hydroxyethyl starch: List of nationally authorised ... · SE/H/0609/002 5520/2013/03 B.BRAUN...
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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 28 September 2017 EMA/637890/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): hydroxyethyl starch Procedure No.: PSUSA/00001694/201703
Transcript of hydroxyethyl starch: List of nationally authorised ... · SE/H/0609/002 5520/2013/03 B.BRAUN...
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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
28 September 2017 EMA/637890/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): hydroxyethyl starch
Procedure No.: PSUSA/00001694/201703
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List of nationally authorised medicinal products EMA/637890/2017 Page 2/25
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
Amidolite, 60 mg/ml soluzione per infusione
SE/H/0414/001 036617052 B.BRAUN MELSUNGEN AG IT
Amidolite, 60 mg/ml soluzione per infusione
SE/H/0414/001 036617076 B.BRAUN MELSUNGEN AG IT
Amidolite, 60 mg/ml soluzione per infusione
SE/H/0414/001 036617037 B.BRAUN MELSUNGEN AG IT
EquiHes 100 mg/ml solution for infusion, Ecobag
SE/H/0609/02 PA 736/24/4 B.BRAUN MELSUNGEN AG IE
EquiHes 100 mg/ml solution for infusion, Ecobag
SE/H/609/02 PA 736/24/4 B.BRAUN MELSUNGEN AG IE
EquiHes 100 mg/ml solution for infusion, Ecoflac Plus
SE/H/609/02 PA 736/24/2 B.BRAUN MELSUNGEN AG IE
EquiHes 60 mg/ml solution for infusion, Ecobag
SE/H/0609/01 PA 736/24/3 B.BRAUN MELSUNGEN AG IE
EquiHes 60 mg/ml solution for infusion, Ecoflac Plus
SE/H/609/01 PA 736/24/1 B.BRAUN MELSUNGEN AG IE
HAES- steril "Fresenius" (HES 200/0,5) 6 % - Infusionslösung
not available 1-22029 FRESENIUS KABI AUSTRIA GMBH AT
HES Hipertónico Fresenius, solución para perfusión
DE/H/0295/001 65.021 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Hesra infusionsvätska, lösning
DE/H/1210/001 25966 SERUMWERK BERNBURG AG SE
Hesra infusionsvätska, lösning
DE/H/1210/001 25966 SERUMWERK BERNBURG AG SE
Hesra infusjonsvæske, oppløsning
DE/H/1210/001 07-5185 SERUMWERK BERNBURG AG NO
Hesra infusjonsvæske, oppløsning
DE/H/1210/001 07-5185 SERUMWERK BERNBURG AG NO
Hesra, infusionsvæske, opløsning
DE/H/1210/001 42013 SERUMWERK BERNBURG AG DK
Hesra, infusionsvæske, opløsning
DE/H/1210/001 42013 SERUMWERK BERNBURG AG DK
Hesra, infusionsvätska, lösning
DE/H/1210/001 24034 SERUMWERK BERNBURG AG FI
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List of nationally authorised medicinal products EMA/637890/2017 Page 3/25
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
Hesra, infusionsvätska, lösning
DE/H/1210/001 24034 SERUMWERK BERNBURG AG FI
Hesra, infuusioneste, liuos DE/H/1210/001 24034 SERUMWERK BERNBURG AG FI Hesra, infuusioneste, liuos DE/H/1210/001 24034 SERUMWERK BERNBURG AG FI HyperHAES 6% in 7,2% NaCl - Infusionslösung
DE/H/0295/001 1-24986 FRESENIUS KABI AUSTRIA GMBH AT
HyperHAES Infusionslösung DE/H/0295/001 48783.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
HyperHES, solution pour perfusion
DE/H/0295/001 NL 26789 FRESENIUS KABI FRANCE S.A.S. FR
Isohes 6% solución para perfusión
SE/H/609/01 68812 B.BRAUN MELSUNGEN AG ES
ISOVOL 6%, solution pour perfusion
not available NL33730 B.BRAUN MELSUNGEN AG FR
PlasmaVolume Redibag roztwór do infuzji
DE/H/1210/001 15420 SERUMWERK BERNBURG AG PL
PlasmaVolume Redibag roztwór do infuzji
DE/H/1210/001 15420 SERUMWERK BERNBURG AG PL
PlasmaVolume Redibag, solucao para perfusao
DE/H/1210/001 5139241 SERUMWERK BERNBURG AG PT
PlasmaVolume Redibag, solucao para perfusao
DE/H/1210/001 5139241 SERUMWERK BERNBURG AG PT
PlasmaVolume Redibag, soluzione per infusione
