Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000
05 September 2019 EMA/496540/2019 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application)
Procedure no.: PSUSA/00010187/201901
List of nationally authorised medicinal products EMA/496540/2019 Page 2/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Aminoven 10% soluţie perfuzabilă not available 9944/2017/01 FRESENIUS KABI AB RO Aminoven 10% soluţie perfuzabilă not available 9944/2017/02 FRESENIUS KABI AB RO Aminoven 10% soluţie perfuzabilă not available 9944/2017/03 FRESENIUS KABI AB RO Aminoven 10 % infusionsvätska, lösning
DE/H/0160/002 15517 FRESENIUS KABI AB SE
Aminovenâ 10 %, Infusionslösung DE/H/0160/002 38718.01.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Aminoven 10%, infusionsvæske, opløsning
DE/H/0160/002 30749 FRESENIUS KABI AB DK
Aminoven® 10 %, Infusionslösung
DE/H/0160/002 0452/99/07/0024 FRESENIUS KABI DEUTSCHLAND GMBH
LU
Aminoven 10% oplossing voor infusie
DE/H/0160/002 RVG 24229 FRESENIUS KABI NEDERLAND B.V.
NL
Aminoven 10%, solução para perfusão
DE/H/0160/002 2969681 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 10 % - Infusionsl ﾃｶsung
DE/H/0160/002 1-23277 FRESENIUS KABI AUSTRIA GMBH
AT
Aminoven 10% Infusionslösung DE/H/0160/002 BE206595 FRESENIUS KABI NV/SA BE Aminoven 10% oplossing voor infusie
DE/H/0160/002 BE206604 FRESENIUS KABI NV/SA BE
Aminoven 10% solución para perfusión
DE/H/0160/002 62.981 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Aminoven 10% solution pour perfusion
DE/H/0160/002 BE240256 FRESENIUS KABI NV/SA BE
Aminoven 16 solution for infusion DE/H/0160/002 PL 08828/0128 FRESENIUS KABI LIMITED UK Aminoven 16 solution for infusion DE/H/0160/002 PA 566/2/5 FRESENIUS KABI
DEUTSCHLAND GMBH IE
List of nationally authorised medicinal products EMA/496540/2019 Page 3/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Aminoven 10% Soluzione per infusione
DE/H/0160/002 034562049 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 10% Soluzione per infusione
DE/H/0160/002 034562064 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 10%, solução para perfusão
DE/H/0160/002 2969780 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 10%, solução para perfusão
DE/H/0160/002 2969889 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 10% Soluzione per infusione
DE/H/0160/002 034562052 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 10% Infusionslösung DE/H/0160/002 BE206604 FRESENIUS KABI NV/SA BE Aminoven 10% oplossing voor infusie
DE/H/0160/002 BE206595 FRESENIUS KABI NV/SA BE
Aminoven 10% oplossing voor infusie
DE/H/0160/002 BE240256 FRESENIUS KABI NV/SA BE
Aminoven 10% oplossing voor infusie
DE/H/0160/002 BE240265 FRESENIUS KABI NV/SA BE
Aminoven 10% solution pour perfusion
DE/H/0160/002 BE206595 FRESENIUS KABI NV/SA BE
Aminoven 10% solution pour perfusion
DE/H/0160/002 BE206604 FRESENIUS KABI NV/SA BE
Aminoven 10% solution pour perfusion
DE/H/0160/002 BE240265 FRESENIUS KABI NV/SA BE
Aminoven 16 solution for infusion DE/H/0160/002 PA 566/2/2 FRESENIUS KABI DEUTSCHLAND GMBH
IE
Neonutrin 15 %, infuzní roztok not available 76/647/99-C FRESENIUS KABI S.R.O. CZ Glamin 134 mg/ml raztopina za not available H/99/00696/001 MEDIAS INTERNATIONAL SI
List of nationally authorised medicinal products EMA/496540/2019 Page 4/28
Vamin 18 g N/l elektrolytfri, infusionsvæske, opløsning
not available 11339 FRESENIUS KABI AB DK
Amino-mel nephro 100 mg/ml raztopina za infundiranje
not available H/94/00163/001 MEDIAS INTERNATIONAL D.O.O.
SI
Aminoplasmal Hepa 10% infuzinis tirpalas
not available LT/1/97/3002/001 B.BRAUN MELSUNGEN AG LT
Aminoven 5 % infusionsvätska, lösning
DE/H/0160/001 15516 FRESENIUS KABI AB SE
Aminoven 5%, infusionsvæske, opløsning
DE/H/0160/001 30748 FRESENIUS KABI AB DK
Aminovenâ 5 %, Infusionslösung DE/H/0160/001 38718.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Aminoven 5% oplossing voor infusie
DE/H/0160/001 RVG 24228 FRESENIUS KABI NEDERLAND B.V.
NL
Aminoven 5% Infusionslösung DE/H/0160/001 BE206552 FRESENIUS KABI NV/SA BE Aminoven 5% oplossing voor infusie
DE/H/0160/001 BE206552 FRESENIUS KABI NV/SA BE
Aminoven 5% solution pour perfusion
DE/H/0160/001 BE240247 FRESENIUS KABI NV/SA BE
Aminoven 8 solution for infusion DE/H/0160/001 PL 08828/0127 FRESENIUS KABI LIMITED UK Aminoven 8 solution for infusion DE/H/0160/001 PA 566/2/1 FRESENIUS KABI
DEUTSCHLAND GMBH IE
Aminoven 5% Soluzione per infusione
DE/H/0160/001 034562013 FRESENIUS KABI ITALIA S.R.L.
