26 October 2017 EMA/722339/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: human plasma (pooled and treated for virus inactivation)
Procedure no.: PSUSA/00001635/201702
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in
MRP/DCP
National Authorisation
MAH of product in the
Member State where
authorisation country)
Authorisation number
Number
Member State
product is authorised
OCTAPLAS® SD* Blutgruppe A zur Infusion
not available
2-00137
AT
20150313
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESMBH OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESMBH OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESMBH OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESMBH OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESMBH OCTAPHARMA BENELUX S.A./N.V. OCTAPHARMA (IP)-LTD.
OCTAPLAS® SD* Blutgruppe B zur Infusion
not available
2-00138
OCTAPLAS® SD* Blutgruppe AB not available zur Infusion
2-00139
OCTAPLAS® SD* Blutgruppe 0 zur Infusion
not available
2-00140
Octaplas LG 45-70 mg/ml Infusionslösung
UK/H/0355/001
236510
octaplasLG, solution pour perfusion octaplasLG, 45–70 mg/ml solution for infusion octaplasLG Octaplas Octaplas® LG OctaplasLG, infusionsvæske, opløsning OctaplasLG, infusionsvæske, opløsning OctaplasLG, infusionsvæske, opløsning OctaplasLG, infusionsvæske, opløsning OctaplasLG, 45...70 mg/ml, infusioonilahus OctaplasmaLG (0) 45 - 70 mg/ml solución para perfusión OctaplasmaLG (A) 45 - 70 mg/ml solución para perfusión
UK/H/0355/001
BE222713
UK/H/0355/001 UK/H/0355/001 not available not available UK/H/0355/001
75/266/16-C 75/038/03-C PEI.H.02698.01.1 58093
OCTAPHARMA OCTAPHARMA OCTAPHARMA OCTAPHARMA
CZ CZ DE DK
UK/H/0355/001
58094
OCTAPHARMA AB
DK
UK/H/0355/001
58095
OCTAPHARMA AB
DK
UK/H/0355/001
58096
OCTAPHARMA AB
DK
UK/H/0355/001
888615
OCTAPHARMA (IP)-LTD.
EE
UK/H/0355/001
80563
OCTAPHARMA S.A.
ES
UK/H/0355/001
81078
OCTAPHARMA S.A.
ES
List of nationally authorised medicinal products EMA/722339/2017
(IP)-LTD. (IP)-LTD. GMBH AB
AT AT AT AT BE BG
Page 2/4
Product Name (in
MRP/DCP
National Authorisation
MAH of product in the
Member State where
authorisation country)
Authorisation number
Number
Member State
product is authorised
OctaplasmaLG (B) 45 - 70 mg/ml solución para perfusión OctaplasmaLG (AB) 45 - 70 mg/ml solución para perfusión octaplasLG OCTAPLASLG, solution pour perfusion OCTAPLASLG, solution pour perfusion OCTAPLASLG, solution pour perfusion OCTAPLASLG, solution pour perfusion octaplasLG 45-70 mg/ml otopina za infuziju OctaplasLG 45-75 mg/ml oldatos infúzió Octaplas fagyasztott oldatos infúzió Octaplas fagyasztott oldatos infúzió Octaplas fagyasztott oldatos infúzió Octaplas fagyasztott oldatos infúzió LG-octaplas solution for infusion PLASMAGRADE soluzione per infusione PLASMASAFE soluzione per infusione Octaplas
UK/H/0355/001
81079
OCTAPHARMA S.A.
ES
UK/H/0355/001
81080
OCTAPHARMA S.A.
ES
UK/H/0355/001 UK/H/0355/001
15619 34009 550 030 9 0
OCTAPHARMA AB OCTAPHARMA FRANCE
FI FR
UK/H/0355/001
34009 550 031 0 6
OCTAPHARMA FRANCE
FR
UK/H/0355/001
34009 550 031 1 3
OCTAPHARMA FRANCE
FR
UK/H/0355/001
34009 550 031 2 0
OCTAPHARMA FRANCE
FR
UK/H/0355/001
HR-H-098600779
OCTAPHARMA (IP)-LTD.
