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

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© 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

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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