, 4
, 5, 6
App
lican
t: A
UR
OB
IND
O P
HA
RM
A (P
TY
) LT
D
Man
ufac
ture
r:
AU
RO
BIN
DO
PH
AR
MA
LTD
, QU
TH
UB
ULI
AP
UR
M
AN
DA
L, A
ND
HR
A P
RA
DE
SH
, IN
DIA
Pac
ker:
A
UR
OB
IND
O P
HA
RM
A L
TD
, QU
TH
UB
ULI
AP
UR
M
AN
DA
L, A
ND
HR
A P
RA
DE
SH
, IN
DIA
Labo
rato
ry:
FP
RC
: A
UR
OB
IND
O P
HA
RM
A L
TD, Q
UT
HU
BU
LIA
PU
R
MA
ND
AL,
AN
DH
RA
PR
AD
ES
H, I
ND
IA
FP
RR
: A
UR
OB
IND
O P
HA
RM
A, R
OS
EB
AN
K,
JOH
AN
NE
SB
UR
G
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
A40
/1.2
/066
2
Nam
e of
med
icin
e:
ZY
DU
S-S
ER
TR
ALI
NE
50
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
SE
RT
RA
LIN
E H
YD
RO
CH
LOR
IDE
E
QU
IVA
LEN
T T
O
SE
RT
RA
LIN
E
50,O
mg
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
, 3
-4, 5
, 6
App
lican
t: Z
YD
US
HE
ALT
HC
AR
E S
.A. (
PT
Y)
LTD
Man
ufac
ture
r:
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
, S
AN
AN
D, A
HM
ED
AB
AD
, IN
DIA
Pac
ker:
Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
LT
D,
SA
NA
ND
, AH
ME
DA
BA
D, I
ND
IA
Labo
rato
ry:
FP
RC
: Z
YD
US
CA
DIL
A H
EA
LTH
CA
RE
LT
D,
SA
NA
ND
, AH
ME
DA
BA
D,
IND
IA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
, SIL
VE
RT
ON
DA
LE, R
SA
IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L P
HA
RM
AC
Y,
NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M
FP
RR
: Z
YD
US
HE
ALT
HC
AR
E S
.A.,
VA
N D
ER
HO
FF
P
AR
K, P
OT
CH
EF
ST
RO
OM
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r.
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
11 1
.4.3
1066
3
GU
LF R
AN
lTlD
lNE
150
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: R
AN
lTlD
lNE
HY
DR
OC
HLO
RID
E E
QU
IVA
LEN
T T
O
RA
NIT
IDIN
E
150,
O m
g
1, 2
, 3, 4
, 5, 6
GU
LF D
RU
G C
OM
PA
NY
(PT
Y)
LTD
ALE
MB
IC L
TD
, PA
NC
HM
AH
ALS
, GU
JAR
AT
, IN
DIA
ALE
MB
IC L
TD
, PA
NC
HM
AH
ALS
, GU
JAR
AT
, IN
DIA
ALE
MB
IC L
TD
, PA
NC
HM
AH
ALS
, GU
JAR
AT
, IN
DIA
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
M
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
, OR
MO
ND
E,
JOH
AN
NE
SB
UR
G
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE, B
OK
SB
UR
G
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE, P
RE
TO
RIA
C
ON
SU
LTIN
G M
ICR
OB
IOLO
GIC
AL
LAB
OR
AT
OR
Y,
MO
RE
HIL
L, B
EN
ON
I P
HA
RM
A-Q
, IN
DU
ST
RIA
-WE
ST
, JO
HA
NN
ES
BU
RG
GU
LF D
RU
G C
OM
PA
NY
, MO
UN
T E
DG
EC
OM
BE
, D
UR
BA
N, R
SA
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
.Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
GU
LF R
AN
lTlD
lNE
75
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: R
AN
lTlD
lNE
HY
DR
OC
HLO
RID
E
EQ
UIV
ALE
NT
TO
R
AN
ITID
INE
75
,O m
g
GU
LF D
RU
G C
OM
PA
NY
(P
TY
) LT
D
ALE
MB
IC L
TD
, PA
NC
HM
AH
ALS
, GU
JAR
AT
, IN
DIA
ALE
MB
IC L
TD
, PA
NC
HM
AH
ALS
, GU
JAR
AT
, IN
DIA
ALE
MB
IC L
TD
, PA
NC
HM
AH
ALS
, GU
JAR
AT
, IN
DIA
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
M
8L
LA
BO
RA
TO
RY
SE
RV
ICE
S. O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, BO
KS
BU
RG
IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S, S
ILV
ER
TO
ND
ALE
, PR
ET
OR
IA
CO
NS
ULT
ING
MIC
RO
BIO
LOG
ICA
L LA
BO
RA
TO
RY
, MO
RE
HIL
L, B
EN
ON
I P
HA
RM
A-Q
, IN
DU
ST
RIA
-WE
ST
, JO
HA
NN
ES
BU
RG
GU
LF D
RU
G C
OM
PA
NY
, MO
UN
T
ED
GE
CO
MB
E, D
UR
BA
N, R
SA
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
30 No. 30525 GOVERNMENT GAZETTE, 14 DECEMBER 2007
0)
E 0 Ln CV (I)
Li
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
/20.
1.1/
0725
AU
RO
XIM
E T
AB
LET
S 1
25 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: C
EF
UR
OX
IME
AX
ET
IL E
QU
IVA
LEN
T T
O
CE
FU
RO
XIM
E
125,
O m
g
1, 2
, 3, 4
, 5, 6
AU
RO
BIN
DO
PH
AR
MA
(P
lY)
LTD
AU
RO
BIN
DO
PH
AR
MA
LT
D, M
ED
AK
DIS
TR
ICT
, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LT
D, M
ED
AK
DIS
TR
ICT
, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LT
D, M
ED
AK
DIS
TR
ICT
, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
, R
OS
EB
AN
K,
JOH
AN
NE
SB
UR
G,
RS
A
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
/5.1
0/07
32
DA
NS
ET
4 m
g
INJE
CT
ION
EA
CH
2,O
ml S
OLU
TIO
N C
ON
TA
INS
: O
ND
AN
SE
TR
ON
HY
DR
OC
HLO
RID
E
EQ
UIV
ALE
NT
TO
ON
DA
NS
ET
RO
N
4,O
mg
1, 2
, 3
,4,
5, 6
SP
EC
PH
AR
M (
PT
Y)
LTD
KLE
VA
S.A
., A
CH
AR
NA
I, G
RE
EC
E
KLE
VA
S.A
., A
CH
AR
NA
I, G
RE
EC
E
KLE
VA
S.A
., A
CH
AR
NA
I, G
RE
EC
E
AN
ALY
TIC
ON
, T
ER
EN
UR
E,
KE
MP
TO
N P
AR
K
SP
EC
PH
AR
M H
ALF
WA
Y H
OU
SE
, MID
RA
ND
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5 M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
- -
A40
15.1
0107
33
DA
NS
ET
8 m
g
INJE
CT
ION
EA
CH
4,O
ml S
OLU
TIO
N C
ON
TA
INS
: O
ND
AN
SE
TR
ON
HY
DR
OC
HLO
RID
E E
QU
IVA
LEN
T
TO
ON
DA
NS
ET
RO
N
8,O
mg
1, 2
, 3,
4,
5, 6
SP
EC
PH
AR
M (P
TY
) LT
D
KLE
VA
S.A
., A
CH
AR
NA
I, G
RE
EC
E
KLE
VA
S.A
.. A
CH
AR
NA
I. G
RE
EC
E
KLE
VA
S.A
.. A
CH
AR
NA
I, G
RE
EC
E
AN
ALY
TIC
ON
, TE
RE
NU
RE
, K
EM
PT
ON
PA
RK
SP
EC
PH
AR
M H
ALF
WA
Y H
OU
SE
, MID
RA
ND
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age.
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
:
FP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
121.
2107
45
ME
TP
HA
GE
500
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: M
ET
FO
RM
IN H
YD
RO
CH
LOR
IDE
50
0,O
mg
1, 2
,3,4
, 5
,6
PH
AR
MA
CA
RE
LIM
ITE
D
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
A
SP
EN
PH
AR
MA
CA
RE
, WIL
SO
NIA
, E
AS
T L
ON
DO
N
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
A
SP
EN
PH
AR
MA
CA
RE
, WIL
SO
NIA
. E
AS
T L
ON
DO
N
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
. PR
ET
OR
IA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S. O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
R
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L P
HA
RM
AC
Y,
NO
RT
H-W
ES
T U
NIV
ER
SIT
Y, P
OT
CH
EF
ST
RO
OM
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
A
SP
EN
PH
AR
MA
CA
RE
, WIL
SO
NIA
, E
AS
T L
ON
DO
N
PH
AR
MA
CA
RE
LT
D. W
OO
DM
EA
D, S
AN
DT
ON
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F I
S
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
:
FP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
12 1
.210
746
ME
TP
HA
GE
850
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: M
ET
FO
RM
IN H
YD
RO
CH
LOR
IDE
85
0,O
mg
PH
AR
MA
CA
RE
LIM
ITE
D
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
A
SP
EN
PH
AR
MA
CA
RE
, WIL
SO
NIA
, E
AS
T L
ON
DO
N
PH
AR
MA
CA
RE
LT
D. K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
A
SP
EN
PH
AR
MA
CA
RE
, WIL
SO
NIA
, E
AS
T L
ON
DO
N
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, PR
ET
OR
IA
M&
L LA
BO
RA
TO
RY
SE
RV
ICE
S, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
R
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L P
HA
RM
AC
Y,
NO
RT
H-W
ES
T U
NIV
ER
SIT
Y. P
OT
CH
EF
ST
RO
OM
PH
AR
MA
CA
RE
LTD
. KO
RS
TE
N, P
OR
T E
LIZ
AB
ET
H
AS
PE
N P
HA
RM
AC
AR
E, W
ILS
ON
IA,
EA
ST
LO
ND
ON
PH
AR
MA
CA
RE
LT
D. W
OO
DM
EA
D, S
AN
DT
ON
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F I
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
A40
120.
2.81
0773
AU
RO
-ST
AV
UD
INE
PO
WD
ER
FO
R O
RA
L S
OLU
TIO
N 1
mgl
ml
PO
WD
ER
EA
CH
1,O
ml S
OLU
TIO
N C
ON
TA
INS
: S
TA
VU
DIN
E
1,0
mg
1, 2
, 3,4
, 5
,6
AU
RO
BIN
DO
PH
AR
MA
(PT
Y)
LTD
AU
RO
BIN
DO
PH
AR
MA
LT
D,
QU
TH
UB
ULL
AP
UR
MA
ND
AL,
AN
DH
RA
P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LT
D,
QU
TH
UB
ULL
AP
UR
MA
ND
AL,
AN
DH
RA
P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LT
D,
QU
TH
UB
ULL
AP
UR
MA
ND
AL.
