List of nationally authorised medicinal products

Transcription

1 26 October 2017 EMA/663700/2017 Human Medicines Evaluation Division Active substance: cromoglicic acid Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 Alleofta 20 mg/ml kapi za oko, otopina u jednodoznom spremniku Alleofta 20 mg/ml kapi za oko, otopina u jednodoznom spremniku Alleophta 20 mg/ml, očná roztoková instilácia v jednodávkovom obale Alleophta 20 mg/ml, očná roztoková instilácia v jednodávkovom obale UK/H/5451/001 HR-H SANOFI-AVENTIS CROATIA D.O.O. UK/H/5451/001 HR-H SANOFI-AVENTIS CROATIA D.O.O. UK/H/5451/001 64/0414/16-S SANOFI-AVENTIS SLOVAKIA SRO UK/H/5451/001 64/0414/16-S SANOFI-AVENTIS SLOVAKIA SRO HR HR SK SK Alleophta unidosis 20 mg/ml, collyre en solution en récipient unidose Alleophta unidosis 20 mg/ml, collyre en solution en récipient unidose Alleophta unidosis 20 mg/ml, collyre en solution en récipient unidose Alleophta unidosis 20 mg/ml, collyre en solution en récipient unidose UK/H/5451/01/DC BE SANOFI BELGIUM BE UK/H/5451/01/DC BE SANOFI BELGIUM BE UK/H/5451/01/DC SANOFI BELGIUM LU UK/H/5451/01/DC SANOFI BELGIUM LU EMA/663700/2017 Page 2/26

3 Alleophta unidosis 20 mg/ml, oogdruppels, oplossing in verpakking voor éénmalig gebruik Alleophta unidosis 20 mg/ml, oogdruppels, oplossing in verpakking voor éénmalig gebruik Alleopti 20 mg/ ml oldatos szemcsepp ALLEOPTI 20 MG/ML OLDATOS SZEMCSEPP Alleopti Komfort 20 mg/ ml oldatos szemcsepp egyadagos tartályban Alleopti Komfort 20 mg/ ml oldatos szemcsepp egyadagos tartályban Alleoptical, 20 mg/ml, krople do oczu, roztwór w pojemniku jednodawkowym Alleoptical, 20 mg/ml, krople do oczu, roztwór w pojemniku jednodawkowym UK/H/5451/01/DC BE SANOFI BELGIUM BE UK/H/5451/01/DC BE SANOFI BELGIUM BE not available OGYI-T-22584/01 SANOFI-AVENTIS ZRT HU not available OGYI-T-22584/04 SANOFI-AVENTIS ZRT HU not available OGYI-T-22584/03 SANOFI-AVENTIS ZRT HU not available OGYI-T-22584/02 SANOFI-AVENTIS ZRT HU UK/H/5451/01/DC AVENTIS PHARMA LTD PL UK/H/5451/01/DC AVENTIS PHARMA LTD PL EMA/663700/2017 Page 3/26

4 Allerg-Abak 20 mg/ml oogdruppels, oplossing FR/H/0234/001 RVG LABORATOIRES THEA NL Allergo-COMOD eye drops not available MA063/00201 URSAPHARM ARZNEIMITTEL GMBH MT Allergo-COMOD neusspray not available RVG URSAPHARM BENELUX B.V. NL Allergo-COMOD ocní kapky, Oční kapky, roztok not available 64/020/01-C URSAPHARM SPOL. S.R.O. CZ Allergo-COMOD oogdruppels not available RVG URSAPHARM BENELUX B.V. NL Allergo-COMOD, 20 mg/ml, krople do oczu, roztwór ALLERGOCOMOD, collyre en solution not available 9762 URSAPHARM POLAND SP. Z. O.O. not available LABORATOIRES URSAPHARM S.A.S. PL FR Allergo-COMOD Augentropfen Allergo-COMOD Nasenspray not available URSAPHARM GES.M.B.H. AT not available URSAPHARM GES.M.B.H. AT Allergocrom not available 64/0662/94-S URSAPHARM ARZNEIMITTEL GMBH SK Allergocrom nosní sprej, Nosní sprej, roztok Allergocrom oční kapky, roztok not available 69/945/97-C URSAPHARM SPOL. S.R.O. CZ not available 64/072/97-C URSAPHARM SPOL. S.R.O. CZ EMA/663700/2017 Page 4/26