DE/H/1210/001MR AIC NR 038809012/M SERUMWERK BERNBURG AG IT
PlasmaVolume Redibag, soluzione per infusione
DE/H/1210/001MR AIC NR 038809012/M SERUMWERK BERNBURG AG IT
Tetraspan 10 % Infusionslösung
SE/H/609/02 66698.00.00 B.BRAUN MELSUNGEN AG DE
Tetraspan 10 % Infusionslösung
SE/H/609/02 0667/07020011 B.BRAUN MELSUNGEN AG LU
Tetraspan 10% g/v, oplossing voor infusie 100 g/l
SE/H/609/02 RVG 34095 B.BRAUN MELSUNGEN AG NL
Tetraspan 10% Infúzny roztok
SE/H/609/02 76/0462/06-S B.BRAUN MELSUNGEN AG SK
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List of nationally authorised medicinal products EMA/637890/2017 Page 4/25
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
Tetraspan 100 mg/ml HES roztwór do infuzji
SE/H/609/02 12810 B.BRAUN MELSUNGEN AG PL
Tetraspan 100 mg/ml Infusionslösung
SE/H/609/02 1-26777 B.BRAUN MELSUNGEN AG AT
Tetraspan 100 mg/ml infusionsvätska, lösning
SE/H/609/02 20016 B.BRAUN MELSUNGEN AG SE
Tetraspan 100 mg/ml infuusioneste, liuos
SE/H/609/02 22261 B.BRAUN MELSUNGEN AG FI
Tetraspan 100 mg/ml raztopina za infundiranje
SE/H/0609/002 5363-I-853/14 B.BRAUN MELSUNGEN AG SI
Tetraspan 100 mg/ml raztopina za infundiranje
SE/H/0609/002 5363-I-854/14 B.BRAUN MELSUNGEN AG SI
Tetraspan 100 mg/ml šķīdums infūzijām
SE/H/609/02 06-0247 B.BRAUN MELSUNGEN AG LV
Tetraspan 100 mg/ml solução para perfusão
SE/H/0609/002 5993381 B. BRAUN MELSUNGEN AG ART 57 PT
Tetraspan 100 mg/ml solução para perfusão
SE/H/0609/002 5993589 B. BRAUN MELSUNGEN AG ART 57 PT
Tetraspan 100 mg/ml solução para perfusão
SE/H/0609/002 5993787 B. BRAUN MELSUNGEN AG ART 57 PT
Tetraspan 100 mg/ml soluţie perfuzabilă
SE/H/0609/002 5520/2013/01 B.BRAUN MELSUNGEN AG RO
Tetraspan 100 mg/ml soluţie perfuzabilă
SE/H/0609/002 5520/2013/02 B.BRAUN MELSUNGEN AG RO
Tetraspan 100 mg/ml soluţie perfuzabilă
SE/H/0609/002 5520/2013/03 B.BRAUN MELSUNGEN AG RO
Tetraspan 100 mg/ml soluţie perfuzabilă
SE/H/0609/002 5520/2013/04 B.BRAUN MELSUNGEN AG RO
Tetraspan 100 mg/ml solution for infusion
SE/H/609/02 PL 03551/0107 B.BRAUN MELSUNGEN AG UK
Tetraspan 100 mg/ml, soluzione per infusione
SE/H/609/02 037596071 B.BRAUN MELSUNGEN AG IT
Tetraspan 100 mg/ml, soluzione per infusione
SE/H/609/02 037596095 B.BRAUN MELSUNGEN AG IT
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List of nationally authorised medicinal products EMA/637890/2017 Page 5/25
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
Tetraspan 100 mg/ml, soluzione per infusione
SE/H/609/02 037596119 B.BRAUN MELSUNGEN AG IT
Tetraspan 100 mg/ml, διάλυμα για έγχυση
SE/H/0609/002 12474/17-2-2012 VIOSER S.A. GR
Tetraspan 6 % Infusionslösung
SE/H/609/01 66697.00.00 B.BRAUN MELSUNGEN AG DE
Tetraspan 6 % Infusionslösung
SE/H/609/01 0667/07020012 B.BRAUN MELSUNGEN AG LU
Tetraspan 6% g/v, oplossing voor infusie 60 g/l
SE/H/609/01 RVG 34094 B.BRAUN MELSUNGEN AG NL
TETRASPAN 6% infuzní roztok
SE/H/609/01 76/459/06-C B.BRAUN MELSUNGEN AG CZ
Tetraspan 6% Infúzny roztok SE/H/609/01 76/0461/06-S B.BRAUN MELSUNGEN AG SK Tetraspan 6% solution for infusion
SE/H/609/01 PL 03551/0106 B.BRAUN MELSUNGEN AG UK
Tetraspan 6%, 60 mg/ml, oplossing voor infusie
SE/H/609/01 BE320765 B.BRAUN MELSUNGEN AG BE
Tetraspan 6%, 60 mg/ml, oplossing voor infusie
SE/H/609/01 BE320731 B.BRAUN MELSUNGEN AG BE
Tetraspan 6%, 60 mg/ml, oplossing voor infusie
SE/H/609/01 BE320747 B.BRAUN MELSUNGEN AG BE
Tetraspan 6%, 60 mg/ml, solution pour perfusion
SE/H/609/01 BE320765 B.BRAUN MELSUNGEN AG BE
Tetraspan 6%, 60 mg/ml, solution pour perfusion
SE/H/609/01 BE320731 B.BRAUN MELSUNGEN AG BE
Tetraspan 6%, 60 mg/ml, solution pour perfusion
SE/H/609/01 BE320747 B.BRAUN MELSUNGEN AG BE
Tetraspan 60 mg/ml HES roztwór do infuzji
SE/H/609/01 12809 B.BRAUN MELSUNGEN AG PL
