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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2016/C 312/02)
— Issuing, maintenance or modification of a national marketing authorization
Date of the decision
Name(s) of the medicinal product
INN (International Non- Proprietary Name)
Holder(s) of the mar-keting authorization
Member State con-cerned
Date of noti-fication
8.8.2016 Saizen (and associated names) and Humatrope (and associated names)
somatropin Not applicable Not applicable 9.8.2016
— Revocation of a national marketing authorization
Date of the decision
Name(s) of the medicinal product
INN (International Non- Proprietary Name)
Holder(s) of the mar-keting authorization
Member State con-cerned
Date of noti-fication
14.7.2016 Colistin combinations colistin See Annex I See Annex I 15.7.2016
C 312/10 EN Official Journal of the European Union 26.8.2016
(1) OJ L 311, 28.11.2001, p. 67.(2) OJ L 311, 28.11.2001, p. 1.
AN
NEX
List
of
the
nam
es, p
harm
aceu
tical
for
ms,
stre
ngth
s of
the
vet
erin
ary
med
icin
al p
rodu
cts,
anim
al s
peci
es, r
oute
of
adm
inis
trat
ion,
and
mar
ketin
g au
thor
isat
ion
hold
ers
in t
he M
embe
r St
ates
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Bulg
aria
Farm
a ve
t Lt
d40
Ote
c Pa
isii s
tr.Sh
umen
Bulg
aria
Коли
тетр
авит
/CO
LI —
TET
-RA
VIT
Oxy
tetr
acyc
line
hy-
droc
hlor
ide
Colis
tin s
ulph
ate
5,0
g3
500
000
UI
Ora
l sol
utio
nCh
icke
ns a
nd p
igs
Ora
l adm
inist
ra-
tion
Bulg
aria
COO
PHAV
ET S
.A.S
.B.
P. 7
Sai
nt H
erbl
on44
153
AN
CEN
IS C
edex
Fran
ce
Коли
султ
рикс
/CO
LISU
LTRI
XTr
imet
hopr
imCo
listin
sul
phat
e3,
75 g
50 M
IUO
ral p
owde
rCh
icke
ns, r
abbi
ts, p
igs,
calv
es a
nd la
mbs
Ora
l adm
inist
ra-
tion
Croa
tiaA
rnik
a Ve
terin
a d.
o.o.
Vodo
vodn
a 20
a10
000
Zagr
ebCr
oatia
COLI
SULT
RIX
Trim
etho
prim
Colis
tin s
ulph
ate
3,75
g50
MIU
Ora
l pow
der
Calv
es, l
ambs
, kid
s, pi
g-le
ts, p
oultr
y an
d ra
bbits
Ora
l
Croa
tiaCe
va S
anté
Ani
mal
e10
Ave
nue
de la
Bal
last
ière
3350
0 Li
bour
neFr
ance
QU
INO
COL
Enro
floxa
cin
Colis
tin s
ulph
ate
100
g41
,67
gO
ral s
olut
ion
Chic
ken,
tur
key
Ora
l
Cypr
usFA
TRO
S.p
.A.
Via
Emili
a, 2
8540
064
Ozz
ano
Emili
a (B
olog
-na
)Ita
ly
BACO
LAM
pow
der
for
oral
so
lutio
n fo
r ca
lves
, she
ep,
goat
s, pi
gs, f
oals,
chi
cken
s, tu
rkey
s (e
xclu
ding
laye
rs)
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
100
mg
500
000
I.U.
Pow
der
for
oral
so
lutio
nCa
lves
, she
ep, g
oats
, pi
gs, f
oals,
chi
cken
s, tu
rkey
s (e
xclu
ding
la
yers
)
Adm
inist
er t
he
dose
sub
divi
ded
into
tw
o ad
min
is-tr
atio
ns e
ach
day,
di
ssol
ved
in
drin
king
wat
er o
r in
milk
.
