28 September 2017 EMA/642432/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): carbomers
Procedure No.: PSUSA/00000557/201701
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
AquaTears®-Augengel CIVIGEL 0,2 %, gel ophtalmique DACRIO GEL® DACRIOGEL® 0,3% Gel oftalmico DACRIOGEL® 0,3% Gel oftalmico GEL LARMES, gel ophtalmique GEL LARMES, gel ophtalmique GEL LARMES, gel ophtalmique en récipient unidose GEL LARMES, gel ophtalmique en récipient unidose GEL LARMES, gel ophtalmique en récipient unidose GEL LARMES, gel ophtalmique en récipient unidose GelTears Geltears 0.2% w/w Carbomer Eye Gel LACRIFLUID 0,13 %, collyre en solution LACRIFLUID 0,13 POUR CENT, collyre en solution en récipient unidose LACRIGEL, gel ophtalmique Lacrigel® C 1 g Augengel enthält 2 mg Carbomer Lacrigel® C sine LACRINORM 0,2 POUR CENT, gel ophtalmique LACRINORM 0,2 POUR CENT, gel ophtalmique LACRINORM 2 mg/g gel ophtalmique LACRINORM 2 mg/g ooggel LACRYVISC 3 mg/g gel oftalmic Lacryvisc 3 mg/g gel oftálmico
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available not available not available
1-22533 NL 20 483 8579/6-2-2007
not available
032148037
ALCON ITALIA S.P.A.
IT
not available not available not available
032148049 331947-5 331948-1
ALCON ITALIA S.P.A. LABORATOIRES THEA LABORATOIRES THEA
IT FR FR
not available
334713-5
LABORATOIRES THEA
FR
not available
334714-1
LABORATOIRES THEA
FR
not available
356 506-2
LABORATOIRES THEA
FR
not available not available
389025-3 PL 03468/0043
LABORATOIRES THEA BAUSCH & LOMB UK LTD.
FR UK
not available
PA 555/011/001
BAUSCH & LOMB UK LTD.
IE
not available
3400935528698
LABORATOIRES EUROPHTA
FR
not available not available
29545-3400937688710 16166-3400933521134
LABORATOIRES EUROPHTA LABORATOIRES EUROPHTA
FR FR
not available not available
57627.00.00 50170.00.00
DR. WINZER PHARMA GMBH DR. WINZER PHARMA GMBH
DE DE
not available
34009 336 665 8 3
LABORATOIRE CHAUVIN
FR
not available
34009 336 666 4 4
LABORATOIRE CHAUVIN
FR
not available not available not available not available
BE 193365 BE 193365 5351/2005/01 3114584
BAUSCH & LOMB PHARMA BAUSCH & LOMB PHARMA LABORATORIES ALCON S.A. ALCON PORTUGAL - PRODUTOS E
BE BE RO PT
List of nationally authorised medicinal products EMA/642432/2017
LABORATOIRES THEA LABORATORIES ALCON S.A. ALCON LABORATORIES HELLAS S.A.
AT FR GR
Page 2/7
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
LACRYVISC 3 mg/g gel za oko LACRYVISC gel ophtalmique en récipient unidose LACRYVISC, gel ophtalmique Lakrimont 2 mg/g ögongel Lakrimont 2mg/g eye gel Lakrimont, øjengel
not available
H/97/00867/001
not available not available SE/H/1517/001 SE/H/1517/01 SE/H/1517/001
NL 17 932 NL 17 931 43207 12-9319 51795
Liposic
not available
30650.00.00
Liposic EDO
not available
40613.00.00
Liposic Fluid Liquigel 2,5 mg/g Augengel LIQUIGEL UD 2,5 mg/g Augengel im Einzeldosisbehältnis LlQUlVISC 2.5 mg/g, eye gel LlQUlVISC 2.5 mg/g, eye gel OCUGEL – 2,5 mg/g – gel ophtalmique OCUGEL - 2,5 mg/g - ooggel OCUGEL – 2,5 mg/g – ooggel OCUGEL Monodoses 2,5 mg/g Augengel OCUGEL Monodoses 2,5 mg/g Augengel OCUGEL Monodoses 2,5 mg/g gel ophtalmique OCUGEL Monodoses 2,5 mg/g gel ophtalmique OCUGEL Monodoses 2,5 mg/g Ooggel OCUGEL, 2,5 mg/g, Augengel OCUGEL, 2,5 mg/g, Augengel
not available not available
MAH of product in the member state
EQUIPAMENTOS OFTALMOLÓGICOS, LDA. SA ALCON-COUVREUR NV
Member State where product is authorised
SI FR FR SE NO DK
40610.00.00 ZUL.-NR. 37899.00.00
LABORATORIES ALCON S.A. LABORATORIES ALCON S.A. BLUMONT PHARMA LTD BLUMONT PHARMA LTD BLUMONT PHARMA LTD DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH LABORATOIRES THEA
not available FR/H/0118/001 FR/H/0118/001
ZUL.-NR. 37898.00.00 PA 1107/002/001 PL 20162/0009
LABORATOIRES THEA LABORATOIRES THEA LABORATOIRES THEA
DE IE UK
not available not available not available
BE199306 2005/038706 BE 199306
S.A. MEDA PHARMA N.V. S.A. MEDA PHARMA N.V. S.A. MEDA PHARMA N.V.
