List of nationally authorised medicinal products

Transcription

1 6 September 2018 EMA/612350/2018 Human Medicines Evaluation Division Active substance: azelastine 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 National Number Corifina 0,5 mg/ml, /H/5289/ MEDA PHARMA U. ES colirio en solución Azelastine 0.5 mg / ml, /H/5289/001 PL 15142/0035 MEDA PHARMACEUTICALS UK Eye Drops, solution. LTD LASTICOM 0,5 mg/ml, /H/5289/ MEDA PHARMA GMBH & CO. IT collirio, soluzione Allergodil akut /H/5289/ MEDA PHARMA GMBH & CO. Augentropfen. 0,5 mg/ml, Augentropfen, Lösung. Oculastin 0,5 mg/ml /H/5289/ MEDA AB SE ögondroppar, lösning Oculastin oogdruppels. /H/5289/001 RVG MEDA PHARMA B.V. NL 0,5 mg/ml, oogdruppels, oplossing. Allergodrop 0,5 mg/ml /H/5289/ MEDA PHARMA GMBH AT Augentropfen Azelastine Eye Drops 0.5 /H/5289/001 PA 1332/010/001 MEDA HEALTH SALES IE mg / ml, Eye Drops, solution IRELAND LIMITED Oculastin /H/5289/ MEDA AS DK Afluon 0,15% w/v, ρινικό not available / MEDA PHARMACEUTICALS GR εκνέφωμα, διάλυμα Azelastinhydrochlorid AL not available ALIUD PHARMA GMBH 0,5 mg/ml Augentropfen Azela-Vision MD sine 0,5 SE/H/1183/01/DC OMNIVISION GMBH mg/ml Augentropfen Azela-Vision MD sine 0,5 SE/H/1183/01/DC OMNIVISION GMBH AT mg/ml Augentropfen Azelastine OmniVision, SE/H/1183/01/DC OMNIVISION GMBH SE 0,5 mg/ml ögondroppar, lösning Azelastin COMOD 0,5 mg/ml Augentropfen, Lösung AT/H/0454/ URSAPHARM GES.M.B.H. AT EMA/612350/2018 Page 2/15

3 National Number Azelastin-COMOD, 0,5 mg/ml collyre en solution Azelastin-COMOD, 0,5 mg/ml collyre en solution VISUZEL 0,5 mg/ml collirio, soluzione Azelastin-COMOD 0.5 mg/ml eye drops, solution Azelastin-COMOD, 0,5 mg/ml oogdruppels, oplossing Pollival 0,5 mg/ml Augentropfen, Lösung Azelastin COMOD, 0,5 mg/ml, krople do oczu, roztwór Azelastin COMOD 0,5 mg/ml oční kapky, roztok Azelastin-COMOD, 0,5 mg/ml oogdruppels, oplossing Azelastin POS 1 mg/ml Pollival 1 mg/ml Azelastin-POS 1 mg/ml neusspray, oplossing AZELASTIN-POS 1 mg/ml nosní sprej, roztok Azelastin-POS 1 mg/ml solution pour pulvérisation nasale AT/H/0454/001 BE URSAPHARM BENELUX B.V. BE AT/H/0454/001/DC URSAPHARM BENELUX B.V. LU AT/H/0454/ VISUFARMA SPA IT AT/H/0454/001 MA63/01001 URSAPHARM ARZNEIMITTEL GMBH AT/H/0454/001/DC BE URSAPHARM BENELUX B.V. BE AT/H/0454/001/DC URSAPHARM ARZNEIMITTEL GMBH AT/H/0454/ URSAPHARM POLAND SP. Z. O.O. AT/H/0454/001 64/057/13-C URSAPHARM SPOL. S.R.O. CZ AT/H/0454/001 RVG URSAPHARM BENELUX B.V. NL AT/H/0351/ URSAPHARM GES.M.B.H. AT AT/H/0351/ URSAPHARM ARZNEIMITTEL GMBH AT/H/0351/002 RVG URSAPHARM BENELUX B.V. NL AT/H/0351/002 69/149/15-C URSAPHARM SPOL. S.R.O. CZ AT/H/0351/002 BE URSAPHARM BENELUX B.V. BE MT PL EMA/612350/2018 Page 3/15

