general notice algemene kennisgewing
TRANSCRIPT
3 STAATSKOERANT, 19 DESEMBER 2008 No.31696
GENERAL NOTICE
ALGEMENE KENNISGEWING
NOTICE 1534 OF 2008
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 101 OF 1965)
1. The applicant shall ensure that the medicine is manufactured and controlled in terms of the current Good Manufacturing Practices as determined by Council.
2, 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,
3, The information in the package insert shall be updated on a regular basis to conform tn the package insert recently approved by Council.
4, The appl!cant must comply with ai' the legal requirements of the Medicines and Related Substances Act, 1965 (Act 101 of 1965).
5, The re9istration of this medicine shall be subject to review at intervals as determined by Council regarding its quality, safety and efficacy, and the registration of this medicine may be varied subject to issues Council may deem fit.
6, The first two production batches must be fully validated in terms of the detailed proces~; 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
7 Tile procluct may be advertised to the professions only. 8 A post-registration inspection must be conducted in the first production batch of
Hie locally manufactured product. 9, A post ,relllstration inspection must be conducted on the first production batch
manufdchlied by each local manufacturer, 'lOA post-re9istration inspection must be conducted on the first production batch of
the imported product. 11, IVlarketlllg of the product may only commence following a satisfactory post
reqistratJO!l Inspection report. 12. One sample of every batch, together with four copies of the protocol for testing of
tile 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 subrliltled to the Council for lot release purposes.
13. The expiry date allocated shall be modified by adding a statement that the virus strains ;m~ currently recommended for South African usage in the specific year.
14. T[1e strains of the master seed viruses must be approved by the Department of Health tor each year.
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App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
She
lf-lif
e:
Dat
e o
f reg
istr
atio
n:
A38
/2.5
/046
o
LAM
OT
RIG
INE
HE
XA
L 1
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: LA
MO
TR
IGIN
E
100.
0 m
g
1,2
.3,4
,5.6
.7
HE
XA
L P
HA
RM
A S
A (
PT
Y)
LTD
WE
LLS
PR
ING
PH
AR
MA
CE
UT
ICA
L C
AN
AD
A,
OA
KV
ILLE
, O
NT
AR
IO.
CA
NA
DA
WE
LLS
PR
ING
PH
AR
MA
CE
UT
ICA
L C
AN
AD
A.
OA
KV
ILLE
, O
NT
AR
IO.
CA
NA
DA
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
& P
AC
KA
GIN
G,
LON
GD
ALE
. JO
HA
NN
ES
BU
RG
WE
LLS
PR
ING
PH
AR
MA
CE
UT
ICA
L C
AN
AD
A.
OA
KV
ILLE
, O
NT
AR
IO.
CA
NA
DA
C
ON
SU
LTIN
G C
HE
MIC
AL
LAB
OR
AT
OR
IES
, A
TLA
SV
ILLE
. B
OK
SB
UR
G
AN
AL
YT
ICO
N.
TE
RE
NU
RE
, K
EM
PT
ON
PA
RK
HE
XA
L P
HA
RM
A,
PIN
ET
OW
N.
KZ
N
24 m
onth
s
10 O
CT
OB
ER
200
8
MR
F 1
5
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 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 o
f reg
istr
atio
n:
A38
12.5
1046
1
LAM
OT
RIG
INE
HE
XA
L 20
0
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: LA
MO
TR
IGIN
E
20
0.0
mg
(f)
1,2
.3,4
,5.6
,7
~ ~ H
EX
AL
PH
AR
MA
SA
(P
TY
) LT
D
(f)
WE
LLS
PR
ING
PH
AR
MA
CE
UT
ICA
L C
AN
AD
A.
6 mO
AK
VIL
LE,
ON
TA
RIO
, C
AN
AD
A
II » Z
WE
LLS
PR
ING
PH
AR
MA
CE
UT
ICA
L C
AN
AD
A.
--I
OA
KV
ILLE
, O
NT
AR
IO.
CA
NA
DA
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
&
<0
PA
CK
AG
ING
, LO
NG
DA
LE.
JOH
AN
NE
SB
UR
G
o m
(f)
WE
LLS
PR
ING
PH
AR
MA
CE
UT
ICA
L C
AN
AD
A,
m
OA
KV
ILLE
. O
NT
AR
IO,
CA
NA
DA
s:: OJ
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TO
RIE
S,
m
AT
LAS
VIL
LE,
BO
KS
BU
RG
II
AN
AL
YT
ICO
N,
TE
RE
NU
RE
, K
EM
PT
ON
PA
RK
o I\
) o en
HE
XA
L P
HA
RM
A,
PIN
ET
OW
N,
KZ
N
24 m
onth
s
10 O
CT
OB
ER
200
8
z o UJ .....
CJ)
<0
C
J)
CD
9 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 reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
/FP
RR
:
FP
RR
She
lf-lif
e:
Dat
e o
f reg
istr
atio
n:
A39
133/
0320
BIO
PLU
S S
YR
UP
ST
RA
WB
ER
RY
SY
RU
P
EA
CH
30,
0 m
l SY
RU
P C
ON
TA
INS
: C
alci
um g
luco
nate
90
0,0
mg
Caf
fein
e 27
0,0
mg
Cal
cium
citr
ate
180,
0 m
g T
hiam
ine
hydr
ochl
orid
e 16
,0 m
g R
ibof
lavi
n 11
,0 m
g P
yrid
oxin
e 9,
0 m
g N
icot
inam
ide
42,0
mg
d-P
anto
then
ol
11,0
mg
Cya
noco
bala
min
26
,0 u
g
1,2
,3,4
,5,6
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
AM
HE
AL T
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TO
N
AD
CO
CK
IN
GR
AM
HE
AL T
HC
AR
E, W
AD
EV
ILLE
, G
ER
MIS
TO
N
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
AD
CO
CK
ING
RA
M H
EA
L TH
CA
RE
, WA
DE
VIL
LE,
GE
RM
IST
ON
AD
CO
CK
ING
RA
M,B
RY
AN
ST
ON
,JO
HA
NN
ES
BU
RG
24
mon
ths
10 O
CT
OB
ER
200
8
MR
F 1
5
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 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
regi
stra
tion:
... o z w
.....
OJA
39/2
0.1.
1/03
81
to
OJ
AZ
ITH
RO
HE
XA
L 50
0 m
g T
AB
LET
S
TA
BL
ET
EA
CH
TA
BLE
T C
ON
TA
INS
: A
ZtT
HR
OM
YC
IN D
IHY
DR
AT
E E
QU
IVA
LEN
T T
O
AZ
ITH
RO
MY
CIN
50
0,0
mg
G) o <
m
JJ
Z s: m
Z1
,2,3
,4,5
,6,7
-t
G
)H
EX
AL
PH
AR
MA
(S
A)
(PT
Y)
LTD
» N
ILSA
N I
LTA
S, G
EBZE
-KO
CA
ELI,
TUR
KEY
m
H
EXA
L A
G, H
OLZ
KIR
CH
EN, G
ERM
AN
Y
~ mIL
SAN
ILT
AS,
GEB
ZE-K
OC
AEL
I, TU
RK
EY
SAL
UT
AS
PHA
RM
A G
mbH
, BA
RLE
BEN
, GER
MA
NY
to
D
IVPH
AR
M M
AN
UFA
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G &
PA
CK
AG
ING
, o
LON
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ALE
, JO
HA
NN
ESB
UR
G
m
(')
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V A
RTI
S PH
AR
MA
, SPA
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EMPT
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PA
RK
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AS,
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I, TU
RK
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HEX
AL
AG
, HO
LZK
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, GER
MA
NY
m
JJ
SALU
TAS
PHA
RM
A G
mbH
, B
AR
LEB
EN, G
ERM
AN
Y
CO
NSU
LT
ING
CH
EMIC
AL
LA
BO
RA
TO
RIE
S, S
TAR
I\
) o oST
RE
ET
, AT
LA
SVIL
LE
, BO
KSB
UR
G, R
SA
())
AN
AL
YT
iCO
N, T
EREN
UR
E, K
EMPT
ON
PA
RK
HE
XA
L P
HA
RM
A,
PIN
ET
OW
N,
RS
A
24 m
onth
s (p
rovi
sion
al)
10 O
CT
OB
ER
200
8
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
C:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
A39
/20.
1.1/
0534
MY
CO
RE
ST
15
0
CA
PS
ULE
EA
CH
CA
PS
UL
E C
ON
TA
INS
: F
LUC
ON
AZ
OLE
15
0,0
mg
1,2
,3,4
.5.6
.7
ZY
DU
S H
EA
L T
HC
AR
E S
A (
PT
Y)
L TO
ZV
DU
S C
AD
ILA
HE
AL
TH
CA
RE
L TO
, S
AN
AN
D,
AH
ME
DA
BA
D.
IND
IA
ZY
DU
S C
AD
ILA
HE
AL
TH
CA
RE
LT
D.
