26 October 2017 EMA/715528/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: influenza vaccine (split virion, inactivated, prepared in cell cultures)
Procedure no.: PSUSA/00010299/201703
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
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
Preflucel 2012/2013,
not available
RVG 108793
NANOTHERAPEUTICS UK
NL
suspensie voor injectie
LIMITED
0,5 ml Griepvaccin (gesplitst virion, geïnactiveerd, bereid in celculturen) Preflucel 2012/2013,
not available
BE393556
suspensie voor injectie
NANOTHERAPEUTICS
BE
BOHUMIL, S.R.O.
0,5 ml. Griepvaccin (gesplitst virion, geïnactiveerd, bereid in celculturen) PREFLUCEL Injekční
not available
59/772/10-C
suspenze v předplněné
NANOTHERAPEUTICS
CZ
BOHUMIL, S.R.O.
injekční stříkačce Vakcína proti chřipce (štěpený virion, inaktivovaná, připravovaná na buněčných kulturách) Preflucel
not available
10-8003
injeksjonsvæske,
NANOTHERAPEUTICS UK
NO
LIMITED
suspensjon i ferdigfylt sprøyte Vaksine mot influensa (inaktivert, splittvirus, fremstilt i cellekulturer) Preflucel injektioneste,
not available
suspensio, esitäytetyssä
29303
NANOTHERAPEUTICS
FI
BOHUMIL, S.R.O.
ruiskussa Influenssarokote List of nationally authorised medicinal products EMA/715528/2017
Page 2/4
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
not available
2-00373
NANOTHERAPEUTICS
AT
(soluissa tuotettu inaktivoitu osavirusrokote) PREFLUCEL Injektionssuspension in
BOHUMIL, S.R.O.
einer Fertigspritze Influenza-Impfstoff (Spaltimpfstoff, inaktiviert, in Zellkulturen hergestellt) PREFLUCEL
not available
BE393556
Injektionssuspension in
NANOTHERAPEUTICS
BE
BOHUMIL, S.R.O.
einer Fertigspritze. Influenza-Impfstoff (Spaltimpfstoff, inaktiviert, in Zellkulturen hergestellt) Preflucel
not available
45349
injektionsvätska,
NANOTHERAPEUTICS UK
SE
LIMITED
suspension i förfylld spruta Vaccin mot influensa (spjälkat virus, inaktiverat, tillverkat i cellkultur) PREFLUCEL Suspensão
not available
injectável em seringa
5380407
NANOTHERAPEUTICS
PT
BOHUMIL, S.R.O.
pré-cheia Vacina contra a gripe (virião fragmentado, inactivo, List of nationally authorised medicinal products EMA/715528/2017
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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
not available
5380415
NANOTHERAPEUTICS
PT
preparado em culturas de células) PREFLUCEL Suspensão injectável em seringa
BOHUMIL, S.R.O.
pré-cheia Vacina contra a gripe (virião fragmentado, inactivo, preparado em culturas de células) PREFLUCEL suspension
not available
BE393556
injectable en seringue
NANOTHERAPEUTICS
BE
BOHUMIL, S.R.O.
préremplie Vaccin grippal (virus fragmenté inactivé, préparé à partir de cultures cellulaires) Preflucel,
not available
47867
injektionsvæske,
NANOTHERAPEUTICS
DK
BOHUMIL, S.R.O.
suspension, fyldt injektionssprøjte PREFLUCEL, zawiesina do
not available
wstrzykiwań w ampułko-
18259
NANOTHERAPEUTICS
PL
BOHUMIL, S.R.O.
strzykawce Szczepionka przeciw grypie (rozszczepiony wirion), inaktywowana, przygotowana w hodowlach komórek
List of nationally authorised medicinal products EMA/715528/2017
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