4 National Number Azelastin-POS 1 mg/ml AT/H/0351/002 BE URSAPHARM BENELUX B.V. BE neusspray, oplossing Azelastin POS, 1 mg/ml, AT/H/0351/ URSAPHARM POLAND SP. Z. PL aerozol do nosa, roztwór O.O. Azelastin-POS AT/H/0351/002/DC URSAPHARM BENELUX B.V. LU Allergodil 0,1%, not available MEDA PHARMA SIA EE ninasprei Allergodil 1,5 mg/ml not available LT/1/97/0233/002 MEDA PHARMA SIA LT nosies purškalas (tirpalas) Allergodil 1,5 mg/ml not available LT/1/97/0233/006 MEDA PHARMA SIA LT nosies purškalas (tirpalas) Allergodil 1,5 mg/ml not available LT/1/97/0233/005 MEDA PHARMA SIA LT nosies purškalas (tirpalas) Allergodil 1,5 mg/ml not available LT/1/97/0233/004 MEDA PHARMA SIA LT nosies purškalas (tirpalas) Allergodil 1,5 mg/ml not available LT/1/97/0233/003 MEDA PHARMA SIA LT nosies purškalas (tirpalas) Lastin 0,13 mg/dos not available MEDA OY FI nässpray, lösning Lastin 0,13 mg/annos not available MEDA OY FI nenäsumute, liuos ALLERGODIL oční kapky not available 64/210/00-C MEDA PHARMA GMBH & CO. CZ Vividrin akut Azelastin /H/5289/ DR. GERHARD MANN CHEM.- antiallergische Augentropfen PHARM. FABRIK GMBH Allergodil 0,05% acu not available MEDA PHARMA SIA LV pilieni, šķīdums Azelastina MABO 0,5 mg/ml colirio en solución not available MABO-FARMA, ES EMA/612350/2018 Page 4/15

5 National Number Allergodil 0,1% deguna not available MEDA PHARMA SIA LV aerosols Vivispray 1 mg/ml MT/H/0234/001 24/0305/17-S PHARMASWISS ČESKÁ SK nosová roztoková aerodisperzia REPUBLIKA S.R.O. Vivispray 1 mg/ml sprej MT/H/0234/001 HR-H PHARMASWISS ČESKÁ HR za nos, otopina REPUBLIKA S.R.O. Azelastin PharmaSwiss 1 MT/H/0234/ PHARMASWISS ČESKÁ mg/ml Nasenspray, Lösung REPUBLIKA S.R.O. Vivispray 1 mg/ml nasal MT/H/0234/001 MA1011/00401 PHARMASWISS ČESKÁ MT spray, solution REPUBLIKA S.R.O. Rhinolast 1,5 mg/ml /H/5291/ MEDA PHARMA GMBH & CO. Rinelaz 0,19 mg/dos /H/5291/ MEDA AB SE nässpray, lösning Allergodil 1,5 mg/ml /H/5291/001 RVG MEDA PHARMA B.V. NL neusspray, oplossing Rhinolast S 0.15% Nasal /H/5291/001 PL 15142/0235 MEDA PHARMACEUTICALS UK Spray LTD Allergodil mit Sucralose /H/5291/ MEDA PHARMA GMBH AT 1,5 mg/ml Nasenspray Allergodil Forte /H/5291/ MEDA AS DK Rhinolast S 1.5 mg/ml /H/5291/001 PA1332/015/004 MEDA HEALTH SALES IE Nasal Spray, Solution IRELAND LIMITED Afluon sucralosa 1,5 /H/5291/ MEDA PHARMA S.L. ES mg/ml, solución para pulverización nasal Allergodil 1,5 mg /ml, /H/5291/ MEDA PHARMA S.P.A. IT Allergodil 1,5 mg /ml, /H/5291/ MEDA PHARMA S.P.A. IT Allergodil 1,5 mg /ml, /H/5291/ MEDA PHARMA S.P.A. IT EMA/612350/2018 Page 5/15