SA
NA
ND
, A
HM
ED
AB
AD
. IN
DIA
ZY
DU
S C
AD
ILA
HE
AL
TH
CA
RE
L TO
, S
AN
AN
D,
AH
ME
DA
BA
D,
IND
IA
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L S
ER
VIC
ES
, S
ILV
ER
TO
ND
ALE
, 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,
PO
TC
HE
FS
TR
OO
M
ZY
DU
S H
EA
LTH
CA
RE
SA
, V
AN
DE
R H
OF
F P
AR
K,
PO
TC
HE
FS
TR
OO
M
24
mon
ths
10
OC
TO
BE
R 2
00
8
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
C:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
A39
17.1
1053
7
AM
LOD
IPIN
E H
EX
AL
10
TA
BLE
T
EA
CH
TA
BL
ET
CO
NT
AIN
S:
AM
LOD
IPIN
E B
ES
YLA
TE
EQ
UIV
AL
EN
T T
O
AM
LOD
IPIN
E
10,0
mg
1,2
.3,4
,5,6
,7
(/)
HE
XA
L P
HA
RM
A (
SA
) (P
TY
) LT
D
~ IL
SA
N I
LTA
S,
GE
BZ
E-K
OC
AE
U,
TU
RK
EY
~
HE
XA
L N
S,
HV
IDO
VR
E.
DE
NM
AR
K
(/) A
0S
ALU
TA
S P
HA
RM
A G
mbH
, B
AR
LEB
EN
, m
G
ER
MA
NY
:0
»D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
&
z P
AC
KA
GIN
G,
LON
GD
ALE
,
;-I .....
JOH
AN
NE
SB
UR
G,R
SA
(0
CJS
ALU
TA
S P
HA
RM
A G
mbH
. B
AR
LEB
EN
, m
G
ER
MA
NY
(/
)
CO
NS
ULT
ING
CH
EM
ICA
L L
AB
OR
AT
OR
IES
, m
~
ST
AR
ST
RE
ET
, A
TLA
SV
ILLE
, B
OK
SB
UR
G,
OJ
m
RS
A
:0
AN
ALY
TIC
ON
, T
ER
EN
UR
E,
KE
MP
TO
N P
AR
K
I\)
0 0 (Xl
HE
XA
L P
HA
RM
A,
WE
ST
ME
AD
, R
SA
24
mon
ths
10 O
CT
OB
ER
200
8
z o Ul .....
OJ
(0
OJ ... ...
0 .... I\) z
Reg
istr
atio
n nu
mbe
r:
A3
9f7
.1/0
53
9
Reg
istr
atio
n nu
mbe
r:
A3
9/2
6/0
64
8
I~ N
ame
of m
edic
ine:
V
AS
CU
LEX
10
Na
me
of m
edic
ine:
E
LiG
AR
D 7
,5 m
g
Dos
age
form
: T
AB
LE
T
Do
sag
e f
orm
: IN
JEC
TIO
N
Act
ive
ingr
edie
nts:
E
AC
H T
AB
LE
T C
ON
TA
INS
: A
ctiv
e in
gred
ient
s:
EA
CH
SY
RIN
GE
DE
LIV
ER
S:
AM
LOD
IPIN
E B
ES
YL
AT
E E
QU
IVA
LE
NT
TO
A
ML
OD
IPIN
E
10
,0 m
g L
EU
PR
OL
IDE
7,
5 m
g
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
1,2
,3,4
,5,6
,7
HE
XA
L P
HA
RM
A (
SA
) (P
TY
) LT
D
ILS
AN
ILT
AS
, G
EB
ZE
-KO
CA
EL
I, T
UR
KE
Y
HE
XA
L A
lS,
HV
IDO
VR
E,
DE
NM
AR
K
SA
LUT
AS
PH
AR
MA
Gm
bH.
BA
RL
EB
EN
, G
ER
MA
NY
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
& P
AC
KA
GIN
G,
LON
GD
ALE
, JO
HA
NN
ES
BU
RG
. R
SA
SA
LUT
AS
PH
AR
MA
Gm
bH,
BA
RLE
BE
N,
GE
RM
AN
Y
CO
NS
UL
TIN
G C
HE
MIC
AL
LA
BO
RA
TO
RIE
S,
ST
AR
S
TR
EE
T,
AT
LA
SV
ILL
E.
BO
KS
BU
RG
. R
SA
A
NA
L Y
TIC
ON
, T
ER
EN
UR
E.
KE
MP
TO
N P
AR
K
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
1,2
,3,4
,5,6
,7
KE
Y O
NC
OL
OG
ICS
(P
TY
) L
TD
AT
RIX
LA
BO
RA
TO
RIE
S I
NC
, F
OR
T
CO
LLIN
S.
CO
LO
RA
DO
, U
SA
C
HE
SA
PE
AK
E B
IOL
OG
ICA
L
LA
BO
RA
TO
RIE
S I
NC
, B
AL
TIM
OR
E,
MA
RY
LA
ND
, U
SA
S
TE
RIS
IS
OM
ED
IX S
ER
VIC
ES
, W
HIP
PA
NY
. N
EW
JE
RS
EY
. U
SA
AT
RIX
LA
BO
RA
TO
RIE
S I
NC
, F
OR
T
CO
LLIN
S.
CO
LO
RA
DO
, U
SA
C
HE
SA
PE
AK
E B
IOL
OG
ICA
L
LA
BO
RA
TO
RIE
S I
NC
, B
ALT
IMO
RE
. M
AR
YL
AN
D,
US
A
AT
RIX
LA
BO
RA
TO
RIE
S IN
C.
FO
RT
C
OLL
INS
, C
OL
OR
AD
O,
US
A
SP
EC
TR
AL
DA
TA
SE
RV
ICE
S I
NC
, C
HA
MP
AIG
N,
ILLI
NO
IS.
US
A
INS
TIT
UT
E F
OR
PH
AR
MA
CE
UT
ICA
L
G) 0 <
m
lJ
z s:: m
Z
-I
G) » N m
:j
m . .....
<D
0 m
()
m
s:: OJ
m
lJ
!\)
0 0 (J;)
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE
. P
RE
TO
RIA
FP
RR
: H
EX
AL
PH
AR
MA
,WE
ST
ME
AD
.RS
A
FP
RR
: K
EY
ON
CO
LO
GIC
S,
HO
UG
HT
ON
, JO
HA
NN
ES
BU
RG
She
lf·lif
e:
24 m
onth
s S
helf-
life:
2
4 m
onth
s
Dat
e o
f reg
istr
atio
n:
10 O
CT
OB
ER
20
08
D
ate
of r
egis
trat
ion:
1
0 O
CT
OB
ER
20
08
MR
F1
5
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 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 o
f reg
istr
atio
n:
A39
1261
0649
ELi
GA
RD
22,
5 m
g
INJE
CT
ION
EA
CH
SY
RIN
GE
DE
LIV
ER
S:
LEU
PR
OLI
DE
2
2,5
mg
1,2
,3,4
,5,6
,7
KE
Y O
NC
OLO
GIC
S {
PrY
} LT
D
AT
RIX
LA
BO
RA
TO
RIE
S I
NC
, F
OR
T C
OLL
INS
, C
OL
OR
AD
O,U
SA
C
HE
SA
PE
AK
E B
IOLO
GIC
AL
LAB
OR
AT
OR
IES
IN
C,
BA
LTIM
OR
E,
MA
RY
LAN
D,
US
A
ST
ER
IS I
SO
ME
DIX
SE
RV
ICE
S,
WH
IPP
AN
Y,
NE
W
JER
SE
Y,U
SA
AT
RIX
LA
BO
RA
TO
RIE
S I
NC
, F
OR
T C
OLL
INS
, C
OL
OR
AD
O,U
SA
C
HE
SA
PE
AK
E B
IOLO
GIC
AL
LAB
OR
AT
OR
IES
IN
C,
BA
LTIM
OR
E,
MA
RY
LAN
D,
US
A
AT
RIX
LA
BO
RA
TO
RIE
S I
NC
, F
OR
T C
OLL
INS
, C
OL
OR
AD
O,U
SA
S
PE
CT
RA
L D
AT
A S
ER
VIC
ES
IN
C,
CH
AM
PA
IGN
, IL
LIN
OIS
, U
SA
IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA
KE
Y O
NC
OLO
GIC
S,
HO
UG
HT
ON
, JO
HA
NN
ES
BU
RG
24
mon
ths
10 O
CT
OB
ER
200
8
MR
F 1
5
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 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 o
f reg
istr
atio
n:
A39
1261
0650
ELi
GA
RD
30,
0 m
g
INJE
CT
ION
EA
CH
SY
RIN
GE
DE
LIV
ER
S:
LEU
PR
OLI
DE
30
,0 m
g
1,2
,3,4
,5,6
,7
KE
Y O
NC
OLO
GIC
S {
PrY
} LT
D
(f)
AT
RIX
LA
BO
RA
TO
RIE
S I
NC
, F
OR
T
~ C
OLL
INS
, C
OLO
RA
DO
, U
SA
~ (f
)C
HE
SA
PE
AK
E B
IOLO
GIC
AL
A
LAB
OR
AT
OR
IES
IN
C,
BA
LTIM
OR
E,
o mM
AR
YLA
ND
, U
SA
:0
S
TE
RIS
IS
OM
ED
IX S
ER
VIC
ES
, W
HIP
PA
NY
, » Z
NE
W J
ER
SE
Y,
US
A
.-i
AT
RIX
LA
BO
RA
TO
RIE
S IN
C,
FO
RT
<0
CO
LLIN
S,
CO
LOR
AD
O,
US
A
Cl m
CH
ES
AP
EA
KE
BIO
LOG
ICA
L (f
)
LAB
OR
AT
OR
IES
IN
C,
BA
LTIM
OR
E,
m
s:::M
AR
YLA
ND
, U
SA
OJ
m
A
TR
IX L
AB
OR
AT
OR
IES
INC
, F
OR
T
:0
CO
LLIN
S,
CO
LOR
AD
O,
US
A
8S
PE
CT
RA
L D
AT
A S
ER
VIC
ES
IN
C,
CD
CH
AM
PA
IGN
, IL
LIN
OIS
, U
SA
IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RT
ON
DA
LE,
PR
ET
OR
IA
KE
Y O
NC
OLO
GIC
S,
HO
UG
HT
ON
, JO
HA
NN
ES
BU
RG
24 m
onth
s
10 O
CT
OB
ER
200
8 z o w
.....