Tetraspan 60 mg/ml Infusionslösung
SE/H/609/01 1-26776 B.BRAUN MELSUNGEN AG AT
Tetraspan 60 mg/ml infusionsvätska, lösning
SE/H/609/01 20015 B.BRAUN MELSUNGEN AG SE
Tetraspan 60 mg/ml infusjonsvæske, oppløsning
SE/H/609/01 06-4186 B.BRAUN MELSUNGEN AG NO
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List of nationally authorised medicinal products EMA/637890/2017 Page 6/25
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
Tetraspan 60 mg/ml infuusioneste, liuos
SE/H/609/01 22260 B.BRAUN MELSUNGEN AG FI
Tetraspan 60 mg/ml infuzinis tirpalas
SE/H/609/01 LT/1/07/0768/001 B.BRAUN MELSUNGEN AG LT
Tetraspan 60 mg/ml infuzinis tirpalas
SE/H/609/01 LT/1/07/0768/003 B.BRAUN MELSUNGEN AG LT
Tetraspan 60 mg/ml infuzinis tirpalas
SE/H/609/01 LT/1/07/0768/005 B.BRAUN MELSUNGEN AG LT
Tetraspan 60 mg/ml innrennslislyf, lausn.
SE/H/609/01 IS/1/09/089/01 B.BRAUN MELSUNGEN AG IS
Tetraspan 60 mg/ml oldatos infúzió
SE/H/0609/001 OGYI-T-20306/01 B. BRAUN MELSUNGEN AG ART 57 HU
Tetraspan 60 mg/ml raztopina za infundiranje
SE/H/0609/001 5363-I-851/14 B. BRAUN MELSUNGEN AG ART 57 SI
Tetraspan 60 mg/ml raztopina za infundiranje
SE/H/0609/001 5363-I-852/14 B. BRAUN MELSUNGEN AG ART 57 SI
Tetraspan 60 mg/ml šķīdums infūzijām
SE/H/609/01 06-0246 B.BRAUN MELSUNGEN AG LV
Tetraspan 60 mg/ml solução para perfusão
SE/H/0609/001 5992789 B. BRAUN MELSUNGEN AG ART 57 PT
Tetraspan 60 mg/ml solução para perfusão
SE/H/0609/001 5992987 B. BRAUN MELSUNGEN AG ART 57 PT
Tetraspan 60 mg/ml solução para perfusão
SE/H/0609/001 5993183 B. BRAUN MELSUNGEN AG ART 57 PT
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/01 B. BRAUN MELSUNGEN AG ART 57 RO
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/02 B. BRAUN MELSUNGEN AG ART 57 RO
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/03 B. BRAUN MELSUNGEN AG ART 57 RO
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/04 B. BRAUN MELSUNGEN AG ART 57 RO
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/01 B. BRAUN MELSUNGEN AG ART 57 RO
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List of nationally authorised medicinal products EMA/637890/2017 Page 7/25
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
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/02 B. BRAUN MELSUNGEN AG ART 57 RO
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/03 B. BRAUN MELSUNGEN AG ART 57 RO
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/04 B. BRAUN MELSUNGEN AG ART 57 RO
Tetraspan 60 mg/ml, infusioonilahus
SE/H/609/01 527706 B.BRAUN MELSUNGEN AG EE
Tetraspan 60 mg/ml, soluzione per infusione
SE/H/609/01 037596018 B.BRAUN MELSUNGEN AG IT
Tetraspan 60 mg/ml, soluzione per infusione
SE/H/609/01 037596032 B.BRAUN MELSUNGEN AG IT
Tetraspan 60 mg/ml, soluzione per infusione
SE/H/609/01 037596057 B.BRAUN MELSUNGEN AG IT
Tetraspan 60 mg/ml, διάλυμα για έγχυση
SE/H/0609/001 12473/17-2-2012 VIOSER S.A. GR
Tetraspan, infusionsvæske, opløsning 100 mg/ml
SE/H/609/02 39472 B.BRAUN MELSUNGEN AG DK
Tetraspan, infusionsvæske, opløsning 60 mg/ml
SE/H/609/01 39471 B.BRAUN MELSUNGEN AG DK
Venofundin SE/H/414/01 36427 B.BRAUN MELSUNGEN AG DK Venofundin 6 g/100 ml soluţie perfuzabilă
not available 7933/2006/02 B.BRAUN MELSUNGEN AG RO
Venofundin 6 g/100 ml soluţie perfuzabilă
not available 7933/2006/03 B.BRAUN MELSUNGEN AG RO
Venofundin 6 g/100 ml soluţie perfuzabilă
not available 7933/2006/01 B.BRAUN MELSUNGEN AG RO
Venofundin 60 mg/ml Infusionslösung
SE/H/0414/001 1-25677 B.BRAUN MELSUNGEN AG AT
Venofundin 60 mg/ml Infusionslösung
SE/H/0414/001 59979.00.00 B.BRAUN MELSUNGEN AG DE
Venofundin 60 mg/ml Infusionsl�sung
SE/H/414/01 0667/04090013 B.BRAUN MELSUNGEN AG LU
Venofundin 60 mg/ml infusionsvätska, lösning