6 National Number Allergodil 1,5 mg /ml, Allergodil 1,5 mg /ml, Allergodil 0,05 % akių lašai (tirpalas) Allergodil 0,05 % akių lašai (tirpalas) Allergodil, 1,5 mg/ml, ninasprei, lahus Azelastinhydrochlorid Kohne Pharma 0,5 mg/ml Augentropfen Allergodil, 0,05% silmatilgad, lahus Azelastinhydrochlorid Stulln 0,5 mg/ml Augentropfen Allestin, 0,5 mg/ml, krople do oczu, roztwór Алергодил 0,05% капки за очи, разтвор Алергодил 0,1% спрей за нос, разтвор AFLUON 0,05% οφθαλμικές σταγόνες, διάλυμα ALLERGODIL 0,1 % Nasenspray ALLERGODIL 0,05 % Augentropfen ALLERGODIL 0,05 % Augentropfen ALLERGODIL 0,1 % Nasenspray /H/5291/ MEDA PHARMA S.P.A. IT /H/5291/ MEDA PHARMA S.P.A. IT not available LT/1/98/0280/002 MEDA PHARMA SIA LT not available LT/1/98/0280/001 MEDA PHARMA SIA LT not available MEDA PHARMA SIA EE /H/3827/001/DC KOHNE PHARMA GMBH not available MEDA PHARMA SIA EE /H/3389/ PHARMA STULLN GMBH /H/3389/ PHARMA STULLN GMBH PL not available MEDA PHARMA GMBH & CO. not available MEDA PHARMA GMBH & CO. not available 97308/13 MEDA PHARMACEUTICALS not available BE MEDA PHARMA N.V. BE not available BE MEDA PHARMA N.V. BE not available MEDA PHARMA N.V. LU not available MEDA PHARMA N.V. LU BG BG GR EMA/612350/2018 Page 6/15

7 National Number AFLUON 1 mg/ml solución para pulverización nasal Lastin S 1,5 mg/ml nefúði, lausn Astepro 1,5 mg/ml nefúði, lausn Алергодил S 0,15% спрей за нос, разтвор Allergodil 1 mg/ml pršilo za nos, raztopina Allergodil 1MG/ML Solução para Pulverização Nasal Allergodil 1MG/ML Solução para Pulverização Nasal AZEP 1mg/ml solução para pulverização nasal AZEP 1mg/ml solução para pulverização nasal Azelastine neusallergie Meda, neusspray 1 mg/ml Allergodil 0,5 mg/ml kapi za oko, otopina Allergodil oldatos orrspray Allergodil oldatos szemcsepp ALLERGODIL 0,05 % Oogdruppels, oplossing ALLERGODIL 0,05 % collyre en solution. not available MEDA PHARMA S.L. ES not available IS/1/16/041/01 MEDA AB IS not available IS/1/16/042/01 MEDA AB IS not available MEDA PHARMA GMBH & CO. not available H/99/00142/001 MEDA PHARMA GMBH & CO. not available MEDA PHARMA GMBH & CO. not available MEDA PHARMA GMBH & CO. not available MEDA PHARMA PRODUTOS FARMACÊUTICOS, PT not available MEDA PHARMA PRODUTOS PT FARMACÊUTICOS, not available RVG MEDA PHARMA B.V. NL not available HR-H MYLAN HRVATSKA D.O.O. HR not available OGYI-T-4877/01 MYLAN EPD KFT. HU not available OGYI-T-4877/02 MYLAN EPD KFT. HU not available BE MEDA PHARMA N.V. BE not available MEDA PHARMA N.V. LU BG SI PT PT EMA/612350/2018 Page 7/15