5 Allergocrom, 20 mg/ml, krople do oczu, roztwór not available 8980 URSAPHARM POLAND SP. Z. O.O. PL Allergoval Kapseln not available KOEHLER PHARMA GMBH Allgil 20 mg/ml ögondroppar, lösning Aspire Allergy Relief 2% w/v eye drops, Solution (eye drops) Aspire Hayfever Relief 2% w/v Eye Drops Boots Allergy Relief 2% w/v Eye Drops Boots Hayfever Relief 2% w/v Eye Drops Catacrom 2% w/v eye drops, solution not available APOFRI AB SE not available PL 35533/0033 ASPIRE PHARMA LIMITED UK not available PL 35533/0031 ASPIRE PHARMA LIMITED UK not available PL03468/0023 BAUSCH & LOMB UK LTD. UK not available PL 35533/0031 ASPIRE PHARMA LIMITED UK UK/H/1718/001 PA 1464/1/1 RAYNER PHARMACEUTICALS IE Catacrom 2% w/v eye drops, solution COLIMUNE SACHETS 100 MG COLIMUNE SACHETS 100 MG UK/H/1718/001 PL11412/0002 MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST not available SANOFI-AVENTIS UTSCHLAND GMBH not available SANOFI-AVENTIS UTSCHLAND GMBH UK EMA/663700/2017 Page 5/26

6 COLIMUNE SACHETS 100 MG COLIMUNE SACHETS 200 MG COLIMUNE SACHETS 200 MG COLIMUNE SACHETS 200 MG not available SANOFI-AVENTIS UTSCHLAND GMBH not available SANOFI-AVENTIS UTSCHLAND GMBH not available SANOFI-AVENTIS UTSCHLAND GMBH not available SANOFI-AVENTIS UTSCHLAND GMBH CROMABAK 20 mg/ml colirio en solución CROMABAK 20 mg/ml collirio soluzione Cromabak 20 mg/ml collyre en solution Cromabak 20 mg/ml collyre en solution Cromabak 20 mg/ml oogdruppels, oplossing Cromabak 20 mg/ml, colírio, solução Cromabak 20 mg/ml, colírio, solução FR/H/0234/ LABORATOIRES THEA ES FR/H/0234/ LABORATOIRES THEA IT not available BE THEA PHARMA BE not available BE THEA PHARMA LU not available BE THEA PHARMA BE not available LABORATOIRES THEA PT not available LABORATOIRES THEA PT EMA/663700/2017 Page 6/26

7 CROMABAK 20 mg/ml, collyre en solution Crominet 20 mg/ml ögondroppar, lösning Crominet 20 mg/ml øyedråper, oppløsning Crominet, øjendråber, opløsning CROMOFREE 2 %, collyre en solution Cromoglicato de Sodio Brown 20 mglml colirio, solucao Cromoglicato de Sodio Brown 20 mglml colirio, solucao FR/H/0234/ LABORATOIRES THEA FR SE/H/1372/ ORIFARM GENERICS A/S SE SE/H/1372/ ORIFARM GENERICS A/S NO SE/H/1372/ ORIFARM GENERICS A/S DK not available LABORATOIRE CHAUVIN FR UK/H/3500/ BROWN & BURK UK LIMITED PT UK/H/3500/ BROWN & BURK UK LIMITED PT CROMOHEXAL not available 64/142/96-C LABORATOIRES THEA CZ CROMOHEXAL 20 mg/1 ml Nosní sprej, roztok not available 24/141/96-C HEXAL AG CZ Cromolux 2% Eye Drops not available PL 03468/0022 BAUSCH & LOMB UK LTD. UK Cromolux 2% Hay fever Eye Drops not available PL03468/0023 BAUSCH & LOMB UK LTD. UK EMA/663700/2017 Page 7/26

