List of nationally authorised medicinal products

Transcription

1 20 July 2016 EMA/270645/2015 Procedure Management and Committees Support Active substance: apomorphine 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 Infusionslösung National Number AT/H/0364/ EVER NEU PHARMA GMBH AT Dacepton 5 mg /ml oplossing voor infusie AT/H/0364/002 BE EVER NEU PHARMA GMBH BE Dacepton 5 mg/ml infusionsvæske, opløsning infusioonilahus AT/H/0364/002/DC EVER NEU PHARMA GMBH DK AT/H/0364/ EVER NEU PHARMA GMBH EE Dopaceptin 5 mg/ml Solution pour perfusion AT/H/0364/ EVER NEU PHARMA GMBH FR Dopaceptin 5 mg/ml Solution pour perfusion AT/H/0364/ EVER NEU PHARMA GMBH FR AT/H/0364/002 OGYI-T-22316/ EVER NEU PHARMA GMBH HU oldatos infúzió 10 Infusionslösung AT/H/0364/ EVER NEU PHARMA GMBH DE infúzny roztok AT/H/0364/002 27/0099/14-S EVER NEU PHARMA GMBH SK infuzinis tirpalas AT/H/0364/002 LT/1/11/2759/008 EVER NEU PHARMA GMBH LT EMA/578674/2016 Page 2/21

3 infuzinis tirpalas National Number AT/H/0364/002 LT/1/11/2759/009 EVER NEU PHARMA GMBH LT infuzinis tirpalas AT/H/0364/002 LT/1/11/2759/010 EVER NEU PHARMA GMBH LT infuzinis tirpalas AT/H/0364/002 LT/1/11/2759/011 EVER NEU PHARMA GMBH LT infuzinis tirpalas AT/H/0364/002 LT/1/11/2759/012 EVER NEU PHARMA GMBH LT infuzinis tirpalas AT/H/0364/002 LT/1/11/2759/013 EVER NEU PHARMA GMBH LT infuzinis tirpalas AT/H/0364/002 LT/1/11/2759/014 EVER NEU PHARMA GMBH LT solution for infusion AT/H/0364/002 PA1774/001/002 EVER NEU PHARMA GMBH IE šķīdums infūzijām AT/H/0364/ EVER NEU PHARMA GMBH LV oplossing voor infusie AT/H/0364/002 RVG EVER NEU PHARMA GMBH NL EMA/578674/2016 Page 3/21

4 infusjonsvæske, oppløsning soluţie perfuzabilă National Number AT/H/0364/002/DC EVER NEU PHARMA GMBH NO AT/H/0364/ /2014/01-05 EVER NEU PHARMA GMBH infusionsvätska, lösning AT/H/0364/ EVER NEU PHARMA GMBH SE raztopina za infundiranje AT/H/0364/ I-1007/14 EVER NEU PHARMA GMBH SI raztopina za infundiranje AT/H/0364/ I-1008/14 EVER NEU PHARMA GMBH SI raztopina za infundiranje AT/H/0364/ I-1009/14 EVER NEU PHARMA GMBH SI raztopina za infundiranje AT/H/0364/ I-1010/14 EVER NEU PHARMA GMBH SI raztopina za infundiranje AT/H/0364/ I-1011/14 EVER NEU PHARMA GMBH SI solution for infusion AT/H/0364/002 PL 40369/0003 EVER NEU PHARMA GMBH UK EMA/578674/2016 Page 4/21

5 Дацептон 5 mg/ml инфузионен разтвор National Number AT/H/0364/002/DC EVER NEU PHARMA GMBH BG AT/H/0364/001 PA1774/001/001 EVER NEU PHARMA GMBH IE AT/H/0364/001/DC EVER NEU PHARMA GMBH DE AT/H/0364/ EVER NEU PHARMA GMBH EE Solution for injection or infusion Injektions- /Infusionslösung, süste- või infusioonilahus solución inyectable y para perfusión EFG Dacepton 10 mg /ml oldatos injekció vagy infúzió Dacepton 10 mg /ml oplossing voor injectie of infusie injeksjons- /infusjonsvæske, oppløsning injektions- /infusionsvätska, lösning AT/H/0364/ EVER NEU PHARMA GMBH ES AT/H/0364/001 OGYI-T-22316/01-03 EVER NEU PHARMA GMBH HU AT/H/0364/001 RVG EVER NEU PHARMA GMBH NL AT/H/0364/001/DC EVER NEU PHARMA GMBH NO AT/H/0364/ EVER NEU PHARMA GMBH SE EMA/578674/2016 Page 5/21