BE LU BE
not available
BE269866
S.A. MEDA PHARMA N.V.
BE
not available
2005/100019
S.A. MEDA PHARMA N.V.
LU
not available
BE269866
S.A. MEDA PHARMA N.V.
BE
not available
2005/100019
S.A. MEDA PHARMA N.V.
LU
not available not available not available
BE269866 BE199306 2005/038706
S.A. MEDA PHARMA N.V. S.A. MEDA PHARMA N.V. S.A. MEDA PHARMA N.V.
BE BE LU
List of nationally authorised medicinal products EMA/642432/2017
DE DE DE DE
Page 3/7
Product Name (in authorisation country)
Oftagel Oftagel 2,5 mg/g acu gels OFTAGEL 2,5 mg/g akių gelis Oftagel 2,5 mg/g augnhlaup OFTAGEL 2,5 mg/g oční gel OFTAGEL 2,5 mg/g očný gél Oftagel 2,5 mg/g ögongel Oftagel 2,5 mg/g ögongel OFTAGEL 2,5 mg/g ögongel i endosbehållare Oftagel 2,5 mg/g ögongel, endosbehållare Oftagel 2,5 mg/g øyegel Oftagel 2,5 mg/g øyegel i endosebeholder Oftagel 2,5 mg/g -silmägeeli Oftagel 2,5 mg/g -silmägeeli kerta-annospipetissä Oftagel 2,5 mg/g szemgél OFTAGEL 2,5 mg/g, augnhlaup í stakskammtaíláti Oftagel 2.5 mg/g silmageel Oftagel, 2,5 mg/g, zel do oczu SICCAFLUID 2,5 mg/g , gel oftálmico SICCAFLUID 2,5 mg/g gel oftalmico SICCAFLUID 2,5 mg/g gel oftálmico Siccafluid 2,5 mg/g gel oftalmico in contenitore monodose Siccafluid 2,5 mg/g gel oftalmico in contenitore monodose Siccafluid 2,5 mg/g gel oftalmico in contenitore
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available not available not available FR/H/118/01/E01 not available not available not available not available
19497 01-0137 LT/1/2000/1467/001 IS/1/03/015/01 64/296/02-C 64/0063/04-S 13023 14206
not available
20849
SANTEN OY
FI
not available FR/H/118/01/E01
22390 03-1678
SANTEN OY SANTEN OY
SE NO
MRP FR/H/118/02 not available
04-3155 13023
SANTEN OY SANTEN OY
NO FI
not available not available
20849 OGYI T-9682/01
SANTEN OY SANTEN OY
FI HU
MRP FR/H/118/02 not available not available
IS/1/05/042/01 311600 9808
SANTEN OY SANTEN OY SANTEN OY
IS EE PL
FR/H/0118/001
62114
LABORATORIOS THEA S.A.
ES
FR/H/0118/001
033816012
LABORATOIRES THEA
IT
FR/H/0118/001
2717585
LABORATOIRES THEA
PT
FR/H/0118/002
033816024
LABORATOIRES THEA
IT
FR/H/0118/002
033816036
LABORATOIRES THEA
IT
FR/H/0118/002
033816048
LABORATOIRES THEA
IT
List of nationally authorised medicinal products EMA/642432/2017
SANTEN OY SANTEN OY SANTEN OY SANTEN OY SANTEN OY SANTEN OY SANTEN OY SANTEN OY
DK LV LT IS CZ SK FI SE
Page 4/7
Product Name (in authorisation country)
monodose Siccafluid 2,5 mg/g gel oftalmico in contenitore monodose SICCAFLUID 2,5 mg/g, gel ophtalmique SICCAFLUID 2,5 mg/g, gel ophtalmique en récipient unidose SICCAFLUID 2,5 mg/g, gel ophtalmique en récipient unidose SICCAFLUID 2,5 mg/g, gel ophtalmique en récipient unidose SICCAFLUID 2,5 mg/g, gel ophtalmique en récipient unidose SICCAFLUID 2,5 mg/g. gel oftálmico en unidosis Siccafluid Unidose, 2,5 mg/g ooggel in verpakking voor éénmalig gebruik SICCAFLUID, 2,5 mg/g, gel oftálmico em recipiente unidose SICCAFLUID, 2,5 mg/g, gel oftálmico em recipiente unidose SICCAFLUID, 2,5 mg/g, gel oftálmico em recipiente unidose SICCAFLUID, 2,5 mg/g, gel oftálmico em recipiente unidose Siccafluid, ooggel 2,5 mg/g Siccafree 2,5 mg/g, ooggel in
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0118/002
033816051
LABORATOIRES THEA
IT
FR/H/0118/001
341752-2
LABORATOIRES THEA
FR
FR/H/0118/002
360 845-2
LABORATOIRES THEA
FR
FR/H/0118/002
360 847-5
LABORATOIRES THEA
FR
FR/H/0118/002
360 846-9
LABORATOIRES THEA
FR
FR/H/0118/002
360 848-1
LABORATOIRES THEA
FR
FR/H/0118/002
66.890
LABORATORIOS THEA S.A.