SE/H/0414/001 18138 B.BRAUN MELSUNGEN AG SE
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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
Venofundin 60 mg/ml infusjonsv�ske, oppl�sning
SE/H/414/01 04-2519 B.BRAUN MELSUNGEN AG NO
Venofundin 60 mg/ml infuusioneste, liuos
SE/H/414/01 19211 B.BRAUN MELSUNGEN AG FI
Venofundin 60 mg/ml solution for infusion
not available S00593 B.BRAUN MELSUNGEN AG CY
Venofundin 60 mg/ml, oplossing voor intraveneuze infusie
SE/H/414/01 RVG 30621 B.BRAUN MELSUNGEN AG NL
Venofundin 60 mg/ml, solução para perfusão
SE/H/0414/001 5130984 B. BRAUN MELSUNGEN AG ART 57 PT
Venofundin 60 mg/ml, solução para perfusão
SE/H/0414/001 5130786 B. BRAUN MELSUNGEN AG ART 57 PT
Venofundin 60 mg/ml, solução para perfusão
SE/H/0414/001 5130588 B. BRAUN MELSUNGEN AG ART 57 PT
Venofundin 60 mg/ml, διάλυμα για έγχυση
SE/H/0414/001 34158/7-12-2004 B.BRAUN MELSUNGEN AG GR
Venohes 60 mg/ml, oplossing voor infusie
SE/H/0414/001 BE362941 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, oplossing voor infusie
SE/H/0414/001 BE296536 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, oplossing voor infusie
SE/H/0414/001 BE296545 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, solution pour perfusion
SE/H/0414/001 BE362941 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, solution pour perfusion
SE/H/0414/001 BE296536 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, solution pour perfusion
SE/H/0414/001 BE296545 B.BRAUN MELSUNGEN AG BE
Vitafusal 6% – Infusionslösung
DE/H/1210/001 1-27873 SERUMWERK BERNBURG AG AT
Vitafusal 6% – Infusionslösung
DE/H/1210/001 1-27873 SERUMWERK BERNBURG AG AT
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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
VITAFUSAL® 10% 10% HES 130/0.42 in Ringer-Acetat, Infusionslösung zur intravenösen Anwendung
not available 71020.00.00 SERUMWERK BERNBURG AG DE
VITAFUSAL® 10% 10% HES 130/0.42 in Ringer-Acetat, Infusionslösung zur intravenösen Anwendung
not available 71020.00.00 SERUMWERK BERNBURG AG DE
VITAFUSAL® 6 % HES 130/0,42 in Ringer-Acetat, Infusionslösung zur intravenösen Anwendung
not available 60252.00.00 SERUMWERK BERNBURG AG DE
VITAFUSAL® 6 % HES 130/0,42 in Ringer-Acetat, Infusionslösung zur intravenösen Anwendung
not available 60252.00.00 SERUMWERK BERNBURG AG DE
VITAFUSAL® 6% 6 % HES 130/0,42 in Ringer-Acetat, Infusionslösung zur intravenösen Anwendung
not available 66030.00.00 SERUMWERK BERNBURG AG DE
VITAFUSAL® 6% 6 % HES 130/0,42 in Ringer-Acetat, Infusionslösung zur intravenösen Anwendung
not available 66030.00.00 SERUMWERK BERNBURG AG DE
VitaHES® 6% HES 130/0,42 in 0,9%iger Kochsalzlösung, Infusionslösung zur intravenösen Anwendung
DE/H/1670/001 60257.00.00 SERUMWERK BERNBURG AG DE
VitaHES® 6% HES 130/0,42 in 0,9%iger Kochsalzlösung, Infusionslösung zur intravenösen Anwendung
DE/H/1670/001 60257.00.00 SERUMWERK BERNBURG AG DE
Voluforte 10% infuzinis tirpalas
DE/H/1568/001 LT/1/10/1979/001 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Voluforte 10% infuzinis tirpalas
DE/H/1568/001 LT/1/10/1979/003 FRESENIUS KABI POLSKA SP. Z O.O.
LT
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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
Voluforte 10% infuzinis tirpalas
DE/H/1568/001 LT/1/10/1979/004 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Voluforte 10% infuzinis tirpalas
DE/H/1568/001 LT/1/10/1979/005 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Voluforte 10% infuzinis tirpalas
DE/H/1568/001 LT/1/10/1979/006 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Voluforte 10% infuzinis tirpalas
DE/H/1568/001 LT/1/10/1979/002 FRESENIUS KABI POLSKA SP. Z O.O.