O
l <0
O
l ... Co)
MR
F15
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
C:
FPR
R:
She
lf-lif
e:
Dat
e o
f reg
istra
tion:
A391
2610
651
ELi
GA
RD
45,
0 m
g
INJE
CTI
ON
EA
CH
SY
RIN
GE
DE
LIV
ER
S:
LEU
PR
OLI
DE
45
,0 m
g
1, 2
, 3,
4,
5, 6
, 7
KE
Y O
NC
OLO
GIC
S (
PT
Y)
L TO
ATR
IX L
AB
OR
ATO
RIE
S IN
C, F
OR
T C
OLL
INS
, C
OLO
RA
DO
,US
A
CH
ES
AP
EA
KE
BIO
LOG
ICA
L LA
BO
RA
TOR
IES
IN
C,
BA
LTIM
OR
E,
MA
RY
LAN
D,
US
A
STE
RIS
ISO
ME
DIX
SE
RV
ICE
S, W
HIP
PA
NY
, N
EW
JE
RS
Ey,
US
A
AT
RIX
LA
BO
RA
TOR
IES
IN
C,
FOR
T C
OLL
INS
, C
OLO
RA
DO
, U
SA
C
HE
SA
PE
AK
E B
IOLO
GIC
AL
LAB
OR
ATO
RIE
S
INC
, BA
LTIM
OR
E,
MA
RY
LAN
D,
US
A
ATR
IX L
AB
OR
ATO
RIE
S I
NC
, FO
RT
CO
LLIN
S,
CO
LOR
AD
O,U
SA
S
PE
CTR
AL
DA
TA S
ER
VIC
ES
IN
C,
CH
AM
PA
IGN
, IL
LIN
OIS
, U
SA
IN
STI
TUTE
FO
R P
HA
RM
AC
EU
TIC
AL
SE
RV
ICE
S,
SIL
VE
RTO
ND
ALE
, P
RE
TO
RIA
KE
Y O
NC
OLO
GIC
S,
HO
UG
HTO
N,
JOH
AN
NE
SB
UR
G
24 m
onth
s
10 O
CTO
BE
R 2
008
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
C;
FPR
C/F
PR
R:
She
lf-lif
e:
Dat
e o
f reg
istra
tion:
... ~ z !=l w
A4
0/3
0.1
/01
80
?6 CD
P
OLI
OR
IX
INJE
CTI
ON
E
AC
H 0
,5 m
l DO
SE
CO
NTA
INS
: P
OLI
O V
IRU
S T
YP
E 1
(MA
HO
NE
Y S
TR
AIN
) 40
,0 0
A
NTI
GE
N U
NIT
S
PO
LIO
VIR
US
TY
PE
2 (M
EF-
1 S
TRA
IN)
8,0
0
AN
TIG
EN
UN
ITS
P
OLI
O V
IRU
S T
YP
E 3
(S
AU
KE
TI S
TRA
IN)
32
,00
G
)
AN
TIG
EN
UN
ITS
o <
m
1, 2
, 3,
4,
5, 6
, 7
:II
ZG
LAX
OS
MIT
HK
LlN
E S
OU
TH A
FR
ICA
(P
TY)
LTD
s:: m
GLA
XO
SM
ITH
KLl
NE
BIO
LOG
ICA
LS,
RIX
EN
SA
RT,
BE
LGIU
M
Z
-I
G) ~ m
~ m
GLA
XO
SM
ITH
KLl
NE
BIO
LOG
ICA
LS,
RIX
EN
SA
RT,
BE
LGIU
M
SA
CH
SIS
CH
ES
SE
RU
MW
ER
K G
mbH
, D
RE
SD
EN
, c.o
G
ER
MA
NY
o
GLA
XO
SM
ITH
KLl
NE
SO
UTH
AFR
ICA
, E
PP
ING
, C
AP
E T
OW
N
m
()
mG
LAX
OS
MIT
HK
LlN
E B
IOLO
GIC
ALS
, R
IXE
NS
AR
T, B
ELG
IUM
s:: CD
m
:II
I\
) o o CXI
GLA
XO
SM
ITH
KLl
NE
SO
UTH
AFR
ICA
, E
PP
ING
, C
AP
E T
OW
N
36 m
onth
s
10 O
CTO
BE
R 2
008
MR
F1
5
MR
F 1
5
Reg
istr
atio
n nu
mbe
r: A
40/3
4/00
89
Reg
istr
atio
n nu
mbe
r: A
40/3
4/00
90
Nam
e of
med
icin
e:
ST
RU
CK
TO
KA
BIV
EN
N
ame
of m
edic
ine:
S
TR
UC
KT
OK
AB
IVE
N E
F
Dos
age
form
: IN
FU
SIO
N
Dos
age
form
: IN
FU
SIO
N
Act
ive
ingr
edie
nts:
E
AC
H 1
000
,0 m
l SO
LUT
ION
CO
NT
AIN
S:
Glu
cose
mon
ohyd
rate
equ
ival
ent t
o G
luco
se 4
20,0
9
L-A
lani
ne
L-A
rgin
ine
Gly
cine
L-
His
tidin
e L-
Isol
euci
ne
L-Le
ucin
e L-
Lysi
ne
L-M
ethi
onin
e L-
Phe
nyla
lani
ne
L-P
rolin
e L-
Ser
ine
Tau
rine
L-T
hreo
nine
L-
Try
ptop
han
L-T
yros
ine
L-V
alin
e C
alci
um c
hlor
ide
Sod
ium
gly
cero
phos
phat
e M
agne
sium
sul
phat
e P
otas
sium
chl
orid
e S
odiu
m a
ceta
te
Zin
c su
lpha
te
Pur
ified
Str
uctu
red
Trig
lyce
rides
14,0
g
12,0
g
11,0
9
3,O
g 5,
Og
7,4
g 6,
6 g
4,3
9 5,
1 9
11,2
9
6,5
g
1,0
g 4,
4 g
2,0
9 0,
4 9
6,2
9 0
,56
g
4,18
g
1,2
9 4,
48 9
3,
4 9
0,01
29
200,
0 9
Act
ive
ingr
edie
nts:
E
AC
H 1
00
0,0
ml
SO
LU
TIO
N C
ON
TA
INS
: G
luco
se m
on
oh
ydra
te e
qu
iva
len
t to
Glu
cose
42
0,0
9
L-A
lan
ine
1
4,0
9
L-A
rgin
ine
1
2,0
9
Gly
cin
e
11
,0 9
L
-His
tid
ine
3
,0 9
L
-Iso
leu
cin
e
5,0
9
L-L
eu
cin
e
7,4
9
L-L
ysin
e
6,6
9
L-M
eth
ion
ine
4
,3 9
L
-Ph
en
yla
lan
ine
5,
1 9
L-P
rolin
e
11
,2 9
L
-Se
rin
e
6,5
9
Ta
uri
ne
1
,0 9
L
-Th
reo
nin
e
4,4
9
L-T
ryp
top
ha
n
2,0
9
L-T
yro
sin
e
0,4
9
L-V
alin
e
6,2
9
Pu
rifi
ed
Str
uct
ure
d T
rig
lyce
rid
es
20
0,0
9
(J) ~ ~ (J) A 0 m
JJ » z _-1
\0
0 m
(j) m s: CD
m
JJ
I\)
0 0 co
Con
ditio
ns o
f reg
istra
tion:
1
,2,3
,4,5
,6,8
C
ondi
tions
of r
egis
trat
ion:
1
,2,3
,4,5
,6,8
App
lican
t: F
RE
SE
NIU
S K
AB
I S
OU
TH A
FR
ICA
(P
TY
) L T
O
App
lican
t: F
RE
SE
NIU
S K
AB
I S
OU
TH
AF
RIC
A (
PT
Y)
LT
D
Man
ufac
ture
r: F
RE
SE
NIU
S K
AB
I A
B,
UP
PS
ALA
, S
WE
DE
N
Man
ufac
ture
r:
FR
ES
EN
IUS
KA
BI
AB
, U
PP
SA
LA
, S
WE
DE
N
Pac
ker:
FR
ES
EN
IUS
KA
BI
AB
, U
PP
SA
LA,
SW
ED
EN
P
acke
r: F
RE
SE
NIU
S K
AB
I A
B,
UP
PS
AL
A,
SW
ED
EN
z !:>
C..:>
-'
OJ
\0
OJ ... U'I
.... en z ~ w
.....