26.8.2016 EN Official Journal of the European Union C 312/11
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Cypr
usVe
toqu
inol
Ita
lia S
.R.L
Via
Pian
a, 2
6547
032
Bert
inor
oIta
ly
ZEM
AM
IX p
rem
ix fo
r m
edi-
cate
d fe
edin
gstu
ff fo
r pi
gsA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e11
,48
g4,
00 g
Prem
ix fo
r m
edi-
cate
d fe
edin
gstu
ffPi
gsPr
emix
for
med
i-ca
ted
feed
ings
tuff
in in
solu
ble
pow
-de
r, to
be
adm
i-ni
ster
ed o
rally
pr
oper
ly m
ixed
in
solid
fee
d.
Czec
h Re
publ
icLA
VET
Phar
mac
eutic
als
Ltd
Ottó
u.1
411
61 B
udap
est
Hun
gary
AM
OXY
COL
plv.
sol.
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
640
mg/
g3
200
000
IU/g
Pow
der
for
oral
so
lutio
n fo
r us
e in
dr
inki
ng w
ater
or
in f
eed
Pigs
, chi
cken
(bro
ilers
)O
ral
Czec
h Re
publ
icCO
OPH
AVET
S.A
.S.
B.P.
7 S
aint
Her
blon
4415
3 A
NCE
NIS
Ced
exFr
ance
BELC
OSP
IRA
ORA
L pr
ášek
pr
o př
ípra
vu p
eror
ální
ho r
oz-
toku
Colis
tin s
ulph
ate
Spir-
amyc
in a
dipa
te50
0 00
0 IU
650
000
IUPo
wde
r fo
r or
al
solu
tion
Calv
es, p
igle
ts, f
oals,
ch
icke
nO
ral
Czec
h Re
publ
icCO
OPH
AVET
S.A
.S.
B.P.
7 S
aint
Her
blon
4415
3 A
NCE
NIS
Ced
exFr
ance
COLI
SULT
RIX
plv.
sol
.Tr
imet
hopr
imCo
listin
sul
phat
e37
,5 m
g50
0 00
0 IU
/gPo
wde
r fo
r or
al
solu
tion
Chic
ken
Ora
l
Czec
h Re
publ
icIn
dust
ria
Italia
na I
nteg
rato
ri
Trei
S.p
.A.
Via
Cora
ssor
i, 62
4110
0 M
oden
aIta
ly
MIC
ROA
MO
X CO
LI p
rem
ix
pro
med
ikac
i krm
iva
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
100
mg/
g60
0 00
0 IU
/gPr
emix
for
med
i-ca
ted
feed
Pigs
Ora
l
C 312/12 EN Official Journal of the European Union 26.8.2016
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Fran
ceM
ERIA
L29
ave
nue
Tony
Gar
nier
6900
7 LY
ON
Fran
ce
BELC
OSP
IRA
ORA
LCo
listin
sul
phat
eSp
iram
ycin
adi
pate
500
000
IU/g
650
000
IU/g
Pow
der
for
oral
us
eCa
ttle,
pig
s, po
ultr
yO
ral u
se
Fran
ceLA
BORA
TOIR
ES B
IOVE
3 Ru
e de
Lor
rain
e62
510
Arq
ues
Fran
ce
COLA
MPI
BA
mpi
cilli
n tr
ihyd
rate
Colis
tin s
ulph
ate
25 m
g/g
0,07
5 M
IU/g
Pow
der
for
oral
us
ePi
gs, c
alve
sO
ral u
se
Fran
ceLA
BORA
TOIR
ES B
IOVE
3 Ru
e de
Lor
rain
e62
510
Arq
ues
Fran
ce
COLA
MPI
OA
mpi
cilli
n tr
ihyd
rate
Colis
tin s
ulph
ate
1 g/
tabl
et1
MIU
/tabl
etTa
blet
Calv
esO
ral u
se
Fran
ceVE
TOQ
UIN
OL
Mag
ny V
erno
is70
200
Lure
Fran
ce
COLI
DIA
RYL
Colis
tin s
ulph
ate
Ery-
thro
myc
in e
stol
ate
83 4
00 I
U/g
16 6
00 I
U/g
Pow
der
for
oral
us
eLa
mb,
goa
t, pi
glet
s, fo
als,
calv
esO
ral u
se
Fran
ceM
ERIA
L29
ave
nue
Tony
Gar
nier
6900
7 LY
ON
Fran
ce
COLI
SULT
RIX
POU
DRE
Colis
tin s
ulph
ate
Trim
etho
prim
500
000
IU/g
37,5
mg/
gPo
wde
r fo
r or
al
use
Lam
b, g
oat,
rabb
its, p
igs,
calv
es, p
oultr
yO
ral u
se
Fran
ceVI
RBA
C1e
re A
venu
e 20
65m
L.I.