8 Crom-Ophtal 1 ml Augentropfen enthält 20 mg Natriumcromoglicat (Ph.Eur.) not available DR. WINZER PHARMA GMBH Crom-Ophtal Nasenspray not available DR. WINZER PHARMA GMBH Crom-Ophtal sine 1 ml Augentropfen enthält 20 mg Natriumcromoglicat (Ph.Eur.) CROMOPTIC 2 %, collyre en solution CROMOPTIC 2 %, collyre en solution en récipient unidose not available DR. WINZER PHARMA GMBH not available LABORATOIRE CHAUVIN FR not available LABORATOIRE CHAUVIN FR CUSICROM FUERTE OFTÁLMICO 40 mg/ml colirio en solución not available NOVARTIS FARMACÉUTICA S.A. ES EM Pharma Allergy Relief 2%w/v Eye Drops, Solution (eye drops) EM Pharma Hayfever Relief 2%w/v Eye Drops not available PL 35533/0033 ASPIRE PHARMA LIMITED UK not available PL 35533/0031 ASPIRE PHARMA LIMITED UK Fenolip 20 mg/ml solução para inalação por nebulização not available ANGELINI FARMACÊUTICA, LDA PT EMA/663700/2017 Page 8/26

9 Fenolip, 10 mg / 0,5 ml, colírio, solução Fenolip, 20 mg/ml, colírio, solução not available ANGELINI FARMACÊUTICA, LDA not available ANGELINI FARMACÊUTICA, LDA PT PT INTAL CFC-FREE INHALER not available PL 04425/0179 AVENTIS PHARMA LTD UK INTAL INHALATIONLÖSUNG 1% INTAL INHALATIONLÖSUNG 1% INTAL INHALATIONLÖSUNG 1% INTAL INHALATIONLÖSUNG 1% not available SANOFI-AVENTIS UTSCHLAND GMBH not available SANOFI-AVENTIS UTSCHLAND GMBH not available SANOFI-AVENTIS UTSCHLAND GMBH not available SANOFI-AVENTIS UTSCHLAND GMBH INTAL N AEROSOL not available SANOFI-AVENTIS UTSCHLAND GMBH INTAL N AEROSOL not available SANOFI-AVENTIS UTSCHLAND GMBH INTAL N AEROSOL not available SANOFI-AVENTIS UTSCHLAND GMBH INTAL N AEROSOL not available SANOFI-AVENTIS UTSCHLAND GMBH EMA/663700/2017 Page 9/26

10 INTAL N AEROSOL not available SANOFI-AVENTIS UTSCHLAND GMBH INTAL N AEROSOL not available SANOFI-AVENTIS UTSCHLAND GMBH INTAL N AEROSOL not available SANOFI-AVENTIS UTSCHLAND GMBH Lecrolyn not available SANTEN OY DK LECROLYN 20 mg/ml acu pilieni, šķīdums LECROLYN 20 mg/ml akių lašai (tirpalas) Lecrolyn 20 mg/ml ögondroppar, lösning, endosbehållare LECROLYN 20 mg/ml silmatilgad, lahus LECROLYN 20 mg/ml - silmätipat, liuos LECROLYN 40 mg/ml acu pilieni, šķīdums LECROLYN 40 mg/ml akių lašai (tirpalas) not available SANTEN OY LV not available LT/1/96/2408/001 SANTEN OY LT not available SANTEN OY SE not available SANTEN OY EE not available SANTEN OY FI not available SANTEN OY LV not available LT/1/96/2408/002 SANTEN OY LT EMA/663700/2017 Page 10/26

11 LECROLYN 40 mg/ml akių lašai, tirpalas LECROLYN 40 mg/ml akių lašai, tirpalas Lecrolyn 40 mg/ml ögondroppar, lösning Lecrolyn 40 mg/ml ögondroppar, lösning, endosbehållare Lecrolyn 40 mg/ml øyedråper, oppløsning i dråpeflaske Lecrolyn 40 mg/ml øyedråper, oppløsning i endosebeholdere LECROLYN 40 mg/ml silmatilgad, lahus LECROLYN 40 mg/ml - silmätipat, liuos Lecrolyn sine 40 mg/ml akių lašai (tirpalas) Lecrolyn sine 40 mg/ml akių lašai (tirpalas) not available LT/1/96/2408/004 SANTEN OY LT not available LT/1/96/2408/005 SANTEN OY LT not available SANTEN OY SE not available SANTEN OY SE not available 8306 SANTEN OY NO not available SANTEN OY NO not available SANTEN OY EE not available SANTEN OY FI SE/H/1402/001 LT/1/15/3711/001 SANTEN OY LT SE/H/1402/001 LT/1/15/3711/002 SANTEN OY LT EMA/663700/2017 Page 11/26