LT
Voluforte, infusioonilahus DE/H/1568/001 681710 FRESENIUS KABI POLSKA SP. Z O.O.
EE
Volulyte 6 % Infusionslösung DE/H/0619/001 0452/09100052 FRESENIUS KABI DEUTSCHLAND GMBH
LU
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/001 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/002 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/003 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/004 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/005 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/006 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/007 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/008 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/009 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/010 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/011 FRESENIUS KABI DEUTSCHLAND GMBH
LT
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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
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/012 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% Infusionslösung DE/H/0619/001 1-27594 FRESENIUS KABI AUSTRIA GMBH AT Volulyte 6% Infusionslösung DE/H/0619/001 BE319112 FRESENIUS KABI NV/SA BE Volulyte 6% Infusionslösung DE/H/0619/001 BE319094 FRESENIUS KABI NV/SA BE Volulyte 6% Infusionslösung DE/H/0619/001 BE319103 FRESENIUS KABI NV/SA BE Volulyte 6% Infusionslösung DE/H/0619/001 BE319121 FRESENIUS KABI NV/SA BE Volulyte 6% Infusionslösung DE/H/0619/001 64677.00.00 FRESENIUS KABI DEUTSCHLAND
GMBH DE
Volulyte 6% oldatos infúzió DE/H/0619/001 OGYI-T-20582/01 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió DE/H/0619/001 OGYI-T-20582/02 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió DE/H/0619/001 OGYI-T-20582/03 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió DE/H/0619/001 OGYI-T-20582/04 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió DE/H/0619/001 OGYI-T-20582/05 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió DE/H/0619/001 OGYI-T-20582/06 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió DE/H/0619/001 OGYI-T-20582/07 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió DE/H/0619/001 OGYI-T-20582/08 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oplossing voor infusie
DE/H/0619/001 BE319094 FRESENIUS KABI NV/SA BE
Volulyte 6% oplossing voor infusie
DE/H/0619/001 BE319103 FRESENIUS KABI NV/SA BE
Volulyte 6% oplossing voor infusie
DE/H/0619/001 BE319112 FRESENIUS KABI NV/SA BE
Volulyte 6% oplossing voor infusie
DE/H/0619/001 BE319121 FRESENIUS KABI NV/SA BE
Volulyte 6% oplossing voor infusie
DE/H/0619/001 RVG 33457 FRESENIUS KABI NEDERLAND B.V. NL
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List of nationally authorised medicinal products EMA/637890/2017 Page 12/25
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
Volulyte 6% otopina za infuziju
not available UP/I-530-09/10-01/379 FRESENIUS KABI D.O.O. HR
Volulyte 6% otopina za infuziju
not available UP/I-530-09/10-01/379 FRESENIUS KABI D.O.O. HR
Volulyte 6% otopina za infuziju
not available UP/I-530-09/10-01/379 FRESENIUS KABI D.O.O. HR
Volulyte 6% šķīdums infūzijām
DE/H/0619/001 08-0103 FRESENIUS KABI DEUTSCHLAND GMBH
LV
Volulyte 6% solución para perfusión
DE/H/0619/001 70228 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Volulyte 6% Solution for Infusion
DE/H/0619/001 PA 566/37/1 FRESENIUS KABI LIMITED IE
Volulyte 6% Solution for Infusion
DE/H/0619/001 PA 566/37/2 FRESENIUS KABI LIMITED IE
Volulyte 6% Solution for Infusion
DE/H/0619/001 MA 134 / 00801 FRESENIUS KABI LIMITED MT
Volulyte 6% Solution for Infusion
DE/H/0619/001 PL 08828/0174 FRESENIUS KABI LIMITED UK
Volulyte 6% solution pour perfusion
DE/H/0619/001 BE319103 FRESENIUS KABI NV/SA BE
Volulyte 6% solution pour perfusion
DE/H/0619/001 BE319094 FRESENIUS KABI NV/SA BE
Volulyte 6% solution pour perfusion
DE/H/0619/001 BE319112 FRESENIUS KABI NV/SA BE
Volulyte 6% solution pour perfusion
DE/H/0619/001 BE319121 FRESENIUS KABI NV/SA BE
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473056 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473017 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473029 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473031 FRESENIUS KABI ITALIA S.R.L. IT
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List of nationally authorised medicinal products EMA/637890/2017 Page 13/25
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
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473043 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473068 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473070 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473082 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473094 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473106 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473118 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6% Soluzione per infusione
DE/H/0619/001 038473120 FRESENIUS KABI ITALIA S.R.L. IT
Volulyte 6%, infuzní roztok DE/H/0619/001 75/262/08-C FRESENIUS KABI DEUTSCHLAND GMBH
CZ
Volulyte 6%, infúzny roztok DE/H/0619/001 76/0106/08-S FRESENIUS KABI DEUTSCHLAND GMBH