6 National Number AT/H/0364/ I-1512/12 EVER NEU PHARMA GMBH SI AT/H/0364/001 PL 40369/0001 EVER NEU PHARMA GMBH UK AT/H/0364/001 BE EVER NEU PHARMA GMBH BE AT/H/0364/001/DC EVER NEU PHARMA GMBH FI AT/H/0364/ EVER NEU PHARMA GMBH ES AT/H/0364/ EVER NEU PHARMA GMBH FI raztopina za injiciranje/infundiranje Solution for injection or infusion solution injectable/pour perfusion injektions- /infusionsvätska, lösning solución para perfusión EFG Dacepton 5 mg /ml infuusioneste, liuos Injektions- /Infusionslösung, injekcní/infuzní roztok AT/H/0364/001/DC EVER NEU PHARMA GMBH AT AT/H/0364/001 27/353/11-C EVER NEU PHARMA GMBH CZ injekcinis / infuzinis tirpalas AT/H/0364/001 LT/1/11/2759/001 EVER NEU PHARMA GMBH LT EMA/578674/2016 Page 6/21

7 injekcinis / infuzinis tirpalas injekcinis / infuzinis tirpalas injekcinis / infuzinis tirpalas injekcinis / infuzinis tirpalas injekcinis / infuzinis tirpalas injekcinis / infuzinis tirpalas šķīdums injekcijām vai infūzijām DACEPTON, 10 mg/ml, roztwór do wstrzykiwań / do infuzji solutie injectabila/perfuzabila National Number AT/H/0364/001 LT/1/11/2759/002 EVER NEU PHARMA GMBH LT AT/H/0364/001 LT/1/11/2759/003 EVER NEU PHARMA GMBH LT AT/H/0364/001 LT/1/11/2759/004 EVER NEU PHARMA GMBH LT AT/H/0364/001 LT/1/11/2759/005 EVER NEU PHARMA GMBH LT AT/H/0364/001 LT/1/11/2759/006 EVER NEU PHARMA GMBH LT AT/H/0364/001 LT/1/11/2759/007 EVER NEU PHARMA GMBH LT AT/H/0364/ EVER NEU PHARMA GMBH LV AT/H/0364/ EVER NEU PHARMA GMBH PL AT/H/0364/ /2011/01 EVER NEU PHARMA GMBH EMA/578674/2016 Page 7/21

8 Injekčný a infúzny roztok National Number AT/H/0364/001 27/0360/11-S EVER NEU PHARMA GMBH SK solutie injectabila/perfuzabila solutie injectabila/perfuzabila solutie injectabila/perfuzabila solutie injectabila/perfuzabila solutie injectabila/perfuzabila solutie injectabila/perfuzabila Инжекционен/инфузион ен разтвор Dacepton, injektions- og infusionsvæske, opløsning AT/H/0364/ /2011/02 EVER NEU PHARMA GMBH AT/H/0364/ /2011/03 EVER NEU PHARMA GMBH AT/H/0364/ /2011/04 EVER NEU PHARMA GMBH AT/H/0364/ /2011/05 EVER NEU PHARMA GMBH AT/H/0364/ /2011/06 EVER NEU PHARMA GMBH AT/H/0364/ /2011/07 EVER NEU PHARMA GMBH AT/H/0364/ EVER NEU PHARMA GMBH BG AT/H/0364/ EVER NEU PHARMA GMBH DK EMA/578674/2016 Page 8/21