12 Lecrolyn sine 40 mg/ml akių lašai (tirpalas) Lecrolyn sine 40 mg/ml augndropar, lausn Lecrolyn sine 40 mg/ml ögondroppar, lösning Lecrolyn sine 40 mg/ml ögondroppar, lösning Lecrolyn sine 40 mg/ml øyedråper, oppløsning Lecrolyn sine 40 mg/ml silmatilgad, lahus Lecrolyn sine 40 mg/ml silmätipat, liuos Lecrolyn sine, øjendråber, opløsning Lecrolyn, øjendråber, opløsning LECROLYN 20 mg/ml ögondroppar, lösning LECROLYN 20 mg/ml ögondroppar, lösning i endosbehållare SE/H/1402/001 LT/1/15/3711/003 SANTEN OY LT SE/H/1402/01/DC IS/1/15/035/01 SANTEN OY IS SE/H/1402/ SANTEN OY FI SE/H/1402/ SANTEN OY SE SE/H/1402/01/DC SANTEN OY NO SE/H/1402/ SANTEN OY EE SE/H/1402/01/DC SANTEN OY FI SE/H/1402/ SANTEN OY DK not available SANTEN OY DK not available SANTEN OY FI not available SANTEN OY FI EMA/663700/2017 Page 12/26

13 LECROLYN 20 mg/ml - silmätipat, liuos kertaannospakkauksessa LECROLYN 40 mg/ml ögondroppar, lösning LECROLYN 40 mg/ml ögondroppar, lösning i endosbehållare LECROLYN 40 mg/ml - silmätipat, liuos kertaannospakkauksessa not available SANTEN OY FI not available SANTEN OY FI not available SANTEN OY FI not available SANTEN OY FI LOMUDAL not available MT SANOFI-AVENTIS NMARK A/S DK LOMUDAL not available SANOFI SPA IT LOMUDAL not available 8593 SANOFI AB SE LOMUDAL 20 MG not available RVG SANOFI-AVENTIS NETHERLANDS B.V. LOMUDAL 20 MG not available RVG SANOFI-AVENTIS NETHERLANDS B.V. NL NL Lomudal 20 mg inhalationspulver, hård kapsel not available 8593 SANOFI AB SE EMA/663700/2017 Page 13/26

14 Lomudal 20 mg inhalationspulver, hård kapsel LOMUDAL 20 mg, solution pour inhalation par nébuliseur Lomudal 20 mg, verneveloplossing Lomudal 20 mg/ml ögondroppar, lösning Lomudal 20 mg/ml ögondroppar, lösning Lomudal 20 mg/ml øyedråper, oppløsning Lomudal 20 mg/ml øyedråper, oppløsning Lomudal 20 mg/ml øyedråper, oppløsning LOMUDAL 20 MG/ML SILMATIPAT, LIUOS LOMUDAL 20 MG/ML SILMATIPAT, LIUOS not available 8593 SANOFI AB SE not available BE SANOFI BELGIUM BE not available BE SANOFI BELGIUM BE not available 9326 SANOFI AB SE not available 9326 SANOFI AB SE not available 6300 SANOFI-AVENTIS NORGE AS NO not available 6300 SANOFI-AVENTIS NORGE AS NO not available 6300 SANOFI-AVENTIS NORGE AS NO not available 7589 SANOFI OY FI not available 7589 SANOFI OY FI EMA/663700/2017 Page 14/26

15 Lomudal 20 mg/ml, augndropar, lausn Lomudal 40 mg/ml ögondroppar, lösning, endosbehållare Lomudal 40 mg/ml ögondroppar, lösning, endosbehållare Lomudal 40 mg/ml øyedråper, oppløsning i endosebeholder Lomudal 40 mg/ml øyedråper, oppløsning i endosebeholder LOMUDAL 40 MG/ML SILMATIPAT, LIUOS KERTA- ANNOSPIPETISSA LOMUDAL 40 MG/ML SILMATIPAT, LIUOS KERTA- ANNOSPIPETISSA LOMUDAL 40mg/ml collirio, soluzione LOMUDAL 40mg/ml spray nasale, soluzione not available SANOFI-AVENTIS NORGE AS IS not available SANOFI AB SE not available SANOFI AB SE not available 7842 SANOFI-AVENTIS NORGE AS NO not available 7842 SANOFI-AVENTIS NORGE AS NO not available SANOFI OY FI not available SANOFI OY FI not available SANOFI SPA IT not available SANOFI SPA IT EMA/663700/2017 Page 15/26