AN
DH
RA
P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
, RO
SE
BA
NK
, JO
HA
NN
ES
BU
RG
. R
SA
24 m
onth
s (p
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
4112
0.1.
1100
07
TA
VA
LOX
X 2
50
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: LE
VO
FLO
XA
CIN
HE
MIH
YD
RA
TE
EQ
UIV
ALE
NT
T
O
LEV
OF
LOX
AC
IN
250,
O m
g
1, 2
, 3, 4
, 5, 6
ClP
LA M
ED
PR
O (P
TY
) LT
D
ClP
LA L
TD
, SA
LCE
TT
E, G
OA
, IN
DIA
ClP
LA L
TD
, SA
LCE
TT
E, G
OA
, IN
DIA
ClP
LA L
TD
, SA
LCE
TT
E, G
OA
, IN
DIA
ClP
LA M
ED
PR
O, R
OS
EN
PA
RK
, BE
LLV
ILLE
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5-
Reg
istr
atio
n nu
mbe
r:
4112
0.1
.I100
08
Nam
e of
med
icin
e:
TA
VA
LOX
X 5
00
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
LEV
OF
LOX
AC
IN H
EM
IHY
DR
AT
E
EQ
UIV
ALE
NT
TO
LE
VO
FLO
XA
CIN
50
0,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5, 6
App
lican
t: C
lPLA
ME
DP
RO
(P
TY
) LT
D
Man
ufac
ture
r:
ClP
LA L
TD
, SA
LCE
TT
E, G
OA
, IN
DIA
Pac
ker:
C
lPLA
LT
D, S
ALC
ET
TE
, GO
A, I
ND
IA
Labo
rato
ry:
FP
RC
: C
lPLA
LT
D, S
ALC
ET
TE
, GO
A, I
ND
IA
FP
RR
: C
lPLA
ME
DP
RO
, RO
SE
NP
AR
K,
BE
LLV
ILLE
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
MR
F 1
5
-
Reg
istr
atio
n nu
mbe
r:
4112
0.1
.I100
07
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
TA
VA
LO
M 2
50
Nam
e of
med
icin
e:
Dos
age
form
: T
AB
LET
D
osag
e fo
rm:
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
LE
VO
FLO
XA
CIN
HE
MIH
YD
RA
TE
EQ
UIV
ALE
NT
T
O
LEV
OF
LOX
AC
IN
250,
O m
g
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
, 3, 4
, 5, 6
App
lican
t: C
lPLA
ME
DP
RO
(P
TY
) LT
D
Man
ufac
ture
r:
ClP
LA L
TD
, SA
LCE
TT
E, G
OA
, IN
DIA
Pac
ker:
C
lPLA
LT
D, S
ALC
ET
TE
, GO
A,
IND
IA
Labo
rato
ry:
FP
RC
: C
lPLA
LT
D, S
ALC
ET
TE
, GO
A, I
ND
IA
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
4112
0.1 .
I100
08
TA
VA
LO
M 5
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: LE
VO
FLO
XA
CIN
HE
MIH
YD
RA
TE
E
QU
IVA
LEN
T T
O
LEV
OF
LOX
AC
IN
500,
O m
g
1, 2
, 3,4
, 5,
6
ClP
LA
ME
DP
RO
(P
TY
) LT
D
ClP
LA
LT
D, S
ALC
ET
TE
, G
OA
, IN
DIA
ClP
LA L
TD
, SA
LCE
TT
E,
GO
A,
IND
IA
ClP
LA L
TD
, SA
LCE
TT
E,
GO
A, I
ND
IA
FP
RR
: C
lPLA
ME
DP
RO
, RO
SE
NP
AR
K,
BE
LLV
ILLE
F
PR
R:
ClP
LA M
ED
PR
O,
RO
SE
NP
AR
K,
BE
LLV
ILLE
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
She
lf-lif
e:
24
mon
ths
(Pro
visi
onal
)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7 D
ate
of r
egis
trat
ion:
5
OC
TO
BE
R 2
007
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
41 12
0.1 .
I100
09
Nam
e of
med
icin
e:
TA
VA
LOX
X 7
50
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
LEV
OF
LOX
AC
IN H
EM
IHY
DR
AT
E E
QU
IVA
LEN
T
TO
LEV
OF
LOX
AC
IN
750,
O m
g
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
, 3, 4
, 5, 6
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
ClP
LA M
ED
PR
O (P
TY)
LTD
ClP
LA L
TD
, SA
LCE
TT
E, G
OA
, IN
DIA
ClP
LA L
TD
, SA
LCE
TT
E, G
OA
, IN
DIA
FP
RC
: C
lPLA
LT
D, S
ALC
ET
TE
, GO
A, I
ND
IA
FP
RR
: C
lPLA
ME
DP
RO
, RO
SE
NP
AR
K, B
ELL
VIL
LE
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
4112
0.1.
1100
10
Nam
e of
med
icin
e:
CIP
LA-L
EV
OF
LOX
AC
IN 2
50
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
LEV
OF
LOX
AC
IN H
EM
IHY
DR
AT
E
EQ
UIV
ALE
NT
TO
LE
VO
FLO
XA
CIN
25
0,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5,
6
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
ClP
LA L
lFE
SC
IEN
CE
S (
PTY
) LT
D
ClP
LA L
TD
, VE
RN
A,
SA
LCE
TT
E, G
OA
, IN
DIA
ClP
LA L
TD
, VE
RN
A,
SA
LCE
TT
E, G
OA
, IN
DIA
FP
RC
: C
lPLA
LT
D, V
ER
NA
, S
ALC
ET
TE
, GO
A,
IND
IA
FP
RR
: C
lPLA
LlF
E S
CIE
NC
ES
, R
OS
EN
PA
RK
, B
ELL
VIL
LE
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
.
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n.
App
l~ca
nt:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
41/2
0.1.
1/00
11
CIP
LA-L
EV
OF
LOX
AC
IN 5
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: LE
VO
FLO
XA
CIN
HE
MIH
YD
RA
TE
EQ
UIV
ALE
NT
TO
LE
VO
FLO
XA
CIN
50
0,O
mg
1, 2
, 3,
4,
5, 6
ClP
LA L
lFE
SC
IEN
CE
S (
PT
Y)
LTD
ClP
LA L
TD
, VE
RN
A. S
ALC
ET
TE
, G
OA
, IN
DIA
ClP
L4
LT
D, V
ER
NA
, SA
LCE
TT
E,
GO
A, I
ND
IA
ClP
LA L
TD
, VE
RN
A, S
ALC
ET
TE
, G
OA
, IN
DIA
ClP
LA L
lFE
SC
IEN
CE
S,
RO
SE
N P
AR
K,
BE
LLV
ILLE
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5.
Reg
istr
atio
n nu
mbe
r:
Nam
e of
rne
dic~
ne:
Dos
age
form
:
Act
we
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
CIP
LA-L
EV
OF
LOX
AC
IN 7
50
TAB
LET
EA
CH
TA
BLE
T C
ON
TA
INS
. LE
VO
FLO
XA
CIN
HE
MIH
YD
RA
TE
E
QU
IVA
LEN
T T
O
LEV
OF
LOX
AC
I N
750,
O r
ng
12
,3
4.5
6
ClP
LA L
lFE
SC
IEN
CE
S (
PT
Y)
LTD
ClP
LA L
TD
, VE
RN
A,
SA
LCE
TT
E, G
OA
, IN
DIA
ClP
LA L
TD
, VE
RN
A. S
ALC
ET
TE
, GO
A,
IND
IA
ClP
LA L
TD
, VE
RN
A,
SA
LCE
TT
E. G
OA
, IN
DIA
FP
RR
: C
lPLA
LIF
E S
CIE
NC
ES
, RO
SE
N P
AR
K,
BE
LLV
ILLE
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r.
4112
1.21
0071
Nam
e of
med
icin
e:
DIA
FO
RM
500
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts.
E
AC
H T
AB
LET
CO
NT
AIN
S:
ME
TF
OR
MIN
HY
DR
OC
HLO
RID
E E
QU
IVA
LEN
T
TO
M
ET
FO
RM
IN
500,
O m
g
Con
ditio
ns o
f reg
istr
atio
n.
1, 2
, 3, 4
, 5, 6
App
lican
t: B
E-T
AB
S P
HA
RM
AC
EU
TIC
ALS
(P
TY
) LT
D
Man
ufac
ture
r
Pac
ker:
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
Labo
rato
ry.
FP
RC
: A
UR
OB
IND
O P
HA
RM
A L
TD
. RA
NG
A R
ED
DY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FP
RC
IFP
RR
: B
E-T
AB
S P
HA
RM
AC
EU
TIC
ALS
, R
OO
DE
PO
OR
T,
RS
A
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts.
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r.
Pac
ker:
Labo
rato
ry.
FP
RC
.
FP
RC
IFP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
4112
1.21
0072
DIA
FO
RM
850
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
. M
ET
FO
RM
IN H
YD
RO
CH
LOR
IDE
E
QU
IVA
LEN
T T
O
ME
TF
OR
MIN
85
0,O
mg
1, 2
, 3, 4
, 5, 6
BE
-TA
BS
PH
AR
MA
CE
UT
ICA
LS (
PT
Y) L
TD
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
BE
-TA
BS
PH
AR
MA
CE
UT
ICA
LS,
RO
OD
EP
OO
RT
, R
SA
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5 M
RF
15
Reg
istr
atio
n nu
mbe
r:
41/2
0.2.
8/01
06
Reg
istr
atio
n nu
mbe
r:
41/2
0.1.
1/01
38
Nam
e of
med
icin
e-
CIP
LA-E
FA
VIR
EN
Z 6
00
Nam
e of
med
icin
e:
BE
TA
RO
XIM
E T
250
Dos
age
form
: T
AB
LET
D
osag
e fo
rm:
TA
BLE
T
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
EF
AV
IRE
NZ
60
0,O
mg
CE
FU
RO
XIM
E A
XE
TIL
EQ
UIV
ALE
NT
TO
C
EF
UR
OX
IME
25
0,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5,
6
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3
,4,
5, 6
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
CIP
M L
IFE
SC
IEN
CE
S (
PT
Y) L
TD
A
pplic
ant:
BE
-TA
BS
PH
AR
MA
CE
UT
ICA
LS (
PT
Y) L
TD
CIP
LA L
TD
, VE
RN
A,
SA
LCE
TT
E, G
OA
, IN
DIA
M
anuf
actu
rer:
A
UR
OB
IND
O P
HA
RM
A L
TD
, ME
DA
K,
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
ClP
LA L
TD
, VE
RN
A,
SA
LCE
TT
E, G
OA
, IN
DIA
P
acke
r:
AU
RO
BIN
DO
PH
AR
MA
LT
D, M
ED
AK
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FP
RC
: C
lPLA
LT
D. V
ER
NA
. S
ALC
ET
TE
, GO
A,
IND
IA
Labo
rato
ry:
FP
RC
: A
UR
OB
IND
O P
HA
RM
A L
TD
, ME
DA
K
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
FP
RR
. C
lPLA
LlF
E S
CIE
NC
ES
, RO
SE
NP
AR
K,
BE
LLV
ILLE
24 m
onth
s (P
rovi
sion
al)
FP
RC
IFP
RR
:
She
lf-lif
e:
BE
-TA
BS
PH
AR
MA
CE
UT
ICA
LS,
RO
OD
EP
OO
RT
, R
SA
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7 D
ate
of r
egis
trat
ion:
5
OC
TO
BE
R 2
007
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: C
EF
UR
OX
IME
AX
ET
IL E
QU
IVA
LEN
T T
O
CE
FU
RO
XIM
E
500,
O m
g
BE
-TA
BS
PH
AR
MA
CE
UT
ICA
LS (
PT
Y)
LTD
AU
RO
BIN
DO
PH
AR
MA
LT
D,
ME
DA
K, D
IST
RIC
T,
AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D,
ME
DA
K D
IST
RIC
T,
AN
DH
RA
PR
AD
ES
H.