D.
0651
6 Ca
rros
Ced
exFr
ance
ENTE
ROG
EL 3
0Co
listin
sul
phat
eSc
opol
amin
eSu
lfagu
anid
ine
10,5
MIU
/syr
-in
ge0,
216
g/sy
ring
e4,
2 g/
syri
nge
Ora
l pas
teFo
als,
calv
esO
ral u
se
26.8.2016 EN Official Journal of the European Union C 312/13
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Fran
ceVI
RBA
C1e
re A
venu
e 20
65m
L.I.
D.
0651
6 Ca
rros
Ced
exFr
ance
INTE
STIV
OCo
listin
sul
phat
eSu
lfagu
anid
ine
2,5
MIU
/tabl
et1
g/ta
blet
Tabl
etLa
mb,
goa
t, ca
lve
Ora
l use
Fran
ceM
ERIA
L29
ave
nue
Tony
Gar
nier
6900
7 LY
ON
Fran
ce
N.P
. 8Co
listin
sul
phat
eN
eom
ycin
sul
fate
300
000
IU/g
60 0
00 I
U/g
Pow
der
for
oral
us
eLa
mb,
goa
t, ra
bbits
, pig
s, ca
lves
, pou
ltry
Ora
l use
Fran
ceQ
ALI
AN
34 r
ue Je
an M
onne
tZI
D’E
tiché
BP20
341
4950
3 Se
gré
Cede
xFr
ance
OXY
COLI
Colis
tin s
ulph
ate
Oxy
tetr
acyc
line
hy-
droc
hlor
ide
200
000
IU/g
0,07
g/g
Prem
ix fo
r m
edi-
cate
d fe
edPi
gs, c
alve
sO
ral u
se
Fran
ceCe
va S
anté
Ani
mal
e10
Ave
nue
de la
Bal
last
ière
3350
0 Li
bour
neFr
ance
PHA
DIL
ACT
Am
pici
llin
trih
ydra
teCo
listin
sul
phat
e5,
00 m
g/g
1 00
0 00
0 IU
/gPo
wde
r fo
r or
al
use
Lam
b, g
oat,
calv
es,
poul
try
Ora
l use
Fran
ceQ
ALI
AN
34 r
ue Je
an M
onne
tZI
D’E
tiché
BP20
341
4950
3 Se
gré
Cede
xFr
ance
PRÉM
ELA
NG
E M
ÉDIC
AM
EN-
TEU
X CS
FRA
NVE
TCo
listin
sul
phat
eSu
lfadi
met
hoxi
ne70
0 00
0 IU
/g21
0 m
g/g
Prem
ixLa
mb,
cal
ves
Ora
l use
Fran
ceVE
TOQ
UIN
OL
Mag
ny V
erno
is70
200
Lure
Fran
ce
SEPT
OTR
YL-C
OLI
STIN
ECo
listin
sul
phat
eSu
lfam
etho
xypy
rida
-zi
ne
2 M
IU/ta
blet
1 g/
tabl
etTa
blet
Lam
b, d
ogs,
foal
s, ca
lves
Ora
l use
C 312/14 EN Official Journal of the European Union 26.8.2016
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Hun
gary
Lave
t G
yógy
szer
gyár
tó K
ft.O
ttó u
. 14
1161
Bud
apes
tH
unga
ry
Am
oxyc
ol p
or b
első
lege
s ol
d-at
hoz
A.U
.V.