IT
List of nationally authorised medicinal products EMA/496540/2019 Page 5/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Aminoven 5% Soluzione per infusione
DE/H/0160/001 034562025 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 5% Soluzione per infusione
DE/H/0160/001 034562037 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 5%, solução para perfusão
DE/H/0160/001 2969483 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 5%, solução para perfusão
DE/H/0160/001 2969582 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 5% Infusionslösung DE/H/0160/001 BE206543 FRESENIUS KABI NV/SA BE Aminoven 5% oplossing voor infusie
DE/H/0160/001 BE206543 FRESENIUS KABI NV/SA BE
Aminoven 5% oplossing voor infusie
DE/H/0160/001 BE240247 FRESENIUS KABI NV/SA BE
Aminoven 5% solution pour perfusion
DE/H/0160/001 BE206543 FRESENIUS KABI NV/SA BE
Aminoven 5% solution pour perfusion
DE/H/0160/001 BE206552 FRESENIUS KABI NV/SA BE
Aminoven 8 solution for infusion DE/H/0160/001 PA 566/2/4 FRESENIUS KABI DEUTSCHLAND GMBH
IE
Vamin 18 gN Electrolyte Free, oplossing voor infusie
not available BE135904 FRESENIUS KABI NV/SA BE
Vamin 18 gN Electrolyte Free, oplossing voor infusie
not available BE135913 FRESENIUS KABI NV/SA BE
Vamin 18 gN Electrolyte Free, Infusionslösung
not available BE135904 FRESENIUS KABI NV/SA BE
Vamin 18 gN Electrolyte Free, Infusionslösung
not available BE135913 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 6/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Vamin 18 gN Electrolyte Free, solution pour perfusion
not available BE135904 FRESENIUS KABI NV/SA BE
Vamin 18 gN Electrolyte Free, solution pour perfusion
not available BE135913 FRESENIUS KABI NV/SA BE
Aminoven 5% Infuzní roztok not available 76/297/01-C FRESENIUS KABI AB CZ Nephrotect soluţie perfuzabilă not available 10051/2017/01 FRESENIUS KABI
DEUTSCHLAND GMBH RO
Nephrotect soluţie perfuzabilă not available 10051/2017/02 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Nephrotect soluţie perfuzabilă not available 10051/2017/03 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Nephrotect soluţie perfuzabilă not available 10051/2017/04 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Vamin 14 gN Electrolyte Free, solution pour perfusion
not available 1148/96/12/0618 FRESENIUS KABI NV/SA LU
Vamin 14 gN Electrolyte Free Infusionslösung
not available BE135922 FRESENIUS KABI NV/SA BE
Vamin 14 gN Electrolyte Free Infusionslösung
not available BE135931 FRESENIUS KABI NV/SA BE
Vamin 14 gN Electrolyte Free, oplossing voor infusie
not available BE135922 FRESENIUS KABI NV/SA BE
Vamin 14 gN Electrolyte Free, oplossing voor infusie
not available BE135931 FRESENIUS KABI NV/SA BE
Vamin 14 gN Electrolyte Free, solution pour perfusion
not available BE135922 FRESENIUS KABI NV/SA BE
Vamin 14 gN Electrolyte Free, solution pour perfusion
not available BE135931 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 7/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PRIMENE 10 %, Infusionslösung not available BE141915 BAXTER SA BE PRIMENE 10 %, Infusionslösung not available BE142073 BAXTER SA BE PRIMENE 10 %, Infusionslösung not available BE141906 BAXTER SA BE PRIMENE 10% solución para perfusión
not available 58115 BAXTER, S.L. ES
PRIMENE 10 %, infusievloeistof not available RVG 12978 BAXTER B.V. NL Primene 10 % pur - Infusionslösung
not available 1-22760 BAXTER HEALTHCARE GMBH
AT
PRIMENE 10%, solução para perfusão
not available 2053387 BAXTER MÉDICO-FARMACÊUTICA, LDA.
PT
PRIMENE 10%, solução para perfusão
not available 2053486 BAXTER MÉDICO-FARMACÊUTICA, LDA.
PT
PRIMENE 10%, solução para perfusão
not available 2053585 BAXTER MÉDICO-FARMACÊUTICA, LDA.
PT
PRIMENE 10%, solução para perfusão
not available 2245280 BAXTER MÉDICO-FARMACÊUTICA, LDA.
PT
PRIMENE 10 % oplossing voor infusie
not available BE141915 BAXTER SA BE
PRIMENE 10 % solution pour perfusion
not available BE141915 BAXTER SA BE
PRIMENE 10 % oplossing voor infusie
not available BE142073 BAXTER SA BE
PRIMENE 10 % solution pour perfusion
not available BE142073 BAXTER SA BE
PRIMENE 10 % oplossing voor infusie
not available BE141906 BAXTER SA BE
PRIMENE 10 % solution pour not available BE141906 BAXTER SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 8/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
perfusion PRIMENE 10 % not available 0143762 BAXTER SA LU PRIMENE 10 % not available 0143809 BAXTER SA LU PRIMENE 10 % not available 0143826 BAXTER SA LU Primene 10% Solution for Infusion
not available PA2299/018/001 BAXTER HOLDING B.V. IE
Vamin 14 g N/l, infusionsvæske, opløsning
not available 11337 FRESENIUS KABI AB DK
Aminovenös N paed 10% Infusievloeistof
not available RVG 09552 FRESENIUS KABI NEDERLAND B.V.
NL
Aminoven 5% soluţie perfuzabilă not available 9943/2017/01 FRESENIUS KABI AB RO Aminoven 5% soluţie perfuzabilă not available 9943/2017/02 FRESENIUS KABI AB RO Aminoven 5% soluţie perfuzabilă not available 9943/2017/03 FRESENIUS KABI AB RO Glamin Infusionslösung not available 38694.00.00 BAXTER DEUTSCHLAND
GMBH DE
Vaminolact solution for infusion not available PL 08828/0123 FRESENIUS KABI LIMITED UK Amino-Mel "nephro" - Infusionsflasche
not available 1-19271 FRESENIUS KABI AUSTRIA GMBH
AT
Aminoven 100 mg/ml raztopina za infundiranje
not available H/03/00166/001 MEDIAS INTERNATIONAL D.O.O.
