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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
© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
3 October 2019 EMA/553019/2019 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: hydroxyethyl starch
Procedure no.: PSUSA/00001694/201903
List of nationally authorised medicinal products EMA/382258/2015 Page 2/44
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
DE/H/5836/001/MR 036617052 B.BRAUN MELSUNGEN AG IT
Amidolite, 60 mg/ml soluzione per infusione
DE/H/5836/001/MR 036617076 B.BRAUN MELSUNGEN AG IT
Amidolite, 60 mg/ml soluzione per infusione
DE/H/5836/001/MR 036617037 B.BRAUN MELSUNGEN AG IT
Isohes 6% solución para perfusión
DE/H/5835/001/MR 68812 B.BRAUN MELSUNGEN AG ES
ISOVOL 6%, solution pour perfusion
not available 3400921842920 B.BRAUN MELSUNGEN AG FR
ISOVOL 6%, solution pour perfusion
not available 3400921842630 B.BRAUN MELSUNGEN AG FR
ISOVOL 6%, solution pour perfusion
not available 3400921842869 B.BRAUN MELSUNGEN AG FR
Tetraspan 10 % Infusionslösung
DE/H/5835/002/MR 0667/07020011 B.BRAUN MELSUNGEN AG LU
Tetraspan 100 mg/ml HES roztwór do infuzji
DE/H/5835/002/MR 12810 B.BRAUN MELSUNGEN AG PL
List of nationally authorised medicinal products EMA/382258/2015 Page 3/44
Tetraspan 100 mg/ml solução para perfusão
SE/H/0609/002 5993381 B.BRAUN MELSUNGEN AG PT
Tetraspan 100 mg/ml solução para perfusão
SE/H/0609/002 5993589 B.BRAUN MELSUNGEN AG PT
Tetraspan 100 mg/ml solução para perfusão
SE/H/0609/002 5993787 B.BRAUN MELSUNGEN AG PT
Tetraspan 100 mg/ml soluţie perfuzabilă
not available 5520/2013/01 B.BRAUN MELSUNGEN AG RO
Tetraspan 100 mg/ml soluţie perfuzabilă
not available 5520/2013/02 B.BRAUN MELSUNGEN AG RO
Tetraspan 100 mg/ml soluţie perfuzabilă
not available 5520/2013/03 B.BRAUN MELSUNGEN AG RO
Tetraspan 100 mg/ml soluţie perfuzabilă
not available 5520/2013/04 B.BRAUN MELSUNGEN AG RO
Tetraspan 6 % Infusionslösung
SE/H/0609/001 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
DE/H/5835/001/MR RVG 34094 B.BRAUN MELSUNGEN AG NL
List of nationally authorised medicinal products EMA/382258/2015 Page 4/44
Tetraspan 6%, 60 mg/ml, oplossing voor infusie
SE/H/0609/001 BE320765 B.BRAUN MELSUNGEN AG BE
Tetraspan 6%, 60 mg/ml, oplossing voor infusie
SE/H/0609/001 BE320731 B.BRAUN MELSUNGEN AG BE
Tetraspan 6%, 60 mg/ml, oplossing voor infusie
SE/H/0609/001 BE320747 B.BRAUN MELSUNGEN AG BE
Tetraspan 6%, 60 mg/ml, solution pour perfusion
SE/H/0609/001 BE320765 B.BRAUN MELSUNGEN AG BE
Tetraspan 6%, 60 mg/ml, solution pour perfusion
SE/H/0609/001 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 raztopina za infundiranje
SE/H/609/01 H/07/01524/002 B.BRAUN MELSUNGEN AG SI
Tetraspan 60 mg/ml raztopina za
SE/H/609/01 H/07/01524/003 B.BRAUN MELSUNGEN AG SI
List of nationally authorised medicinal products EMA/382258/2015 Page 5/44
infundiranje
Tetraspan 60 mg/ml raztopina za infundiranje
SE/H/609/01 H/07/01524/001 B.BRAUN MELSUNGEN AG SI
Tetraspan 60 mg/ml solução para perfusão
DE/H/5835/001/MR 5992789 B.BRAUN MELSUNGEN AG PT
Tetraspan 60 mg/ml solução para perfusão
DE/H/5835/001/MR 5992987 B.BRAUN MELSUNGEN AG PT
Tetraspan 60 mg/ml solução para perfusão
DE/H/5835/001/MR 5993183 B.BRAUN MELSUNGEN AG PT
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/01 B.BRAUN MELSUNGEN AG RO
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/02 B.BRAUN MELSUNGEN AG RO
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/03 B.BRAUN MELSUNGEN AG RO
Tetraspan 60 mg/ml soluţie perfuzabilă
not available 5519/2013/04 B.BRAUN MELSUNGEN AG RO
Tetraspan 60 mg/ml, soluzione per infusione
SE/H/609/01 037596018 B.BRAUN MELSUNGEN AG IT
List of nationally authorised medicinal products EMA/382258/2015 Page 6/44
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
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 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
DE/H/5836/001/MR 59979.00.00 B.BRAUN MELSUNGEN AG DE
Venofundin 60 mg/ml Infusionslösung
DE/H/5836/001/MR 59979.00.00 B.BRAUN MELSUNGEN AG DE