16 LOMUDAL FORTE not available RVG SANOFI-AVENTIS NETHERLANDS B.V. NL LOMUDAL FREONITON 5 MG/ANNOS INHALAATIOSUMUTE, SUSPENSIO not available SANOFI OY FI LOMUDAL G.I. not available SANOFI AB SE LOMUDAL G.I. not available SANOFI AB SE LOMUDAL NASAL not available SANOFI-AVENTIS NMARK A/S DK LOMUDAL NASAL not available SANOFI AB SE LOMUDAL NASAL not available SANOFI AB SE LOMUDAL NASAL 5,2 MG/ANNOS NENASUMUTE, LIUOS LOMUDAL NASAL 5,2 MG/ANNOS NENASUMUTE, LIUOS Lomudal Nasal 5,2 mg/dose nesespray, oppløsning Lomudal Nasal 5,2 mg/dose nesespray, oppløsning not available SANOFI OY FI not available SANOFI OY FI not available 00/7496 SANOFI-AVENTIS NORGE AS NO not available 00/7496 SANOFI-AVENTIS NORGE AS NO EMA/663700/2017 Page 16/26

17 LOMUDAL NEBULISER SOL. FOR INH. (GLASS VIALS) not available SANOFI BELGIUM LU Lomudal, øjendråber, opløsning Lomudal, øjendråber, opløsning Lomudal, øjendråber, opløsning, enkeltdosisbeholder Lomudal, øjendråber, opløsning, enkeltdosisbeholder not available SANOFI-AVENTIS NMARK A/S not available SANOFI-AVENTIS NMARK A/S not available SANOFI-AVENTIS NMARK A/S not available SANOFI-AVENTIS NMARK A/S DK DK DK DK LOMUDAL, SOLUTION POUR NEBULISATION LOMUDAL, SOLUTION POUR NEBULISATION Lomudal Gastrointestinum 100 mg kapselit not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available 8299 ITALCHIMICI S.P.A. FI LOMUSOL 2% not available 0006/ SANOFI BELGIUM LU Lomusol 2% neusdruppels, oplossing Lomusol 2% solution pour instillation nasale not available BE SANOFI BELGIUM BE not available BE SANOFI BELGIUM BE EMA/663700/2017 Page 17/26

18 LOMUSOL 4 POUR CENT, solution pour pulvérisation nasale LOMUSOL 4 POUR CENT, solution pour pulvérisation nasale Lomusol 4% neusspray, oplossing Lomusol 4% solution pour pulvérisation nasale not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available BE SANOFI BELGIUM BE not available BE SANOFI BELGIUM BE LOMUSOL 4% SPRAY not available SANOFI BELGIUM LU MULTICROM 2 %, collyre en solution MULTICROM UNIDOSES 2 POUR CENT, collyre en récipient unidose MULTICROM UNIDOSES 2 POUR CENT, collyre en récipient unidose MULTICROM UNIDOSES 2 POUR CENT, collyre en récipient unidose not available LABORATOIRES THEA FR not available LABORATOIRES THEA FR not available LABORATOIRES THEA FR not available LABORATOIRES THEA FR EMA/663700/2017 Page 18/26

19 MULTICROM UNIDOSES 2 POUR CENT, collyre en récipient unidose not available LABORATOIRES THEA FR NALCROM not available RVG SANOFI-AVENTIS NETHERLANDS B.V. NALCROM not available RVG SANOFI-AVENTIS NETHERLANDS B.V. NL NL NALCROM not available 14/0305/89-S ITALCHIMICI S.P.A. SK Nalcrom 100 mg capsule rigide Nalcrom 100 mg, tvrdé tobolky not available ITALCHIMICI S.P.A. IT not available 14/305/89-S/C ITALCHIMICI S.P.A. CZ NALCROM 100MG CAPSULES not available PL 04425/0370 AVENTIS PHARMA LTD UK Nalcrom 250 mg granulato per soluzione orale NALCROM 250 mg granulato per soluzione orale Nalcrom 500 mg granulato per soluzione orale NALCROM 500 mg granulato per soluzione orale not available ITALCHIMICI S.P.A. IT not available ITALCHIMICI S.P.A. IT not available ITALCHIMICI S.P.A. IT not available ITALCHIMICI S.P.A. IT EMA/663700/2017 Page 19/26