SI
Аминостерил N-Хепа 8% not available 20000853 FRESENIUS KABI DEUTSCHLAND GMBH
BG
AminosterilR N Hepa 8% not available RVG 08732 FRESENIUS KABI NEDERLAND B.V.
NL
Аминовен 10% инфузионен разтвор
not available 20020806 FRESENIUS KABI DEUTSCHLAND GMBH
BG
Aminoven Infant 100 mg/ml not available 5363-I-2175/10 MEDIAS INTERNATIONAL SI
List of nationally authorised medicinal products EMA/496540/2019 Page 9/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
raztopina za infundiranje za otroke
D.O.O.
Aminoven Infant 100 mg/ml raztopina za infundiranje za otroke
not available 5363-I-2176/10 MEDIAS INTERNATIONAL D.O.O.
SI
Vamin 14 Electrolyte-Free not available PL 08828/0119 FRESENIUS KABI LIMITED UK Vamin 18 Electrolyte-Free not available PL 08828/0120 FRESENIUS KABI LIMITED UK Aminosteril N-Hepa 8 % infuzinis tirpalas
DE/H/0357/001 LT/1/05/0297/001 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Aminosteril® N-Hepa 8 %, Infusionslösung
DE/H/0357/001 298.03.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Aminosteril N-Hepa 8% škidums infuzijam
DE/H/0357/001 05-0371 FRESENIUS KABI DEUTSCHLAND GMBH
LV
Aminosteril N-Hepa 8%, infusioonilahus
DE/H/0357/001 482205 FRESENIUS KABI DEUTSCHLAND GMBH
EE
Aminosteril Hepa 8%, solução para perfusão
DE/H/0357/001 5490388 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminosteril Hepa 8%, solução para perfusão
DE/H/0357/001 5490487 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminosteril N-Hepa 8 % infuzinis tirpalas
DE/H/0357/001 LT/1/05/0297/002 FRESENIUS KABI DEUTSCHLAND GMBH
LT
AMINOVEN 10% Infuzní roztok not available 76/298/01-C FRESENIUS KABI AB CZ Synthamin 9 reformulado solución para perfusión
not available 58192 BAXTER, S.L. ES
Synthamin 9 reformulado sin electrolitos solución para perfusión
not available 58.193 BAXTER, S.L. ES
List of nationally authorised medicinal products EMA/496540/2019 Page 10/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Synthamin 14 reformulado solución para perfusión
not available 58194 BAXTER, S.L. ES
Synthamin 14 reformulado sin electrolitos solución para perfusión
not available 58.195 BAXTER, S.L. ES
Synthamin 17 reformulado solución para perfusión
not available 58196 BAXTER, S.L. ES
Synthamin 17 reformulado sin electrolitos solución para perfusión
not available 58.197 BAXTER, S.L. ES
PRIMENE® not available 45730/10/18-03-2011 BAXTER HELLAS GR VINTENE, solution injectable pour perfusion
not available 34009 323 197 0 1 BAXTER SAS FR
VINTENE, solution injectable pour perfusion
not available 34009 323 714 5 7 BAXTER SAS FR
VINTENE, solution injectable pour perfusion
not available 34009 323 715 1 8 BAXTER SAS FR
VINTENE, solution injectable pour perfusion
not available 34009 327 253 2 8 BAXTER SAS FR
VINTENE, solution injectable pour perfusion
not available 34009 330 996 2 6 BAXTER SAS FR
VINTENE, solution injectable pour perfusion
not available 34009 552 742 7 8 BAXTER SAS FR
VINTENE, solution injectable pour perfusion
not available 34009 573 350 0 7 BAXTER SAS FR
VINTENE, solution injectable pour perfusion
not available 34009 573 351 7 5 BAXTER SAS FR
Synthamin 14, 8.5% Amino Acid not available PL 00116/0292 BAXTER HEALTHCARE LTD. UK
List of nationally authorised medicinal products EMA/496540/2019 Page 11/28
not available PL 00116/0293 BAXTER HEALTHCARE LTD. UK
Synthamin 14, 8.5% Amino Acid Intravenous Infusion without Electrolytes
not available PL 00116/0295 BAXTER HEALTHCARE LTD. UK
Synthamin 17, 10.0% Amino Acid Intravenous Infusion without Electrolytes
not available PL 00116/0296 BAXTER HEALTHCARE LTD. UK
Synthamin 9, 5.5% amino acid intravenous infusion
not available PL 00116/0291 BAXTER HEALTHCARE LTD. UK
Synthamin 9, 5.5% Amino Acid Intravenous Infusion without Electrolytes
not available PL 00116/0294 BAXTER HEALTHCARE LTD. UK
NEPHROTECT infuzní roztok not available 76/994/92-S/C FRESENIUS KABI DEUTSCHLAND GMBH
CZ
Glamin DE/H/0102/001 RVG 19631 FRESENIUS KABI NEDERLAND B.V.
NL
Vaminolac infusionsvätska, lösning
not available 11469 FRESENIUS KABI AB SE
Vamin 14,Διάλυμα για έγχυση not available 100303/14/08-01-2015 FRESENIUS KABI HELLAS A.E.