SK
Volulyte 6%, roztwór do infuzji
DE/H/0619/001 14844 FRESENIUS KABI DEUTSCHLAND GMBH
PL
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/01 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/02 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/03 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/04 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/05 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/06 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
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List of nationally authorised medicinal products EMA/637890/2017 Page 14/25
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
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/07 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/08 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/09 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/10 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/11 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, soluţie perfuzabilă
DE/H/0619/001 1583/2009/12 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6%, Διάλυμα για έγχυση
DE/H/0619/001 20656 FRESENIUS KABI DEUTSCHLAND GMBH
CY
Volulyte 6%W/V, Διάλυμα για έγχυση
DE/H/0619/001 63062/12/27-05-2013 FRESENIUS KABI HELLAS A.E. GR
Volulyte 60 mg/ml infusionsvätska, lösning
DE/H/0619/001 23245 FRESENIUS KABI AB SE
Volulyte 60 mg/ml infusjonsvæske, oppløsning
DE/H/0619/001 05-3865 FRESENIUS KABI NORGE AS NO
Volulyte 60 mg/ml infuusioneste, liuos
DE/H/0619/001 21810 FRESENIUS KABI AB FI
Volulyte 60 mg/ml innrennslislyf, lausn
DE/H/0619/001 IS/1/06/010/01 FRESENIUS KABI AB IS
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/001 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/002 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/007 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/008 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/009 MEDIAS INTERNATIONAL D.O.O. SI
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List of nationally authorised medicinal products EMA/637890/2017 Page 15/25
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
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/010 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/011 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/012 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/003 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/004 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/005 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/006 MEDIAS INTERNATIONAL D.O.O. SI
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105614 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105556 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105564 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105572 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105606 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105622 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105630 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105648 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105655 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105663 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
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List of nationally authorised medicinal products EMA/637890/2017 Page 16/25
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
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105671 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte 60 mg/ml Solução para Perfusão
DE/H/0619/001 5105705 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Volulyte, 6% infusioonilahus DE/H/0619/001 581708 FRESENIUS KABI DEUTSCHLAND GMBH
EE
Volulyte, infusionsvæske, opløsning
DE/H/0619/001 38802 FRESENIUS KABI AB DK
Voluven (HES 130/0,4) 6 % - Infusionslösung
DE/H/0223/001 1-23687 FRESENIUS KABI AUSTRIA GMBH AT
Voluven 10 % Infusionslösung
DE/H/1568/001 72143.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Voluven 10 % infúzny roztok DE/H/1568/001 76/0134/10-S FRESENIUS KABI S.R.O SK Voluven 10 % oldatos infúzió DE/H/1568/001 OGYI-T-8387/12 FRESENIUS KABI DEUTSCHLAND
GMBH HU
Voluven 10 % oldatos infúzió DE/H/1568/001 OGYI-T-8387/13 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 10 % oldatos infúzió DE/H/1568/001 OGYI-T-8387/14 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 10 % oldatos infúzió DE/H/1568/001 OGYI-T-8387/16 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 10 % oldatos infúzió DE/H/1568/001 OGYI-T-8387/17 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 10 % oldatos infúzió DE/H/1568/001 OGYI-T-8387/15 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 10 % solution for infusion
DE/H/1568/001 PA 566/020/4 FRESENIUS KABI LIMITED IE
Voluven 10 % solution for infusion
DE/H/1568/001 PL 08828/0207 FRESENIUS KABI LIMITED UK
Voluven 10% solución para perfusión
not available 73.468 FRESENIUS KABI ESPAÑA S.A.U. ES
Voluven 10% Solution for Infusion
DE/H/1568/001 PA0566/020/005 FRESENIUS KABI LIMITED IE
Voluven 10%, 10% + 0,9%, roztwór do infuzji
DE/H/1568/001 17196 FRESENIUS KABI POLSKA SP. Z O.O.
