List of nationally authorised medicinal products

Transcription

1 11 October 2017 EMA/784453/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): ipratropium / salbutamol 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 provided the source is acknowledged.

2 Brometo de ipratrópio + Salbutamol Cipla, 0,525 mg/2,5 ml + 3 mg/2,5 ml, solução para inalação por nebulização Brometo de ipratrópio + Salbutamol Cipla, 0,525 mg/2,5 ml + 3 mg/2,5 ml, solução para inalação por nebulização Ipratropiumbromid/Salbutamol Cipla 0,5 mg/2,5mg per 2,5 ml, lösning för nebulisator Ipratropijev bromid/salbutamol Cipla 0,5 mg/2,5 mg u 2,5 ml, otopina za atomizator Ipratropiumbromide/Salbutamol Cipla 0,5/2,5 mg per 2,5 ml, Ipratropiumbromide/Salbutamol Cipla 0,5 mg/2,5 ml + 2,5 mg/2,5 ml, Ipratropium bromide/salbutamol Cipla 0.5 mg/2.5 mg per 2.5 ml Nebuliser solution not available CIPLA (EU) LIMITED PT not available CIPLA (EU) LIMITED PT NL/H/3022/ CIPLA EUROPE NV SE NL/H/3022/001 HR-H CIPLA EUROPE NV HR NL/H/3022/001 RVG CIPLA EUROPE NV NL NL/H/3022/001 BE CIPLA EUROPE NV BE NL/H/3022/ / CIPLA EUROPE NV GR NL/H/3022/ CIPLA EUROPE NV IT NL/H/3022/ CIPLA EUROPE NV IT NL/H/3022/ CIPLA EUROPE NV IT NL/H/3022/ CIPLA EUROPE NV IT NL/H/3022/ CIPLA EUROPE NV IT EMA/784453/2017 Page 2/7

3 NL/H/3022/ CIPLA EUROPE NV IT Bromure d'ipratropium/salbutamol Cipla 0,5 NL/H/3022/ CIPLA EUROPE NV LU mg/2,5 ml + 2,5 mg/2,5 ml solution pour inhalation par nébuliseur Zerseos 0.5 mg/2.5 mg per 2.5 ml Nebuliser NL/H/3022/001 PL 36390/0161 CIPLA (EU) LIMITED UK solution Ipratropiu/Salbutamol Cipla 0,5 mg/2,5 mg NL/H/3022/ /2014/01 CIPLA EUROPE NV RO Ipratropiu/Salbutamol Cipla 0,5 mg/2,5 mg NL/H/3022/ /2014/02 CIPLA EUROPE NV RO Ipratropiu/Salbutamol Cipla 0,5 mg/2,5 mg NL/H/3022/ /2014/03 CIPLA EUROPE NV RO Ipratropiu/Salbutamol Cipla 0,5 mg/2,5 mg NL/H/3022/ /2014/04 CIPLA EUROPE NV RO Ipratropiu/Salbutamol Cipla 0,5 mg/2,5 mg NL/H/3022/ /2014/05 CIPLA EUROPE NV RO Ipratropiu/Salbutamol Cipla 0,5 mg/2,5 mg NL/H/3022/ /2014/06 CIPLA EUROPE NV RO Ipratropiumbromid/salbutamol "Cipla", NL/H/3022/ CIPLA EUROPE NV DK inhalationsvæske til nebulisator, opløsning, enkeltdosisbeholder Ipratropiumbromidi/Salbutamoli Cipla 0,5 NL/H/3022/ CIPLA EUROPE NV FI mg/2,5 mg per 2,5 ml sumutinliuos Ipratropiumbromidi/Salbutamoli Cipla 0,5 NL/H/3022/ CIPLA EUROPE NV FI mg/2,5mg per 2,5 ml lösning för nebulisator Ipratropiumbromid/Salbutamol Cipla 0,5 NL/H/3022/ CIPLA EUROPE NV AT mg/2,5 mg pro 2,5 ml Lösung für einen Vernebler Ипратропиев бромид / салбутамол Сипла NL/H/3022/ CIPLA EUROPE NV BG 0,5 mg/2,5 mg на 2,5 ml разтвор за небулизатор BREVA 0,375% + mg 0,075% Soluzione da not available VALEAS S.P.A. IT EMA/784453/2017 Page 3/7