GR
Vaminolac not available 10839 FRESENIUS KABI AB FI AMIPED, solution pour perfusion DE/H/3752/001 NL 43531 B.BRAUN MELSUNGEN AG FR Amiped 10% Infusionslösung DE/H/3752/001 89202.00.00 B.BRAUN MELSUNGEN AG DE Nutramin VLI, infuzní roztok not available 76/018/00-C FRESENIUS KABI S.R.O. CZ VAMINOLACT 65,3 mg/ml not available H/00/01610/001 MEDIAS INTERNATIONAL SI
List of nationally authorised medicinal products EMA/496540/2019 Page 12/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
raztopina za infundiranje za otroke
D.O.O.
VAMINOLACT 65,3 mg/ml raztopina za infundiranje za otroke
not available H/00/01610/003 MEDIAS INTERNATIONAL D.O.O.
SI
VAMINOLACT 65,3 mg/ml raztopina za infundiranje za otroke
not available H/00/01610/002 MEDIAS INTERNATIONAL D.O.O.
SI
VAMINOLACT 65,3 mg/ml raztopina za infundiranje za otroke
not available H/00/01610/004 MEDIAS INTERNATIONAL D.O.O.
SI
Aminoven 10% šķīdums infūzijām not available 01-0417 FRESENIUS KABI AB LV Vamin 14 g N/l elektrolytfri, infusionsvæske, opløsning
not available 11338 FRESENIUS KABI AB DK
Vamin 14 zonder electrolyten not available RVG 10288 FRESENIUS KABI NEDERLAND B.V.
NL
Aminoven 15% Infuzní roztok not available 76/299/01-C FRESENIUS KABI AB CZ Vamin 14 g N/l infusionsvätska, lösning
not available 10094 FRESENIUS KABI AB SE
Aminoven 5 % infusionsvätska, lösning
DE/H/0160/001 15516 FRESENIUS KABI AB SE
Aminoven 5%, infusionsvæske, opløsning
DE/H/0160/001 30748 FRESENIUS KABI AB DK
Aminovenâ 5 %, Infusionslösung DE/H/0160/001 38718.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Aminoven 5% oplossing voor infusie
DE/H/0160/001 RVG 24228 FRESENIUS KABI NEDERLAND B.V.
NL
Aminoven 5% Infusionslösung DE/H/0160/001 BE206552 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 13/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Aminoven 5% oplossing voor infusie
DE/H/0160/001 BE206552 FRESENIUS KABI NV/SA BE
Aminoven 5% solution pour perfusion
DE/H/0160/001 BE240247 FRESENIUS KABI NV/SA BE
Aminoven 8 solution for infusion DE/H/0160/001 PL 08828/0127 FRESENIUS KABI LIMITED UK Aminoven 8 solution for infusion DE/H/0160/001 PA 566/2/1 FRESENIUS KABI
DEUTSCHLAND GMBH IE
Aminoven 5% Soluzione per infusione
DE/H/0160/001 034562013 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 5% Soluzione per infusione
DE/H/0160/001 034562025 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 5% Soluzione per infusione
DE/H/0160/001 034562037 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 5%, solução para perfusão
DE/H/0160/001 2969483 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 5%, solução para perfusão
DE/H/0160/001 2969582 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 5% Infusionslösung DE/H/0160/001 BE206543 FRESENIUS KABI NV/SA BE Aminoven 5% oplossing voor infusie
DE/H/0160/001 BE206543 FRESENIUS KABI NV/SA BE
Aminoven 5% oplossing voor infusie
DE/H/0160/001 BE240247 FRESENIUS KABI NV/SA BE
Aminoven 5% solution pour perfusion
DE/H/0160/001 BE206543 FRESENIUS KABI NV/SA BE
Aminoven 5% solution pour perfusion
DE/H/0160/001 BE206552 FRESENIUS KABI NV/SA BE
Aminoven 8 solution for infusion DE/H/0160/001 PA 566/2/4 FRESENIUS KABI IE
List of nationally authorised medicinal products EMA/496540/2019 Page 14/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DEUTSCHLAND GMBH AMINOSTERIL N-HEPA 8%, roztwór do infuzji
not available R/2267 FRESENIUS KABI DEUTSCHLAND GMBH
PL
FREAMINE III not available 022748103 BAXTER S.P.A. IT FREAMINE III not available 022748038 BAXTER S.P.A. IT FREAMINE III not available 022748089 BAXTER S.P.A. IT FREAMINE III not available 022748091 BAXTER S.P.A. IT Aminovenoes N Paed 10%, infúzní roztok
not available 76/1001/92-S/C FRESENIUS KABI AB CZ
Aminoven infant 6% not available 30588.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Аминовен 10% инфузионен разтвор
not available 20020806 FRESENIUS KABI DEUTSCHLAND GMBH
BG
Aminoven 10 % otopina za infuziju
not available HR-H-457163400 FRESENIUS KABI D.O.O. HR
Glavamin, infusionsvæske, opløsning
DE/H/0102/001 17849 FRESENIUS KABI AB DK
Glavamin Infusionslösung DE/H/0102/001 1-21374 FRESENIUS KABI AUSTRIA GMBH
AT
Glavamin DE/H/0102/001 31606.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Glavamin Infusionlösung DE/H/0102/001 BE203095 FRESENIUS KABI NV/SA BE Glavamin oplossing voor infusiue DE/H/0102/001 BE203095 FRESENIUS KABI NV/SA BE Glavamin solution pour infusion DE/H/0102/001 BE203104 FRESENIUS KABI NV/SA BE Glavamin Infusionlösung DE/H/0102/001 BE176793 FRESENIUS KABI NV/SA BE Glavamin Infusionlösung DE/H/0102/001 BE203104 FRESENIUS KABI NV/SA BE Glavamin oplossing voor infusiue DE/H/0102/001 BE176793 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 15/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Glavamin oplossing voor infusiue DE/H/0102/001 BE203104 FRESENIUS KABI NV/SA BE Glavamin solution pour infusion DE/H/0102/001 BE176793 FRESENIUS KABI NV/SA BE Glavamin solution pour infusion DE/H/0102/001 BE203095 FRESENIUS KABI NV/SA BE Vamin 14 g N/l elektrolytfri infusionsvätska, lösning
not available 10095 FRESENIUS KABI AB SE
Vamin 18 g N/l elektrolytfri infusionsvätska, lösning
not available 10096 FRESENIUS KABI AB SE
PRIMENE 10% Soluzione Per infusione
not available 026905099 BAXTER S.P.A. IT
PRIMENE 10% Soluzione Per infusione
not available 026905101 BAXTER S.P.A. IT
Aminoven Infant 10% Infusionslösung
not available 30588.01.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Aminoven 15 % infusionsvätska, lösning
DE/H/0160/003 15518 FRESENIUS KABI AB SE
Aminoven Forte, infusionsvæske, opløsning
DE/H/0160/003 30750 FRESENIUS KABI AB DK
Aminoven 15 % - Infusionsl ﾃｶsung
DE/H/0160/003 1-23278 FRESENIUS KABI AUSTRIA GMBH
AT
Aminovenâ 15 %, Infusionslösung DE/H/0160/003 38718.02.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Aminoven 15% solución para perfusión
DE/H/0160/003 62.983 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Aminoven 15% oplossing voor infusie
DE/H/0160/003 RVG 24230 FRESENIUS KABI NEDERLAND B.V.