IND
IA
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
4111
.210
142
AS
PE
N M
IRT
AZ
AP
INE
15
rng
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: M
lRT
AZ
AP
lNE
1
5.0
rng
1. 2
.3,4
, 5.
6
PH
AR
MA
CA
RE
LIM
ITE
D
ALP
HA
PH
AR
M P
TY
LT
D,
BR
ISB
AN
E, Q
UE
EN
SLA
ND
, A
US
TR
ALI
A
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
. PO
RT
ELI
ZA
BE
TH
ALP
HA
PH
AR
M P
TY
LT
D, B
RIS
BA
NE
, Q
UE
EN
SLA
ND
, A
US
TR
ALI
A
PH
AR
MA
CA
RE
LT
D. K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
G
ER
AR
D L
AB
OR
AT
OR
IES
, DU
BLI
N, I
RE
LAN
D
GE
NE
RIC
S U
K L
TD
. ST
AT
ION
CLO
SE
, H
ER
TF
OR
DS
HIR
E, U
K
Labo
rato
ry:
FP
RC
. A
UR
OB
IND
O P
HA
RM
A L
TD
. M
ED
AK
DIS
TR
ICT
. A
ND
HR
A P
RA
DE
SH
, IN
DIA
FP
RC
IFP
RR
: B
E-T
AB
S P
HA
RM
AC
EU
TIC
ALS
, R
OO
DE
PO
OR
T,
RS
A
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
:
FP
RR
She
lf-lif
e:
ALP
HA
PH
AR
M P
TY
LT
D, B
RIS
BA
NE
, Q
UE
EN
SLA
ND
. A
US
TR
ALI
A
GE
RA
RD
LA
BO
RA
TO
RIE
S. D
UB
LIN
, IR
ELA
ND
G
EN
ER
ICS
UK
LT
D, S
TA
TIO
N C
LOS
E.
HE
RT
FO
RD
SH
IRE
, UK
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S,
GR
OE
NK
LOO
F, P
RE
TO
RIA
R
ES
EA
RC
H I
NS
TIT
UT
E F
OR
IN
DU
ST
RIA
L P
HA
RM
AC
Y
NO
RT
H-W
ES
T U
NIV
ER
SIT
Y, P
OT
CH
EF
ST
RO
OM
M
BL
LAB
OR
AT
OR
Y S
ER
VIC
ES
. O
RM
ON
DE
. JO
HA
NN
ES
BU
RG
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
PH
AR
MA
CA
RE
LT
D, W
OO
DM
EA
D,
SA
ND
TO
N
24 m
onth
s
MR
F 1
5 M
RF
15
-.
-
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 15
-
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
.
FP
RC
IFP
RR
:
FP
RR
She
lf-lif
e:
Dat
e o
f re
gist
ratio
n:
AS
PE
N M
lRT
AZ
AP
lNE
30
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: M
lRT
AZ
AP
lNE
30
,O m
g
PH
AR
MA
CA
RE
LIM
ITE
D
ALP
HA
PH
AR
M P
W LT
D, B
RIS
BA
NE
, Q
UE
EN
SM
ND
, A
US
TR
ALI
A
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
. PO
RT
ELI
ZA
BE
TH
ALP
HA
PH
AR
M P
TY
LT
D. B
RIS
BA
NE
, Q
UE
EN
SLA
ND
, AU
ST
RA
LIA
P
HA
RM
AC
AR
E L
TD
, KO
RS
TE
N, P
OR
T E
LIZ
AB
ET
H
GE
RA
RD
MB
OR
AT
OR
IES
. DU
BLI
N, I
RE
MN
D
GE
NE
RIC
S U
K L
TD
, ST
AT
ION
CLO
SE
, H
ER
TF
OR
DS
HIR
E, U
K
ALP
HA
PH
AR
M P
TY
LT
D, B
RIS
BA
NE
. Q
UE
EN
SLA
ND
, AU
ST
RA
LIA
G
ER
AR
D V
\BO
RA
TO
RIE
S.
DU
BLI
N, I
RE
LAN
D
GE
NE
RIC
S U
K L
TD
, ST
AT
ION
CLO
SE
, H
ER
TF
OR
DS
HIR
E, U
K
SO
UT
H A
FR
ICA
N B
UR
EA
U O
F S
TA
ND
AR
DS
, G
RO
EN
KLO
OF
, P
RE
TO
RIA
R
ES
EA
RC
H IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L P
HA
RM
AC
Y.
NO
RT
H-W
ES
T U
NIV
ER
SIT
Y.
PO
TC
HE
FS
TR
OO
M
M&
L L
AB
OR
AT
OR
Y S
ER
VIC
ES
, OR
MO
ND
E,
JOH
AN
NE
SB
UR
G
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
, PO
RT
ELI
ZA
BE
TH
PH
AR
MA
CA
RE
LT
D, W
OO
DM
EA
D,
SA
ND
TO
N
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 15
Reg
istr
atio
n nu
mbe
r:
41/1
.210
144
Nam
e of
med
icin
e:
AS
PE
N M
lRT
AZ
AP
lNE
45
mg
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
MlR
TA
ZA
PlN
E
45.0
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3
,4, 5, 6
App
lican
t: P
HA
RM
AC
AR
E L
IMIT
ED
Man
ufac
ture
r:
Pac
ker:
ALP
HA
PH
AR
M P
TY
LT
D, B
RIS
BA
NE
, QU
EE
NS
1 AN
D.
AU
ST
RA
LIA
P
HA
RM
AC
AR
E L
TD
, KO
RS
TE
N, P
OR
T E
LIZ
AB
ET
H
ALP
HA
PH
AR
M P
TY
LT
D, B
RIS
BA
NE
. Q
UE
EN
SM
ND
, A
US
TR
ALI
A
PH
AR
MA
CA
RE
LT
D, K
OR
ST
EN
, P
OR
T E
LIZ
AB
ET
H
GE
RA
RD
LA
BO
RA
TO
RIE
S.
DU
BLI
N, I
RE
MN
D
GE
NE
RIC
S U
K L
TD
. ST
AT
ION
CLO
SE
, H
ER
TF
OR
DS
HIR
E, U
K
Labo
rato
ry:
FP
RC
: A
LPH
AP
HA
RM
PT
Y L
TD
, BR
ISB
AN
E.
QU
EE
NS
LAN
D.
AU
ST
RA
LIA
G
ER
AR
D L
AB
OR
AT
OR
IES
, D
UB
LIN
. IR
ELA
ND
G
EN
ER
ICS
UK
LT
D, S
TA
TIO
N C
LOS
E,
HE
RT
FO
RD
SH
IRE
. UK
S
OU
TH
AF
RIC
AN
BU
RE
AU
OF
ST
AN
DA
RD
S.
GR
OE
NK
LOO
F,
PR
ET
OR
IA
RE
SE
AR
CH
IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L P
HA
RM
AC
Y, N
OR
TH
-WE
ST
UN
IVE
RS
ITY
. P
OT
CH
EF
ST
RO
OM
M
&L
LA
BO
RA
TO
RY
SE
RV
ICE
S. O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
FP
RC
IFP
RR
: P
HA
RM
AC
AR
E L
TD
. KO
RS
TE
N, P
OR
T E
LIZ
AB
ET
H
FP
RR
P
HA
RM
AC
AR
E L
TD
. WO
OD
ME
AD
. S
AN
DT
ON
She
lf-lif
e:
24
mon
ths
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7 -
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
ed~
ents
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
41/2
0 21
0155
ME
TR
ON
IDA
ZO
LE B
BR
AU
N 5
00 m
gI10
0 m
l
INF
US
ION
EA
CH
100
,O m
l SO
LUT
ION
CO
NT
AIN
S
ME
TR
ON
IDA
ZO
LE
500
0 m
g
1, 2
, 3
,4, 5
, 6
B B
RA
UN
ME
DIC
AL
(PT
Y)
LTD
B B
RA
UN
ME
LSU
NG
EN
AG
, M
ELS
UN
GE
N,
GE
RM
AN
Y
B B
RA
UN
ME
DIC
AL
S A
, B
AR
CE
LON
A, S
PA
IN
B B
RA
UN
ME
LSU
NG
EN
AG
, M
ELS
UN
GE
N,
GE
RM
AN
Y
B B
RA
UN
ME
DIC
AL
S A
, B
AR
CE
LON
A S
PA
IN
B B
RA
UN
ME
LSU
NG
EN
AG
ME
LSU
NG
EN
, G
ER
MA
NY
M
&L
LAB
OR
AT
OR
Y S
ER
VIC
ES
, OR
MO
ND
E,
JOH
AN
NE
SB
UR
G
CO
Sl
PH
AR
MA
CE
UT
ICA
LS I
ND
US
TR
IA-W
ES
T
JOH
AN
NE
SB
UR
G
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
IAS
VIL
LE
, B
OK
SB
UR
G
B B
RA
UN
ME
DIC
AL,
HO
NE
YD
EW
, G
AU
TE
NG
, R
S A
36 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
at~
on nu
mbe
r:
Nam
e of
med
icin
e.
Dos
age
form
,
Act
ive
ingr
edie
nts
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
ZY
DU
S D
ES
LOR
AT
AD
INE
5 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
. D
ES
LOR
AT
AD
INE
5
0 m
g
ZY
DU
S H
EA
LTH
CA
RE
S.A
. (P
TY
) LT
D
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
, S
AN
AN
D, A
HM
ED
AB
AD
, IN
DIA
ZY
DU
S C
AD
ILA
HE
ALT
HC
AR
E L
TD
, S
AN
AN
D, A
HM
ED
AB
AD
, IN
DIA
ZY
DU
S C
AD
llA
HE
ALT
HC
AR
E L
TD
, S
AN
AN
D, A
HM
ED
AB
AD
, IN
DIA
IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE
RE
SE
AR
CH
IN
ST
ITU
TE
FO
R IN
DU
ST
RIA
L P
HA
RM
AC
Y,
NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M
ZY
DU
S H
EA
LTH
CA
RE
S.A
., V
AN
DE
R
HO
FF
PA
RK
, PO
TC
HE
FS
TR
OO
M
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r.