List of nationally authorised medicinal products EMA/382258/2015 Page 7/44
Venofundin 60 mg/ml Infusionslösung
DE/H/5836/001/MR 0667/04090013 B.BRAUN MELSUNGEN AG LU
Venofundin 60 mg/ml, oplossing voor intraveneuze infusie
DE/H/5836/001/MR RVG 30621 B.BRAUN MELSUNGEN AG NL
Venofundin 60mg/ml, διάλυμα για έγχυση
DE/H/5836/001/MR 34158/7-12-2004 B.BRAUN MELSUNGEN AG GR
Venohes 60 mg/ml, oplossing voor infusie
DE/H/5836/001/MR BE362941 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, oplossing voor infusie
DE/H/5836/001/MR BE296536 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, oplossing voor infusie
DE/H/5836/001/MR BE296545 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, solution pour perfusion
DE/H/5836/001/MR BE362941 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, solution pour perfusion
DE/H/5836/001/MR BE296536 B.BRAUN MELSUNGEN AG BE
Venohes 60 mg/ml, solution pour perfusion
DE/H/5836/001/MR BE296545 B.BRAUN MELSUNGEN AG BE
VITAFUSAL® 10% 10% HES 130/0.42 in Ringer-Acetat,
not available 71020.00.00 SERUMWERK BERNBURG AG
DE
List of nationally authorised medicinal products EMA/382258/2015 Page 8/44
Infusionslösung zur intravenösen Anwendung
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
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 DE/H/1568/001 681710 FRESENIUS KABI POLSKA SP. Z O.O.
EE
Voluforte 10% infuzinis tirpalas
DE/H/1568/001 LT/1/10/1979/001 FRESENIUS KABI POLSKA SP. Z O.O.
LT
List of nationally authorised medicinal products EMA/382258/2015 Page 9/44
Voluforte 10% infuzinis tirpalas
DE/H/1568/001 LT/1/10/1979/003 FRESENIUS KABI POLSKA SP. Z O.O.
LT
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
Volulyte DE/H/0619/001 581708 FRESENIUS KABI DEUTSCHLAND GMBH
EE
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
List of nationally authorised medicinal products EMA/382258/2015 Page 10/44
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
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/012 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/013 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/014 FRESENIUS KABI DEUTSCHLAND GMBH
LT
List of nationally authorised medicinal products EMA/382258/2015 Page 11/44
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/015 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/016 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/017 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/018 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% infuzinis tirpalas
DE/H/0619/001 LT/1/08/1161/019 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/03 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/04 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/05 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/06 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/07 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
List of nationally authorised medicinal products EMA/382258/2015 Page 12/44
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/10 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/11 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/12 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/01 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/02 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/08 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/09 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/13 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/14 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/16 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
List of nationally authorised medicinal products EMA/382258/2015 Page 13/44
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/15 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/17 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/18 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
Volulyte 6% soluţie perfuzabilă
DE/H/0619/001 10443/2017/19 S.C. FRESENIUS KABI ROMÂNIA S.R.L.