NL
Aminoven 15% Infusionslösung DE/H/0160/003 BE206577 FRESENIUS KABI NV/SA BE Aminoven 15% oplossing voor DE/H/0160/003 BE206577 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 16/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
infusie Aminoven 15% solution pour perfusion
DE/H/0160/003 BE206586 FRESENIUS KABI NV/SA BE
Aminoven 25 solution for infusion DE/H/0160/003 PL 08828/0129 FRESENIUS KABI LIMITED UK Aminoven 25 solution for infusion DE/H/0160/003 PA 566/2/3 FRESENIUS KABI
DEUTSCHLAND GMBH IE
Aminoven 15%, solução para perfusão
DE/H/0160/003 2969988 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 15% Soluzione per infusione
DE/H/0160/003 034562076 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 15% Soluzione per infusione
DE/H/0160/003 034562088 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 15% Soluzione per infusione
DE/H/0160/003 034562090 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 15% Soluzione per infusione
DE/H/0160/003 034562102 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 15%, solução para perfusão
DE/H/0160/003 2970184 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 15%, solução para perfusão
DE/H/0160/003 2970283 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 15%, solução para perfusão
DE/H/0160/003 2970085 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 15% Infusionslösung DE/H/0160/003 BE206561 FRESENIUS KABI NV/SA BE Aminoven 15% Infusionslösung DE/H/0160/003 BE206586 FRESENIUS KABI NV/SA BE Aminoven 15% oplossing voor infusie
DE/H/0160/003 BE206561 FRESENIUS KABI NV/SA BE
Aminoven 15% oplossing voor DE/H/0160/003 BE206586 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 17/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
infusie Aminoven 15% oplossing voor infusie
DE/H/0160/003 BE240274 FRESENIUS KABI NV/SA BE
Aminoven 15% oplossing voor infusie
DE/H/0160/003 BE240283 FRESENIUS KABI NV/SA BE
Aminoven 15% solution pour perfusion
DE/H/0160/003 BE206561 FRESENIUS KABI NV/SA BE
Aminoven 15% solution pour perfusion
DE/H/0160/003 BE206577 FRESENIUS KABI NV/SA BE
Aminoven 15% solution pour perfusion
DE/H/0160/003 BE240283 FRESENIUS KABI NV/SA BE
Aminoven 25 solution for infusion DE/H/0160/003 PA 566/2/6 FRESENIUS KABI DEUTSCHLAND GMBH
IE
Аминоплазмал Хепа – 10 % Инфузионен разтвор
not available 9600040 B.BRAUN MELSUNGEN AG BG
Aminoven 15 % infusionsvätska, lösning
DE/H/0160/003 15518 FRESENIUS KABI AB SE
Aminoven Forte, infusionsvæske, opløsning
DE/H/0160/003 30750 FRESENIUS KABI AB DK
Aminoven 15 % - Infusionsl ﾃｶsung
DE/H/0160/003 1-23278 FRESENIUS KABI AUSTRIA GMBH
AT
Aminovenâ 15 %, Infusionslösung DE/H/0160/003 38718.02.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Aminoven 15% solución para perfusión
DE/H/0160/003 62.983 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Aminoven 15% oplossing voor infusie
DE/H/0160/003 RVG 24230 FRESENIUS KABI NEDERLAND B.V.