0>
(£)
0>
Labo
rato
ry:
FPR
C:
FRE
SE
NIU
S K
AB
I A
B,
UP
PS
ALA
, S
WE
DE
N
BO
DE
NE
UaI
NT
RA
ME
D,K
OR
ST
EN
,PO
RT
E
LIZA
BE
TH
KH
ULU
LEK
AN
I LA
BO
RA
TOR
Y S
ER
VIC
ES
, C
OV
EN
TRY
PA
RK
, M
IDR
AN
D
Labo
rato
ry:
FPR
C:
FR
ES
EN
IUS
KA
BI A
B,
UP
PS
ALA
, S
WE
DE
N
BO
DE
NE
Va
INTR
AM
ED
, K
OR
STE
N,
PO
RT
ELI
ZAB
ETH
K
HU
LULE
KA
NI
LAB
OR
ATO
RY
SE
RV
ICE
S,
CO
VE
NTR
Y
PA
RK
, M
IDR
AN
D
Gl o <
m
FPR
R:
She
lf-lif
e:
Dat
e o
f reg
istra
tion:
FRE
SE
NIU
S K
AB
I S
A,
HA
LFW
AY
HO
US
E
24 m
onth
s (P
rovi
sion
al)
10 O
CTO
BE
R 2
008
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
FR
ES
EN
IUS
KA
BI S
A,
HA
LFW
AY
HO
US
E
24 m
onth
s (P
rovi
sion
al)
10 O
CTO
BE
R 2
008
Jl Z s:: m
Z
-l
Gl » N m
~ m
.... (£) o m
()
m s:: OJ
m
Jl rg o (Xl
MR
F 1
5
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 reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
/FP
RR
:
FP
RR
:
She
lf-lif
e:
Dat
e o
f reg
istr
atio
n:
A40
/2.2
1044
1
ST
ILN
OX
MR
12,
5
TA
BLE
T
EA
CH
TA
BL
ET
CO
NT
AIN
S:
ZO
LPID
EM
TA
RT
RA
TE
12
,5 m
g
1,2
,3,4
,5,6
,7,8
SA
NO
FI-
SY
NT
HE
LAB
O (
PT
Y)
LTD
SA
NO
FI
WIN
TH
RO
P I
ND
US
TR
IE,
TO
UR
S,
FR
AN
CE
SA
NO
FI
WIN
TH
RO
P I
ND
US
TR
IE,
TO
UR
S,
FR
AN
CE
A
VE
NT
IS P
HA
RM
A,
WA
L T
LOO
, P
RE
TO
RIA
SA
NO
FI
WIN
TH
RO
P I
ND
US
TR
IE,
TO
UR
S,
F
RA
NC
E
M&
L L
AB
OR
AT
OR
Y S
ER
VIC
ES
, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
AV
EN
TIS
PH
AR
MA
, W
AL
TL
OO
, P
RE
TO
RIA
SA
NO
FI-
SY
NT
HE
LAB
O,
MID
RA
ND
,
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
10 O
CT
OB
ER
20
08
MR
F1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e o
f med
icin
e:
Dos
age
form
:
Act
ive
innr
prtiA
nt<:
:.·
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
/FP
RR
:
FP
RR
:
She
lf-lif
e:
Dat
e o
f reg
istr
atio
n:
A40
/2.2
/044
3
IVE
DA
L M
R 1
2,5
TA
BL
ET
EA
CH
TA
BL
ET
CO
NT
AIN
S:
ZO
LPID
EM
TA
RT
RA
TE
12
,5 m
g
1,2
,3,4
,5,6
,7,8
(J
)S
AN
OF
I-S
YN
TH
EL
AB
O (
PT
Y)
LTD
;p!
SA
NO
FI
WIN
TH
RO
P I
ND
US
TR
IE,
TO
UR
S,
~ (J)
FR
AN
CE
A
oS
AN
OF
I W
INT
HR
OP
IN
DU
ST
RIE
, T
OU
RS
, m
F
RA
NC
E
JJ »
AV
EN
TIS
PH
AR
MA
, W
AL
TLO
O,
PR
ET
OR
IA
z :-l
SA
NO
FI
WIN
TH
RO
P I
ND
US
TR
IE,
TO
UR
S,
<0F
RA
NC
E
M&
L L
AB
OR
AT
OR
Y S
ER
VIC
ES
, O
RM
ON
DE
, m
o (J
)JO
HA
NN
ES
BU
RG
m s: OJ
m
JJ
AV
EN
TIS
PH
AR
MA
, WA
LTLO
O,
PR
ET
OR
IA
o I\l o
SA
NO
FI-
SY
NT
HE
LA
BO
, M
IDR
AN
D,
co
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
10
OC
TO
BE
R 2
008
z !=>
w
.....
Ol
<0
Ol ... ......
.... 0)
MR
F15
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
MO
/1.2
1050
3
AR
LOF
T50
Reg
istra
tion
num
ber:
Nam
e of
med
icin
e:
MO
/1 .2
1050
4
AR
LOFT
100
z 9 w
.....
0)
(J;)
0)
Dos
age
form
: TA
BLE
T D
osag
e fo
rm:
TAB
LET
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:
EA
CH
TA
BLE
T C
ON
TAIN
S:
SE
RTR
ALI
NE
HY
DR
OC
HLO
RID
E E
QU
IVA
LEN
T TO
S
ER
TRA
LIN
E
50,0
mg
1,2
,3,4
,5,6
,7
AR
RO
W P
HA
RM
A S
OU
TH A
FR
ICA
(P
TY)
LTD
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
O,
BIR
ZEB
BU
GIA
, M
ALT
A
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
O.
BIR
ZEB
BU
GIA
, M
ALT
A
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G &
PA
CK
AG
ING
, LO
NG
DA
LE,
JOH
AN
NE
SB
UR
G
TEC
HN
IKO
N L
AB
OR
ATO
RIE
S,
RO
BE
RTV
ILLE
, FL
OR
IDA
, R
SA
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
D,
BIR
ZEB
BU
GIA
, M
ALT
A
TEC
HN
IKO
N L
AB
OR
ATO
RIE
S,
RO
BE
RTV
ILLE
, FL
OR
IDA
, R
SA
A
RR
OW
GE
NE
RIC
S L
TO,
DU
BLI
N,
IRE
LAN
D
M&
L LA
BO
RA
TOR
Y S
ER
VIC
ES
, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
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:
EA
CH
TA
BLE
T C
ON
TAIN
S:
SE
RTR
ALI
NE
HY
DR
OC
HLO
RID
E
EQ
UIV
ALE
NT
TO
SE
RTR
ALI
NE
10
0,0
mg
1,2
,3,4
,5,6
,7
AR
RO
W P
HA
RM
A S
OU
TH A
FR
ICA
(P
TY)
LTD
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
D,
BIR
ZEB
BU
GIA
, M
ALT
A
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
D,
BIR
ZEB
BU
GIA
, M
ALT
A
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G &
P
AC
KA
GIN
G,
LON
GD
ALE
, JO
HA
NN
ES
BU
RG
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, R
OB
ER
TVIL
LE,
FLO
RID
A,
RS
A
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
D,
BIR
ZEB
BU
GIA
, M
ALT
A
TEC
HN
IKO
N L
AB
OR
ATO
RIE
S,
RO
BE
RTV
ILLE
, FL
OR
IDA
, R
SA
A
RR
OW
GE
NE
RIC
S L
TO,
DU
BLI
N,
IRE
LAN
D
M&
L LA
BO
RA
TOR
Y S
ER
VIC
ES
, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
G) 0 <
m
JJ z s: m
z --I
G)
}>
N m
--I
--I m
.....
(J;) 0 m
("
) m s: co m
JJ
I\)
0 0 CD
FPR
R:
AR
RO
W P
HA
RM
A S
A,
WO
OD
ME
AD
, R
SA
FP
RR
: A
RR
OW
PH
AR
MA
SA
, W
OO
DM
EA
D,
RS
A
She
lf-lif
e:
36 m
onth
s S
helf-
life:
36
mon
ths
Dat
e of
regi
stra
tion:
10
OC
TOB
ER
200
8 D
ate
of re
gist
ratio
n:
10 O
CTO
BE
R 2
008
MR
F15
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
C:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
A40
/1.2
1050
5
AR
RO
W S
ER
TRA
LIN
E 5
0
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
SE
RTR
ALI
NE
HY
DR
OC
HLO
RID
E E
QU
IVA
LEN
T
TO
SE
RTR
ALI
NE
50
,0 m
g
1,2
,3,4
,5,6
,7
AR
RO
W P
HA
RM
A S
OU
TH A
FRIC
A (
PTY
) LT
D
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
D,
BIR
ZEB
BU
GIA
, M
ALT
A
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
D,
BIR
ZEB
BU
GIA
, M
ALT
A
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G &
PA
CK
AG
ING
, LO
NG
DA
LE,
JOH
AN
NE
SB
UR
G
TEC
HN
IKO
N L
AB
OR
ATO
RIE
S,
RO
BE
RTV
ILLE
, FL
OR
IDA
, R
SA
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
D,
BIR
ZEB
BU
GIA
, M
ALT
A
TEC
HN
IKO
N L
AB
OR
ATO
RIE
S,
RO
BE
RTV
ILLE
, FL
OR
IDA
, R
SA
A
RR
OW
GE
NE
RIC
S L
TD,
DU
BLI
N,
IRE
LAN
D
M&
L LA
BO
RA
TOR
Y S
ER
VIC
ES
, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
AR
RO
W P
HA
RM
A S
A,
WO
OD
ME
AD
, R
SA
36 m
onth
s
10 O
CTO
BE
R 2
008
MR
F 15
Reg
istra
tion
num
ber:
Nam
e o
f 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
R:
She
lf-lif
e:
Dat
e o
f reg
istra
tion:
A40
11.2
1050
6
AR
RO
W S
ER
TRA
LIN
E 1
00
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TAIN
S:
SE
RTR
ALI
NE
HY
DR
OC
HLO
RID
E
EQ
UIV
ALE
NT
TO
SE
RTR
ALI
NE
10
0,0
mg
1,2
,3,4
,5,6
,7
en
AR
RO
W P
HA
RM
A S
OU
TH A
FRIC
A (
PTY
) ~
LTD
~ en
A
RR
OW
PH
AR
MA
(M
ALT
A)
LTD
, A
oB
IRZE
BB
UG
IA,
MA
LTA
m
:D
A
RR
OW
PH
AR
MA
(M
ALT
A)
» B
IRZE
BB
UG
IA,
MA
LTA
z :-I
D
IVP
HA
RM
MA
NU
FAC
TUR
ING
&
-'"
PA
CK
AG
ING
, LO
NG
DA
LE,
<.0 o
JOH
AN
NE
SB
UR
G
m
enTE
CH
NIK
ON
LA
BO
RA
TOR
IES
, m
RO
BE
RTV
ILLE
, FL
OR
IDA
, R
SA
~
OJ
AR
RO
W P
HA
RM
A (
MA
LTA
) LT
D,
m
:DB
IRZE
BB
UG
IA,
MA
LTA
I\
) oTE
CH
NIK
ON
LA
BO
RA
TOR
IES
, o
RO
BE
RTV
ILLE
, FL
OR
IDA
, R
SA
co
A
RR
OW
GE
NE
RIC
S L
TD,
DU
BLI
N,
IRE
LAN
D
M&
L LA
BO
RA
TOR
Y S
ER
VIC
ES
, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
AR
RO
W P
HA
RM
A S
A,
WO
OD
ME
AD
, R
SA
36 m
onth
s
10 O
CTO
BE
R 2
008
z !'