8 National Number Allergodil očná instilácia not available 64/0157/99-S MEDA PHARMA GMBH & CO. SK ALLERGODIL 0,05 % not available BE MEDA PHARMA N.V. BE collyre en solution. Allergodil-Filmtabletten not available MEDA PHARMA GMBH AT Allergodil Filmtabletten not available MEDA PHARMA GMBH & CO. 2,2 mg/filmtablette ALLERGODIL, 0,5 mg/ml, not available MEDA PHARMA GMBH & CO. PL krople do oczu, roztwór Allergodil filmom not available 24/0206/97-S MEDA PHARMA GMBH & CO. SK obalené tablety Allergodil-Nasenspray not available MEDA PHARMA GMBH AT Allergodil Nasenspray 1 mg / 1 ml, Nasenspray, Lösung not available MEDA PHARMA GMBH & CO. ALLERGODIL, 1 mg/ml (0,1%), aerozol do nosa, roztwór ALLERGODIL, 0,1 %, spray nasal ALLERGODIL 0,1 % Neusspray not available 7602 MEDA PHARMA GMBH & CO. not available BE MEDA PHARMA N.V. BE not available BE MEDA PHARMA N.V. BE Allergodil not available 24/0205/97-S MEDA PHARMA GMBH & CO. SK ALLERGODIL, 0,1 %, not available MEDA PHARMA N.V. LU spray nasal Allergodil akut Nasenspray 1 mg / 1 ml, not available MEDA PHARMA GMBH & CO. Allergodil akut Duo Augentropfen: 0,5 mg / ml Augentropfen, Lösung Nasenspray: 1 mg / ml not available MEDA PHARMA GMBH & CO. PL EMA/612350/2018 Page 8/15

9 National Number Allergodil Kombipackung Augentropfen: 0,5 mg / ml Augentropfen, Lösung Nasenspray: 1 mg / ml Rhinolast 140 micrograms per Spray, Nasal Spray Vividrin akut Azelastin Kombi-Packung gegen Heuschnupfen Augentropfen: 0,5 mg / ml Augentropfen, Lösung Nasenspray : 1 mg / ml Vividrin akut Azelastin Nasenspray gegen Heuschnupfen 1 mg / 1 ml, AFLUON 0,1% w/v ρινικό εκνέφωμα, διάλυμα LASTIN 0,5 mg/ml øyedråper, oppløsning Lastin 0,13 mg/dose nesespray, oppløsning Lastin 0,13 mg/dos nässpray, lösning Lastin 0,13 mg/úðaskammt, nefúði, lausn Rhinolast Hayfever 140 micrograms per spray, nasal spray solution. not available MEDA PHARMA GMBH & CO. not available PA 1332/15/1 MEDA HEALTH SALES IRELAND LIMITED not available MEDA PHARMA GMBH & CO. not available MEDA PHARMA GMBH & CO. not available 7733/ MEDA PHARMACEUTICALS GR not available MEDA AS NO not available MEDA AS NO not available MEDA AB SE not available MEDA AB IS not available PA1322/015/002 MEDA HEALTH SALES IRELAND LIMITED IE IE EMA/612350/2018 Page 9/15

10 National Number Allespray 1mg/ml Spray not available MEDA PHARMA S.P.A. IT Nasale, Soluzione Allergodil Nevel, not available RVG MEDA PHARMA B.V. NL neusspray, oplossing 1 mg/ml Allergospray-Nasenspray not available MEDA PHARMA GMBH AT Allergodil, næsespray, not available MEDA AS DK opløsning Azelastinhydrochlorid /H/3827/001/DC KOHNE PHARMA GMBH Kohne Pharma 0,5 mg/ml Augentropfen Azelastine hydrochloride /H/3827/ KOHNE PHARMA GMBH PL Kohne 0,5 mg/ml, krople do oczu, roztwór Astepro 0,15% w/v, not available / MEDA PHARMACEUTICALS GR ρινικό εκνέφωμα, διάλυμα Azelastín Xantis 1 mg/ml MT/H/0256/001 24/0364/17-S XANTIS PHARMA LIMITED SK nosová roztoková aerodisperzia Azelastine Xantis 1 MT/H/0256/001 MA1188/00101 XANTIS PHARMA LIMITED MT mg/ml nasal spray solution Azelastin POS 0,5 mg/ml AT/H/0351/ URSAPHARM ARZNEIMITTEL AT Augentropfen, Lösung GMBH Azelastin-POS 0,5 mg/ml AT/H/0351/ URSAPHARM ARZNEIMITTEL Augentropfen, Lösung GMBH Azelamed 0,5 mg/ml /H/3889/001 HR-H MIBE PHARMACEUTICALS HR kapi za oko, otopina D.O.O. Azelamed 1 mg/ml sprej /H/3889/002 HR-H MIBE PHARMACEUTICALS HR za nos, otopina D.O.O. Azedil 0,5 mg/ml /H/3889/001/DC RMAPHARM GMBH AT Augentropfen Azedil 1 mg/ml Nasenspray /H/3889/ RMAPHARM GMBH AT EMA/612350/2018 Page 10/15