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
MR
F 1
5
41/7
.1.3
/028
6 R
egis
trat
ion
num
ber:
ZA
RT
AN
25
mg
N
ame
of m
edic
ine:
TA
BLE
T
Dos
age
form
:
EA
CH
TA
BLE
T C
ON
TA
INS
: LO
SA
RT
AN
PO
TA
SS
IUM
25
,O m
g
Act
ive
ingr
edie
nts:
1,2
, 3,4
, 5, 6
C
ondi
tions
of r
egis
trat
ion:
PH
AR
MA
DY
NA
MIC
S (P
TY
) LT
D
AC
TA
VS
HF
, HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
A
CT
AV
IS H
F, K
OP
AV
OG
UR
, IC
ELA
ND
App
lican
t:
Man
ufac
ture
r:
AC
TA
VIS
HF
, HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
P
acke
r A
CT
AV
IS H
F, K
OP
AV
OG
UR
, IC
ELA
ND
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
8 P
AC
KA
GIN
G,
LON
GD
ALE
, IN
DU
ST
RIA
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, RO
BE
RT
VIL
LE,
FLO
RID
A
PH
AR
MA
CE
UT
ICA
L E
NT
ER
PR
ISE
S, N
'DA
BE
NI,
KZ
N
FP
RC
: A
CT
AV
IS H
F, H
AF
NA
RF
JOR
DU
R, I
CE
LAN
D
AC
TA
VIS
HF
, KO
PA
VO
GU
R, I
CE
LAN
D
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE, B
OK
SB
UR
G
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S, R
OB
ER
TV
ILLE
, F
LOR
IDA
FP
RR
: P
HA
RM
A D
YN
AM
ICS
, WE
ST
LAK
E, R
SA
24 m
onth
s (P
rovi
sion
al)
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
41/7
.1.3
/028
7
ZA
RT
AN
50
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: LO
SA
RT
AN
PO
TA
SS
IUM
50
,O m
g
1, 2
, 3,4
, 5, 6
PH
AR
MA
DY
NA
MIC
S (
PT
Y)
LTD
AC
TA
VIS
HF
, H
AF
NA
RF
JOR
DU
R,
ICE
LAN
D
AC
TA
VIS
HF
, KO
PA
VO
GU
R, I
CE
LAN
D
AC
TA
VIS
HF
, HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
A
CT
AV
IS H
F. K
OP
AV
OG
UR
, IC
ELA
ND
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
&
PA
CK
AG
ING
, LO
NG
DA
LE, I
ND
US
TR
IA
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S,
RO
BE
RT
VIL
LE, F
LOR
IDA
P
HA
RM
AC
EU
TIC
AL
EN
TE
RP
RIS
ES
, N
'DA
BE
NI,
KZ
N
AC
TA
VIS
HF
, HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
A
CT
AV
IS H
F,
KO
PA
VO
GU
R, I
CE
LAN
D
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
, B
OK
SB
UR
G
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S,
RO
BE
RT
VIL
LE, F
LOR
IDA
PH
AR
MA
DY
NA
MIC
S, W
ES
TLA
KE
. R
SA
24 m
onth
s (P
rovi
sion
al)
I
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7 D
ate
of r
egis
trat
ion:
5
OC
TO
BE
R 2
007
I
MR
F 1
5
Reg
istr
atio
n n
um
be
r 41
/7.1
.3/0
288
Nam
e of
med
icin
e:
ZA
RT
AN
12.
5 m
g
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts.
E
AC
H T
AB
LET
CO
NT
AIN
S.
LOS
AR
TA
N P
OT
AS
SIU
M
12,5
mg
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
, 3, 4
, 5, 6
App
lican
t: P
HA
RM
A D
YN
AM
ICS
(P
N)
LTD
Man
ufac
ture
r.
AC
TA
VIS
HF
, HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
A
CT
AV
IS H
F, K
OP
AV
OG
UR
, IC
ELA
ND
Pac
ker:
A
CT
AV
IS H
F, H
AF
NA
RF
JOR
DU
R,
ICE
LAN
D
AC
TA
VIS
HF
, KO
PA
VO
GU
R,
ICE
LAN
D
DIV
PH
AR
M M
AN
UF
AC
TU
RIN
G 8
PA
CK
AG
ING
, LO
NG
DA
LE, I
ND
US
TR
IA
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S,
RO
BE
RT
VIL
LE,
FLO
RID
A
PH
AR
MA
CE
UT
ICA
L E
NT
ER
PR
ISE
S,
N'D
AB
EN
I,
KZ
N
Labo
rato
ry:
FP
RC
: A
CT
AV
IS H
F, H
AF
NA
RF
JOR
DU
R,
ICE
LAN
D
AC
TA
VIS
HF
, K
OP
AV
OG
UR
, IC
ELA
ND
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
, B
OK
SB
UR
G
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S,
RO
BE
RT
VIL
LE,
FLO
RID
A
FP
RR
: P
HA
RM
A D
YN
AM
ICS
, WE
ST
LAK
E.
RS
A
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
'
Act
ive
rngr
edie
nts'
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
ZA
RT
AN
100
mg
TA
BLE
S
EA
CH
TA
BLE
T C
ON
TA
INS
: LO
SA
RT
AN
PO
TA
SS
IUM
10
0,O
mg
PH
AR
MA
DY
NA
MIC
S (
PN
) LT
D
AC
TA
VIS
HF
, H
AF
NA
RF
JOR
DU
R,
ICE
LAN
D
AC
TA
VIS
HF
, KO
PA
VO
GU
R.
ICE
LAN
D
AC
TA
VIS
HF
, HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
A
CT
AV
IS H
F,
KO
PA
VO
GU
R,
ICE
LAN
D
DIV
PH
AR
M M
AN
UF
AC
TU
RIN
G 8
P
AC
KA
GIN
G,
LON
GD
ALE
, IN
DU
ST
RIA
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, R
OB
ER
TV
ILLE
, F
LOR
IDA
P
HA
RM
AC
EU
TIC
AL
EN
TE
RP
RIS
ES
, N
'DA
BE
NI,
KZ
N
AC
TA
VIS
HF
, H
AF
NA
RF
JOR
DU
R,
ICE
LAN
D
AC
TA
VIS
HF
, KO
PA
VO
GU
R, I
CE
LAN
D
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
AT
LAS
VIL
LE,
BO
KS
BU
RG
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, R
OB
ER
TV
ILLE
. F
LOR
IDA
PH
AR
MA
DY
NA
MIC
S, W
ES
TLA
KE
, RS
A
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
:
FP
RR
She
lf-lif
e:
Dat
e of
regi
stra
tion:
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: S
UM
AT
RIP
TA
N S
UC
CIN
AT
E E
QU
IVA
LEN
T T
O
SU
MA
TR
IPT
AN
50
,O m
g
ME
RC
K G
EN
ER
ICS
RS
A (
PT
Y)
LTD
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
. W
AD
EV
ILLE
, G
ER
MIS
TO
N
GE
NP
HA
RM
PH
AR
MA
CE
UT
ICA
LS, E
TO
BIC
OK
E,
ON
TA
RIO
. CA
NA
DA
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
. W
AD
EV
ILLE
, G
ER
MIS
TO
N
GE
NP
HA
RM
PH
AR
MA
CE
UT
ICA
LS. E
TO
BIC
OK
E,
ON
TA
RIO
, CA
NA
DA
G
ER
AR
D L
AB
OR
AT
OR
IES
, DU
BLI
N,
IRE
LAN
D
ME
RC
K F
AR
MA
y Q
UlM
lCA
S.A
, M
OLL
ET
DE
L V
ALL
ES
, B
AR
CE
LON
A, S
PA
IN
GE
NE
RIC
S U
K.
ST
AT
ION
CLO
SE
. H
ER
TF
OR
DS
HIR
E
GE
NP
HA
RM
PH
AR
MA
CE
UT
ICA
LS, E
TO
BIC
OK
E,
ON
TA
RIO
, CA
NA
DA
G
ER
AR
D L
AB
OR
AT
OR
IES
, DU
BLI
N,
IRE
LAN
D
ME
RC
K F
AR
MA
y Q
UlM
lCA
S.A
, M
OLL
ET
DE
L V
ALL
ES
, B
AR
CE
LON
A, S
PA
IN
GE
NE
RIC
S U
K, S
TA
TIO
N C
LOS
E,
HE
RT
FO
RD
SH
IRE
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
. W
AD
EV
ILLE
, G
ER
MIS
TO
N
ME
RC
K G
EN
ER
ICS
RS
A. M
OD
DE
RF
ON
TE
IN
24
mon
ths
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
:
FP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
EA
CH
TA
BLE
T C
ON
TA
INS
: S
UM
AT
RIP
TA
N S
UC
CIN
AT
E E
QU
IVA
LEN
T T
O
SU
MA
TR
IPT
AN
10
0,O
mg
1,2
, 3
,4. 5
, 6
ME
RC
K G
EN
ER
ICS
RS
A (
PT
Y)
LTD
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
. W
AD
EV
ILLE
, GE
RM
IST
ON
G
EN
PH
AR
M P
HA
RM
AC
EU
TIC
ALS
, ET
OB
ICO
KE
. O
NT
AR
IO, C
AN
AD
A
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
W
AD
EV
ILLE
, GE
RM
IST
ON
G
EN
PH
AR
M P
HA
RM
AC
EU
TIC
ALS
, ET
OB
ICO
KE
O
NT
AR
IO, C
AN
AD
A
GE
RA
RD
LA
BO
RA
TO
RIE
S,
DU
BLI
N, I
RE
LAN
D
ME
RC
K F
AR
MA
y Q
UlM
lCA
S.A
. M
OLL
ET
DE
L
VA
LLE
S,
BA
RC
ELO
NA
, S
PA
IN
GE
NE
RIC
S U
K, S
TA
TIO
N C
LOS
E.
HE
RT
FO
RD
SH
IRE
GE
NP
HA
RM
PH
AR
MA
CE
UT
ICA
LS, E
TO
BIC
OK
E,
ON
TA
RIO
. CA
NA
DA
G
ER
AR
D L
AB
OR
AT
OR
IES
, D
UB
LIN
, IR
ELA
ND
M
ER
CK
FA
RM
A y
QU
lMlC
A S
.A,
MO
LLE
T D
EL
V
ALL
ES
, B
AR
CE
LON
A,
SP
AIN
G
EN
ER
ICS
UK
, ST
AT
ION
CLO
SE
, H
ER
TF
OR
DS
HIR
E
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
, W
AD
EV
ILLE
, G
ER
MIS
TO
N
ME
RC
K G
EN
ER
ICS
RS
A. M
OD
DE
RF
ON
TE
IN
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry.