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
640,
0 m
g/g
133,
3 m
g/g
Pow
der
for
oral
so
lutio
nPi
gs, c
hick
ens
In d
rink
ing
wat
er
use
Hun
gary
Indu
stri
a Ita
liana
Int
egra
tori
Tr
ei S
.p.A
.Vi
ale
Cora
ssor
i, 62
4110
0 M
oden
aIta
ly
BETA
MIC
YN g
yógy
prem
ix
sert
ések
rés
zére
A.U
.V.
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
100
g/kg
600
MIU
/kg
Prem
ix fo
r m
edi-
cate
d fe
edin
g st
uff
Pigs
In f
eed
use
Hun
gary
Rhon
e Ve
t Kf
t.Pe
tőfi
u. 9
.20
53 H
erce
ghal
omH
unga
ry
Colis
utri
x be
lsőle
ges
por
Trim
etho
prim
Colis
tin s
ulph
ate
3,75
g/1
00 g
50 M
IU/1
00 g
Pow
der
for
oral
so
lutio
nCa
ttle
(cal
ves)
, she
ep
(lam
bs),
pigs
and
chi
ck-
ens,
rabb
it, g
oat
In d
rink
ing
wat
er
use
Italy
Fatr
o S.
p.a.
Via
Emili
a, 2
8540
064
Ozz
ano
Emili
aIta
ly
COM
BOM
IXA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e11
5 m
g/g
40 m
g/g
Prem
ix fo
r m
edi-
cate
d fe
edin
g st
uff
Pigs
, chi
cken
s (o
ther
th
an la
ying
hen
s in
lay)
Ora
l
Italy
Indu
stri
a Ita
liana
Int
egra
tori
Tr
ei S
.P.A
.Vi
a A
ffaro
sa, 4
4201
0 —
Rio
Sal
icet
oIta
ly
BETA
MIC
YNA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e10
0 g/
kg60
0 M
IU/k
gPr
emix
for
med
i-ca
ted
feed
ing
stuf
fPi
gsO
ral
Italy
Dox
al I
talia
S.p
.a.
larg
o D
oneg
ani 2
2012
1 —
Mila
noIta
ly
CLO
VER
BMP
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
115
g/kg
40 g
/kg
Prem
ix fo
r m
edi-
cate
d fe
edin
g st
uff
Pigs
Ora
l
26.8.2016 EN Official Journal of the European Union C 312/15
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Italy
Indu
stri
a Ita
liana
Int
egra
tori
Tr
ei S
.P.A
.Vi
a A
ffaro
sa, 4
4201
0 —
Rio
Sal
icet
oIta
ly
DU
OBA
ND
oxyc
yclin
e hy
clat
eCo
listin
sul
phat
e60
mg/
g1
200
000
UI/g
Prem
ix fo
r m
edi-
cate
d fe
edin
g st
uff
Pigs
, rab
bits
Ora
l
Italy
Virb
ac S
.r.l.
Via
Cald
era
2120
153
Mila
noIta
ly
DU
ALM
IXA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e11
5 m
g/g
4 m
g/g
(2
0 00
0 U
I/mg)
Prem
ix fo
r m
edi-
cate
d fe
edin
g st
uff
Pigs
, chi
cken
s (e
xcep
t he
ns p
rodu
cing
egg
s fo
r hu
man
con
sum
ptio
n)
Ora
l
Italy
Fatr
o S.
p.a.