11 National Number Azedil 0,5 mg/ml Augentropfen, Lösung Azedil 1 mg/ml Azedil Kombi-Packung mit 0,5 mg/ml Augentropfen, Lösung und 1 mg/ml Azelamed, 0,5 mg/ml, krople do oczu, roztwór Azelamed, 1 mg/ml, aerozol do nosa, roztwór Azelastinhydrochlorid Kohne Pharma 0,5 mg/ml Augentropfen Azelastine Galenicum 1 mg/ml nasal spray, solution Azelastin Galenicum 1 mg/ml Nasenspray, Losung ALLERGODIL 1 mg/ml Nosni sprej, roztok Astepro 1,5 mg/ml Astepro 1.5 mg/ml Nasal Spray, Solution Astepro 1,5 mg/ml, solución para pulverización nasal Astepro 1,5 mg/ml neusspray, oplossing Astepro 0.15% Nasal Spray /H/3889/ RMAPHARM AG /H/3889/ RMAPHARM AG /H/3889/ RMAPHARM AG /H/3889/ SUN-FARM SP. Z.O.O. PL /H/3889/ SUN-FARM SP. Z.O.O. PL /H/3827/001/DC KOHNE PHARMA GMBH MT/H/0235/001 MA255/02001 GALENICUM HEALTH, S.L. MT MT/H/0235/ GALENICUM HEALTH, S.L. not available 24/002/97-C MEDA PHARMA GMBH & CO. CZ /H/5292/ MEDA PHARMA GMBH & CO. /H/5292/001 PA1332/39/2 MEDA HEALTH SALES IE IRELAND LIMITED /H/5292/ MEDA PHARMA U. ES /H/5292/001 RVG MEDA PHARMA B.V. NL /H/5292/001 PL 15142/0236 MEDA PHARMACEUTICALS LTD UK EMA/612350/2018 Page 11/15

12 National Number Astepro næsespray, opløsning Astepro 0,15 % Nasenspray Astepro 0,19 mg/dos nässpray, lösning Astepro 1,5 mg/ml, Astepro 1,5 mg/ml, Astepro 1,5 mg/ml, Astepro 1,5 mg/ml, Astepro 1,5 mg/ml, Azela-Vision sine 0,5 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis Azela-Vision sine 0,5 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis Allergodil 0,5 mg/ml Augentropfen ALLERGODIL 0,5 mg/ml, collirio, soluzione ALLERGODIL 0,5 mg/ml collirio, soluzione Lastin 0,5 mg/ml ögondroppar, lösning Allergodil Augentropfen 0,5 mg/ml, Augentropfen, Lösung /H/5292/ MEDA AS DK /H/5292/ MEDA PHARMA GMBH AT /H/5292/ MEDA AB SE /H/5292/ MEDA PHARMA S.P.A. IT /H/5292/ MEDA PHARMA S.P.A. IT /H/5292/ MEDA PHARMA S.P.A. IT /H/5292/ MEDA PHARMA S.P.A. IT /H/5292/ MEDA PHARMA S.P.A. IT /H/3852/001/DC FORMERLY SE/H/1105/001/DC /H/3852/001/DC FORMERLY SE/H/1105/001/DC OMNIVISION GMBH AT OMNIVISION GMBH /H/5290/ MEDA PHARMA GMBH AT /H/5290/ MEDA PHARMA S.P.A. IT /H/5290/ MEDA PHARMA S.P.A. IT /H/5290/ MEDA OY FI /H/5290/ MEDA PHARMA GMBH & CO. EMA/612350/2018 Page 12/15