FP
RC
:
FP
RC
IFP
RR
.
FP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
XIX
IA-S
UM
AT
RIP
TA
N 5
0
TAB
LET
EA
CH
TA
BLE
T C
ON
TA
INS
: S
UM
AT
RIP
TA
N S
UC
CIN
AT
E E
QU
IVA
LEN
T T
O
SU
MA
TR
IPT
AN
50
.0 m
g
XlX
lA P
HA
RM
AC
EU
TIC
ALS
(P
TY
) LT
D
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
, W
AD
EV
ILLE
, GE
RM
IST
ON
G
EN
PH
AR
M P
HA
RM
AC
EU
TIC
ALS
. ET
OB
ICO
KE
, O
NT
AR
IO, C
AN
AD
A
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
. W
AD
EV
ILLE
, GE
RM
IST
ON
G
EN
PH
AR
M P
HA
RM
AC
EU
TIC
ALS
. ET
OB
ICO
KE
, O
NT
AR
IO, C
AN
AD
A
GE
RA
RD
LA
BO
RA
TO
RIE
S, D
UB
LIN
, IR
ELA
ND
M
ER
CK
FA
RM
A y
QU
lMlC
A S
A, M
OLL
ET
DE
L V
ALL
ES
. BA
RC
ELO
NA
, SP
AIN
G
EN
ER
ICS
UK
, ST
AT
ION
CLO
SE
. HE
RT
FO
RD
SH
IRE
GE
NP
HA
RM
PH
AR
MA
CE
UT
ICA
LS, E
TO
BIC
OK
E,
ON
TA
RIO
, CA
NA
DA
G
ER
AR
D L
AB
OR
AT
OR
IES
. DU
BLI
N, I
RE
LAN
D
ME
RC
K F
AR
MA
y Q
UlM
lCA
S.A
, MO
LLE
T D
EL
VA
LLE
S,
BA
RC
ELO
NA
, SP
AIN
G
EN
ER
ICS
UK
, ST
AT
ION
CLO
SE
, HE
RT
FO
RD
SH
IRE
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
, W
AD
EV
ILLE
, GE
RM
IST
ON
XlX
lA P
HA
RM
AC
EU
TIC
ALS
, M
OD
DE
RF
ON
TE
IN
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts.
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
IFP
RR
:
FP
RR
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
XIX
IA-S
UM
AT
RIP
TA
N 1
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
S
UM
AT
RIP
TA
N S
UC
CIN
AT
E E
QU
IVA
LEN
T T
O
SU
MA
TR
IPT
AN
10
0.0
mg
1,2
, 3
,4,
5, 6
XlX
lA P
HA
RM
AC
EU
TIC
ALS
(PT
Y)
LTD
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
. W
AD
EV
ILLE
, GE
RM
IST
ON
G
EN
PH
AR
M P
HA
RM
AC
EU
TIC
ALS
. ET
OB
ICO
KE
, O
NT
AR
IO. C
AN
AD
A
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
, W
AD
EV
ILLE
, GE
RM
IST
ON
G
EN
PH
AR
M P
HA
RM
AC
EU
TIC
ALS
. ET
OB
ICO
KE
. O
NT
AR
IO, C
AN
AD
A
GE
RA
RD
LA
BO
RA
TO
RIE
S. D
UB
LIN
, IR
ELA
ND
M
ER
CK
FA
RM
A y
QU
lMlC
A S
A.
MO
LLE
T D
EL
VA
LLE
S,
BA
RC
ELO
NA
, SP
AIN
G
EN
ER
ICS
UK
, ST
AT
ION
CLO
SE
, H
ER
TF
OR
DS
HIR
E
GE
NP
HA
RM
PH
AR
MA
CE
UT
ICA
LS, E
TO
BIC
OK
E,
ON
TA
RIO
, C
AN
AD
A
GE
RA
RD
LA
BO
RA
TO
RIE
S, D
UB
LIN
, IR
ELA
ND
M
ER
CK
FA
RM
A y
QU
lMlC
A S
.A, M
OLL
ET
DE
L V
ALL
ES
, B
AR
CE
LON
A, S
PA
IN
GE
NE
RIC
S U
K, S
TA
TIO
N C
LOS
E,
HE
RT
FO
RD
SH
IRE
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
. W
AD
EV
ILLE
, G
ER
MIS
TO
N
XlX
lA P
HA
RM
AC
EU
TIC
ALS
. MO
DD
ER
FO
NT
EIN
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 15
M
RF
15
Reg
istra
tion
num
ber:
41/7
.5/0
381
Nam
e of
med
icin
e:
AU
RO
-SIM
VA
STA
TIN
5 m
g
Dos
age
form
: TA
BLE
T
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NTA
INS
: S
lMV
AS
TATl
N
5,0
mg
Con
ditio
ns o
f reg
istra
tion:
1,
2, 3
, 4, 5
, 6
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
AU
RO
BIN
DO
PH
AR
MA
(P
TY)
LTD
AU
RO
BIN
DO
PH
AP
.MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TRIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TRIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FPR
C:
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TRIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FP
RR
: A
UR
OB
IND
O P
HA
RM
A, R
OS
EB
AN
K, R
SA
24 m
onth
s (P
rovi
sion
al)
Reg
istra
tion
num
ber:
41 17
.510
382
Nam
e of
med
icin
e:
AU
RO
-SIM
VA
STA
TIN
10
rng
Dos
age
form
: TA
BLE
T
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
SlM
VA
ST
AT
lN
10,O
rng
Con
ditio
ns o
f reg
istra
tion:
1,
2, 3
, 4, 5
,6
App
lican
t:
Man
ufac
iure
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
FP
RC
:
AU
RO
BIN
DO
PH
AR
MA
(P
TY)
LTD
AU
RO
BIN
DO
PH
AR
MA
LTD
, RA
NG
A
RE
DD
Y D
ISTR
ICT,
AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LTD
. RA
NG
A
RE
DD
Y D
ISTR
ICT,
AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TRIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FPR
R:
AU
RO
BIN
DO
PH
AR
MA
, RO
SE
BA
NK
, RS
A
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istra
tion:
5
OC
TOB
ER
200
7 D
ate
of r
egis
tratio
n:
5 O
CTO
BE
R 2
007
---
--
MR
F 1
5
Reg
istr
at~
on nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ing
red
~e
nts
-
Con
ditio
ns o
f reg
istr
atio
n.
App
lican
t:
Man
ufac
ture
r.
Pac
ker:
Labo
rato
ry:
FP
RC
.
41 17
.510
383
AU
RO
-SIM
VA
ST
AT
IN 2
0 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
S
l MV
AS
TA
TIN
20
,O m
g
AU
RO
BIN
DO
PH
AR
MA
(P
TY
) LT
D
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TR
ICT
. AN
DH
RA
PR
AD
ES
H, I
ND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TR
ICT
. AN
DH
RA
PR
AD
ES
H
FP
RR
. A
UR
OB
IND
O P
HA
RM
A, R
OS
EB
AN
K, R
SA
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Ac
he
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry
FP
RC
:
41 I7
510
384
AU
RO
-SIM
VA
ST
AT
IN 4
0 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
S
lMV
AS
TA
TlN
40
,O m
g
1,2
,3,4
,5,6
AU
RO
BIN
DO
PH
AR
MA
(P
TY
) LT
D
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H
FP
RR
: A
UR
OB
IND
O P
HA
RM
A,
RO
SE
BA
NK
, RS
A
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istra
tion
num
ber:
4
1 /7.
5/03
85
Nam
e of
med
icin
e:
AU
RO
-SIM
VA
ST
AT
IN 8
0 m
g
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
S IM
VA
ST
AT
IN
80,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5, 6
App
lican
t:
Man
ufac
ture
r
Pac
ker.
Labo
rato
ry:
She
lf-lif
e:
AU
RO
BIN
DO
PH
AR
MA
(P
TY)
LTD
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
FPR
C:
AU
RO
BIN
DO
PH
AR
MA
LTD
. RA
NG
A R
ED
DY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FP
RR
: A
UR
OB
IND
O P
HA
RM
A, R
OS
EB
AN
K,
RS
A
24 m
onth
s (P
rovi
sion
al)
Dat
e of
regi
stra
tion:
5
OC
TO
BE
R 2
007
MR
F 1
5
Reg
istra
tion
num
ber:
41
120.
1.11
0390
Nam
e of
med
icin
e:
ME
RC
K-C
IPR
OF
LOX
AC
IN I
V
Dos
age
form
: IN
FU
SIO
N
Act
ive
ingr
edie
nts:
E
AC
H 1
00,O
ml S
OLU
TIO
N
CO
NT
AIN
S:
CIP
RO
FLO
XA
CIN
20
0,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5, 6
App
lican
t:
Man
ufac
ture
r
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
XlX
lA P
HA
RM
AC
EU
TIC
ALS
(P
TY)
LTD
BlO
ME
ND
l S.A
., B
ER
NE
DO
, ALA
VA
, S
PA
IN
BlO
ME
ND
l S.A
., B
ER
NE
DO
, ALA
VA
, S
PA
IN
DIV
PH
AR
M M
AN
UF
AC
TU
RIN
G &
P
AC
KA
GIN
G, L
ON
GD
ALE
, JO
HA
NN
ES
BU
RG
FP
RC
: B
lOM
EN
Dl S
.A.,
BE
RN
ED
O, A
LAV
A,
SP
AIN
R
ES
EA
RC
H IN
ST
ITU
TE
FO
R I
ND
US
TR
IAL
PH
AR
MA
CY
. NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S, A
TLA
SV
ILLE
, B
OK
SB
UR
G
FP
RR
: X
lXlA
PH
AR
MA
CE
UT
ICA
LS,
MO
DD
ER
FO
NT
EIN
, RS
A
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e.
Dos
age
form
:
Act
ive
ingr
edie
nts
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
CH
OLE
ST
E 1
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: S
lMV
AS
TA
TlN
10
,O m
g
BE
-TA
BS
PH
AR
MA
CE
UT
ICA
LS (
PN
) LT
D
AU
RO
BIN
DO
PH
AR
MA
. RA
NG
A R
ED
DY
D
IST
RIC
T. A
ND
HR
A P
RA
DE
SH
. IN
DIA
AU
RO
BIN
DO
PH
AR
MA
, RA
NG
A R
ED
DY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
, RA
NG
A R
ED
DY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FP
RC
IFP
RR
: B
E-T
AB
S P
HA
RM
AC
EU
TIC
ALS
, RO
OD
EP
OO
RT
, R
SA
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
ed~
ents
.
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
.