20 NALCROM DRANK 100 MG not available RVG SANOFI-AVENTIS NETHERLANDS B.V. NALCROM DRANK 200 MG not available RVG SANOFI-AVENTIS NETHERLANDS B.V. NL NL Natriumcromoglicaat Apotex 20 mg/ml not available RVG APOTEX EUROPE B.V. NL NATRIUMCROMOGLICAAT OOGDRUPPELS 20 G/ML not available RVG BASIC PHARMA MANUFACTURING BV NL Natriumkromoglikat ABECE 20 mg/ml ögondroppar, lösning Numark Hayfever Relief 2% w/v Eye Drops OPHTACALM 2 %, collyre en solution en récipient unidose OPHTACALM 2 %, collyre en solution en récipient unidose OPHTACALM 2 %, collyre en solution en récipient unidose OPHTACALMFREE 2%, collyre en solution not available EVOLAN PHARMA AB SE not available PL 35533/0031 ASPIRE PHARMA LIMITED UK not available LABORATOIRE CHAUVIN FR not available LABORATOIRE CHAUVIN FR not available LABORATOIRE CHAUVIN FR not available LABORATOIRE CHAUVIN FR OPTICROM not available RVG SANOFI-AVENTIS NETHERLANDS B.V. NL EMA/663700/2017 Page 20/26

21 OPTICROM 2 % collyre en solution OPTICROM 2 % collyre en solution OPTICROM 2 % oogdruppels, oplossing Natrium cromoglicaat not available BE MELISANA NV BE not available MELISANA NV LU not available BE MELISANA NV BE Opticrom 2% Augentropfen not available BE MELISANA NV BE Opticrom 2% Augentropfen not available MELISANA NV LU Opticrom 20 mg/ ml oldatos szemcsepp Opticrom 20 mg/ml colirio en solución en envase unidosis Opticrom 20 mg/ml colirio en solución en envase unidosis not available OGYI-T-3691/02 SANOFI-AVENTIS ZRT HU UK/H/5451/01/DC SANOFI-AVENTIS, S.A. ES UK/H/5451/01/DC SANOFI-AVENTIS, S.A. ES Opticrom 20 mg/ml Colírio, solução em frasco contagotas multidose Opticrom 20mg/ml Colírio, Solução em Unidose not available SANOFI - PRODUTOS FARMACEUTICOS LDA not available SANOFI - PRODUTOS FARMACEUTICOS LDA PT PT EMA/663700/2017 Page 21/26

22 Opticrom 20mg/ml Colírio, Solução em Unidose Opticrom Allergy 2%w/v Eye Drops, solution Opticrom Allergy 2%w/v Eye Drops, solution Opticrom Allergy 2%w/v Eye Drops, solution not available SANOFI - PRODUTOS FARMACEUTICOS LDA not available PA 540/116/2 SANOFI-AVENTIS IRELAND LTD not available PA 540/116/2 SANOFI-AVENTIS IRELAND LTD not available PA 540/116/2 SANOFI-AVENTIS IRELAND LTD PT IE IE IE OPTICROM ALLERGY 2.0% W/W EYE DROPS, SOLUTION OPTICROM ALLERGY 2.0% W/W EYE DROPS, SOLUTION not available PL 04425/0323 AVENTIS PHARMA LTD UK not available PL 04425/0323 AVENTIS PHARMA LTD UK Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution UK/H/5451/01/DC PA 540/116/3 SANOFI-AVENTIS IRELAND LTD UK/H/5451/01/DC PA 540/116/3 SANOFI-AVENTIS IRELAND LTD IE IE Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution UK/H/5451/01/DC PL 04425/0688 AVENTIS PHARMA LTD UK EMA/663700/2017 Page 22/26