13 National Number Allergodil, 0,5 mg/ml, /H/5290/ MEDA PHARMA PRODUTOS PT colírio, solução FARMACÊUTICOS, Allergodil, 0,5 mg/ml, /H/5290/ MEDA PHARMA PRODUTOS PT colírio, solução FARMACÊUTICOS, Allergodil, 0,5 mg/ml, /H/5290/ MEDA PHARMA PRODUTOS PT colírio, solução FARMACÊUTICOS, Afluón 0,5 mg / ml, /H/5290/ MYLAN IRE HEALTHCARE ES colirio en solución LIMITED Optilast. 0.5 mg / ml, /H/5290/001 PL 46302/0136 MYLAN PRODUCTS LIMITED UK Eye Drops, solution Allergodil oogdruppels /H/5290/001 RVG MEDA PHARMA B.V. NL 0,5 mg/ml, oogdruppels, oplossing. Lastin 0,5 mg/ml /H/5290/ MEDA OY FI silmätipat, liuos Lastin 0,5 mg/ml /H/5290/ MEDA AB SE ögondroppar, lösning Optilast. /H/5290/001 PA 1332/009/001 MEDA HEALTH SALES IE 0.5 mg / ml, Eye Drops, solution IRELAND LIMITED Allergodil, øjendråber, /H/5290/ MEDA AS DK opløsning Allergodil 1,5 mg/ml not available MEDA PHARMA SIA LV deguna aerosols, šķīdums ALLERGODIL 0,127 not available MEDA PHARMA SAS FR mg/dose, solution pour pulvérisation nasale Loxin /H/5290/ DR. GERHARD MANN CHEM.- PHARM. FABRIK GMBH ALLERGODIL 0,05 POUR not available MEDA PHARMA SAS FR CENT, collyre en solution ALLERGODIL 0,05 POUR CENT, collyre en solution not available MEDA PHARMA SAS FR EMA/612350/2018 Page 13/15

14 National Number Allergodil 0,1% nosies purškalas (tirpalas) Azelastina MABO 0,5 mg/ml colirio en solución PROALLERGODIL 0,127 mg/dose, solution pour pulvérisation nasale PROALLERGODIL 0,127 mg/dose, solution pour pulvérisation nasale PROALLERGODIL 0,127 mg/dose, solution pour pulvérisation nasale Azelastin Devatis 0,5 mg/ml Augentropfen im Einzeldosisbehältnis Azelastinehydrochloride Devatis 0,5 mg/ml, oogdruppels, oplossing in verpakking voor éénmalig gebruik Tebarat 0,5 mg/ml colirio en solución en envase unidosis Tebarat 0,5 mg/ml colírio, solução em recipiente unidose Tebarat 0,5 mg/ml colírio, solução em recipiente unidose Tebarat 0,5 mg/ml colírio, solução em recipiente unidose not available LT/1/97/0233/001 MEDA PHARMA SIA LT not available MABO-FARMA, ES not available MEDA PHARMA SAS FR not available MEDA PHARMA SAS FR not available MEDA PHARMA SAS FR NL/H/2860/ VATIS GMBH NL/H/2860/001 RVG VATIS GMBH NL ES/H/0178/ LABORATORIOS SALVAT, ES/H/0178/001/DC LABORATORIOS SALVAT, ES/H/0178/ LABORATORIOS SALVAT, ES/H/0178/ LABORATORIOS SALVAT, ES PT PT PT EMA/612350/2018 Page 14/15

15 National Number Tebarat 0,5 mg/ml collirio, soluzione in contenitore monodose Tebarat 0,5 mg/ml collirio, soluzione in contenitore monodose Tebarat 0,5 mg/ml collirio, soluzione in contenitore monodose ES/H/0178/ LABORATORIOS SALVAT, ES/H/0178/ LABORATORIOS SALVAT, ES/H/0178/ LABORATORIOS SALVAT, IT IT IT EMA/612350/2018 Page 15/15