RO
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 BE533395 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/382258/2015 Page 14/44
Volulyte 6% Infusionslösung
DE/H/0619/001 BE533404 FRESENIUS KABI NV/SA BE
Volulyte 6% Infusionslösung
not available 64678.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Volulyte 6% Infusionslösung
DE/H/0619/001 64677.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Volulyte 6% Infusionslösung
DE/H/0619/001 0452/09100052 FRESENIUS KABI DEUTSCHLAND GMBH
LU
Volulyte 6% infuzní roztok
DE/H/0619/001 75/262/08-C FRESENIUS KABI DEUTSCHLAND GMBH
CZ
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
List of nationally authorised medicinal products EMA/382258/2015 Page 15/44
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% oldatos infúzió
DE/H/0619/001 OGYI-T-20582/09 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió
DE/H/0619/001 OGYI-T-20582/10 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió
DE/H/0619/001 OGYI-T-20582/11 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió
DE/H/0619/001 OGYI-T-20582/12 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió
DE/H/0619/001 OGYI-T-20582/13 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió
DE/H/0619/001 OGYI-T-20582/14 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Volulyte 6% oldatos infúzió
DE/H/0619/001 OGYI-T-20582/15 FRESENIUS KABI DEUTSCHLAND GMBH
HU
List of nationally authorised medicinal products EMA/382258/2015 Page 16/44
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 BE533395 FRESENIUS KABI NV/SA BE
Volulyte 6% oplossing voor infusie
DE/H/0619/001 BE533404 FRESENIUS KABI NV/SA BE
Volulyte 6% oplossing voor infusie
DE/H/0619/001 RVG 33457 FRESENIUS KABI NEDERLAND B.V.
NL
Volulyte 6% šķīdums infūzijām
DE/H/0619/001 08-0103 FRESENIUS KABI DEUTSCHLAND GMBH
LV
Volulyte 6% solución para perfusión
DE/H/0619/001 70.228 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Volulyte 6% Solution for Infusion
DE/H/0619/001 MA1123/02201 FRESENIUS KABI ITALIA S.R.L.
MT
List of nationally authorised medicinal products EMA/382258/2015 Page 17/44
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% solution pour perfusion
DE/H/0619/001 BE533395 FRESENIUS KABI NV/SA BE
Volulyte 6% solution pour perfusion
DE/H/0619/001 BE533404 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
List of nationally authorised medicinal products EMA/382258/2015 Page 18/44
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% soluzione per infusione
DE/H/0619/001 038473132 FRESENIUS KABI ITALIA S.R.L.
IT
Volulyte 6% soluzione per infusione
DE/H/0619/001 038473144 FRESENIUS KABI ITALIA S.R.L.
IT
List of nationally authorised medicinal products EMA/382258/2015 Page 19/44
Volulyte 6% soluzione per infusione
DE/H/0619/001 038473169 FRESENIUS KABI ITALIA S.R.L.
IT
Volulyte 6% soluzione per infusione
DE/H/0619/001 038473157 FRESENIUS KABI ITALIA S.R.L.
IT
Volulyte 6% soluzione per infusione
DE/H/0619/001 038473171 FRESENIUS KABI ITALIA S.R.L.
IT
Volulyte 6% soluzione per infusione
DE/H/0619/001 038473183 FRESENIUS KABI ITALIA S.R.L.
IT
Volulyte 6% soluzione per infusione
DE/H/0619/001 038473195 FRESENIUS KABI ITALIA S.R.L.
IT
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%, solution pour perfusion
not available 34009 395 519 4 4 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 523 1 6 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 524 8 4 FRESENIUS KABI FRANCE S.A.S.
FR
List of nationally authorised medicinal products EMA/382258/2015 Page 20/44
Volulyte 6%, solution pour perfusion
not available 34009 395 525 4 5 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 526 0 6 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 527 7 4 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 528 3 5 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 530 8 5 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 531 4 6 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 520 2 6 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 521 9 4 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, solution pour perfusion
not available 34009 395 522 5 5 FRESENIUS KABI FRANCE S.A.S.