9 APO-go Ampullen 10 National Number UK/H/0342/ BRITANNIA mg/ml Injektions- /Infusionslösung APO-go 10 mg/ml UK/H/0342/ BRITANNIA injektions- /infusionsvätska, lösning APO-go Ampul UK/H/0342/ BRITANNIA AT SE DK APO-go Ampullen 10 mg/ml Injektions- /Infusionslösung APO-go 10 mg/ml injekčný alebo infúzny roztok APO-GO-AMP 10 mg/ml oplossing voor injectie of infusie UK/H/0342/ BRITANNIA UK/H/0342/002 27/0461/11-S BRITANNIA UK/H/0342/002 BE BRITANNIA UK/H/0342/ /2012/01 BRITANNIA DE SK BE Apo-go 10mg/ml Solução injetável ou para perfusão APO-go 10 mg/ml raztopina za injiciranje ali infundiranje v ampuli UK/H/0342/ BRITANNIA UK/H/0342/ I-673/12 BRITANNIA PT SI EMA/578674/2016 Page 9/21

10 APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion APO-GO-AMP 10 mg/ml oplossing voor injectie of infusie Apo-go 10mg/ml Solução injetável ou para perfusão Apo-go 10mg/ml Solução injetável ou para perfusão Apo-go 10mg/ml Solução injetável ou para perfusão Apo-go 10mg/ml Solução injetável ou para perfusão Apo-go 10mg/ml Solução injetável ou para perfusão National Number UK/H/0342/002 PA0356/010/002 BRITANNIA UK/H/0342/002 BE BRITANNIA UK/H/0342/ BRITANNIA UK/H/0342/ BRITANNIA UK/H/0342/ BRITANNIA UK/H/0342/ BRITANNIA UK/H/0342/ BRITANNIA UK/H/0342/ /2012/03 BRITANNIA IE BE PT PT PT PT PT UK/H/0342/ /2012/02 BRITANNIA EMA/578674/2016 Page 10/21

11 National Number UK/H/0342/ /2012/09 BRITANNIA UK/H/0342/ /2012/07 BRITANNIA UK/H/0342/ /2012/08 BRITANNIA UK/H/0342/ /2012/05 BRITANNIA UK/H/0342/ /2012/12 BRITANNIA UK/H/0342/ /2012/11 BRITANNIA UK/H/0342/ /2012/06 BRITANNIA UK/H/0342/ /2012/04 BRITANNIA UK/H/0342/ /2012/10 BRITANNIA EMA/578674/2016 Page 11/21

12 APO-go Ampullen 10 mg/ml oplossing voor injectie of infusie APO-go, 10mg/ml süstevõi infusioonilahus National Number UK/H/0342/002 RVG BRITANNIA UK/H/0342/ BRITANNIA NL EE APO-go 10 mg/ml Solución Inyectable o para Perfusión en Ampollas APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion Apomorphin Archimedes 10 mg/ml Injektionslösung/Infusion slösung Apomorphinhydrochlorid 10 mg/ml Injektionslösung/Infusion slösung Apomorfina Archimedes 10 mg/ml solución inyectable/para perfusión Apomorphine hydrochloride 10mg/ml solution for injection/infusion UK/H/0342/ BRITANNIA UK/H/0342/002 PL 04483/0072 BRITANNIA UK/H/3238/001 ZUL NR ARCHIMEDES PHARMA UK LIMITED UK/H/3238/ ARCHIMEDES PHARMA UK LIMITED UK/H/3238/ ARCHIMEDES PHARMA UK LIMITED UK/H/3238/001 PL12406/0024 ARCHIMEDES PHARMA UK LIMITED ES UK AT DE ES UK EMA/578674/2016 Page 12/21

13 Apomorphin hameln rds 10 mg/ml Injektions- /Infusionslösung APO-go Pumpfill 5 mg/ml infusionsvätska, lösning i förfylld spruta APO-go PFS, 5 mg/ml, roztwór do infuzji National Number AT/H/0365/001/DC HAMELN RDS GMBH AT UK/H/0342/ BRITANNIA UK/H/0342/ BRITANNIA SE PL Britaject 5 mg/ml oldatos infúzió előretöltött fecskendőben Britaject 5 mg/ml infusjonsvæske, oppløsning i ferdigfylt sprøyte Apo-go 5mg/ml Solução para perfusão em seringa pré-cheia APO-go PFS 5mg/ml Solution for Infusion in Pre-filled Syringe APO-go PFS 5mg/ml Solution for Infusion in Pre-filled Syringe APO-go Pumpfill 5mg/ml innrennslislyf, lausn í áfylltri sprautu UK/H/0342/003 OGYI-T-22069/04 BRITANNIA UK/H/0342/ BRITANNIA UK/H/0342/ BRITANNIA UK/H/0342/003 PL 04483/0074 BRITANNIA UK/H/0342/003 PA0356/10/3 BRITANNIA UK/H/0342/003 IS/1/11/073/01 BRITANNIA HU NO PT UK IE IS EMA/578674/2016 Page 13/21

