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Jan 11, 2018 - List of nationally authorised medicinal products. EMA/24585/2018. Page 2/8. Product Name (in authorisatio
11 January 2018 EMA/24585/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: esomeprazole / naproxen
Procedure no.: PSUSA/00001270/201704
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
country)
number
Number
member state
product is authorised
VIMOVO 500 mg/20 mg tabletter
NL/H/1848/001
43248
ASTRAZENECA AB
SE
NL/H/1848/001
20110035
ASTRAZENECA AB
BG
NL/H/1848/001
1-29937
ASTRAZENECA OSTERREICH
AT
med modifierad frisättning Вимово 500 mg/20 mg таблетки с изменено освобождаване VimovoTM 500 mg/20 mg Tabletten mit veränderter
GMBH
Wirkstofffreisetzung VimovoTM 500 mg/20 mg Tabletten
NL/H/1848/001
85145.00.00
ASTRAZENECA GMBH
DE
NL/H/1848/001
28063
ASTRAZENECA AB
FI
NL/H/1848/001
10-0640
ASTRAZENECA AB
LV
NL/H/1848/001
BE382496
ASTRAZENECA S.A. / N.V.
BE
NL/H/1848/001
BE382505
ASTRAZENECA S.A. / N.V.
BE
NL/H/1848/001
BE382505
ASTRAZENECA S.A. / N.V.
BE
NL/H/1848/001
BE382496
ASTRAZENECA S.A. / N.V.
BE
NL/H/1848/001
LT/1/10/2302/003
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/009
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/012
ASTRAZENECA AB
LT
mit veränderter Wirkstofffreisetzung Vimovo 500 mg/20 mg säädellysti vapauttavat tabletit VIMOVO™ 500 mg/20 mg ilgstošās darbības tabletes VIMOVO 500 mg/20 mg tabletten met gereguleerde afgifte VIMOVO 500 mg/20 mg comprimés à libération modifiée VIMOVO 500 mg/20 mg tabletten met gereguleerde afgifte VIMOVO 500 mg/20 mg comprimés à libération modifiée Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės
List of nationally authorised medicinal products EMA/24585/2018
Page 2/8
Product Name (in authorisation
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
country)
number
Number
member state
product is authorised
Vimovo 500 mg/20 mg modifikuoto
NL/H/1848/001
LT/1/10/2302/001
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/004
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/002
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/007
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/010
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/005
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/011
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/008
ASTRAZENECA AB
LT
NL/H/1848/001
LT/1/10/2302/006
ASTRAZENECA AB
LT
NL/H/1848/001
5350459
ASTRAZENECA PRODUTOS
PT
atpalaidavimo tabletes Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės Vimovo 500 mg/20 mg modifikuoto atpalaidavimo tabletės VIMOVO 500 mg/20 mg comprimidos de libertação
FARMACEUTICOS LDA
modificada VIMOVO 500 mg/20 mg
NL/H/1848/001
5350442
comprimidos de libertação
ASTRAZENECA PRODUTOS
PT
FARMACEUTICOS LDA
modificada VIMOVO 500 mg/20 mg comprimidos de libertação
NL/H/1848/001
5346010
ASTRAZENECA PRODUTOS
PT
FARMACEUTICOS LDA
modificada
List of nationally authorised medicinal products EMA/24585/2018
Page 3/8
Product Name (in authorisation
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
country)
number
Number
member state
product is authorised
VIMOVO 500 mg/20 mg
NL/H/1848/001
5346028
ASTRAZENECA PRODUTOS
PT
comprimidos de libertação
FARMACEUTICOS LDA
modificada VIMOVO™ 500 mg/20 mg
NL/H/1848/001
73.182
comprimidos de liberación
ASTRAZENECA
ES
FARMACÉUTICA SPAIN, S.A.
modificada VIMOVO™ 500 mg/20 mg modified-
NL/H/1848/001
PL 17901/0263
ASTRAZENECA UK LIMITED
UK
NL/H/1848/001
RVG 106235
ASTRAZENECA BV
NL
NL/H/1848/001
2011040076
ASTRAZENECA S.A. / N.V.
LU
NL/H/1848/001/DC
PA 970/60/1
ASTRAZENECA UK LIMITED
IE
NL/H/1848/001
040611016/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
714110
ASTRAZENECA AB
EE
NL/H/1848/001
09-7130
ASTRAZENECA AB
NO
NL/H/1848/001
9516/2016/01
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/02
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/05
ASTRAZENECA AB
RO
release tablets▼ VIMOVO® 500 mg/20 mg tabletten met gereguleerde afgifte VIMOVO 500 mg/20 mg comprimés à libération modifiée VIMOVO™ 500 mg/20 mg modifiedrelease tablets VIMOVO 500 mg/20 mg compresse a rilascio modificato Vimovo, 500 mg/20 mg toimeainet modifitseeritult vabastavad tabletid Vimovo 500 mg/20 mg tabletter med modifisert frisetting VIMOVO 500 mg/20 mg comprimate cu eliberare modificată VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA
List of nationally authorised medicinal products EMA/24585/2018
Page 4/8
Product Name (in authorisation
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
country)
number
Number
member state
product is authorised
VIMOVO 500 MG/20 MG
NL/H/1848/001
9516/2016/03
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/04
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/06
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/07
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/13
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/12
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/11
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/10
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/09
ASTRAZENECA AB
RO
COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA
List of nationally authorised medicinal products EMA/24585/2018
Page 5/8
Product Name (in authorisation
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
country)
number
Number
member state
product is authorised
VIMOVO 500 MG/20 MG
NL/H/1848/001
9516/2016/08
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/14
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/15
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/16
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/18
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/17
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/19
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/20
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/21
ASTRAZENECA AB
RO
COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA
List of nationally authorised medicinal products EMA/24585/2018
Page 6/8
Product Name (in authorisation
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
country)
number
Number
member state
product is authorised
VIMOVO 500 MG/20 MG
NL/H/1848/001
9516/2016/22
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/23
ASTRAZENECA AB
RO
NL/H/1848/001
9516/2016/24
ASTRAZENECA AB
RO
NL/H/1848/001
040611079/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
040611042/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
040611067/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
040611030/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
040611055/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
040611028/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
040611117/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
040611093/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
040611105/M
ASTRAZENECA S.P.A.
IT
COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 MG/20 MG COMPRIMATE CU ELIBERARE MODIFICATA VIMOVO 500 mg/20 mg compresse a rilascio modificato VIMOVO 500 mg/20 mg compresse a rilascio modificato VIMOVO 500 mg/20 mg compresse a rilascio modificato VIMOVO 500 mg/20 mg compresse a rilascio modificato VIMOVO 500 mg/20 mg compresse a rilascio modificato VIMOVO 500 mg/20 mg compresse a rilascio modificato VIMOVO 500 mg/20 mg compresse a rilascio modificato VIMOVO 500 mg/20 mg compresse a rilascio modificato VIMOVO 500 mg/20 mg compresse a rilascio modificato
List of nationally authorised medicinal products EMA/24585/2018
Page 7/8
Product Name (in authorisation
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
country)
number
Number
member state
product is authorised
VIMOVO 500 mg/20 mg compresse
NL/H/1848/001
040611129/M
ASTRAZENECA S.P.A.
IT
NL/H/1848/001
040611081/M
ASTRAZENECA S.P.A.
IT
a rilascio modificato VIMOVO 500 mg/20 mg compresse a rilascio modificato
List of nationally authorised medicinal products EMA/24585/2018
Page 8/8
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