23 Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution OPTICROM AQUEOUS / VISICROM EYE DROPS OPTICROM AQUEOUS / VISICROM EYE DROPS UK/H/5451/01/DC PL 04425/0688 AVENTIS PHARMA LTD UK not available PL 04425/0324 AVENTIS PHARMA LTD UK not available PL 04425/0324 AVENTIS PHARMA LTD UK OPTICROM EYE DROPS not available PA 540/116/1 SANOFI-AVENTIS IRELAND LTD OPTICROM EYE DROPS not available PA 540/116/1 SANOFI-AVENTIS IRELAND LTD OPTICROM EYE DROPS not available PA 540/116/1 SANOFI-AVENTIS IRELAND LTD IE IE IE OPTICROM HAYFEVER 2% W/V EYE DROPS OPTICROM HAYFEVER 2% W/V EYE DROPS OPTICROM OLDATOS SZEMCSEPP not available PL 04425/0628 AVENTIS PHARMA LTD UK not available PL 04425/0628 AVENTIS PHARMA LTD UK not available OGYI-T-3691/01 SANOFI-AVENTIS ZRT HU OPTICROM UNIT DOSE not available RVG SANOFI-AVENTIS NETHERLANDS B.V. NL OpticromTM Allergy 2.0% w/v Eye Drops, Solution not available MA 082/01901 SANOFI MALTA LTD MT EMA/663700/2017 Page 23/26

24 OpticromTM Allergy 2.0% w/v Eye Drops, Solution not available MA 082/01901 SANOFI MALTA LTD MT OPTICRON 2 POUR CENT, collyre OPTICRON UNIDOSE, collyre en récipient unidose not available COOPERATION PHARMACEUTIQUE FRANCAISE not available COOPERATION PHARMACEUTIQUE FRANCAISE FR FR Optrex Allergy 2%w/v Eye Drops, Solution (eye drops) Optrex Allergy Eye Drops (sodium cromoglicate 2%) Optrex Hayfever Relief 2%w/v Eye Drops Pollenase Hayfever Relief 2%w/v Eye Drops SODIO CROMOGLICATO SANOFI SODIO CROMOGLICATO SANOFI Sodium Cromoglicate 2% w/v Eye Drops, Solution not available PL 35533/0033 ASPIRE PHARMA LIMITED UK not available PL03468/0023 BAUSCH & LOMB UK LTD. UK not available PL 35533/0031 ASPIRE PHARMA LIMITED UK not available PL 35533/0031 ASPIRE PHARMA LIMITED UK UK/H/5451/01/DC SANOFI SPA IT UK/H/5451/01/DC SANOFI SPA IT not available PL 35533/0032 ASPIRE PHARMA LIMITED UK EMA/663700/2017 Page 24/26

25 Sodium Cromoglicate 2% w/v Eye Drops, Solution Sodium Cromoglicate 2% w/v Eye Drops, Solution Tesco Allergy Eye Drops sodium cromoglicate 2% UK/H/3500/001 PL 25298/0033 BROWN & BURK UK LIMITED UK UK/H/3500/001 PL 25298/0033 BROWN & BURK UK LIMITED UK not available PL03468/0023 BAUSCH & LOMB UK LTD. UK Vivicrom Eye Drops not available PL 03468/0035 BAUSCH & LOMB UK LTD. UK VIVIDRIN not available 75843/ PHARMASWISS ČESKÁ REPUBLIKA S.R.O. VIVIDRIN not available 75843/ PHARMASWISS ČESKÁ REPUBLIKA S.R.O. Vividrin 2% eye drops not available DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH GR GR CY Vividrin Antiallergic Eye Drops, Solution 2%w/v not available PA 555/5/2 BAUSCH & LOMB UK LTD. IE Vividrin Eye Drops not available PL 03468/0035 BAUSCH & LOMB UK LTD. UK Vividrin Hay Fever Eye Drops Vividrin Preservative Free SDU 2% w/v Eye Drops solution not available PL 03468/0035 BAUSCH & LOMB UK LTD. UK not available PA 555/5/3 BAUSCH & LOMB UK LTD. IE EMA/663700/2017 Page 25/26

26 Vividrin antiallergische Augentropfen Vividrin antiallergische Augentropfen Vividrin iso EDO antiallergische Augentropfen not available DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH not available DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH not available DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH LU Vividrin MDO not available DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH Vividrin Nasenspray gegen Heuschnupfen Vividrin Nasenspray gegen Heuschnupfen not available DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH not available DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH LU EMA/663700/2017 Page 26/26