FP
RC
IFP
RR
:
S he
if-lif
e:
48 m
onth
s S
helf-
life:
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7 D
ate
of r
egis
trat
ion:
CH
OLE
ST
E 2
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: S
IMV
AS
TA
TIN
20
,O m
g
BE
-TA
BS
PH
AR
MA
CE
UT
ICA
LS (P
TY
) LT
D
AU
RO
BIN
DO
PH
AR
MA
, RA
NG
A R
ED
DY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
, RA
NG
A R
ED
DY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
, RA
NG
A R
ED
DY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
BE
-TA
BS
PH
AR
MA
CE
UT
ICA
LS,
RO
OD
EP
OO
RT
, R
SA
48 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r.
Nam
e of
med
icin
e:
Dos
age
form
-
Act
ive
ingr
edie
nts.
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r.
Pac
ker
Labo
rato
ry:
FP
RC
:
CH
OLE
ST
E 4
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: S
IMV
AS
TA
TIN
40
,O m
g
BE
-TA
BS
PH
AR
MA
CE
UT
ICA
LS (P
TY
) LT
D
AU
RO
BIN
DO
PH
AR
MA
, RA
NG
A R
ED
CY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
, RA
NG
A R
ED
DY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
, RA
NG
A R
ED
DY
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FP
RC
IFP
RR
: B
E-T
AB
S P
HA
RM
AC
EU
TIC
ALS
, RO
OD
EP
OO
RT
, R
SA
S he
lf-lif
e:
48 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
4112
1.12
1042
2
Nam
e of
med
icin
e:
FlN
CA
R 5
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
FlN
AS
TE
RlD
E
5,O m
g
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3,4
, 5, 6
App
lican
t: C
lPLA
ME
DP
RO
(P
N)
LTD
Man
ufac
ture
r:
ClP
LA L
TD
, VIR
GO
NA
GA
R,
BA
NG
ALO
RE
, IN
DIA
Pac
ker:
C
lPLA
LT
D, V
IRG
ON
AG
AR
, BA
NG
ALO
RE
, IN
DIA
Labo
rato
ry:
FP
RC
: C
lPLA
LT
D, V
IRG
ON
AG
AR
, B
AN
GA
LOR
E,
IND
IA
FP
RR
: C
lPLA
ME
DP
RO
, R
OS
EN
PA
RK
, BE
LVIL
LE
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
-
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
rat~
on:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry.
She
lf-lif
e:
FP
RC
:
FP
RR
:
Dat
e of
reg
istr
atio
n:
--
- -
- -
41/2
1 2
05
19
SU
LPH
ON
UR
1 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
G
LlM
EP
lRlD
E
1,0
mg
1, 2
, 3,
4,
5, 6
SP
EC
PH
AR
M (P
TY
) LT
D
SP
EC
IFA
R S
.A.,
VA
RV
AR
A. A
TH
EN
S, G
RE
EC
E
SP
EC
IFA
R S
.A.,
VA
RV
AR
A. A
TH
EN
S, G
RE
EC
E
SP
EC
IFA
R S
.A.,
VA
RV
AR
A, A
TH
EN
S, G
RE
EC
E
AN
ALY
TIC
ON
, TE
RE
NU
RE
, KE
MP
TO
N P
AR
K
SP
EC
PH
AR
M, H
ALF
WA
Y H
OU
SE
, MID
RA
ND
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e.
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
41/2
1.21
0520
SU
LPH
ON
UR
2 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: G
LlM
EP
lRlD
E
2.0
rng
1, 2
, 3
,4,
5, 6
SP
EC
PH
AR
M (P
TY
) LT
D
SP
EC
IFA
R S
.A.,
VA
RV
AR
A, A
TH
EN
S,
GR
EE
CE
SP
EC
IFA
R S
.A..
VA
RV
AR
A, A
TH
EN
S.
GR
EE
CE
SP
EC
IFA
R S
.A.,
VA
RV
AR
A, A
TH
EN
S,
GR
EE
CE
A
NA
LW
ICO
N,
TE
RE
NU
RE
, K
EM
PT
ON
P
AR
K
SP
EC
PH
AR
M, H
ALF
WA
Y H
OU
SE
. M
IDR
AN
D
24 m
onth
s (P
rovs
iona
l)
5 O
CT
OB
ER
200
7 -
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
-
Act
ive
ingr
ed~
ents
.
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
4112
1.21
0521
SU
LPH
ON
UR
4 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
. G
LlM
EP
lRlD
E
4,0
mg
1, 2
, 3
,4, 5
, 6
SP
EC
PH
AR
M (
PT
Y)
LTD
SP
EC
IFA
R S
.A.,
VA
RV
AR
A, A
TH
EN
S,
GR
EE
CE
SP
EC
IFA
R S
.A.,
VA
RV
AR
A,
AT
HE
NS
, G
RE
EC
E
SP
EC
IFA
R S
.A.,
VA
RV
AR
A, A
TH
EN
S,
GR
EE
CE
A
NA
LYT
ICO
N, T
ER
EN
UR
E,
KE
MP
TO
N P
AR
K,
RS
A
SP
EC
PH
AR
M, H
ALF
WA
Y H
OU
SE
, MID
RA
ND
24 m
onth
s (P
rovi
sion
al)
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
.
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
4111
.210
529
AU
RO
ZA
PIN
E 1
5 rn
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: M
IRT
AZ
AP
INE
15
,O rn
g
1, 2
, 3, 4
, 5, 6
AU
RO
BIN
DO
PH
AR
MA
(P
TY
) LT
D
AU
RO
BIN
DO
PI I
AR
MA
LT
D, R
AFJ
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H.
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
FP
RR
: A
UR
OB
IND
O P
HA
RM
A,
RO
SE
BA
NK
, RS
A
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5 M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e.
Dos
age
form
Act
ive
mgr
ed~
ents
Con
ditio
ns o
f reg
istra
tion
App
lican
t:
Man
ufac
ture
r.
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
FP
RC
.
FPR
R:
Dat
e of
reg
istra
tion.
41/1
.2/0
530
AU
RO
ZA
PIN
E 3
0 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
. M
IRT
AZ
AP
INE
30
,O m
g
Reg
istr
atio
n nu
mbe
r:
4 1/
1.2/
0531
Nam
e of
med
icin
e:
AU
RO
-CIT
ALO
PR
AM
Dos
age
form
. T
AB
LET
Act
ive
Ingr
edie
nts,
E
AC
H T
AB
LET
CO
NT
AIN
S:
CIT
ALO
PR
AM
HY
DR
OB
RO
MID
E
EQ
UIV
ALE
NT
TO
C
ITA
LOP
RA
M
20,O
mg
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
, 3,4
, 5, 6
AU
RO
BIN
DO
PH
AR
MA
(P
TY
) LT
D
App
lican
t.
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
Man
ufac
ture
r.
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
Pac
ker:
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LTD
, RA
NG
A R
ED
DY
La
bora
tory
: D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
, R
OS
EB
AN
K, R
SA
24 m
onth
s
AU
RO
BIN
DO
PH
AR
MA
(PT
Y)
LTD
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H.
IND
IA
FP
RC
. A
UR
OB
IND
O P
HA
RM
A L
TD
, RA
NG
A
RE
DD
Y D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
. IN
DIA
FP
RR
: A
UR
OB
IND
O P
HA
RM
A, R
OS
EB
AN
K,
JOH
AN
NE
SB
UR
G,
RS
A
24 m
onth
s
5 O
CT
OB
ER
200
7 D
ate
of r
eg
~st
rat~
on
5
OC
TO
BE
R 2
007
-- -
-- -. -
-
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
.
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
RA
N-S
UM
AT
RIP
TA
N 5
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: S
UM
AT
RIP
TA
N S
UC
CIN
AT
E E
QU
IVA
LEN
T T
O
SU
MA
TR
IPT
AN
50
,O m
g
1, 2
, 3, 4
, 5, 6
RA
NB
AX
Y (S
A)
(PT
Y)
LTD
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D. D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D, R
SA
FP
RR
: R
AN
BA
XY
S.A
., C
EN
TU
RIO
N, R
SA
She
lf-lif
e:
24 m
onth
s
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e.
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
4117
.310
677
RA
N-S
UM
AT
RIP
TA
N 1
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: S
UM
AT
RIP
TA
N S
UC
CIN
AT
E E
QU
IVA
LEN
T
TO
S
UM
AT
RIP
TA
N
100,
O m
g
1, 2
,3,
4, 5
, 6
RA
NB
AX
Y (S
A) (
PT
Y)
LTD
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D. R
SA
RA
NB
AX
Y S
.A.,
CE
NT
UR
ION
, RS
A
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e-
Dos
age
form
Act
we
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
MlG
O 5
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: S
UM
AT
RIP
TA
N S
UC
CIN
AT
E E
QU
IVA
LEN
T T
O
SU
MA
TR
IPT
AN
50
,O m
g
RA
NB
AX
Y (S
A)
(PT
Y) L
TD
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
. IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI L
AB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D, R
SA
RA
NB
AX
Y S
.A.,
CE
NT
UR
ION
, RS
A
24 m
onth
s
5 O
CT
OB
ER
200
7
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f re
gist
ratio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
41 17
.310
679
MlG
O 1
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: S
UM
AT
RIP
TA
N S
UC
CIN
AT
E E
QU
IVA
LEN
T
TO
S
UM
AT
RIP
TA
N
100,
O m
g
1, 2
, 3, 4
, 5,
6
RA
NB
AX
Y (
SA
) (P
TY
) LT
D
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
RA
NB
AX
Y L
AB
OR
AT
OR
IES
LT
D, D
EW
AS
, M
AD
HY
A P
RA
DE
SH
, IN
DIA
K
HU
LULE
KA
NI
LAB
OR
AT
OR
Y S
ER
VIC
ES
, M
IDR
AN
D,
RS
A
RA
NB
AX
Y S
.A.,
CE
NT
UR
ION
, RS
A
24
mon
ths
5 O
CT
OB
ER
200
7
MR
F 1
5 M
RF
15
Reg
istr
atio
n nu
mbe
r:
4112
0.2.
8106
80
Reg
istr
atio
n nu
mbe
r:
4112
0.2.
8106
81
Nam
e of
med
icin
e:
AU
RO
-ZID
OV
UD
INE
CA
PS
ULE
S 1
00 m
g
Nam
e of
med
icin
e:
AU
RO
-ZID
OV
UD
INE
CA
PS
ULE
S 2
50 m
g
Dos
age
form
: C
AP
SU
LE
Dos
age
form
: C
AP
SU
LE
Act
ive
ingr
edie
nts:
E
AC
H C
AP
SU
LE C
ON
TA
INS
: A
ctiv
e in
gred
ient
s:
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
ZlD
OV
UD
lNE
10
0,O
rng
Z
lDO
VU
DlN
E
250.
0 rn
g
Con
ditio
ns o
f re
gist
ratio
n I, 2, 3
, 4, 5
, 6
Con
ditio
ns o
f re
gist
ratio
n:
1, 2
,3,4
,5,
6
App
lican
t:
Man
ufac
ture
r
Pac
ker:
Labo
rato
ry.