PL
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List of nationally authorised medicinal products EMA/637890/2017 Page 17/25
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
Voluven 10%, infuzní roztok DE/H/1568/001 76/417/10-C FRESENIUS KABI S.R.O CZ Voluven 100 mg/ml infusionsvätska, lösning
DE/H/1568/001 26753 FRESENIUS KABI AB SE
Voluven 100 mg/ml infuusioneste, liuos
DE/H/1568/001 24831 FRESENIUS KABI AB FI
Voluven 100 mg/ml raztopina za infundiranje
DE/H/1568/001 H/10/01658/004 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Voluven 100 mg/ml raztopina za infundiranje
DE/H/1568/001 H/10/01658/005 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Voluven 100 mg/ml raztopina za infundiranje
DE/H/1568/001 H/10/01658/006 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Voluven 100 mg/ml raztopina za infundiranje
DE/H/1568/001 H/10/01658/001 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Voluven 100 mg/ml raztopina za infundiranje
DE/H/1568/001 H/10/01658/002 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Voluven 100 mg/ml raztopina za infundiranje
DE/H/1568/001 H/10/01658/003 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Voluven 6 % Infusionslösung DE/H/0223/001 0452/05018652 FRESENIUS KABI DEUTSCHLAND GMBH
LU
Voluven 6 % oldatos infúzió not available OGYI-T-8387/06 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 6 % oldatos infúzió not available OGYI-T-8387/08 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 6 % oldatos infúzió not available OGYI-T-8387/09 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 6 % oldatos infúzió not available OGYI-T-8387/04 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 6 % oldatos infúzió not available OGYI-T-8387/03 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 6 % oldatos infúzió not available OGYI-T-8387/02 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 6 % oldatos infúzió not available OGYI-T-8387/05 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 6% infuzní roztok not available 75/234/01-C FRESENIUS KABI DEUTSCHLAND GMBH
CZ
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List of nationally authorised medicinal products EMA/637890/2017 Page 18/25
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
Voluven 6% innrennslislyf, lausn
DE/H/0223/001 IS/1/00/002/01 FRESENIUS KABI AB IS
Voluven 6% oldatos infúzió not available OGYI-T-8387/10 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 6% otopina za infuziju
not available UP/I-530-09/09-02/366 FRESENIUS KABI D.O.O. HR
Voluven 6% otopina za infuziju
not available UP/I-530-09/09-02/365 FRESENIUS KABI D.O.O. HR
Voluven 6% otopina za infuziju
not available UP/I-530-09/09-02/366 FRESENIUS KABI D.O.O. HR
Voluven 6% otopina za infuziju
not available UP/I-530-09/09-02/365 FRESENIUS KABI D.O.O. HR
Voluven 6% otopina za infuziju
not available UP/I-530-09/09-02/366 FRESENIUS KABI D.O.O. HR
Voluven 6% otopina za infuziju
not available UP/I-530-09/09-02/365 FRESENIUS KABI D.O.O. HR
Voluven 6% Solution for Infusion
DE/H/0223/001 PA 566/20/2 FRESENIUS KABI LIMITED IE
Voluven 6% Solution for Infusion
DE/H/0223/001 PA 566/20/3 FRESENIUS KABI LIMITED IE
Voluven 6% Solution for Infusion
DE/H/0223/001 PA 566/20/1 FRESENIUS KABI LIMITED IE
Voluven 6% solution for infusion
DE/H/0223/001 PL 08828/0145 FRESENIUS KABI LIMITED UK
Voluven 6% διάλυμα για έγχυση
DE/H/0223/001 9010/2-2-2017 FRESENIUS KABI HELLAS A.E. GR
Voluven 6% Infusionslösung
DE/H/0272/001 44943.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Voluven 60 g/1000 ml solutie perfuzabila
not available 864/2008/01 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/13 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/14 FRESENIUS KABI DEUTSCHLAND GMBH
RO
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List of nationally authorised medicinal products EMA/637890/2017 Page 19/25
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
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/15 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/16 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/17 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/03 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/05 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/06 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/07 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/04 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/08 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/09 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/10 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/02 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/11 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/12 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 mg/ml infusjonsvæske, oppløsning
DE/H/0223/001 2000-0070 FRESENIUS KABI NORGE AS NO
Voluven 60 mg/ml infuusioneste, liuos
DE/H/0223/001 15390 FRESENIUS KABI AB FI
VOLUVEN 60 mg/ml raztopina za infundiranje
not available H/02/01994/001 MEDIAS INTERNATIONAL D.O.O. SI
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List of nationally authorised medicinal products EMA/637890/2017 Page 20/25
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
VOLUVEN 60 mg/ml raztopina za infundiranje
not available H/02/01994/002 MEDIAS INTERNATIONAL D.O.O. SI
VOLUVEN 60 mg/ml raztopina za infundiranje
not available H/02/01994/001 MEDIAS INTERNATIONAL D.O.O. SI
VOLUVEN 60 mg/ml raztopina za infundiranje
not available H/02/01994/002 MEDIAS INTERNATIONAL D.O.O. SI
Voluven 60 mg/ml, infusionsvätska, lösning
DE/H/0223/001 16106 FRESENIUS KABI AB SE
Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão
DE/H/1568/001 5283627 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão
DE/H/1568/001 5283643 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão
DE/H/1568/001 5283650 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão
DE/H/1568/001 5283668 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão
DE/H/1568/001 5283676 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 100 mg/ml + 9 mg/ml solução para perfusão
DE/H/1568/001 5283635 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4766382 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4765988 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4767182 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
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List of nationally authorised medicinal products EMA/637890/2017 Page 21/25
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
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4766481 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4766085 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4767281 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 3369287 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 3369089 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 3369386 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 3369881 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5459920 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5459938 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5459946 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4766580 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4766184 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
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List of nationally authorised medicinal products EMA/637890/2017 Page 22/25
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
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4767380 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4766689 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4766283 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4767489 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 3369485 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 3369584 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 3369980 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5459953 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 3369188 FRESENIUS KABI PHARMA PORTUGAL LDA.