NL
List of nationally authorised medicinal products EMA/496540/2019 Page 18/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Aminoven 15% Infusionslösung DE/H/0160/003 BE206577 FRESENIUS KABI NV/SA BE Aminoven 15% oplossing voor infusie
DE/H/0160/003 BE206577 FRESENIUS KABI NV/SA BE
Aminoven 15% solution pour perfusion
DE/H/0160/003 BE206586 FRESENIUS KABI NV/SA BE
Aminoven 25 solution for infusion DE/H/0160/003 PL 08828/0129 FRESENIUS KABI LIMITED UK Aminoven 25 solution for infusion DE/H/0160/003 PA 566/2/3 FRESENIUS KABI
DEUTSCHLAND GMBH IE
Aminoven 15%, solução para perfusão
DE/H/0160/003 2969988 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 15% Soluzione per infusione
DE/H/0160/003 034562076 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 15% Soluzione per infusione
DE/H/0160/003 034562088 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 15% Soluzione per infusione
DE/H/0160/003 034562090 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 15% Soluzione per infusione
DE/H/0160/003 034562102 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 15%, solução para perfusão
DE/H/0160/003 2970184 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 15%, solução para perfusão
DE/H/0160/003 2970283 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 15%, solução para perfusão
DE/H/0160/003 2970085 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 15% Infusionslösung DE/H/0160/003 BE206561 FRESENIUS KABI NV/SA BE Aminoven 15% Infusionslösung DE/H/0160/003 BE206586 FRESENIUS KABI NV/SA BE Aminoven 15% oplossing voor DE/H/0160/003 BE206561 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 19/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
infusie Aminoven 15% oplossing voor infusie
DE/H/0160/003 BE206586 FRESENIUS KABI NV/SA BE
Aminoven 15% oplossing voor infusie
DE/H/0160/003 BE240274 FRESENIUS KABI NV/SA BE
Aminoven 15% oplossing voor infusie
DE/H/0160/003 BE240283 FRESENIUS KABI NV/SA BE
Aminoven 15% solution pour perfusion
DE/H/0160/003 BE206561 FRESENIUS KABI NV/SA BE
Aminoven 15% solution pour perfusion
DE/H/0160/003 BE206577 FRESENIUS KABI NV/SA BE
Aminoven 15% solution pour perfusion
DE/H/0160/003 BE240283 FRESENIUS KABI NV/SA BE
Aminoven 25 solution for infusion DE/H/0160/003 PA 566/2/6 FRESENIUS KABI DEUTSCHLAND GMBH
IE
Neonutrin 5 %, infuzní roztok not available 76/645/99-C FRESENIUS KABI S.R.O. CZ Vamin 18 Electrolyte Free, Διάλυμα για έγχυση
not available 86659/13/03-06-2014 FRESENIUS KABI HELLAS A.E.
GR
Aminoven Infant 10% Infusionslösung
not available 30588.01.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Vaminolact, solução para perfusão
not available 2194686 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Vaminolact, solução para perfusão
not available 3925484 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Vaminolact, solução para perfusão
not available 3925583 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Vaminolact, solução para not available 2194785 FRESENIUS KABI PHARMA PT
List of nationally authorised medicinal products EMA/496540/2019 Page 20/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
perfusão PORTUGAL, LDA. Vamin 14 gN, solution pour perfusion
not available 1148/96/12/0616 FRESENIUS KABI NV/SA LU
Vamin 14 gN, oplossing voor infusie
not available BE136017 FRESENIUS KABI NV/SA BE
Vamin 14 gN, oplossing voor infusie
not available BE136001 FRESENIUS KABI NV/SA BE
Vamin 14 gN, solution pour perfusion
not available BE136017 FRESENIUS KABI NV/SA BE
Vamin 14 gN, solution pour perfusion
not available BE136001 FRESENIUS KABI NV/SA BE
Vamin 14 gN, Infusionslösung not available BE136017 FRESENIUS KABI NV/SA BE Vamin 14 gN, Infusionslösung not available BE136001 FRESENIUS KABI NV/SA BE TPH – Soluzione per infusione not available 029189040 BAXTER S.P.A. IT TPH – Soluzione per infusione not available 029189053 BAXTER S.P.A. IT TPH – Soluzione per infusione not available 029189065 BAXTER S.P.A. IT Aminoplasmal® Hepa-10% not available 61/91/5-10-92 B.BRAUN MELSUNGEN AG GR Vaminolact, solution pour perfusion
not available 1148/94/03/0062 FRESENIUS KABI NV/SA LU
Vaminolact, oplossing voor infusie not available BE150324 FRESENIUS KABI NV/SA BE Vaminolact, oplossing voor infusie not available BE150315 FRESENIUS KABI NV/SA BE Vaminolact, solution pour perfusion
not available BE150324 FRESENIUS KABI NV/SA BE
Vaminolact, solution pour perfusion
not available BE150315 FRESENIUS KABI NV/SA BE
Vaminolact, Infusionslösung not available BE150324 FRESENIUS KABI NV/SA BE Vaminolact, Infusionslösung not available BE150315 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 21/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Glavamin not available 11788 FRESENIUS KABI AB FI Vamin 14 not available RVG 10287 FRESENIUS KABI
NEDERLAND B.V. NL
PRIMENE 10% not available PL 0116/0283 BAXTER HEALTHCARE LTD. UK Aminosteril N-Hepa 80 mg/ml raztopina za infundiranje
not available H/94/00165/001 MEDIAS INTERNATIONAL D.O.O.
SI
Aminosteril N-Hepa 80 mg/ml raztopina za infundiranje
not available H/94/00165/002 MEDIAS INTERNATIONAL D.O.O.
SI
Vaminolact Solution for Infusion not available PA 566/13/1 FRESENIUS KABI LIMITED IE Vaminolact Solution for Infusion not available PA 566/13/2 FRESENIUS KABI LIMITED IE VAMIN INFANT Διάλυμα αμινοξέων για ενδοφλέβια διατροφή
not available 100302/14/14-01-2015 FRESENIUS KABI HELLAS A.E.
GR
Glamin soluzione per infusione DE/H/0102/001 032105076 FRESENIUS KABI ITALIA S.R.L.
IT
Glamin soluzione per infusione DE/H/0102/001 032105090 FRESENIUS KABI ITALIA S.R.L.
IT
Glamin soluzione per infusione DE/H/0102/001 032105102 FRESENIUS KABI ITALIA S.R.L.
IT
Glamin soluzione per infusione DE/H/0102/001 032105114 FRESENIUS KABI ITALIA S.R.L.
IT
Glamin soluzione per infusione DE/H/0102/001 032105088 FRESENIUS KABI ITALIA S.R.L.