14 APO-go PFS 5mg/ml Solution for Infusion in Pre-filled Syringe APO-go 5 mg/ml infúzny roztok naplnený v injekčnej striekačke APO-go 5 mg/ml Infusionslösung in einer Fertigspritze APO-go 5 mg/ml Infusionslösung in einer Fertigspritze APO-go 5 mg/ml oplossing voor infusie in een voorgevulde spuit APO-go PFS 5 mg/ml Solución para Perfusión en Jeringa Precargada Apomorfine hydrochloride PharmSwed 5 mg/ml, oplossing voor infusie Apomorfin PharmSwed 5 mg/ml infusjonsvæske, oppløsning Apomorfin PharmSwed 5 mg/ml innrennslislyf, lausn National Number UK/H/0342/003 MA 957/00101 BRITANNIA UK/H/0342/003 27/0463/11-S BRITANNIA UK/H/0342/ BRITANNIA UK/H/0342/ BRITANNIA UK/H/0342/003 RVG BRITANNIA UK/H/0342/ BRITANNIA SE/H/1272/001 RVG PharmSwed PHARMACEUTICALS SALES & DEVELOPMENT SWEDEN AB SE/H/1272/ PharmSwed PHARMACEUTICALS SALES & DEVELOPMENT SWEDEN AB SE/H/1272/001 IS71/12/122/01 PharmSwed PHARMACEUTICALS SALES & DEVELOPMENT SWEDEN AB MT SK AT DE NL ES NL NO IS EMA/578674/2016 Page 14/21

15 Apomorfin PharmSwed, infusionsvæske, opløsning Apomorphine hydrochloride 5mg/ml solution for infusion Apomorphine hydrochloride 5 mg/ml, solution for infusion Apomorphinhydrochlorid PharmSwed 5 mg/ml Infusionslösung Apomorfin PharmSwed 5 mg/ml, infusionsvätska, lösning APO-go PEN oplossing voor injectie 10 mg/ml National Number SE/H/1272/ PharmSwed PHARMACEUTICALS SALES & DEVELOPMENT SWEDEN AB SE/H/1272/001 PA1807/001/001 PharmSwed PHARMACEUTICALS SALES & DEVELOPMENT SWEDEN AB SE/H/1272/001 PL 41183/0001 PharmSwed PHARMACEUTICALS SALES & DEVELOPMENT SWEDEN AB SE/H/1272/ PharmSwed PHARMACEUTICALS SALES & DEVELOPMENT SWEDEN AB SE/H/1272/ PharmSwed PHARMACEUTICALS SALES & DEVELOPMENT SWEDEN AB UK/H/0342/001 RVG BRITANNIA DK IE UK DE SE NL APO go PEN, 10 mg/ml, roztwór do wstrzykiwan UK/H/0342/ BRITANNIA PL APO-GO-PEN 10 mg/ml oplossing voor injectie UK/H/0342/001 BE BRITANNIA BE Britaject PEN 10 mg/ml oldatos injekció UK/H/0342/001 OGYI-T-22069/01 BRITANNIA HU EMA/578674/2016 Page 15/21