w
-'"
0>
<.0 0> .... co
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e o
f med
icin
e:
Dos
age
fom
n:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istr
atio
n:
App
lican
t:
Man
ufa
ctu
rer:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RR
:
She
lf-lif
e:
Dat
e o
f reg
istr
atio
n:
A40
f30.
1/05
41
PE
DIA
CE
L
INJE
CT
ION
EA
CH
0,5
ml
DO
SE
CO
NT
AIN
S:
PE
RT
US
SIS
TO
XO
ID
20,0
~g
FIL
AM
EN
TO
US
HA
EM
AG
GLU
TIN
IN
20,0
~g
FIM
BR
IAL
AG
GLU
TIN
OG
EN
S 2
+3
5,0 ~g
PE
RT
AC
TIN
3,
0 ~g
DIP
HT
HE
RIA
TO
XO
ID
15,0
Lf
TE
TA
NU
S T
OX
OID
5,
0 L
f IN
AC
TIV
AT
ED
PO
LIO
MY
ELI
TIS
VA
CC
INE
: T
YP
E 1
40
,0 D
-Ant
igen
Uni
ts
TY
PE
2
8,0
D-A
ntig
en U
nits
T
YP
E 3
32
,0 D
-Ant
igen
Uni
ts
HA
EM
OP
HIL
US
b C
ON
JUG
AT
E V
AC
CIN
E 1
0,0 ~g
boun
d to
T
ET
AN
US
PR
OT
EIN
20
,0 ~g
1,2
,3,4
,5,6
,7
AV
EN
TIS
PH
AR
MA
(P
TY
) LT
D
AV
EN
TIS
PA
ST
EU
R L
TD
, T
OR
ON
TO
, O
NT
AR
IO,
Can
ada
A
VE
NT
IS P
AS
TE
UR
, M
AR
CY
L'E
TO
ILE
, F
RA
NC
E
AV
EN
TIS
PA
ST
EU
R L
TD
, T
OR
ON
TO
, O
NT
AR
IO,
CA
NA
DA
AV
EN
TIS
PA
ST
EU
R L
TD
, T
OR
ON
TO
, O
NT
AR
IO,
CA
NA
DA
W
INT
HR
OP
PH
AR
MA
CE
UT
ICA
LS,
WA
L T
LOO
, P
RE
TO
RIA
AV
EN
TIS
PH
AR
MA
, M
IDR
AN
D
36 m
onth
s
10 O
CT
OB
ER
200
8
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Nam
e o
f med
icin
e:
Dos
age
fom
n:
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 o
f reg
istr
atio
n:
N o z 9 w ....
A4
0f2
2f0
56
9
(J) c.o
SA
BA
X M
IDA
ZO
LAM
IN
JEC
TIO
N 5
mg/
5 m
l (J
)
INJE
CT
ION
EA
CH
5,0
ml S
OLU
TIO
N C
ON
TA
INS
: M
IDA
ZO
LAM
5,
0 m
g
G) o <
m
JJ
Z s:: m
z -I
G) » N
1,2
,3,4
,5,6
,7,8
m
::j
AD
CO
CK
ING
RA
M C
RIT
ICA
L C
AR
E (
PT
Y)
LTD
m
P
HA
RM
A-Q
, IN
DU
ST
RIA
, JO
HA
NN
ES
BU
RG
.... <0
o m
()P
HA
RM
A-Q
, IN
DU
ST
RIA
, JO
HA
NN
ES
BU
RG
m
s:: OJ
mP
HA
RM
A-Q
, IN
DU
ST
RIA
, JO
HA
NN
ES
BU
RG
JJ
I\
) o o (Xl
AD
CO
CK
IN
GR
AM
CR
ITIC
AL
CA
RE
, A
ER
OT
ON
,
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
10 O
CT
OB
ER
200
8
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
C:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
A40
/2.2
1057
0
SA
BA
X M
IDA
ZO
LAM
IN
JEC
TIO
N 1
5 m
g/3
ml
INJE
CT
ION
EA
CH
3,0
ml
SO
LUTI
ON
CO
NT
AIN
S:
MID
AZO
LAM
15
,0 m
g
1,2
,3,4
,5,6
,7,8
AD
CO
CK
IN
GR
AM
CR
ITIC
AL
CA
RE
(P
TY)
LTD
PH
AR
MA
-Q,
IND
US
TR
IA,
JOH
AN
NE
SB
UR
G
PH
AR
MA
-Q,
IND
US
TR
IA,
JOH
AN
NE
SB
UR
G
PH
AR
MA
-Q,
IND
US
TR
IA,
JOH
AN
NE
SB
UR
G
AD
CO
CK
IN
GR
AM
CR
ITIC
AL
CA
RE
, A
ER
OTO
N,
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
10 O
CT
OB
ER
200
8
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
C:
FPR
R:
She
lf-lif
e:
Dat
e o
f reg
istra
tion:
A40
/2.2
/057
1
SA
BA
X M
IDA
ZO
LAM
IN
JEC
TIO
N
50 m
g/10
ml
INJE
CT
ION
EA
CH
10,
0 m
l SO
LUTI
ON
CO
NT
AIN
S:
(J')
MID
AZ
OLA
M
50,0
mg
);! ~ 1
,2,3
,4,5
,6,7
,8
(J') A
AD
CO
CK
IN
GR
AM
CR
ITIC
AL
CA
RE
(P
TY)
o mLT
D
:D »
PH
AR
MA
-Q,
IND
US
TR
IA,
z .-i
JOH
AN
NE
SB
UR
G
PH
AR
MA
-Q,
IND
US
TR
IA,
<D
oJO
HA
NN
ES
BU
RG
m
(J
')
PH
AR
MA
-Q,
IND
US
TR
IA,
m s:JO
HA
NN
ES
BU
RG
lJJ
m
:D
I\
) o o OJ
AD
CO
CK
IN
GR
AM
CR
ITIC
AL
CA
RE
, A
ER
OT
ON
,JO
HA
NN
ES
BU
RG
24 m
onth
s (P
rovi
sion
al)
10 O
CT
OB
ER
200
8
z 9 Ul
Ol
<D
Ol
/I) ...
MR
F15
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
C:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
41f7
.1.3
/017
6
QU
INA
CE
5 m
g
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
QU
INA
PR
IL H
YD
RO
CH
LOR
IDE
EQ
UIV
ALE
NT
TO
QU
INA
PR
IL
5,0
mg
1,2
,3,4
,5,6
,7
PH
AR
MA
DY
NA
MIC
S (
PTY
) LT
D
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
, IC
ELA
ND
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, R
OB
ER
TVIL
LE,
FLO
RID
A,
RS
A
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
, IC
ELA
ND
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, R
OB
ER
TVIL
LE,
FLO
RID
A,
RS
A
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G &
PA
CK
AG
ING
, LO
NG
DA
LE, J
OH
AN
NE
SB
UR
G
PH
AR
MA
CE
UTI
CA
L E
NTE
RP
RIS
ES
, N
'DA
BE
NI,
KZN
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
, IC
ELA
ND
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, R
OB
ER
TVIL
LE,
FLO
RID
A,
RS
A
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TOR
IES
, S
TAR
S
TRE
ET,
ATL
AS
VIL
LE,
BO
KS
BU
RG
PH
AR
MA
DY
NA
MIC
S,
SIL
VE
RW
OO
D,
WE
STL
AK
E
24 m
onth
s
10 O
CTO
BE
R 2
008
MR
F1
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:
FPR
C:
FPR
R:
She
lf-lif
e:
Dat
e of
reg
istra
tion:
41f7
.1.3
/017
7
QU
INA
CE
10
mg
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TAIN
S:
QU
INA
PR
IL H
YD
RO
CH
LOR
IDE
E
QU
IVA
LEN
T TO
Q
UIN
AP
RIL
1,2
,3,4
,5,6
,7
PH
AR
MA
DY
NA
MIC
S (
PTY
) LT
D
~ Z
9 w
en
(0
en
10,0
mg
Gl o <
m
II
Z :::
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
, IC
ELA
ND
m
Z
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, -;
R
OB
ER
TVIL
LE,
FLO
RID
A,
RS
A
Gl ~
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
, IC
ELA
ND
m
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, =1
RO
BE
RTV
ILLE
, FL
OR
IDA
, R
SA
J11
D
IVP
HA
RM
MA
NU
FAC
TUR
ING
&
PA
CK
AG
ING
, LO
NG
DA
LE,
JOH
AN
NE
SB
UR
G
(0
PH
AR
MA
CE
UTI
CA
L E
NTE
RP
RIS
ES
, o m
N
'DA
BE
NI,
KZN
()
m :::
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
, IC
ELA
ND
OJ
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, m
II
RO
BE
RTV
ILLE
, FL
OR
IDA
, R
SA
I\
)
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TOR
IES
, o o
STA
R S
TRE
ET,
ATL
AS
VIL
LE,
BO
KS
BU
RG
C
!)