FR
Volulyte 6%, Διάλυμα για έγχυση
DE/H/0619/001 20656 FRESENIUS KABI DEUTSCHLAND GMBH
CY
List of nationally authorised medicinal products EMA/382258/2015 Page 21/44
Volulyte 6%W/V, Διάλυμα για έγχυση
DE/H/0619/001 81364/25-9-2017 FRESENIUS KABI HELLAS A.E.
GR
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 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/002 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/007 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/008 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/009 FRESENIUS KABI AUSTRIA GMBH
SI
List of nationally authorised medicinal products EMA/382258/2015 Page 22/44
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/010 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/011 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/012 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/003 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/004 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/005 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/006 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/013 FRESENIUS KABI AUSTRIA GMBH
SI
List of nationally authorised medicinal products EMA/382258/2015 Page 23/44
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/014 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/016 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/015 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/017 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/018 FRESENIUS KABI AUSTRIA GMBH
SI
Volulyte 60 mg/ml raztopina za infundiranje
DE/H/0619/001 H/08/01657/019 FRESENIUS KABI AUSTRIA GMBH
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
List of nationally authorised medicinal products EMA/382258/2015 Page 24/44
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
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, infusionsvæske, opløsning
DE/H/0619/001 38802 FRESENIUS KABI AB DK
List of nationally authorised medicinal products EMA/382258/2015 Page 25/44
Voluven DE/H/1568/001 43009 FRESENIUS KABI AB DK
Voluven not available 391102 FRESENIUS KABI DEUTSCHLAND GMBH
EE
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 % 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
List of nationally authorised medicinal products EMA/382258/2015 Page 26/44
Voluven 10%, 10% + 0,9%, roztwór do infuzji
DE/H/1568/001 17196 FRESENIUS KABI POLSKA SP. Z O.O.
PL
Voluven 10%, infuzní roztok
DE/H/1568/001 75/417/10-C FRESENIUS KABI S.R.O. CZ
Voluven 10%, infúzny roztok
DE/H/1568/001 76/0134/10-S FRESENIUS KABI S.R.O. SK
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
List of nationally authorised medicinal products EMA/382258/2015 Page 27/44
Voluven 100 mg/ml raztopina za infundiranje
DE/H/1568/001 H/10/01658/003 FRESENIUS KABI DEUTSCHLAND GMBH
SI
Voluven 6 % Infusionslösung
not available 42093.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Voluven 6 % Infusionslösung
DE/H/0223/001 2005018652 FRESENIUS KABI DEUTSCHLAND GMBH
LU
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/002 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/003 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/004 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/005 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/006 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/007 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/008 FRESENIUS KABI DEUTSCHLAND GMBH
LT
List of nationally authorised medicinal products EMA/382258/2015 Page 28/44
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/009 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/010 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/011 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/012 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/013 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/014 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/015 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/016 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/017 FRESENIUS KABI DEUTSCHLAND GMBH
LT
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/018 FRESENIUS KABI DEUTSCHLAND GMBH
LT
List of nationally authorised medicinal products EMA/382258/2015 Page 29/44
Voluven 6 % infuzinis tirpalas
not available LT/1/02/2879/001 FRESENIUS KABI DEUTSCHLAND GMBH
LT
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 % oldatos infúzió
not available OGYI-T-8387/01 FRESENIUS KABI DEUTSCHLAND GMBH
HU
Voluven 6 % oldatos infúzió
not available OGYI-T-8387/10 FRESENIUS KABI DEUTSCHLAND GMBH
HU
List of nationally authorised medicinal products EMA/382258/2015 Page 30/44
Voluven 6 %; Infusionslösung
DE/H/272/001 44943.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Voluven 6% šķīdums infūzijām
not available 03-0177 FRESENIUS KABI DEUTSCHLAND GMBH
LV
Voluven 6% Solución para perfusión
DE/H/272/001 64.001 FRESENIUS KABI DEUTSCHLAND GMBH
ES
Voluven 6% διάλυμα για έγχυση
DE/H/0223/001 9010/2-2-2017 FRESENIUS KABI HELLAS A.E.