IT
Proteïnsteril Hepa 8% not available BE114177 FRESENIUS KABI NV/SA BE Proteïnsteril Hepa 8% not available BE114177 FRESENIUS KABI NV/SA BE Proteïnsteril Hepa 8% not available BE114177 FRESENIUS KABI NV/SA BE Amino-Mel "nephro" - not available 1-19271 FRESENIUS KABI AUSTRIA AT
List of nationally authorised medicinal products EMA/496540/2019 Page 22/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Infusionsflasche GMBH Aminosteril N Hepa 8%, infuzní roztok
not available 76/1003/92-S/C FRESENIUS KABI AB CZ
Vaminolac, infusionsvæske, opløsning
not available 11132 FRESENIUS KABI AB DK
Vamin 18 zonder electrolyten not available RVG 10289 FRESENIUS KABI NEDERLAND B.V.
NL
Vaminolact not available RVG 09570 FRESENIUS KABI NEDERLAND B.V.
NL
Vaminolact, solution pour perfusion
not available 1148/94/03/0062 FRESENIUS KABI NV/SA LU
Vaminolact, oplossing voor infusie not available BE150324 FRESENIUS KABI NV/SA BE Vaminolact, oplossing voor infusie not available BE150315 FRESENIUS KABI NV/SA BE Vaminolact, solution pour perfusion
not available BE150324 FRESENIUS KABI NV/SA BE
Vaminolact, solution pour perfusion
not available BE150315 FRESENIUS KABI NV/SA BE
Vaminolact, Infusionslösung not available BE150324 FRESENIUS KABI NV/SA BE Vaminolact, Infusionslösung not available BE150315 FRESENIUS KABI NV/SA BE Neonutrin 10 %, infuzní roztok not available 76/646/99-C FRESENIUS KABI S.R.O. CZ Aminoplasmal Paed 100 mg/ml, oplossing voor infusie
DE/H/3362/001 RVG 110858 B.BRAUN MELSUNGEN AG NL
Aminoplasmal Paed 10% Infusionslösung
DE/H/3362/001 85178.00.00 B.BRAUN MELSUNGEN AG DE
Amiped, soluzione per infusione DE/H/3362/001 041942018 B.BRAUN MELSUNGEN AG IT Amiped, soluzione per infusione DE/H/3362/001 041942020 B.BRAUN MELSUNGEN AG IT Aminoplasmal Paed 10% DE/H/3362/001 135126 B. BRAUN MELSUNGEN AG AT
List of nationally authorised medicinal products EMA/496540/2019 Page 23/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Infusionslösung ART 57 Aminoplasmal Paed 10%, roztwór do infuzji
DE/H/3362/001 21477 B. BRAUN MELSUNGEN AG ART 57
PL
Aminoplasmal Paed 100 mg/ml raztopina za infundiranje
DE/H/3362/001 5363-I-1310/13 B. BRAUN MELSUNGEN AG ART 57
SI
Aminoplasmal Paed 100 mg/ml raztopina za infundiranje
DE/H/3362/001 5363-I-1311/13 B. BRAUN MELSUNGEN AG ART 57
SI
Aminoplasmal Paediatric 10% solution for infusion
DE/H/3362/001 PL 03551/0133 B. BRAUN MELSUNGEN AG ART 57
UK
Aminoplasmal Paediatric oplossing voor infusie
DE/H/3362/001 BE443606 B.BRAUN MELSUNGEN AG BE
Aminoplasmal Paediatric oplossing voor infusie
DE/H/3362/001 BE443615 B.BRAUN MELSUNGEN AG BE
Aminoplasmal Paediatric solution pour perfusion
DE/H/3362/001 BE443606 B.BRAUN MELSUNGEN AG BE
Aminoplasmal Paediatric solution pour perfusion
DE/H/3362/001 BE443615 B.BRAUN MELSUNGEN AG BE
Amiped, infusionsvæske, opløsning
DE/H/3362/001 49774 B.BRAUN MELSUNGEN AG DK
Amiped infuzní roztok DE/H/3362/001 76/482/13-C B. BRAUN MELSUNGEN AG ART 57
CZ
Aminoplasmal Paed 10% διάλυμα για έγχυση
DE/H/3362/001 26166 B. BRAUN MELSUNGEN AG ART 57
GR
Aminoplasmal Paed 10 % solución para perfusión
DE/H/3362/001 78871 B. BRAUN MELSUNGEN AG ART 57
ES
Amiped 10 % infúzny roztok DE/H/3362/001 76/0324/13-S B.BRAUN MELSUNGEN AG SK Aminoplasmal Paed 100 mg/ml DE/H/3362/001 5590245 B.BRAUN MELSUNGEN AG PT
List of nationally authorised medicinal products EMA/496540/2019 Page 24/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
solução para perfusão Amiped infusjonsvæske, oppløsning
DE/H/3362/001 11-8692 B.BRAUN MELSUNGEN AG NO
Aminoplasmal Paed 100 mg/ml solução para perfusão
DE/H/3362/001 5590252 B.BRAUN MELSUNGEN AG PT
Aminoplasmal Paed 10% Infusionslösung
DE/H/3362/001 2013110370 B.BRAUN MELSUNGEN AG LU
Аминовен 10% инфузионен разтвор
not available 20020806 FRESENIUS KABI DEUTSCHLAND GMBH
BG
Nephrotect, solução para perfusão DE/H/0281/001 5452388 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Nephrotect, solução para perfusão DE/H/0281/001 5452487 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Nephrotect, solução para perfusão DE/H/0281/001 5452586 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Nephrotect DE/H/0281/001 13931.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Nephrotect solución para perfusión
DE/H/0281/001 67038 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Nephrotect, solução para perfusão DE/H/0281/001 5452685 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Nephrotect, διάλυμα για έγχυση DE/H/0281/001 12478/17-2-2012 FRESENIUS KABI HELLAS A.E.
GR
Nephrotect, διάλυμα για έγχυση DE/H/0281/001 20261 FRESENIUS KABI HELLAS A.E.