PH
AR
MA
DY
NA
MIC
S,
SIL
VE
RW
OO
D,
WE
STL
AK
E
24 m
onth
s
10 O
CTO
BE
R 2
008
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
C:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
4117
.1.3
/017
8
QU
INA
CE
20
mg
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
QU
INA
PR
IL H
YD
RO
CH
LOR
IDE
EQ
UIV
ALE
NT
TO
QU
INA
PR
IL
20,0
mg
1,2
,3,4
,5,6
,7
PH
AR
MA
DY
NA
MIC
S (
PTY
) LT
O
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
,ICE
LAN
D
TEC
HN
IKO
N L
AB
OR
ATO
RIE
S,
RO
BE
RTV
ILLE
. FL
OR
IDA
, R
SA
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
. IC
ELA
ND
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, R
OB
ER
TVIL
LE,
FLO
RID
A,
RS
A
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G &
PA
CK
AG
ING
, LO
NG
DA
LE, J
OH
AN
NE
SB
UR
G
PH
AR
MA
CE
UTI
CA
L E
NTE
RP
RIS
ES
, N
'DA
BE
NI,
KZN
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
, IC
ELA
ND
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, R
OB
ER
TVIL
LE,
FLO
RID
A,
RS
A
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TOR
IES
, S
TAR
S
TRE
ET,
ATL
AS
VIL
LE,
BO
KS
BU
RG
PH
AR
MA
DY
NA
MIC
S,
SIL
VE
RW
OO
D, W
ES
TLA
KE
24 m
onth
s
10 O
CTO
BE
R 2
008
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
C:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
4117
.1.3
/017
9
QU
INA
CE
40
mg
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
QU
INA
PR
IL H
YD
RO
CH
LOR
IDE
E
QU
IVA
LEN
T TO
Q
UIN
AP
RIL
40
,0 m
g
1,2
,3,4
,5,6
,7
(J)
PH
AR
MA
DY
NA
MIC
S (
PTY
) LT
D
~ ~ A
CTA
VIS
Hf,
HA
FNA
RFJ
OR
DU
R,IC
ELA
ND
TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, 6
RO
BE
RTV
ILLE
, FL
OR
IDA
. R
SA
m
::I
l ~
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
, IC
ELA
ND
Z
.:-
lTE
CH
NIK
ON
LA
BO
RA
TOR
IES
, .....
R
OB
ER
TVIL
LE,
FLO
RID
A,
RS
A
r.o
DIV
PH
AR
M M
AN
UFA
CTU
RIN
G &
CJ
m
PA
CK
AG
ING
, LO
NG
DA
LE, J
OH
AN
NE
SB
UR
G
(J)
PH
AR
MA
CE
UTI
CA
L E
NTE
RP
RIS
ES
, m s::
N'D
AB
EN
I, KZ
N
(II m
AC
TAV
IS H
f, H
AFN
AR
FJO
RD
UR
, IC
ELA
ND
::I
l TE
CH
NIK
ON
LA
BO
RA
TOR
IES
, I\
) 8R
OB
ER
TVIL
LE,
FLO
RID
A,
RS
A
a>
CO
NS
ULT
ING
CH
EM
ICA
L LA
BO
RA
TOR
IES
, S
TAR
STR
EE
T, A
TLA
SV
ILLE
, B
OK
SB
UR
G
PH
AR
MA
DY
NA
MIC
S, S
ILV
ER
WO
OD
, W
ES
TLA
KE
24 m
onth
s
10 O
CTO
BE
R 2
008
z o (,0) .....
0>
r.o
0>
I\) w
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 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 o
f reg
istr
atio
n:
4117
.1.3
/021
2
QU
INA
CE
CO
101
12,5
TA
BLE
T
EA
CH
TA
BLE
T C
ON
TA
INS
: Q
UIN
AP
RIL
HY
DR
OC
HL
OR
IDE
EQ
UIV
ALE
NT
TO
Q
UIN
AP
RIL
10,
0 m
g H
YD
RO
CH
LOR
OT
HIA
ZID
E 1
2,5
mg
1,2
,3,4
,5,6
.7
PH
AR
MA
DY
NA
MIC
S (
PT
Y)
LTD
AC
TA
VIS
Hf,
HA
FN
AR
FJO
RD
UR
. IC
ELA
ND
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, R
OB
ER
TV
ILLE
, F
LOR
IDA
. R
SA
AC
TA
VIS
Hf,
HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, R
OB
ER
TV
ILLE
. F
LOR
IDA
, R
SA
D
IVP
HA
RM
MA
NU
FA
CT
UR
ING
& P
AC
KA
GIN
G.
LON
GD
ALE
, JO
HA
NN
ES
BU
RG
P
HA
RM
AC
EU
TIC
AL
EN
TE
RP
RIS
ES
, N
'DA
BE
NI,
K
ZN
AC
TA
VIS
Hf,
HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
T
EC
HN
IKO
N L
AB
OR
AT
OR
IES
, R
OB
ER
TV
ILLE
, F
LOR
IDA
, R
SA
C
ON
SU
LTIN
G C
HE
MIC
AL
LA
BO
RA
TO
RIE
S,
ST
AR
S
TR
EE
T.
AT
LA
SV
ILL
E,
BO
KS
BU
RG
PH
AR
MA
DY
NA
MIC
S,
SIL
VE
RW
OO
D, W
ES
TL
AK
E
24 m
onth
s
10 O
CT
OB
ER
200
8
MR
F 1
5
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 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 o
f reg
istr
atio
n:
N
.j:> z o w
.....
(j)
4117
.1.3
/021
3 to
(j
)
QU
INA
CE
CO
20/
12.5
TA
BLE
T
EA
CH
TA
BL
ET
CO
NT
AIN
S:
Q
UIN
AP
RIL
HY
DR
OC
HL
OR
IDE
E
QU
IVA
LEN
T T
O
QU
INA
PR
IL 2
0,0
mg
G) o
HY
DR
OC
HL
OR
OT
HIA
ZID
E 1
2,5
mg
< m1
,2,3
,4,5
,6.7
JJ
Z
P
HA
RM
A D
YN
AM
ICS
(P
TY
) LT
D
s: m
zA
CT
AV
IS H
f, H
AF
NA
RF
JOR
DU
R,
ICE
LAN
D
-l
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S,
G)
RO
BE
RT
VIL
LE,
FLO
RID
A,
RS
A
» N m
AC
TA
VIS
Hf,
HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
::j
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S,
m
RO
BE
RT
VIL
LE,
FLO
RID
A,
RS
A
toD
IVP
HA
RM
MA
NU
FA
CT
UR
ING
&
PA
CK
AG
ING
, LO
NG
DA
LE,
o m
JOH
AN
NE
SB
UR
GP
HA
RM
AC
EU
TIC
AL
()
m
EN
TE
RP
RIS
ES
, N
'DA
BE
NI,
KZ
N
s: OJ
AC
TA
V1S
Hf,
HA
FN
AR
FJO
RD
UR
, IC
ELA
ND
m
JJ
TE
CH
NIK
ON
LA
BO
RA
TO
RIE
S,
I\:)
RO
BE
RT
VIL
LE,
FLO
RID
A,
RS
A
o oC
ON
SU
LTIN
G C
HE
MIC
AL
LA
BO
RA
TO
RIE
S,
OJ
ST
AR
ST
RE
ET
, A
TLA
SV
1LLE
, B
OK
SB
UR
G
PH
AR
MA
DY
NA
MIC
S,
SIL
VE
RW
OO
D,
WE
ST
LA
KE
24 m
onth
s
10 O
CT
OB
ER
20
08
MR
F15
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
C: FP
RR
She
lf-lif
e:
Dat
e of
regi
stra
tion:
4117
.3/0
244
TRIP
TAM
50
mg
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
SU
MA
TRIP
TAM
5
0,0
mg
1,2
,3,4
,5,6
,7
PH
AR
MA
CA
RE
LIM
ITE
D
GE
NP
HA
RM
PH
AR
MA
CE
UTI
CA
LS I
NC
, E
TOB
ICO
KE
, ON
TAR
IO,
CA
NA
DA
GE
NP
HA
RM
PH
AR
MA
CE
UTI
CA
LS I
NC
, E
TOB
ICO
KE
, ON
TAR
IO,
CA
NA
DA
G
ER
AR
D L
AB
OR
ATO
RIE
S,
DU
BLI
N,
IRE
LAN
D
GE
NP
HA
RM
PH
AR
MA
CE
UTI
CA
LS I
NC
, E
TOB
ICO
KE
, O
NTA
RIO
, C
AN
AD
A
GE
RA
RD
LA
BO
RA
TOR
IES
, D
UB
LIN
, IR
ELA
ND
S
OU
TH A
FRIC
AN
BU
RE
AU
OF
STA
ND
AR
DS
, G
RO
EN
KlO
OF
, P
RE
TOR
IA
M&
l LA
BO
RA
TOR
Y S
ER
VIC
ES
, OR
MO
ND
E,
JOH
AN
NE
SB
UR
G
RE
SE
AR
CH
IN
STI
TUTE
FO
R IN
DU
STR
IAL
PO
TCH
EFS
TRO
OM
PH
AR
MA
CA
RE
lTD
,WO
OD
ME
AD
,SA
ND
TO
N
24 m
onth
s
10 O
CTO
BE
R 2
008
MR
F 15
Reg
istra
tion
num
ber:
Nam
e o
f 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
C/F
PR
R
She
lf-lif
e:
Dat
e o
f reg
istra
tion:
4117
.1.3
1029
0
EX
FOR
GE
5/8
0 m
g
TAB
LET
EA
CH
TA
BLE
T C
ON
TAIN
S:
AM
LOD
IPIN
E B
ES
YLA
TE E
QU
IVA
LEN
T TO
A
MLO
DIP
INE
5,
0 m
g V
ALS
AR
TAN
80
,0 m
g en
1,2
,3.4
,5,6
.7
~ N
OV
AR
TIS
SO
UTH
AFR
ICA
(P
TY)
LTD
~ en
NO
VA
RTI
S P
HA
RM
A S
TEIN
AG
, S
TEIN
, /\ o
SW
ITZE
RLA
ND
m
II
NO
VA
RTI
S P
HA
RM
A S
TEIN
AG
, S
TEIN
, » z
SW
ITZE
RLA
ND
;-
I A
LLP
AC
K A
G,
RE
INA
CH
, S
WIT
ZER
LAN
D
KO
NA
PH
AR
MA
AG
, P
RA
TTE
LN,
SW
ITZE
RLA
ND
<0
CJIV
ER
S-L
EE
AG
, B
UR
GD
OR
F, S
WIT
ZER
LAN
D
m
NO
VA
RTI
S S
A,
SP
AR
TAN
, K
EM
PTO
N P
AR
K
en m
:;;::N
OV
AR
TIS
PH
AR
MA
STE
IN A
G,
STE
IN.