16 Britaject 10 mg/ml injeksjonsvæske, oppløsning i ferdigfylt penn. solução injetável National Number UK/H/0342/ BRITANNIA UK/H/0342/ BRITANNIA NO PT APO-go 10 mg/ml raztopina za injiciranje v peresniku Solution for Injection UK/H/0342/ I-671/12 BRITANNIA UK/H/0342/001 PL 04483/0073 BRITANNIA SI UK Solution for Injection UK/H/0342/ PA0356/10/1 BRITANNIA IE Britaject PEN 10mg/ml injekcinis tirpalas UK/H/0342/001 LT/1/12/2917/007 BRITANNIA LT solução injetável UK/H/0342/ BRITANNIA PT solução injetável UK/H/0342/ BRITANNIA PT Solution for Injection UK/H/0342/001 MA 957/00102 BRITANNIA MT EMA/578674/2016 Page 16/21

17 Apogo PEN 10 mg/ml injektioneste, liuos National Number UK/H/0342/ BRITANNIA FI APO-go Pen, injektionsvæske, opløsning АПО-го ПИСАЛКА 10 mg/ml инжекционен разтвор APO-go 10 mg/ml injekčný roztok naplnený v pere solución inyectable UK/H/0342/ BRITANNIA UK/H/0342/001 R-8828 BRITANNIA UK/H/0342/001 27/0462/11-S BRITANNIA UK/H/0342/ BRITANNIA DK BG SK ES Injektionslösung UK/H/0342/ BRITANNIA DE stungulyf, lausn UK/H/0342/001 IS/1/11/072/01 BRITANNIA IS šķīdums injekcijām UK/H/0342/ BRITANNIA LV Britaject PEN 10 mg/ml injekční roztok UK/H/0342/001 27/787/11-C BRITANNIA CZ EMA/578674/2016 Page 17/21

18 APO-go PEN 10 mg/ml Injektionslösung National Number UK/H/0342/ BRITANNIA AT injektionsvätska, lösning UK/H/0342/ BRITANNIA SE Apomorphine hameln rds AT/H/0365/001/DC n/a HAMELN RDS GMBH FR 10mg/ml, solution jejectable/pour perfusion APO-go Ampoules UK/H/0342/ R-8971/ BRITANNIA BG Britaject UK/H/0342/ LT/1/12/2917/ BRITANNIA LT APO-GO-AMP UK/H/0342/ BRITANNIA LU APO-go 10 mg/ml raztopina za injiciranje ali infundiranje v ampuli UK/H/0342/ I-672/12 BRITANNIA APO-go PEN UK/H/0342/ ML BRITANNIA SI CY APO-go UK/H/0342/ /01/3989 BRITANNIA EE EMA/578674/2016 Page 18/21

19 National Number APO-go PEN UK/H/0342/ / BRITANNIA GR APO-go PEN UK/H/0342/ BRITANNIA LU Apo-go PEN UK/H/0342/ /2012/10-12 BRITANNIA Apo-go PFS UK/H/0342/ R-8829/ BRITANNIA BG APO-go PFS UK/H/0342/ ML BRITANNIA CY APO-go PFS UK/H/0342/ BRITANNIA GR APO-go PFS UK/H/0342/ BRITANNIA LU APO-go UK/H/0342/ /2012/01-12 BRITANNIA Dopaceptin AT/H/0364/001/DC EVER NEU PHARMA GMBH GR EMA/578674/2016 Page 19/21

20 National Number Dopaceptin AT/H/0364/002/DC 49653/ EVER NEU PHARMA GMBH GR Dacepton AT/H/0364/002/ DC EVER NEU PHARMA GMBH PL APOFIN 50 mg/5 ml soluzione iniettabile per infusione sottocutanea not available CHIESI FARMACEUTICI S.P.A. APOFIN STYLO not available CHIESI FARMACEUTICI S.P.A. IT IT APOFIN STYLO not available CHIESI FARMACEUTICI S.P.A. IT BRITAJECT 10 mg/ml oldatos injekció vagy infúzió Apokinon 10 mg/ml, solution injecatble (SC) UK/H/0342/002 OGYI-T-22069/02-03 BRITANNIA HU NL Laboratoire AGUETTANT FR Apokinon 30 mg/3 ml, solution injecatble en stylo pré-rempli Apokinon 5 mg/ml, solution injecatble NL Laboratoire AGUETTANT FR NL Laboratoire AGUETTANT FR EMA/578674/2016 Page 20/21

21 National Number Apomorphin Teclapharm GmbH DE EMA/578674/2016 Page 21/21