CY
Nephrotect DE/H/0281/001 RVG 32054 FRESENIUS KABI NEDERLAND B.V.
NL
List of nationally authorised medicinal products EMA/496540/2019 Page 25/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Nephrotect Infusionslösung DE/H/0281/001 BE283351 FRESENIUS KABI NV/SA BE Nephrotect oplossing voor infusie DE/H/0281/001 BE283367 FRESENIUS KABI NV/SA BE Nephrotect solution pour perfusion
DE/H/0281/001 BE283367 FRESENIUS KABI NV/SA BE
Nephrotect Infusionslösung DE/H/0281/001 BE283367 FRESENIUS KABI NV/SA BE Nephrotect solution pour perfusion
DE/H/0281/001 BE283351 FRESENIUS KABI NV/SA BE
Nephrotect oplossing voor infusie DE/H/0281/001 BE283351 FRESENIUS KABI NV/SA BE Aminoven 10 % infusionsvätska, lösning
DE/H/0160/002 15517 FRESENIUS KABI AB SE
Aminovenâ 10 %, Infusionslösung DE/H/0160/002 38718.01.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Aminoven 10%, infusionsvæske, opløsning
DE/H/0160/002 30749 FRESENIUS KABI AB DK
Aminoven® 10 %, Infusionslösung
DE/H/0160/002 0452/99/07/0024 FRESENIUS KABI DEUTSCHLAND GMBH
LU
Aminoven 10% oplossing voor infusie
DE/H/0160/002 RVG 24229 FRESENIUS KABI NEDERLAND B.V.
NL
Aminoven 10%, solução para perfusão
DE/H/0160/002 2969681 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 10 % - Infusionsl ﾃｶsung
DE/H/0160/002 1-23277 FRESENIUS KABI AUSTRIA GMBH
AT
Aminoven 10% Infusionslösung DE/H/0160/002 BE206595 FRESENIUS KABI NV/SA BE Aminoven 10% oplossing voor infusie
DE/H/0160/002 BE206604 FRESENIUS KABI NV/SA BE
Aminoven 10% solución para perfusión
DE/H/0160/002 62.981 FRESENIUS KABI DEUTSCHLAND GMBH
ES
List of nationally authorised medicinal products EMA/496540/2019 Page 26/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Aminoven 10% solution pour perfusion
DE/H/0160/002 BE240256 FRESENIUS KABI NV/SA BE
Aminoven 16 solution for infusion DE/H/0160/002 PL 08828/0128 FRESENIUS KABI LIMITED UK Aminoven 16 solution for infusion DE/H/0160/002 PA 566/2/5 FRESENIUS KABI
DEUTSCHLAND GMBH IE
Aminoven 10% Soluzione per infusione
DE/H/0160/002 034562049 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 10% Soluzione per infusione
DE/H/0160/002 034562064 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 10%, solução para perfusão
DE/H/0160/002 2969780 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 10%, solução para perfusão
DE/H/0160/002 2969889 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Aminoven 10% Soluzione per infusione
DE/H/0160/002 034562052 FRESENIUS KABI ITALIA S.R.L.
IT
Aminoven 10% Infusionslösung DE/H/0160/002 BE206604 FRESENIUS KABI NV/SA BE Aminoven 10% oplossing voor infusie
DE/H/0160/002 BE206595 FRESENIUS KABI NV/SA BE
Aminoven 10% oplossing voor infusie
DE/H/0160/002 BE240256 FRESENIUS KABI NV/SA BE
Aminoven 10% oplossing voor infusie
DE/H/0160/002 BE240265 FRESENIUS KABI NV/SA BE
Aminoven 10% solution pour perfusion
DE/H/0160/002 BE206595 FRESENIUS KABI NV/SA BE
Aminoven 10% solution pour perfusion
DE/H/0160/002 BE206604 FRESENIUS KABI NV/SA BE
Aminoven 10% solution pour DE/H/0160/002 BE240265 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/496540/2019 Page 27/28
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
perfusion Aminoven 16 solution for infusion DE/H/0160/002 PA 566/2/2 FRESENIUS KABI
DEUTSCHLAND GMBH IE
Vamin 14 solution for infusion not available PL 08828/0118 FRESENIUS KABI LIMITED UK Vaminolac, innrennslislyf, lausn not available 880083 FRESENIUS KABI AB IS Aminoplasmal Hepa associação solução para perfusão
not available 5393970 B. BRAUN MEDICAL LDA. PT
Aminoplasmal Hepa associação solução para perfusão
not available 5394002 B. BRAUN MEDICAL LDA. PT
Aminoplasmal Hepa associação solução para perfusão
not available 8740001 B. BRAUN MEDICAL LDA. PT
Aminoplasmal Hepa associação solução para perfusão
not available 8740019 B. BRAUN MEDICAL LDA. PT
Aminopäd 10 % Infusionslösung not available 9283.01.00 BAXTER DEUTSCHLAND GMBH
DE
PRIMENE 10 %, solution injectable pour perfusion
not available 34009 328 541 1 0 BAXTER SAS FR
PRIMENE 10 %, solution injectable pour perfusion
not available 34009 328 542 8 8 BAXTER SAS FR
PRIMENE 10 %, solution injectable pour perfusion
not available 34009 328 543 4 9 BAXTER SAS FR
PRIMENE 10 %, solution injectable pour perfusion
not available 34009 328 544 0 0 BAXTER SAS FR
PRIMENE 10 %, solution injectable pour perfusion
not available 34009 328 545 7 8 BAXTER SAS FR
PRIMENE 10 %, solution injectable pour perfusion
not available 34009 328 546 3 9 BAXTER SAS FR
List of nationally authorised medicinal products EMA/496540/2019 Page 28/28