OJ
SW
ITZE
RLA
ND
m
II
NO
VA
RTI
S P
HA
RM
A A
NA
LY
TIC
A S
A,
LOC
AR
NO
, t\
)S
WIT
ZER
LAN
D
o M
&l L
AB
OR
ATO
RY
SE
RV
ICE
S,
OR
MO
ND
E,
(l) o
JOH
AN
NE
SB
UR
G
NO
VA
RTI
S S
A,
SP
AR
TAN
, K
EM
PTO
N P
AR
K
24 m
onth
s
10 O
CTO
BE
R 2
008
z p (,J .....
en
<0
en ~
MR
F 1
5
Reg
istr
atio
n nu
mbe
r:
Na
me
of m
edic
ine:
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
/FP
RR
:
She
lf-lif
e:
Dat
e o
f reg
istr
atio
n:
4117
.1.3
/029
1
EX
FO
RG
E 5
1160
mg
TA
BLE
T
EA
CH
TA
BL
ET
CO
NT
AIN
S:
AM
LOD
IPIN
E B
ES
YLA
TE
EQ
UIV
ALE
NT
TO
A
MLO
DIP
INE
5,
0 m
g
VA
LSA
RT
AN
16
0,0
mg
1,2
,3,4
,5,6
,7
NO
VA
RT
IS S
OU
TH
AF
RIC
A (
PT
Y)
LTD
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, S
WIT
ZE
RLA
ND
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, S
WIT
ZE
RLA
ND
A
LLP
AC
K A
G,
RE
INA
CH
, S
WIT
ZE
RLA
ND
K
ON
AP
HA
RM
A A
G,
PR
AT
TE
LN,
SW
ITZ
ER
LAN
D
IVE
RS
-LE
E A
G,
BU
RG
DO
RF
, S
WIT
ZE
RLA
ND
N
OV
AR
TIS
SA
, S
PA
RT
AN
, K
EM
PT
ON
PA
RK
NO
VA
RT
IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, S
WIT
ZE
RLA
ND
N
OV
AR
TIS
PH
AR
MA
AN
AL
YT
ICA
SA
, LO
CA
RN
O,
SW
ITZ
ER
LAN
D
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L L
AB
OR
AT
OR
Y S
ER
VIC
ES
, O
RM
ON
DE
, JO
HA
NN
ES
BU
RG
NO
VA
RT
IS S
A,
SP
AR
TA
N,
KE
MP
TO
N P
AR
K
24
mon
ths
10 O
CT
OB
ER
20
08
MR
F1
5
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 reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
:
FP
RC
/FP
RR
:
She
lf-lif
e:
Dat
e o
f reg
istr
atio
n:
N
(J) z o w
.....
0)
(l)
0)
41 f7
.1.3
1029
2
EX
FO
RG
E 1
0/16
0 m
g
TA
BLE
T
EA
CH
TA
BL
ET
CO
NT
AIN
S:
AM
LOD
IPIN
E B
ES
YLA
TE
EQ
UIV
ALE
NT
TO
Q
AM
LOD
IPIN
E
10,0
mg
oV
ALS
AR
TA
N
160,
0 m
g <
m
J)
1,2
,3,4
,5,6
,7
z s:: N
OV
AR
TIS
SO
UT
H A
FR
ICA
(PT
Y)
LTD
m
z -I
NO
VA
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IS P
HA
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TE
IN A
G,
ST
EIN
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ER
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~ N
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ST
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-IS
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AT
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, S
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RLA
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o
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VA
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IS S
A,
SP
AR
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N,
KE
MP
TO
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AR
K
m
(') m
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VA
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IS P
HA
RM
A S
TE
IN A
G,
ST
EIN
, s::
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ITZ
ER
LAN
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mN
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AR
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, LO
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ER
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L L
AB
OR
AT
OR
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ER
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ES
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RM
ON
DE
, o o
JOH
AN
NE
SB
UR
G
en
NO
VA
RT
IS S
A,
SP
AR
TA
N,
KE
MP
TO
N P
AR
K
24 m
onth
s
10 O
CT
OB
ER
200
8
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
FPR
R
She
lf-lif
e:
Dat
e of
regi
stra
tion:
41
/34
/05
58
RE
NA
GE
L
TA
BLE
T
EA
CH
TA
BL
ET
CO
NT
AIN
S:
S
EV
E L
AM
ER
HY
DR
OC
HL
OR
IDE
8
oo
,Om
g
1,2
,3,4
,5,6
,7
LE B
AS
I P
HA
RM
AC
EU
TIC
AL
S C
C
GE
NZ
YM
E I
RE
LA
ND
LT
D,
WA
TE
RF
OR
D,
IRE
LAN
D
GE
NZ
YM
E I
RE
LA
ND
L TO
, W
AT
ER
FO
RD
, IR
ELA
ND
GE
NZ
YM
E I
RE
LAN
D L
TD
, W
AT
ER
FO
RD
, IR
EL
AN
D
RE
SE
AR
CH
IN
ST
ITU
TE
FO
R I
ND
US
TR
IAL
P
HA
RM
AC
Y,
NO
RT
H-W
ES
T U
NIV
ER
SIT
Y,
P
OT
CH
EF
ST
RO
OM
IN
ST
ITU
TE
FO
R P
HA
RM
AC
EU
TIC
AL
S S
ER
VIC
ES
, S
ILV
ER
TO
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ALE
, P
RE
TO
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ON
SU
LTIN
G C
HE
MIC
AL
LA
BO
RA
TO
RIE
S,
ST
AR
S
TR
EE
T.
AT
LAS
VIL
LE,
BO
KS
BU
RG
LEB
AS
I P
HA
RM
AC
EU
TIC
ALS
, P
OT
CH
EF
ST
RO
OM
24 m
onth
s
10
OC
TO
BE
R 2
00
8
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
C/F
PR
R:
FPR
R:
She
lf-lif
e:
Dat
e of
regi
stra
tion:
41
/20
.2.8
/05
96
PR
OP
AN
ST
AV
UD
INE
20
mg
CA
PS
ULE
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
ST
AV
UD
INE
1,2
.3,4
,5,6
.7,8
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
AM
HE
AL
TH
CA
RE
, m
W
AD
EV
ILLE
, G
ER
MIS
TO
N
lJ » Z
AD
CO
CK
IN
GR
AM
HE
AL
TH
CA
RE
, :-I
W
AD
EV
ILLE
, G
ER
MIS
TO
N
.....
<0
AD
CO
CK
ING
RA
M H
EA
L TH
CA
RE
, 0
WA
DE
VIL
LE,
GE
RM
IST
ON
(J
) m
AD
CO
CK
IN
GR
AM
LT
D,
AE
RO
TO
N,
m s::JO
HA
NN
ES
BU
RG
II
I m
lJ
rv
0 0 co
AD
CO
CK
IN
GR
AM
LT
D,
BR
YA
NS
TO
N.
JOH
AN
NE
SB
UR
G
24 m
onth
s (P
rovi
sion
al)
10
OC
TO
BE
R 2
00
8
z !'
Ci) ..... m
en
I\,)
.....
20
,Om
g
(J) ~ ~ (J) 0 '"
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 reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
IFP
RR
:
FP
RR
:
She
lf-lif
e:
Dat
e o
f reg
istr
atio
n:
41/2
0.2.
8/05
97
PR
OP
AN
ST
AV
UD
INE
30
mg
CA
PS
ULE
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
S
TA
VU
DIN
E
30
,Om
g
1,2
,3,4
,5,6
,7,8
AD
CO
CK
IN
GR
AM
LIM
ITE
D
AD
CO
CK
IN
GR
AM
HE
AL
TH
CA
RE
, W
AD
EV
ILL
E.