4 nebulizzare o soluzione orale BREVA Aerosol dosato not available VALEAS S.P.A. IT COMBIPRASAL 0.5 mg / 2.5 mg per 2.5 ml NL/H/2736/001 PA1815/001/001 PHARMA STULLN GMBH IE nebuliser solution IPRASA 0,5 mg / 2,5 mg per 2,5 ml, NL/H/2736/001 RVG PHARMA STULLN GMBH NL COMBIPRASAL 0,5 mg / 2,5 mg Lösung für NL/H/2736/ PENTA ARZNEIMITTEL GMBH DE einen Vernebler COMBIPRASAL 0.5 mg / 2.5 mg nebuliser NL/H/2736/001 PL 20905/0001 PHARMA STULLN GMBH UK solution Ipramol Steri-Neb 0.5mg / 2.5mg per 2.5ml IE/H/0163/001 PA 282/79/1 NORTON HEALTHCARE LTD T/A IE Nebuliser Solution. IVAX PHARMACEUTICALS UK Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol 0,5 mg / 2,5 mg per 2,5 ml, IE/H/0163/ TEVA SWEDEN AB FI sumutinliuos Ipramol 0,5 mg / 2,5 mg per 2,5 ml, lösning för nebulisator IE/H/0163/ TEVA SWEDEN AB SE EMA/784453/2017 Page 4/7

5 Ipramol Steri-Neb 0,5/2,5mg ανά 2,5ml IE/H/0163/ / TEVA PHARMA B.V. GR Διάλυμα για Εισπνοή με Εκνεφωτή Nebu-Iprasal 0,5 mg/2,5 mg/2,5 ml IE/H/0163/001 BE TEVA PHARMA BELGIUM BE N.V./S.A Ipramol Steri-Neb 0.5mg / 2.5mg per 2.5ml IE/H/0163/001 PL00530/0961 NORTON HEALTHCARE LTD T/A UK Nebuliser Solution. IVAX PHARMACEUTICALS UK Ipramol Teva 0,5 mg+2,5 mg/2,5 ml Steri- IE/H/0163/ TEVA GMBH DE Neb Lösung für einen Vernebler Ipramol 0,5 mg/2,5 mg in 2,5 ml soluzione IE/H/0163/ TEVA ITALIA S.R.L. IT Ipramol Steri-Neb IE/H/0163/ TEVA DENMARK A/S DK Ipramol 0,5 mg/2,5ml + 2,5 mg/2,5ml IE/H/0163/ TEVA PHARMA PRODUTOS PT FARMACÊUTICOS LDA NEBU-IPRASAL 0,5 mg/2,5 mg/2,5 ml IE/H/0163/001 BE TEVA PHARMA BELGIUM BE LÖSUNG FÜR EINEN VERNEBLER N.V./S.A Nebu-Iprasal 0,5 mg / 2,5 mg / 2,5 ml IE/H/0163/001 BE TEVA PHARMA BELGIUM BE N.V./S.A Ipramol 0,5 mg/2,5ml + 2,5 mg/2,5ml IE/H/0163/ TEVA PHARMA PRODUTOS PT FARMACÊUTICOS LDA Ipramol Steri-Neb 0,5 mg / 2,5 mg per 2,5 IE/H/0163/001 RVG TEVA NEDERLAND B.V. NL ml, Ipramol 0,5 mg/2,5 mg per 2,5 ml, lösning IE/H/0163/ TEVA SWEDEN AB FI för nebulisator Zerseos 0,5 mg/2,5 mg per 2,5 ml, NL/H/3597/001 RVG CIPLA (EU) LIMITED NL Zerseos 0.5 mg/2.5 mg per 2.5 ml nebuliser NL/H/3597/001 PA 1809/022/001 CIPLA (EU) LIMITED IE solution Salipra 0,5 mg/2,5 mg lösning för nebulisator not available ALTERNOVA A/S SE Combivent, inhalationsvæske til nebulisator, not available BOEHRINGER INGELHEIM DK opløsning, enkeltdosisbeholder Combivent UDVs 500 micrograms/2.5 mg not available PA 7/52/2 BOEHRINGER INGELHEIM LTD. IE per 2.5 ml Nebuliser solution Atrodual lösning för nebulisator i endosbehållare not available BOEHRINGER INGELHEIM FI EMA/784453/2017 Page 5/7