ES
FR/H/0118/002
RVG 32027
LABORATOIRES THEA
NL
FR/H/0118/002
5418587
LABORATOIRES THEA
PT
FR/H/0118/002
5418686
LABORATOIRES THEA
PT
FR/H/0118/002
5418785
LABORATOIRES THEA
PT
FR/H/0118/002 FR/H/0118/001 not available
5418884 RVG 29145 RVG 109107
LABORATOIRES THEA LABORATOIRES THEA LABORATOIRES THEA
PT NL NL
List of nationally authorised medicinal products EMA/642432/2017
Page 5/7
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
RVG 109106
LABORATOIRES THEA
NL
not available
36060.00.00
URSAPHARM ARZNEIMITTEL GMBH
DE
not available
43176/10/12-05-2011
ALCON LABORATORIES HELLAS S.A.
GR
not available
9011.00.00
ALCON PHARMA GMBH
DE
not available not available
26211.00.00 PA 555/6/1
DE IE
Vidisic 2 mg/g augnhlaup
not available
910075
Vidisic 2 mg/g gel oftalmic
not available
6192/2006/01
VIDISIC 2 mg/g Ocní gel VIDISIC 2 mg/g ooggel Vidisic 2mg/g gel ophtalmique Vidisic Carbogel 2 mg/ g ooggel Vidisic Carbogel E.D.O. 2 mg/g ooggel VIDISIC EDO 2 mg/g ooggel Vidisic EDO 2mg/g gel ophtalmique Vidisic Gel, 2 mg/ml, gel oftálmico Vidisic Preservative Free Single Dose Unit
not available not available not available not available
64/366/00-C BE145196 BE145196 RVG 14862
ALCON PHARMA GMBH BAUSCH & LOMB UK LTD. DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH BAUSCH & LOMB PHARMA BAUSCH & LOMB PHARMA BAUSCH & LOMB PHARMA
not available not available
RVG 29773 BE230045
BAUSCH & LOMB PHARMA BAUSCH & LOMB PHARMA
NL BE
not available
BE 230045
BAUSCH & LOMB PHARMA
BE
not available
8720904
BAUSCH & LOMB, S.A.
PT
not available
PA 555/6/2
IE
Vidisic szemgél Vidisic® 1 g Augengel enthält 2 mg Carbomer
not available
OGYI-T-4655/01
not available
40612.00.00
Vidisic® EDO® Vidisic® EDO®
not available not available
2000040030 1997095601
BAUSCH & LOMB UK LTD. DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.-
verpakking voor éénmalig gebruik Siccamed 2,5 mg/g, ooggel Siccapos Gel, 2,0 mg/g, Augengel THILOGEL® Οφθαλμική Γέλη 0,3% Thilo-Tears® Gel 3 mg/g Augengel Thilo-Tears® SE 3 mg/g Augengel Vidisic 0.2 % w/w Eye Gel
List of nationally authorised medicinal products EMA/642432/2017
IS RO CZ BE BE NL
HU DE LU LU Page 6/7
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
not available
30620.00.00
not available not available not available
64/0156/93-S 40611.00.00 40614.00.00
not available
57885.00.00
Viscotears 2 mg/g Gel oftálmico Viscotears 2 mg/g ögongel Viscotears 2 mg/g ögongel, endosbehållare Viscotears 2 mg/g øyegel Viscotears 2 mg/g øyegel
not available not available
60.886 12508
not available not available not available
15934 7939 99-6836
Viscotears 2 mg/g silmägeeli
not available
10692
Viscotears Liquid Gel Viscotears silmägeeli kertaannospakkauksessa Viscotears Single Dose Unit 2.0mg/g Eye Gel
not available
PL13757/0020
not available
15608
not available
PL13757/0019
Viscotears, øjengel Viscotears, øjengel i enkeltdosisbeholdere VISCOTER 0,2% οφθαλμική γέλη
not available
15552
not available
32063
not available
24481/10-04-2012
Видизик 2 mg / g гел за очи ОФТАГЕЛ 2,5 mg/g гел за очи
not available not available
20060553 20060214
Vidisic® EDO® 1 g Augengel enthält 2 mg Carbomer VIDISIC® očný gél (carbomerum) Visc-Ophtal® Visc-Ophtal® sine Visc-Ophtal® sine 1 g Augengel enthält 2 mg Carbomer
List of nationally authorised medicinal products EMA/642432/2017
MAH of product in the member state
PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. WINZER PHARMA GMBH DR. WINZER PHARMA GMBH
Member State where product is authorised
DE SK DE DE
DR. WINZER PHARMA GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH LABORATOIRES THEA
DE
LABORATOIRES THEA LABORATOIRES THEA LABORATOIRES THEA DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH
SE NO NO
LABORATOIRES THEA DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH SANTEN OY
GR
ES SE
FI UK FI UK DK DK
BG BG
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