GR
Voluven 6%. Innrennslislyf, lausn.
DE/H/0223/001 IS/1/00/002/01 FRESENIUS KABI AB IS
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
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
List of nationally authorised medicinal products EMA/382258/2015 Page 31/44
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
List of nationally authorised medicinal products EMA/382258/2015 Page 32/44
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/12 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 g/1000 ml soluţie perfuzabilă
not available 864/2008/01 FRESENIUS KABI DEUTSCHLAND GMBH
RO
Voluven 60 mg/ml infusjonsvæske, oppløsning
DE/H/0223/001 00-70 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 FRESENIUS KABI AUSTRIA GMBH
SI
Voluven 60 mg/ml raztopina za infundiranje
not available H/02/01994/002 FRESENIUS KABI AUSTRIA GMBH
SI
VOLUVEN 60 mg/ml raztopina za infundiranje
not available H/02/01994/003 FRESENIUS KABI AUSTRIA GMBH
SI
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
List of nationally authorised medicinal products EMA/382258/2015 Page 33/44
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
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 4766481 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
List of nationally authorised medicinal products EMA/382258/2015 Page 34/44
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
List of nationally authorised medicinal products EMA/382258/2015 Page 35/44
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
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
List of nationally authorised medicinal products EMA/382258/2015 Page 36/44
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 5732557 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5732565 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5732573 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5732607 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5732615 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
List of nationally authorised medicinal products EMA/382258/2015 Page 37/44
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5732623 FRESENIUS KABI PHARMA PORTUGAL, LDA.
PT
Voluven Fresenius 60 mg/ml + 9 mg/ml solução para perfusão
DE/H/0223/001 5732631 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
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
List of nationally authorised medicinal products EMA/382258/2015 Page 38/44
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 034660314 FRESENIUS KABI ITALIA S.R.L.
IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660326 FRESENIUS KABI ITALIA S.R.L.
IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660338 FRESENIUS KABI ITALIA S.R.L.
IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660340 FRESENIUS KABI ITALIA S.R.L.
IT
List of nationally authorised medicinal products EMA/382258/2015 Page 39/44
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660353 FRESENIUS KABI ITALIA S.R.L.
IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660365 FRESENIUS KABI ITALIA S.R.L.
IT
Voluven soluzione per infusione al 6%
DE/H/0223/001 034660377 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, 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
List of nationally authorised medicinal products EMA/382258/2015 Page 40/44
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
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
List of nationally authorised medicinal products EMA/382258/2015 Page 41/44
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 BE529173 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) oplossing voor infusie
DE/H/0223/001 BE529182 FRESENIUS KABI NV/SA BE
Voluven, 6% (60 mg/ml) oplossing voor infusie
DE/H/0223/001 BE215564 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/382258/2015 Page 42/44
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
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, 6% infuzní roztok
not available 75/234/01-C FRESENIUS KABI DEUTSCHLAND GMBH
CZ
Voluven, infusionsvæske, opløsning
DE/H/0223/001 31342 FRESENIUS KABI AB DK
Voluven, solution pour perfusion
not available 367 403-5 FRESENIUS KABI FRANCE S.A.S.
FR
List of nationally authorised medicinal products EMA/382258/2015 Page 43/44
Voluven, solution pour perfusion
not available 367 404-1 FRESENIUS KABI FRANCE S.A.S.
FR
Voluven®, 6 % (60 mg/ml) oplossing voor infusie
DE/H/0223/001 RVG 25169 FRESENIUS KABI NEDERLAND B.V.
NL
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 6% + 0,9% инфузионен разтвор
not available 20020810 FRESENIUS KABI DEUTSCHLAND GMBH
BG
Волулайт 6% инфузионен разтвор
DE/H/0619/001 20110163 FRESENIUS KABI BULGARIA EOOD
BG
List of nationally authorised medicinal products EMA/382258/2015 Page 44/44