G
ER
MIS
TO
N
AD
CO
CK
IN
GR
AM
HE
AL T
HC
AR
E.
WA
DE
VIL
LE
.
GE
RM
IST
ON
AD
CO
CK
IN
GR
AM
HE
AL
TH
CA
RE
. W
AD
EV
ILL
E,
G
ER
MIS
TO
N
AD
CO
CK
IN
GR
AM
LT
D,
AE
RO
TO
N.
JO
HA
NN
ES
BU
RG
AD
CO
CK
IN
GR
AM
LT
D,
BR
YA
NS
TO
N,
JO
HA
NN
ES
BU
RG
24
mon
ths
(Pro
visi
onal
)
10
OC
TO
BE
R 2
008
MR
F 1
5
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 reg
istr
atio
n:
App
lican
t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
FP
RC
/FP
RR
:
FP
RR
:
She
lf-lif
e:
Dat
e o
f re
gist
ratio
n:
41/2
0.2.
8/05
98
PR
OP
AN
ST
AV
UD
INE
40
mg
CA
PS
ULE
EA
CH
CA
PS
ULE
CO
NT
AIN
S:
ST
AV
UD
INE
1.2
.3.4
,5,6
.7.8
AD
CO
CK
IN
GR
AM
LIM
ITE
D
I\)
(XI z 9 c..l .....
O'l
(!)
O'l G) 0 <
40
,0 m
g m
::0
z s: m
z -I
G)
AD
CO
CK
ING
RA
M H
EA
L T
HC
AR
E,
»W
AD
EV
ILLE
. G
ER
MIS
TO
N
N m
AD
CO
CK
IN
GR
AM
HE
ALT
H C
AR
E.
~ W
AD
EV
ILLE
. G
ER
MIS
TO
N
J11
.....
AD
CO
CK
IN
GR
AM
HE
AL
TH
CA
RE
, (!
) 0W
AD
EV
ILLE
. G
ER
MIS
TO
N
m
AD
CO
CK
IN
GR
AM
LT
D,
AE
RO
TO
N.
(') m
JOH
AN
NE
SB
UR
G
s: to m
::0
I\)
AD
CO
CK
IN
GR
AM
LT
D.
BR
YA
NS
TO
N,
I gJO
HA
NN
ES
BU
RG
24
mo
nth
s (P
rovi
sion
al)
10 O
CT
OB
ER
200
8
MR
F1
5
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 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
1.21
0700
GL
iMA
RY
L 1
mg
TA
BL
ET
EA
CH
TA
BL
ET
CO
NT
AIN
S:
GLi
ME
PIR
IDE
1,
0 m
g
1,2
,3,4
,5,6
,7
XIX
IA P
HA
RM
AC
EU
TIC
ALS
(P
TY
) LT
D
ME
RC
K F
AR
MA
YQ
UIM
ICA
, M
OL
LE
T D
EL
VA
LLE
S,
BA
RC
ELO
NA
, S
PA
IN
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
,
WA
DE
VIL
LE,
GE
RM
IST
ON
ME
RC
K F
AR
MA
YQ
UIM
ICA
, M
OL
LE
T D
EL
VA
LLE
S,
BA
RC
ELO
NA
, S
PA
IN
GE
NE
RIC
S (
UK
) L T
O,
ST
AT
ION
CLO
SE
,
HE
RT
FO
RD
SH
IRE
, U
K
GE
RA
RD
LA
BO
RA
TO
RIE
S,
DU
BLI
N,
IRE
LAN
D
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
,
WA
DE
VIL
LE,
GE
RM
IST
ON
ME
RC
K F
AR
MA
YQ
UIM
ICA
, M
OL
LE
T D
EL
VA
LLE
S,
BA
RC
ELO
NA
, S
PA
IN
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
,
WA
DE
VIL
LE,
GE
RM
IST
ON
R
ES
EA
RC
H I
NS
TIT
UT
E F
OR
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
XIX
1A P
HA
RM
AC
EU
TIC
ALS
, M
OD
DE
RF
ON
TE
IN,
RS
A
24 m
onth
s
10 O
CT
OB
ER
200
8
MR
F 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 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 o
f reg
istr
atio
n:
41/2
1.2/
0701
GL
iMA
RY
L 2
mg
TA
BL
ET
EA
CH
TA
BL
ET
CO
NT
AIN
S:
GL
iME
PIR
IDE
2,
0 m
g
1,2
,3,4
,5,6
,7
(f)
XIX
IA P
HA
RM
AC
EU
TIC
ALS
(P
TY
) L T
O
~ M
ER
CK
FA
RM
A Y
QU
IMIC
A,
MO
LLE
T D
EL
~ (f
)V
ALL
ES
, B
AR
CE
LON
A,
SP
AIN
A
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FA
CT
UR
ING
, o
WA
DE
VIL
LE,
GE
RM
IST
ON
m
JJ
M
ER
CK
FA
RM
A Y
QU
IMIC
A,
MO
LL
ET
DE
L » Z
VA
LLE
S,
BA
RC
ELO
NA
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PA
IN
~-I
GE
NE
RIC
S (
UK
) LT
D,
ST
AT
ION
CLO
SE
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ER
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OR
DS
HIR
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UK
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RA
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N,
IRE
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o
M
ER
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AR
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L M
AN
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RIN
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m
(f)
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DE
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LE,
GE
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IST
ON
m
s:
ME
RC
K F
AR
MA
YQ
UIM
ICA
, M
OL
LE
T D
EL
III
VA
LLE
S,
BA
RC
ELO
NA
, S
PA
IN
m
JJM
ER
CK
PH
AR
MA
CE
UT
ICA
L M
AN
UF
AC
TU
RIN
G,
I\)
WA
DE
VIL
LE,
GE
RM
IST
ON
o o
RE
SE
AR
CH
IN
ST
ITU
TE
FO
R I
ND
US
TR
IAL
co
PH
AR
MA
CY
, N
OR
TH
WE
ST
UN
IVE
RS
ITY
, P
OT
CH
EF
ST
RO
OM
XIX
IA P
HA
RM
AC
EU
TIC
ALS
, M
OD
DE
RF
ON
TE
IN,
RS
A
24 m
onth
s
10 O
CT
OB
ER
200
8
z o (,i) .... (l)
«)
(l)
III
(I)
t.) o z 9 (,J .....
MRF
15
MRF
15
m
en
Reg
istra
tion
num
ber:
4112
1.2/
0702
R
egis
tratio
n nu
mbe
r: 41
/8.1
/108
6
Nam
e of
med
icin
e:
GLI
MA
RY
L 4
mg
Nam
e of
med
icin
e:
KO
GE
NA
TE F
S 2
50
Dos
age
form
: TA
BLE
T D
osag
e fo
nn:
INJE
CTI
ON
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
EA
CH
TA
BLE
T C
ON
TAIN
S:
GLI
ME
PIR
IDE
4,
0 m
g
1, 2
, 3,
4,
5, 6
, 7
XIX
IA P
HA
RM
AC
EU
TIC
ALS
(P
lY)
L TO
ME
RC
K F
AR
MA
YQ
UIM
ICA
, M
OLL
ET
DE
L V
ALL
ES
, B
AR
CE
LON
A, S
PA
IN
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FAC
TUR
ING
, W
AD
EV
ILLE
, G
ER
MIS
TON
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
istra
tion:
App
lican
t:
Man
ufac
ture
r:
EA
CH
VIA
L C
ON
TAIN
S:
OC
TOC
OG
ALF
A
250,
0 I.U
.
1,2
,3,4
,5,6
,7
BA
YE
R (
PTY
) LT
D
BA
YE
R C
OR
PO
RA
TIO
N,
BE
RK
ELE
Y,
CA
LIFO
RN
IA.
US
A
G> o <
m
JJ z So: m
z -i
G>
Pac
ker:
Labo
rato
ry:
FPR
C:
ME
RC
K F
AR
MA
YQ
UIM
ICA
, M
OLL
ET
DE
L V
ALL
ES
, B
AR
CE
LON
A.
SP
AIN
G
EN
J:R
ICS
(U
K)
LTO
, STA
TIO
N C
LOS
E,
HE
RTF
OR
DS
HIR
E,
UK
G
ER
AR
D L
AB
OR
ATO
RIE
S,
DU
BLI
N,
IRE
LAN
D
ME
RC
K P
HA
RM
AC
EU
TIC
AL
MA
NU
FAC
TUR
ING
, W
AD
EV
ILLE
, G
ER
MIS
TON
ME
RC
K F
AR
MA
YQ
UIM
1CA
, MO
LLE
T D
EL
VA
LLE
S,
BA
RC
ELO
NA
, S
PA
IN
ME
RC
K P
HA
RM
AC
EU
TIC
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num
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Na
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Do
sag
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rm:
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ive
ingr
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nts:
Co
nd
itio
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of r
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lican
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nu
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form
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edie
nts:
Con
ditio
ns o
f reg
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App
lican
t:
Man
ufac
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r:
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ker:
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ditio
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me
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edic
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Dos
age
form
:
Act
ive
ingr
edie
nts:
Con
ditio
ns o
f reg
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atio
n:
App
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t:
Man
ufac
ture
r:
Pac
ker:
Labo
rato
ry:
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lf-lif
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form
:
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edie
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Con
ditio
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f reg
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n:
App
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t:
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ufac
ture
r:
Pac
ker:
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rato
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lf-lif
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