She
lf-lif
e:
AU
RO
BIN
DO
PH
AR
MA
(PT
Y) L
TD
A
pplic
ant:
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
Man
ufac
ture
r:
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H, I
ND
IA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
RE
DD
Y
Pac
ker:
D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FP
RC
: A
UR
OB
IND
O P
HA
RM
A L
TD
, RA
NG
A R
ED
DY
La
bora
tory
: D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
FP
RR
: A
UR
OB
IND
O P
HA
RM
A, R
OS
EB
AN
K,
JOH
AN
NE
SB
UR
G,
RS
A
24 m
onth
s (P
rovi
sion
aO
AU
RO
BIN
DO
PtiA
RM
A (
PF
) LT
D
AU
RO
BIN
DO
PH
AR
MA
LT
D, W
NG
A
RE
DD
Y D
IST
RIC
T, A
ND
HR
A P
RA
DE
SH
, IN
DIA
AU
RO
BIN
DO
PH
AR
MA
LT
D, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
RA
PR
AD
ES
H,
IND
IA
FP
RC
A
UR
OB
IND
O P
HA
RM
A L
TD
, R
AN
GA
R
ED
DY
DIS
TR
ICT
, AN
DH
W P
WD
ES
H,
IND
IA
FP
RR
: A
UR
OB
IND
O P
HA
RM
A, R
OS
EB
AN
K,
JOH
AN
NE
SB
UR
G, R
SA
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
5 O
CT
OB
ER
200
7 D
ate
of r
egis
trat
ion:
5
OC
TO
BE
R 2
007
MR
F 15
M
RF
15
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C:
FPR
CIF
PR
R:
FPR
R:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
4117
.110
881
AM
LOD
IPIN
E-W
INTH
RO
P 5
mg
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
AM
LOD
lPlN
E B
ES
ILA
TE E
QU
IVA
LEN
T T
O
AM
LOD
lPlN
E
5.0
rng
1, 2
,3,
4, 5
, 6
SA
NO
FI-S
YN
THE
LAB
O (
PTY
) LT
D
UN
ICH
EM
LA
BO
RA
TOR
IES
LTD
, PIL
ER
NE
, B
AR
DE
Z, G
OA
, IN
DIA
UN
ICH
EM
LA
BO
RA
TOR
IES
LTD
, PIL
ER
NE
, B
AR
DE
Z, G
OA
, IN
DIA
A
VE
NTI
S P
HA
RM
A, W
ALT
LOO
, PR
ETO
RIA
UN
ICH
EM
LA
BO
RA
TOR
IES
LTD
, PIL
ER
NE
, B
AR
DE
Z, G
OA
, IN
DIA
R
ES
EA
RC
H IN
STI
TUTE
FO
R I
ND
US
TRIA
L P
HA
RM
AC
Y, N
OR
TH-W
ES
T U
NIV
ER
SIT
Y,
PO
TCH
EFS
TRO
OM
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O, P
RE
TOR
IA
SA
NO
FI-S
YN
THE
LAB
O, M
IDR
AN
D, R
SA
24 m
onth
s
5 O
CTO
BE
R 2
007
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
C:
FPR
CIF
PR
R:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
4117
.110
882
AM
LOD
IPIN
E-W
INTH
RO
P 1
0 m
g
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
AM
LOD
lPlN
E B
ES
lL4T
E E
QU
IVA
LEN
T TO
A
MLO
DlP
lNE
10
,O rn
g
1, 2
, 3, 4
, 5, 6
SA
NO
FI-S
YN
THE
LAB
O (
PN
) LT
D
UN
ICH
EM
LA
BO
RA
TOR
IES
LT
D,
PIL
ER
NE
, BA
RD
EZ,
GO
A, I
ND
IA
UN
ICH
EM
LA
BO
RA
TOR
IES
LTD
, P
ILE
RN
E, B
AR
DE
Z, G
OA
, IN
DIA
A
VE
NTI
S P
HA
RM
A, W
ALT
LOO
, PR
ETO
RIA
UN
ICH
EM
LA
BO
RA
TOR
IES
LTD
, P
ILE
RN
E, B
AR
DE
Z, G
OA
, IN
DIA
R
ES
EA
RC
H IN
STI
TUTE
FO
R IN
DU
STR
IAL
PH
AR
MA
CY
, NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
PO
TC
HE
FS
TR
OO
M
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O,
PR
ETO
RIA
SA
NO
FI-S
YN
THE
LAB
O,
MID
RA
ND
, RS
A
24 m
onth
s
5 O
CTO
BE
R 2
007
MR
F 15
- MR
F 15
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry: F
PR
CIF
PR
R:
She
lf-lif
e:
Dat
e of
reg
ir
3811
0.11
0219
CH
IEF
CO
UG
H S
YR
UP
- H
ON
EY
FLA
VO
UR
SY
RU
P
EA
CH
5,O
ml S
YR
UP
CO
NTA
INS
: G
UA
IPH
EN
ES
IN
100,
O m
g
1, 2
, 3, 4
, 5, 6
, 7
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
LTD
, BR
YA
NS
TON
, JO
HA
NN
ES
BU
RG
24 m
onth
s (p
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t.
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry:
FP
RC
:
FPR
R:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
A40
12.2
1075
3
AD
CO
MID
AZO
LAM
INJE
CTI
ON
5 m
g15
ml
INJE
CTI
ON
EA
CH
5,O
ml A
MP
OU
LE C
ON
TAIN
S:
MID
AZO
LAM
5,
0 m
g
1,2
, 3,4
, 5, 6
, 7
AD
CO
CK
IN
GR
AM
LIM
ITE
D
PH
AR
MA
-Q, I
ND
US
TRIA
, JO
HA
NN
ES
BU
RG
PH
AR
MA
-Q,
IND
US
1-R
IA, J
OH
AN
NE
SB
UR
G
PH
AR
MA
-Q, I
ND
US
TRIA
, JO
HA
NN
ES
BU
RG
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
LT
D, B
RY
AN
STO
N,
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
MR
F I
5
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e.
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n
.App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
.
FP
RR
.
Dat
e of
reg
istr
atio
n:
AD
CO
MID
AZ
OLA
M IN
JEC
TIO
N 1
5 rn
gl3
ml
INJE
CTI
ON
EA
CH
3,O
ml A
MP
OU
LE C
ON
TA
INS
: M
IDA
ZO
LAM
15
,O m
g
1, 2
, 3, 4
, 5, 6
. 7
AD
CO
CK
IN
GR
AM
LIM
ITE
D
PH
AR
MA
-Q, I
ND
US
TR
IA. J
OH
AN
NE
SB
UR
G
PH
AR
MA
-Q, I
ND
US
TR
IA, J
OH
AN
NE
SB
UR
G
PH
AR
MA
-Q. I
ND
US
TRIA
, JO
HA
NN
ES
BU
RG
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TON
A
DC
OC
K I
NG
RA
M L
TD
, BR
YA
NS
TO
N,
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
MR
F 1
5 -- Reg
istr
atio
n nu
mbe
r:
A40
12.2
1075
5
Nam
e of
med
icin
e:
AD
CO
MID
AZ
OLA
M IN
JEC
TIO
N
50 r
ng1l
O m
l
Dos
age
form
. IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H 1
0,O
ml A
MP
OU
LE C
ON
TAIN
S:
MID
AZ
OLA
M
50,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3, 4
, 5, 6
, 7
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
AD
CO
CK
IN
GR
AM
LIM
ITE
D
PH
AR
MA
-Q, I
ND
US
TR
IA.
JOH
AN
NE
SB
UR
G
PH
AR
MA
-Q, I
ND
US
TR
IA,
JOH
AN
NE
SB
UR
G
FP
RC
: P
HA
RM
A-Q
, IN
DU
ST
RIA
, JO
HA
NN
ES
BU
RG
FP
RR
: A
DC
OC
K I
NG
RA
M H
EA
LTH
CA
RE
, W
AD
EV
ILLE
, GE
RM
IST
ON
A
DC
OC
K I
NG
RA
M L
TD
, BR
YA
NS
TO
N,
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istr
atio
n:
16 N
OV
EM
BE
R 2
007
MR
F 15
-
Reg
istra
tion
num
ber:
4112
1.12
/022
1
Nam
e of
med
icin
e:
FlN
PE
ClA
1 m
g
Dos
age
form
: TA
BLE
T
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NTA
INS
: F
lNA
ST
ER
lDE
1,
0 m
g
Con
ditio
ns o
f reg
istra
tion:
1, 2
, 3, 4
, 5, 6
App
lican
t:
Man
ufac
ture
r.
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
ClP
LA M
ED
PR
O (
PTY
) LT
D
ClP
LA L
TD
, VIR
GO
NA
GA
R, B
AN
GA
LOR
E, I
ND
IA
ClP
LA L
TD, V
IRG
ON
AG
AR
, BA
NG
ALO
RE
, IN
DIA
FPR
C:
ClP
LA L
TD
, VIR
GO
NA
GA
R,
BA
NG
ALO
RE
, IN
DIA
FPR
R:
ClP
LA M
ED
PR
O, R
OS
EN
PA
RK
, BE
LLV
ILLE
24 M
onth
s (P
rovi
sion
al)
Dat
e of
reg
istra
tion:
16
NO
VE
MB
ER
200
7
MR
F 1
5
Reg
istra
tion
num
ber:
41
120.
2.81
0231
Nam
e of
med
icin
e:
ZY
UO
RIN
TA
BLE
TS
Dos
age
form
: TA
BLE
T
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NTA
INS
: Z
lDO
VU
DlN
E
300.
0 m
g
Con
ditio
ns o
f reg
istra
tion:
1,
2,
3, 4
, 5, 6
,7
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
She
lf-lif
e:
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE, G
ER
MIS
TON
A
DC
OC
K I
NG
RA
M L
TD, A
ER
OTO
N,
JOH
AN
NE
SB
UR
G
FPR
CIF
PR
R
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE, G
ER
MIS
TON
A
DC
OC
K I
NG
RA
M L
TD, A
ER
OT
ON
, JO
HA
NN
ES
BU
RG
FPR
R:
AD
CO
CK
IN
GR
AM
LT
D, B
RY
AN
STO
N,
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
Dat
e of
regi
stra
tion:
16
NO
VE
MB
ER
200
7 -
MR
F 1
5
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e.
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r,
Pac
ker:
Labo
rato
ry. F
PR
CIF
PR
R:
FPR
R:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
41 12
0.2.