6 ipratropiumbromid/salbutamol Combivent 0,5 mg/2,5 ml + 2,5 mg/2,5 ml not available 632/01/09/7766 SCS BOEHRINGER INGELHEIM LU Lösung für einen Vernebler Combivent 0,5 mg/2,5 ml + 2,5 mg/2,5 ml not available BE SCS BOEHRINGER INGELHEIM BE Lösung für einen Vernebler Atrodual sumutinliuos kerta-annossäiliössä not available BOEHRINGER INGELHEIM FI Combivent 0,5 mg/2,5 ml + 2,5 mg/2,5 ml not available 632/01/09/7766 SCS BOEHRINGER INGELHEIM LU Solution pour inhalation par nébuliseur Combivent Unidose 0,52 mg/2,5 ml + 3 not available BOEHRINGER INGELHEIM, PT mg/2,5 ml UNIPESSOAL, LDA. Combivent Unidose 0,52 mg/2,5 ml + 3 not available BOEHRINGER INGELHEIM, PT mg/2,5 ml UNIPESSOAL, LDA. Combivent Unidose 0,52 mg/2,5 ml + 3 not available BOEHRINGER INGELHEIM, PT mg/2,5 ml UNIPESSOAL, LDA. Combivent Unit Dose, not available RVG BOEHRINGER INGELHEIM B.V. NL Berovent διάλυμα για εισπνοή με εκνεφωτή not available BOEHRINGER INGELHEIM CY ELLAS AE Berovent διάλυμα για εισπνοή με εκνεφωτή not available 37256/10 BOEHRINGER INGELHEIM GR ELLAS AE Combivent UDVs not available PL 00015/0197 BOEHRINGER INGELHEIM LTD. UK Combivent 0,5 mg/2,5 mg lösning för not available BOEHRINGER INGELHEIM SE nebulisator, endosbehållare Combivent 0,5 mg/2,5 ml + 2,5 mg/2,5 ml not available BE SCS BOEHRINGER INGELHEIM BE Solution pour inhalation par nébuliseur Combivent 0,5 mg/2,5 ml + 2,5 mg/2,5 ml not available BE SCS BOEHRINGER INGELHEIM BE Verneveloplossing Combivent Lösung für einen Vernebler in not available BOEHRINGER INGELHEIM RCV AT Einzeldosisbehältnissen GMBH & CO KG COMBIPRASAL 0.5 mg/2.5 mg solución para not available LABORATORIO ALDO-UNIÓN, ES inhalación por nebulizador S.L. Ipratropium/Salbutamol "Sandoz" NL/H/2221/ SANDOZ A/S DK Ipratropiumbromide/Salbutamol Sandoz 0,5 mg/2,5 mg per 2,5 ml Unit Dose, NL/H/3022/001 RVG SANDOZ B.V. NL EMA/784453/2017 Page 6/7

7 Ipratropiumbromide/Salbutamol Sandoz 0,5/2,5 mg per 2,5 ml, Copralineb 0.5 mg/2.5 mg per 2.5 ml Nebuliser Solution Ipratropium/Salbutamol Sandoz 0,5 mg/2,5 mg lösning för nebulisator NL/H/2221/001 RVG SANDOZ B.V. NL NL/H/2221/001 PL 04416/1296 SANDOZ LTD UK NL/H/2221/ SANDOZ A/S SE EMA/784453/2017 Page 7/7