Via
Emili
a, 2
8540
064
Ozz
ano
Emili
aIta
ly
BACO
LAM
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
500
mg/
g2
500
000
IU/g
Pow
der
for
oral
so
lutio
nCa
lves
, she
ep a
nd g
oats
, pi
gs, p
onie
s, ch
icke
ns,
turk
eys
(exc
ludi
ng h
ens)
Ora
l
Italy
Inte
rvet
Pro
duct
ions
S.r.
l.Vi
a N
ettu
nens
e, k
m 2
0,30
004
011
— A
prili
aIta
ly
NA
DA
SIN
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
500
mg/
g20
0 m
g/g
Ora
l pow
der
for
use
in d
rink
ing
wat
er o
r liq
uid
feed
Calv
es, p
igs,
chic
kens
(o
ther
tha
n la
ying
hen
s),
turk
eys
Ora
l
Italy
Veto
quin
ol I
talia
S.r.
l.Vi
a Pi
ana,
265
4703
2 Be
rtin
oro
Italy
NEO
MIX
CO
MPL
EXN
eom
ycin
sul
fate
Colis
tin s
ulph
ate
200
mg/
g20
000
IU
/gO
ral p
owde
r, fo
r us
e in
dri
nkin
g w
ater
or
liqui
d fe
ed
Calv
es, p
igle
ts, b
roile
rs
and
turk
eys
Ora
l
C 312/16 EN Official Journal of the European Union 26.8.2016
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Italy
Véto
quin
ol It
alia
S.r.
l.Vi
a Pi
ana
265
4703
2 Be
rtin
oro
Italy
ZEM
AM
IXA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e10
0 m
g/g
40 m
g/g
Ora
l pow
der
Pigs
Ora
l use
Italy
Virb
ac S
.r.l.
Via
Cald
era
2120
153
Mila
noIta
ly
STA
BOX
COLI
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
100
mg/
g80
0 00
0 IU
/gPr
emix
for
med
i-ca
ted
feed
ing
Pigs
, chi
cken
s (e
xcep
t he
ns p
rodu
cing
egg
s fo
r hu
man
con
sum
ptio
n)
Ora
l
Latv
iaCe
va S
anté
Ani
mal
e10
Ave
nue
de la
Bal
last
ière
3350
0 Li
bour
neFr
ance
Qui
noco
l Ora
l Sol
utio
nEn
roflo
xaci
nCo
listin
sul
phat
e10
0 g
41,6
7 g
Solu
tion
for
oral
us
eCh
icke
n, t
urke
ysO
ral u
se
Lith
uani
aLa
vet
Phar
mac
eutic
als
Ltd
Ottó
u. 1
4.H
-116
1 Bu
dape
stH
unga
ry
AM
OXY
COL,
ger
iam
ieji
milt
e-lia
iA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e64
0 m
g/m
l3
200
000
IU/m
lW
ater
sol
uble
ora
l so
lutio
nPi
g, c
hick
enO
ral
Lith
uani
aCO
OPH
AVET
S.A
.S.
B.P.
7 S
aint
Her
blon
4415
3 A
NCE
NIS
Ced
exFr
ance
COLI
SULT
RIX,
ger
iam
ieji
mil-
telia
iTr
imet
hopr
imCo
listin
sul
phat
e3,
75 g
/100
g50
MIU
/100
gO
ral p
owde
rCa
lves
, lam
b, k
id, p
ig-
lets
, pou
ltry
and
rabb
itsO
ral
Lith
uani
aCO
OPH
AVET
S.A
.S.
B.P.
7 S
aint
Her
blon
4415
3 A
NCE
NIS
Ced
exFr
ance
BELC
OSP
IRA
ORA
L, g
eria
-m
ieji
milt
elia
iSp
iram
ycin
adi
pate
Colis
tin s
ulph
ate
65 M
IU/1
00 g
50 M
IU/1
00 g
Ora
l pow
der
Calv
es, l
amb,
kid
, foa
ls,
pigl
ets,
poul
try
and
rab-
bits
.