HR
UK/H/0355/001
OGYI-T-20223/05
OCTAPHARMA (IP)-LTD.
HU
not available
OGYI-T-20223/02
OCTAPHARMA (IP)-LTD.
HU
not available
OGYI-T-20223/03
OCTAPHARMA (IP)-LTD.
HU
not available
OGYI-T-20223/04
OCTAPHARMA (IP)-LTD.
HU
not available
OGYI-T-20223/01
OCTAPHARMA (IP)-LTD.
HU
UK/H/0355/001 not available
PA 521/4/2 041868011
OCTAPHARMA-LTD KEDRION S.P.A.
IE IT
not available
033369012
KEDRION S.P.A.
IT
not available
octaplasma infuzinis tirpalas octaplasLG
UK/H/0355/001 UK/H/0355/001
AIC N. 034540017; AIC N. 533 OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESMBH LT/1/15/3801/001 OCTAPHARMA (IP)-LTD. 0345205 (NATIONAL); OCTAPHARMA BENELUX 1196/09050311 (AMM) S.A./N.V.
List of nationally authorised medicinal products EMA/722339/2017
IT LT LU
Page 3/4
Product Name (in
MRP/DCP
National Authorisation
MAH of product in the
Member State where
authorisation country)
Authorisation number
Number
Member State
product is authorised
octaplasma ķīdums infūzijām octaplasLG, solution for infusion Omniplasma Octaplasma 45-70 mg/ml infusjonsvæske, oppløsning octaplasLG, roztwór do infuzji Octaplas
UK/H/0355/001 UK/H/0355/001 UK/H/0355/001 UK/H/0355/001
15-0256 MA754/00901 RVG 25407 14-10475
UK/H/0355/001 not available
22806 2830487
Novoplas (AB Plasma)
not available
OctaplasLG soluţie perfuzabilă
UK/H/0355/001
OctaplasLG soluţie perfuzabilă
UK/H/0355/001
OctaplasLG soluţie perfuzabilă
UK/H/0355/001
OctaplasLG soluţie perfuzabilă
UK/H/0355/001
octaplasLG, infusionsvätska lösning octaplasLG 45-70 mg/ml raztopina za infundiranje octaplasLG 45-70 mg/ml raztopina za infundiranje octaplasLG 45-70 mg/ml raztopina za infundiranje octaplasLG Octaplasma 45 – 70 mg/ml infúzny roztok octaplasLG, solution for infusion
OCTAPHARMA OCTAPHARMA OCTAPHARMA OCTAPHARMA
(IP)-LTD. (IP)-LTD. GMBH AS
LV MT NL NO PL PT
UK/H/0355/001
OCTAPHARMA (IP)-LTD. OCTAPHARMA PRODUTOS FARMACEUTICOS, LDA. 5319686 OCTAPHARMA PRODUTOS FARMACEUTICOS, LDA. 8288/2015/01 (BLOOD GROUP OCTAPHARMA (IP)-LTD. A) 8288/2015/02 (BLOOD GROUP OCTAPHARMA (IP)-LTD. B) 8288/2015/03 (BLOOD GROUP OCTAPHARMA (IP)-LTD. AB) 8288/2015/04 (BLOOD GROUP OCTAPHARMA (IP)-LTD. 0) 16273 OCTAPHARMA AB
UK/H/0355/001
H/16/02216/001
OCTAPHARMA (IP)-LTD.
SI
UK/H/0355/001
H/16/02216/002
OCTAPHARMA (IP)-LTD.
SI
UK/H/0355/001
H/16/02216/003
OCTAPHARMA (IP)-LTD.
SI
UK/H/0355/001 UK/H/0355/001
H/16/02216/004 75/0190/16-S
OCTAPHARMA (IP)-LTD. OCTAPHARMA (IP)-LTD.
SI SK
UK/H/0355/001
PL 10673/0009
OCTAPHARMA-LTD
UK
List of nationally authorised medicinal products EMA/722339/2017
PT RO RO RO RO SE
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