List of nationally authorised medicinal products
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1 24 January 2018 EMA/141276/2018 Human Medicines Evaluation Division Active substance: irinotecan (except for liposomal formulations) 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 koncentrat za otopinu za infuziju koncentrat za otopinu za infuziju koncentrat za otopinu za infuziju not available HR-H PFIZER CROATIA D.O.O. HR not available HR-H PFIZER CROATIA D.O.O. HR not available HR-H PFIZER CROATIA D.O.O. HR FR/H/0108/ PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT FR/H/0108/ PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. FR/H/0108/ PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. FR/H/0108/002 BE PFIZER S.A. (BELGIUM) BE FR/H/0108/002 BE PFIZER S.A. (BELGIUM) BE FR/H/0108/002 BE PFIZER S.A. (BELGIUM) BE EMA/141276/2018 Page 2/7
3 FR/H/0108/002 BE PFIZER S.A. (BELGIUM) BE FR/H/0108/002 BE PFIZER S.A. (BELGIUM) BE FR/H/0108/002 BE PFIZER S.A. (BELGIUM) BE FR/H/0108/002 RVG PFIZER B.V. NL FR/H/0108/002 RVG PFIZER B.V. NL FR/H/0108/002 RVG PFIZER B.V. NL FR/H/0108/002 PA 19/53/3 PFIZER LIMITED IE not available 505/04703 PFIZER HELLAS, A.E. MT not available 505/04702 PFIZER HELLAS, A.E. MT not available 505/04701 PFIZER HELLAS, A.E. MT FR/H/0108/002 PL 00057/0627 PFIZER LIMITED UK FR/H/0108/002 PL 00057/0627 PFIZER LIMITED UK EMA/141276/2018 Page 3/7
4 concentrato per soluzione per e concentrato per soluzione per e concentrato per soluzione per e, innrennslisþykkni, lausn, innrennslisþykkni, lausn, innrennslisþykkni, lausn solution solution solution solution FR/H/0108/002 PL 00057/0626 PFIZER LIMITED UK FR/H/0108/002 PL 00057/0627 PFIZER LIMITED UK FR/H/0108/002 PL 00057/0626 PFIZER LIMITED UK FR/H/0108/002 PL 00057/0626 PFIZER LIMITED UK FR/H/0108/ /M PFIZER LIMITED IT FR/H/0108/ /M PFIZER LIMITED IT FR/H/0108/ /M PFIZER LIMITED IT not available (IS) PFIZER APS IS not available (IS) PFIZER APS IS not available (IS) PFIZER APS IS FR/H/0108/002 BE PFIZER S.A. (BELGIUM) BE FR/H/0108/002 BE PFIZER S.A. (BELGIUM) BE FR/H/0108/002 BE PFIZER S.A. (BELGIUM) BE EMA/141276/2018 Page 4/7
5 solution solution solution (IV) solution (IV) solution (IV) πυκνό πυκνό πυκνό πυκνό CAMPTO koncentrát pro infuzní roztok CAMPTO koncentrát pro infuzní roztok CAMPTO koncentrát pro infuzní roztok CAMPTO, 20 mg/ml, koncentrat do sporządzania roztworu do infuzji CAMPTO, 20 mg/ml, koncentrat do sporządzania roztworu do infuzji FR/H/0108/ PFIZER HOLDING FRANCE FR FR/H/0108/ PFIZER HOLDING FRANCE FR FR/H/0108/ PFIZER HOLDING FRANCE FR not available PFIZER HELLAS, A.E. CY FR/H/0108/ / PFIZER HELLAS, A.E. GR FR/H/0108/ / PFIZER HELLAS, A.E. GR FR/H/0108/ / PFIZER HELLAS, A.E. GR not available 44/014/98-C PFIZER, SPOL. S R.O. CZ not available 44/014/98-C PFIZER, SPOL. S R.O. CZ not available 44/014/98-C PFIZER, SPOL. S R.O. CZ not available PFIZER EUROPE MA EEIG PL not available PFIZER EUROPE MA EEIG PL EMA/141276/2018 Page 5/7
6 CAMPTO, 20 mg/ml, koncentrat do sporządzania roztworu do infuzji Campto, koncentrat til svæske, opløsning Campto, koncentrat til svæske, opløsning Campto, koncentrat til svæske, opløsning Irinotecán Aurovitas 20 mg/ml concentrado para solución para perfusión solution à diluer pour perfusion solution à diluer pour perfusion not available PFIZER EUROPE MA EEIG PL FR/H/0108/ PFIZER APS DK FR/H/0108/ PFIZER APS DK FR/H/0108/ PFIZER APS DK UK/H/1013/ AUROVITAS SPAIN,S.A.U. ES NL/H/1326/001 BE EUROGENERICS N.V./S.A. BE NL/H/1326/001 BE EUROGENERICS N.V./S.A. BE NL/H/1326/001 BE EUROGENERICS N.V./S.A. BE NL/H/1326/001 BE EUROGENERICS N.V./S.A. BE NL/H/1326/001 BE EUROGENERICS N.V./S.A. BE NL/H/1326/001 BE EUROGENERICS N.V./S.A. BE NL/H/1326/001 BE EUROGENERICS N.V./S.A. BE NL/H/1326/001 BE EUROGENERICS N.V./S.A. BE EMA/141276/2018 Page 6/7
7 solution à diluer pour perfusion NL/H/1326/001 BE EUROGENERICS N.V./S.A. BE EMA/141276/2018 Page 7/7
List of nationally authorised medicinal products
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27 October 2016 EMA/735253/2016 Procedure Management and Committees Support Active substance: eletriptan Procedure no.: PSUSA/00001204/201602 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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22 July 2015 EMA/586234/2015 Procedure Management and Committees Support Active substance: amiodarone Procedure no.: PSUSA/00000166/201412 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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14 April 2016 EMA/316649/2016 Procedure Management and Committees Support List of nationally authorised medicinal products Active substance(s): olodaterol Procedure No.: PSUSA/00010245/201509 30 Churchill
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14 January 2016 EMA/230198/2016 Procedure Management and Committees Support Active substance: terlipressin Procedure no.: PSUSA/00002905/201504 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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