Ora
l
26.8.2016 EN Official Journal of the European Union C 312/17
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Luxe
mbo
urg
VETO
QU
INO
LM
agny
Ver
nois
7020
0 Lu
reFr
ance
COLI
DIA
RYL
Eryt
hrom
ycin
est
olat
eCo
listin
sul
phat
e83
400
UI/g
16 6
00 U
I/gPo
wde
r fo
r or
al
use
Lam
b, g
oat,
pigl
ets,
foal
s, ca
lves
Ora
l use
Luxe
mbo
urg
VETO
QU
INO
LM
agny
Ver
nois
7020
0 Lu
reFr
ance
SEPT
OTR
YL-C
OLI
STIN
ECo
listin
sul
phat
eSu
lfam
etho
xypy
rida
-zi
ne
2 M
IU/ta
blet
1 g/
tabl
etTa
blet
Lam
b, d
ogs,
foal
s, ca
lves
Ora
l use
Net
herla
nds
Dop
harm
a B.
V.Za
lmw
eg 2
449
41 V
X R
aam
sdon
ksve
erTh
e N
ethe
rland
s
AM
OXY
-CO
L W
SPA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e15
0 m
g/g
500
000
IU/g
Pow
der
for
oral
us
e vi
a dr
inki
ng
wat
er
Pigs
Ora
l, vi
a dr
inki
ng
wat
er
Pola
ndD
opha
rma
B.V.
Zalm
weg
24
4941
VX
Raa
msd
onks
veer
The
Net
herla
nds
Am
oxy-
col W
SPA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e15
0 m
g/g
500
000
IU/g
Pow
der
for
oral
so
lutio
nPi
gsO
ral u
se
Pola
ndFa
tro
S.p.
A.
Via
Emili
a28
5-40
064
Ozz
ano
Emili
aIta
ly
Baco
lam
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
100
mg/
g50
0 00
0 IU
/gPo
wde
r fo
r ad
-m
inist
ratio
n in
dr
inki
ng w
ater
or
milk
Cattl
e, c
hick
ens,
pigs
Ora
l use
Pola
ndSk
anVe
t Po
land
Sp.
z o
.o.
Skie
resz
ewo,
ul.
Kisz
kow
ska
962
-200
Gni
ezno
Pola
nd
Cola
mox
320
0/64
0A
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e64
0 m
g/g
3 20
0 00
0 IU
/gPo
wde
r fo
r or
al
solu
tion
Chic
ken,
pig
sO
ral u
se
C 312/18 EN Official Journal of the European Union 26.8.2016
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Pola
ndD
rwal
ewsk
ie Z
akła
dy P
rzem
y-sł
uBi
owet
eryn
aryj
nego
S.A
ul. G
róje
cka
605
-651
Drw
alew
Pola
nd
Spira
col A
DSp
iram
ycin
adi
pate
Colis
tin s
ulph
ate
100
000
IU/g
130
000
IU/g
Pow
der
for
use
in
drin
king
wat
erCa
ttle,
chi
cken
s, pi
gsO
ral u
se
Port
ugal
DIV
ASA
FA
RMAV
IC D
E PO
R-TU
GA
L Pr
odut
os e
Equ
ipa-
men
tos
Vete
riná
rios,
Lda.
Prac
eta
Jaim
e Co
rtes
ão,
No
1 —
R/C
Loj
a Es
q.26
25-1
70 P
óvoa
de
Sant
a Ir
iaPo
rtug
al
NU
TRIV
ET T
OTA
L, p
ó pa
ra
susp
ensã
o or
al, p
ara
vite
los
e co
rdei
ros
Am
pici
llin
trih
ydra
teCo
listin
sul
phat
e0,
7 g
1 50
0 00
0 IU
Pow
der
for
oral
su
spen
sion
for
ad-
min
istra
tion
in
drin
king
wat
er
Calv
es a
nd la
mbs
Ora
l
Port
ugal
VETL
IMA
-Soc
ieda
de D
istri
bui-
dora
de
Prod
utos
Agr
o-Pe
-cu
ário
s, S.