PT
Voluven Fresenius 6 % Infusionslösung
DE/H/0223/001 45010.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660011 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660035 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660047 FRESENIUS KABI ITALIA S.R.L. IT
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List of nationally authorised medicinal products EMA/637890/2017 Page 23/25
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
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660050 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660062 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660098 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660100 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660276 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660288 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660290 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660302 FRESENIUS KABI ITALIA S.R.L. IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660023 FRESENIUS KABI ITALIA S.R.L. IT
VOLUVEN, (60 mg + 9 mg)/ml, roztwór do infuzji
not available 9370 FRESENIUS KABI DEUTSCHLAND GMBH
PL
VOLUVEN, (60 mg + 9 mg)/ml, roztwór do infuzji
not available 9370 FRESENIUS KABI DEUTSCHLAND GMBH
PL
Voluven, 10% (100 mg/ml) Infusionslösung
DE/H/1568/001 BE 368943 FRESENIUS KABI NV/SA BE
Voluven, 10% (100 mg/ml) Infusionslösung
DE/H/1568/001 BE 368934 FRESENIUS KABI NV/SA BE
Voluven, 10% (100 mg/ml) oplossing voor infusie
DE/H/1568/001 BE 368943 FRESENIUS KABI NV/SA BE
Voluven, 10% (100 mg/ml) oplossing voor infusie
DE/H/1568/001 BE 368934 FRESENIUS KABI NV/SA BE
Voluven, 10% (100 mg/ml) oplossing voor infusie
DE/H/1568/001 RVG 102156 FRESENIUS KABI NEDERLAND B.V. NL
Voluven, 10% (100 mg/ml) solution pour perfusion
DE/H/1568/001 BE 368943 FRESENIUS KABI NV/SA BE
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List of nationally authorised medicinal products EMA/637890/2017 Page 24/25
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
Voluven, 10% (100 mg/ml) solution pour perfusion
DE/H/1568/001 BE 368934 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) Infusionslösung
DE/H/0223/001 BE215573 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) Infusionslösung
DE/H/0223/001 BE215582 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) Infusionslösung
DE/H/0223/001 BE215591 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) Infusionslösung
DE/H/0223/001 BE215625 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) Infusionslösung
DE/H/0223/001 BE215634 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) Infusionslösung
DE/H/0223/001 BE215564 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) oplossing voor infusie
DE/H/0223/001 BE215573 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) oplossing voor infusie
DE/H/0223/001 BE215582 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) oplossing voor infusie
DE/H/0223/001 BE215591 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) oplossing voor infusie
DE/H/0223/001 BE215625 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) oplossing voor infusie
DE/H/0223/001 BE215634 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) oplossing voor infusie
DE/H/0223/001 BE215564 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) oplossing voor infusie
DE/H/0223/001 RVG 25169 FRESENIUS KABI NEDERLAND B.V. NL
Voluven, 6% (60 mg/ml) solution pour perfusion
DE/H/0223/001 BE215573 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) solution pour perfusion
DE/H/0223/001 BE215582 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) solution pour perfusion
DE/H/0223/001 BE215591 FRESENIUS KABI NV/SA BE
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List of nationally authorised medicinal products EMA/637890/2017 Page 25/25
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
Voluven, 6% (60 mg/ml) solution pour perfusion
DE/H/0223/001 BE215625 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) solution pour perfusion
DE/H/0223/001 BE215634 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) solution pour perfusion
DE/H/0223/001 BE215564 FRESENIUS KABI NV/SA BE
Voluven, infusionsvæske, opløsning
DE/H/0223/001 31342 FRESENIUS KABI AB DK
Voluven, infusionsvæske, opløsning
DE/H/1568/001 43009 FRESENIUS KABI AB DK
Voluven, solution pour perfusion
not available 367 403-5 FRESENIUS KABI FRANCE S.A.S. FR
VOLUVEN, solution pour perfusion
not available 367 404-1 FRESENIUS KABI FRANCE S.A.S. FR
Voluven® 6% solución para perfusión
DE/H/0272/001 64.001 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Vonten 10% soluzione per infusione
DE/H/1568/001 040747026 FRESENIUS KABI ITALIA S.R.L. IT
Vonten 10% soluzione per infusione
DE/H/1568/001 040747038 FRESENIUS KABI ITALIA S.R.L. IT
Vonten 10% soluzione per infusione
DE/H/1568/001 040747040 FRESENIUS KABI ITALIA S.R.L. IT
Vonten 10% soluzione per infusione
DE/H/1568/001 040747053 FRESENIUS KABI ITALIA S.R.L. IT
Vonten 10% soluzione per infusione
DE/H/1568/001 040747065 FRESENIUS KABI ITALIA S.R.L. IT
Vonten 10% soluzione per infusione
DE/H/1568/001 040747014 FRESENIUS KABI ITALIA S.R.L. IT
Волувен 10% инфузионен разтвор
DE/H/1568/001 20120381 FRESENIUS KABI BULGARIA EOOD BG
Волулайт 6% инфузионен разтвор
DE/H/0619/001 20110163 FRESENIUS KABI BULGARIA EOOD BG