8102
32
NE
RlV
TA
BLE
TS
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
NE
VlR
AP
lNE
20
0.0
mg
1, 2
, 3. 4
, 5, 6
, 7
AD
CO
CK
ING
RA
M L
IMIT
ED
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E. W
AD
EV
ILLE
. G
ER
MIS
TON
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TON
A
DC
OC
K I
NG
RA
M L
TD, A
ER
OTO
N,
JOH
AN
NE
SB
UR
G
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E. W
AD
EV
ILLE
, G
ER
MIS
TON
A
DC
OC
K IN
GR
AM
LTD
, AE
RO
TO
N,
JOH
AN
NE
SB
UR
G
AD
CO
CK
IN
GR
AM
LT
D, B
RY
AN
ST
ON
, JO
HA
NN
ES
BU
RG
24 m
onth
s (P
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
MR
F 15
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts.
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
IFP
RR
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istra
tion.
41 12
0.2.
8102
33
RE
TLA
M T
AB
LETS
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
LAM
lVU
DlN
E
150,
O m
g
1,2
, 3,4
,5,6
,7
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
IST
ON
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
IST
ON
A
DC
OC
K I
NG
RA
M L
TD
, AE
RO
TO
N,
JOH
AN
NE
SB
UR
G
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
LTD
, A
ER
OTO
N.J
OH
AN
NE
SB
UR
G
AD
CO
CK
IN
GR
AM
LTD
, BR
YA
NS
TO
N,
JOH
AN
NE
SB
UR
G
24 m
onth
s (p
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
MR
F 15
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Fvl
anuf
ac!~
~~
et :
Pac
ker:
Labo
rato
ry: F
PR
CIF
PR
R:
41 /2
0.2.
8/02
34
ZETR
OD
IN T
AB
LETS
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
ZlD
OV
UD
lNE
30
0,O
mg
1,2
,3,4
,5,6
,7
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
ING
RA
M L
TD, A
ER
OT
ON
, JO
HA
NN
ES
BU
RG
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
ING
RA
M L
TD. A
ER
OT
ON
, JO
HA
NN
ES
BU
RG
MR
F 1
5
Reg
istra
tion
num
ber:
41/2
0.2.
8/03
08
Nam
e of
med
icin
e:
LAV
OS
SO
LUTI
ON
Dos
age
form
: S
OLU
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H 1
,O m
l SO
LUTI
ON
CO
NTA
INS
: LA
MlV
UD
lNE
10
,O m
g
Con
ditio
ns o
f reg
istra
tion:
1, 2
,3,4
,5,6
,7
App
lican
t: A
DC
OC
K IN
GR
AM
LIM
ITE
D
Man
ufac
ture
r: A
DC
OC
K IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE, G
ER
MIS
TON
Pac
ker:
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE, G
ER
MIS
TON
Labo
rato
ry:
FPR
CIF
PR
R:
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, W
AD
EV
ILLE
. GE
RM
ISTO
N
FPR
R:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
AD
CO
CK
ING
RA
M L
TD, B
RY
AN
ST
ON
, JO
HA
NN
ES
BU
RG
24 m
onth
s (P
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
FPR
R:
AD
CO
CK
ING
RA
M L
TD, B
RY
AN
STO
N,
JOH
AN
NE
SB
UR
G
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istra
tion:
16
NO
VE
MB
ER
200
7
MR
F 15
Reg
istra
tion
num
ber:
41 12
0.2.
8105
08
Nam
e of
med
icin
e:
ZYD
OR
IN S
YR
UP
ALC
OH
OL
AN
D S
UG
AR
FR
EE
Dos
age
form
. S
YR
UP
Act
ive
ingr
edie
nts:
E
AC
H 5
,O m
l SY
RU
P C
ON
~TA
INS
: Zl
DO
VU
DlN
E
50,O
rng
Con
ditio
ns o
f reg
istra
tion:
1,
2, 3
, 4. 5
, 6, 7
App
lican
t: A
DC
OC
K I
NG
RA
M L
IMIT
ED
Man
ufac
ture
r: A
DC
OC
K I
NG
RA
M H
EA
LTH
CA
RE
, WA
DE
VIL
LE,
GE
RM
ISTO
N
Pac
ker:
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TON
Labo
rato
ry:
FPR
CIF
PR
R:
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TON
FPR
R:
AD
CO
CK
IN
GR
AM
LTD
, BR
YA
NS
TON
, JO
HA
NN
ES
BU
RG
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
regi
stra
tion:
16
NO
VE
MB
ER
200
7
MR
F 15
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FPR
CIF
PR
R:
41/2
0.2.
8105
09
ZYD
OR
IN S
YR
UP
SY
RU
P
EA
CH
5,O
ml S
YR
UP
CO
NTA
INS
: Zl
DO
VU
DlN
E
50,O
mg
1, 2
, 3, 4
,5, 6
, 7
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
FPR
R:
AD
CO
CK
IN
GR
AM
LTD
. BR
YA
NS
TON
, JO
HA
NN
ES
BU
RG
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
regi
stra
tion:
16
NO
VE
MB
ER
200
7
MR
F 15
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry: F
PR
CIF
PR
R:
FPR
R:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
ZETR
OD
IN S
OLU
TIO
N A
LCO
HO
L A
ND
SU
GA
R
FRE
E
SO
LUTI
ON
EA
CH
5,O
ml S
OLU
TIO
N C
ON
TAIN
S:
ZID
OV
UD
INE
50
,O m
g
AD
CO
CK
ING
RA
M L
IMIT
ED
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
. G
ER
MIS
TON
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
ING
RA
M L
TD
, BR
YA
NS
TON
, JO
HA
NN
ES
BU
RG
24 m
onth
s (P
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
MR
F 15
Reg
istra
tion
num
ber:
41
120.
2.81
0513
Nam
e of
med
icin
e:
ZETR
OD
IN S
YR
UP
Dos
age
form
: S
YR
UP
Act
ive
ingr
edie
nts:
E
AC
H 5
,O m
l SY
RU
P C
ON
TAIN
S:
ZlD
OV
UD
lNE
50
,O m
g
Con
ditio
ns o
f reg
istra
tion:
1,
2,3
, 4,5
, 6. 7
App
lican
t: A
DC
OC
K IN
GR
AM
LIM
ITE
D
Man
ufac
ture
r: A
DC
OC
K IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
Pac
ker.
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, W
AD
EV
ILLE
, GE
RM
ISTO
N
Labo
rato
ry: F
PR
CIF
PR
R:
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
FPR
R:
AD
CO
CK
ING
RA
M L
TD, B
RY
AN
STO
N,
JOH
AN
NE
SB
UR
G
She
lf-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
e of
reg
istra
tion:
16
NO
VE
MB
ER
200
7
MR
F 15
. R
egis
tratio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
fom
.
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry: F
PR
UF
PR
R:
RE
TLA
M S
CI U
TlO
N A
LCO
HO
L A
ND
SU
GA
R
FRE
E
SO
LUTI
ON
EA
CH
1,O
rnl S
OLU
TIO
N C
ON
TAIN
S:
LAM
lVU
DlN
E
10,O
mg
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
Atv
l HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TON
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TON
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E. W
AD
EV
ILLE
. G
ER
MIS
TON
FPR
R:
AD
CO
CK
IN
GR
AM
LT
D, B
RY
AN
ST
ON
, JO
HA
NN
ES
BU
RG
She
!f-lif
e:
24 m
onth
s (P
rovi
sion
al)
Dat
-7 o
f re
gist
ratio
n:
16 N
OV
EM
BE
R 2
007
MR
F I5
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
IFP
RR
:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
4112
0.2
8105
16
LAV
OS
SO
LUTI
ON
ALC
OH
OL
AN
D
SU
GA
R F
RE
E
SO
LUTI
ON
EA
CH
1,O
ml S
OLU
TIO
N C
ON
TAIN
S:
LAM
lVU
DlN
E
10,O
rng
1, 2
, 3, 4
, 5, 6
, 7
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE,
GE
RM
ISTO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E.
WA
DE
VIL
LE, G
ER
M IS
TON
AD
CO
CK
IN
GR
AM
LT
D, B
RY
AN
ST
ON
, JO
HA
NN
ES
BU
RG
24 m
onth
s (P
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
MR
F 15
-.
-
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker
Labo
rato
ry: F
PR
CIF
PR
R,
FP
RR
:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
41/2
0.2.
8109
27
RE
NZI
R 6
00 m
g
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: E
FA
VIR
EN
Z
600.
0 m
g
1, 2, 3
,4, 5
, 6, 7
AD
CO
CK
ING
RA
M L
IMIT
ED
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, WA
DE
VIL
LE,
GE
RM
IST
ON
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
. G
ER
MIS
TO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TO
N
AD
CO
CK
IN
GR
AM
LT
D, A
ER
OTO
N,
JOH
AN
NE
SB
UR
G
AD
CO
CK
IN
GR
AM
LT
D, B
RY
AN
ST
ON
, JO
HA
NN
ES
BU
RG
24 m
onth
s (P
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
MR
F 15
--
Reg
istr
atio
n nu
mbe
r:
41/2
0.2.
8/09
28
Nam
e of
med
icin
e:
RE
FA
VIN
600
mg
Dos
age
form
: T
AB
LET
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LET
CO
NT
AIN
S:
EF
AV
IRE
NZ
60
0,O
mg
Con
ditio
ns o
f reg
istr
atio
n:
1, 2
, 3,4
,5,
6,7
App
lican
t: A
DC
OC
K I
NG
RA
M L
IMIT
ED
Man
ufac
ture
r:
Pac
ker:
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, W
AD
EV
ILLE
, GE
RM
ISTO
N
AD
CO
CK
ING
RA
M H
EA
LTH
CA
RE
, W
AD
EV
ILLE
, GE
RM
ISTO
N
Labo
rato
ry:
FP
RC
IFP
RR
: A
DC
OC
K IN
GR
AM
HE
ALT
HC
AR
E,
WA
DE
VIL
LE, G
ER
MIS
TON
A
DC
OC
K IN
GR
AM
LT
D, A
ER
OT
ON
, JO
HA
NN
ES
BU
RG
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
AD
CO
CK
IN
GR
AM
LT
D, B
RY
AN
ST
ON
, JO
HA
NN
ES
BU
RG
24 m
onth
s (P
rovi
sion
al)
16 N
OV
EM
BE
R 2
007
MR
F 1
5 --
Reg
istr
atio
n nu
mbe
r:
Nam
e of
med
icin
e:
Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry: F
PR
CIF
PR
R:
FP
RR
:
She
lf-lif
e:
Dat
e of
reg
istr
atio
n:
41 12
0.2.
8109
29
AD
CO
-EF
AV
IRE
NZ
600
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: E
FA
VIR
EN
Z
600,
O m
g
1, 2
, 3,4
, 5, 6
, 7
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TO
N
AD
CO
CK
IN
GR
AM
HE
ALT
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TO
N
AD
CO
CK
IN
GR
AM
LT
D, A
ER
OT
ON
, JO
HA
NN
ES
BU
RG
AD
CO
CK
IN
GR
AM
LT
D, B
RY
AN
ST
ON
, JO
HA
NN
ES
BU
RG
24 m
onth
s (P
rovi
sion
al)
16 N
OV
EM
BE
R 2
007