A.
Cent
ro E
mpr
esar
ial d
a R
ainh
a,
Lote
27
2050
-501
Vila
Nov
a da
Rai
n-ha Po
rtug
al
COLI
MIX
(116
g/k
g/40
g/k
g),
pré-
mist
ura
med
icam
ento
sa
para
alim
ento
med
icam
ento
so
para
suí
nos
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
116
g/kg
40 g
/kg
Prem
ix fo
r m
edi-
cate
d fe
edin
g st
uff
Pigs
Ora
l
Port
ugal
Fatr
o S.
p.A
Via
Emili
a N
o 28
5O
zzan
o Em
ilia
Italy
Prem
axol
, 100
mg/
g +
40 m
g/
g de
pré
-mist
ura
med
icam
en-
tosa
par
a al
imen
to m
edic
a-m
ento
so p
ara
suín
os, f
rang
os e
ga
linha
s (e
xcep
to p
oede
iras)
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
100
mg/
g40
mg/
gPr
emix
for
med
i-ca
ted
feed
ing
stuf
fPi
gs a
nd c
hick
ens
(ex-
cept
layi
ng)
Ora
l
26.8.2016 EN Official Journal of the European Union C 312/19
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Rom
ania
Indu
stri
a Ita
liana
Int
egra
tori
Tr
ei S
.p.A
Vial
e Co
rass
ori,
6241
100
Mod
ena
Italy
DU
OBA
ND
oxyc
yclin
e hy
clat
eCo
listin
sul
phat
e60
mg/
g1
200
000
IU/g
Prem
ixPi
gsM
ixed
in fe
edin
g st
uffs
Rom
ania
Indu
stri
a Ita
liana
Int
egra
tori
Tr
ei S
.p.A
Vial
e Co
rass
ori,
6241
100
Mod
ena
Italy
MIC
ROA
MO
X CO
LIA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e10
0 m
g/g
600
000
IU/g
Prem
ixPi
gsM
ixed
in fe
edin
g st
uffs
Rom
ania
COO
PHAV
ET S
AS
Her
blon
4415
0 A
ncen
isFr
ance
COLI
SULT
RIX
Trim
etho
prim
Colis
tin s
ulph
ate
37,5
mg
500
000
IUPo
wde
r fo
r or
al
solu
tion
Calv
es, l
ambs
, kid
s, pi
gs,
rabb
its a
nd p
oultr
yO
ral a
dmin
istra
-tio
n in
dri
nkin
g w
ater
or
liqui
d fe
ed
Rom
ania
SC R
OM
VAC
COM
PAN
Y SA
Sos.
Cent
urii
nr.7
0771
94 V
olun
tari
Rom
ania
GA
LIPR
OTE
CT C
Oxy
tetr
acyc
line
hy-
droc
hlor
ide
Colis
tin s
ulph
ate
12 m
g/ta
blet
5 m
g/ta
blet
Tabl
ets
Poul
try
(gro
use
and
web
-foot
ed)
Ora
l adm
inist
ra-
tion
indi
vidu
ally
Rom
ania
Lave
t Ph
arm
ecut
ical
s LT
D.
Otto
u.1
4.H
-116
1 Bu
dape
stH
unga
ry
AM
OXY
COL
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
640
mg/
g3
200
000
IU/g
Pow
der
for
oral
so
lutio
nPi
gs, c
hick
ens
Ora
l adm
inist
ra-
tion
in d
rink
ing
wat
er
C 312/20 EN Official Journal of the European Union 26.8.2016
Mem
ber
Stat
e EU
/ EE
AM
arke
ting
auth
orisa
tion
hold
erN
ame
INN
Stre
ngth
Phar
mac
eutic
al fo
rmA
nim
al s
peci
esRo
ute
of a
dmin
is-tr
atio
n
Slov
akia
Phar
mag
al s
pol.
s.r.o
.M
urga
šova
594
9 01
Nitr
aSl
ovak
ia
Am
ikol
per
orál
ny p
rášo
kA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e57
,5 m
g/g
8,1
mg/
gO
ral p
owde
rPi
g, c
alve
s, po
ultr
y (c
hick
en, t
urke
y), p
igeo
nO
ral a
dmin
istra
-tio
n, a
fter
inco
r-po
ratio
n in
to t
he
feed
Slov
akia
Phar
mag
al s
pol.
s.r.o
.M
urga
šova
594
9 01
Nitr
aSl
ovak
ia
Am
ikol
pre
mix
na
med
ikác
iu
krm
iva
Am
oxic
illin
tri
hydr
ate
Colis
tin s
ulph
ate
57,5
mg/
g20
0 00
0 IU
/gPr
emix
for
med
i-ca
ted
feed
ing
stuf
fPi
gO
ral a
dmin
istra
-tio
n, a
fter
inco
r-po
ratio
n in
to t
he
feed
Slov
akia
Phar
mag
al s
pol.
s.r.o
.M
urga
šova
594
9 01
Nitr
aSl
ovak
ia
Am
ikol
-S p
rášo
k na
per
orál
ny
rozt
okA
mox
icill
in t
rihy
drat
eCo
listin
sul
phat
e57
5 m
g/g
81 m
g/g
Pow
der
for
oral
so
lutio
nPi
g, c
alve
s, po
ultr
y (c
hick
en, t
urke
y), p
igeo
nO
ral a
dmin
istra
-tio
n vi
a dr
inki
ng
wat
er
Slov
akia
Phar
mag
al s
pol.
s.r.o
.M
urga
šova
594
9 01
Nitr
aSl
ovak
ia
SUTR
ICO
L pr
ášok
na
pero
r-ál
ny r
ozto
kCo
listin
sul
phat
eSu
lfadi
mid
ine
sodi
um
Trim
etho
prim
300
000
IU/g
50 m
g/g
12,5
mg/
g
Pow
der
for
oral
so
lutio
nBr
oile
r ch
icke
n, p
ig,
rabb
it, c
alve
Ora
l adm
inist
ra-
tion
via
drin
king
w
ater
Slov
akia
Phar
mag
al s
pol.
s.r.o
.M
urga
šova
594
9 01
Nitr
aSl
ovak
ia
TETR
AKO
L pr
ášok
na
pero
r-ál
ny r
ozto
kCh
lort
etra
cycl
ine
hy-
droc
hlor
ide
Colis
tin s
ulph
ate
120
mg/
g12
0 00
0 IU
/gPo
wde
r fo
r or
al
solu
tion
Pig,
cal
ves,
poul
try
(chi
cken
)O
ral a
dmin
istra
-tio
n vi
a dr
inki
ng
wat
er
Spai
nCE
NAV
ISA
, S.A
.Ca
mí P
edra
Est
ela
s/n.
Reu
s (T
arra
gona
)43
205
Spai
n
TRIS
OL
Am
pici
llin
trih
ydra
teCo
listin
sul
phat
e20
0 m
g/g
1 02
5 00
0 IU
/gO
ral p
owde
rLa
mbs
In d
rink
ing
wat
er
use
Spai
nLA
BORA
TORI
OS
MA
YMO
, S.
A.
Via
Aug
usta
, 302
.Ba
rcel
ona
0801
7Sp
ain
COLI
PHU
R 10
0 00
0/
1 20
0 00
0 U
I/ml s
oluc
ión
para
ad
min
istra
ción
en
agua
de
bebi
da
Neo
myc
in s
ulfa
teCo
listin
sul
phat
e10
0 00
0 IU
/ml
1 20
0 00
0 IU
/ml
Solu
tion
for
use
in
drin
king
wat
erPi
g fo
r fa
tteni
ngIn
dri
nkin
g w
ater
us
e
26.8.2016 EN Official Journal of the European Union C 312/21