Jun 21, 2017 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name (in authorisation
21 June 2017 EMA/475695/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: rabeprazole
Procedure no.: PSUSA/00002601/201610
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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
PARIET® 10 mg, magensaftresistente Tabletten
UK/H/0248/001
BE199692
JANSSEN-CILAG NV
BE
PARIET® 20 mg, magensaftresistente Tabletten
UK/H/0248/002
BE199701
JANSSEN-CILAG NV
BE
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 3 55 148 5 1
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 369 072 6 3
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 374 965 5 1
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 355 146 2 2
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 274 469 6 2
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 356 741 1 1
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 357 976 2 9
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 356 743 4 0
JANSSEN-CILAG
FR
List of nationally authorised medicinal products EMA/475695/2017
Page 2/13
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
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 3 55 145 6 1
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 355 151 6 2
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 355 152 2 3
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 356 742 8 9
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 357 971 0 0
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 356 748 6 9
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 369 073 2 4
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 355 149 1 2
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 356 746 3 0
JANSSEN-CILAG
FR
List of nationally authorised medicinal products EMA/475695/2017
Page 3/13
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
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 374 470 4 4
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 356 749 2 0
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 357 977 9 7
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 355 143 3 2
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 357 972 7 8
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 374 964 9 0
JANSSEN-CILAG
FR
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 356 745 7 9
JANSSEN-CILAG
FR
PARIET® 20 mg, magensaftresistente Tabletten
UK/H/0248/002
0162/04028079
JANSSEN-CILAG NV
LU
PARIET® 10 mg, magensaftresistente Tabletten
UK/H/0248/001
0162/04028078
JANSSEN-CILAG NV
LU
List of nationally authorised medicinal products EMA/475695/2017
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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
PARIET 20mg gastro-resistant tablet
UK/H/0248/001
PL 10555/0008
EISAI LTD
UK
PARIET 10mg gastro-resistant tablet
UK/H/0248/001
PL 10555/0010
EISAI LTD
UK
Pariet 10 mg magensaftresistente Tabletten
UK/H/0248/001
44258.00.00
EISAI GMBH
DE
Pariet 20 mg magensaftresistente Tabletten
UK/H/0248/002
44258.01.00
EISAI GMBH
DE
Pariet, enterotabletter
UK/H/0248/001
30243
EISAI AB
DK
Pariet, enterotabletter
UK/H/0248/002
30244
EISAI AB
DK
PARIET 10 mg enterotabletti
UK/H/0248/001
13715
EISAI AB
FI
PARIET 20 mg enterotabletti
UK/H/0248/002
13716
EISAI AB
FI
Pariet 10 mg enterotablett
UK/H/0248/001
14696
EISAI AB
SE
List of nationally authorised medicinal products EMA/475695/2017
Page 5/13
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
Pariet 20 mg enterotablett
UK/H/0248/002
14697
EISAI AB
SE
Pariet 10 mg sýruþolnar töflur
not available
MTNR 990403
EISAI AB
IS
Pariet 20 mg sýruþolnar töflur
not available
MTNR 990404
EISAI AB
IS
PARIET® 20 mg gastro-resistant tablet
not available
18888
JANSSEN-CILAG INTERNATIONAL NV
CY
PARIET® 10 mg gastro-resistant tablet
not available
18887
JANSSEN-CILAG INTERNATIONAL NV
CY
Pariet 20 mg filmtabletta
not available
OGYI-T-7563/05
JANSSEN-CILAG KFT.
HU
Pariet 10 mg filmtabletta
not available
OGYI-T-7563/01
JANSSEN-CILAG KFT.
HU
Pariet 10 mg filmtabletta
not available
OGYI-T-7563/02
JANSSEN-CILAG KFT.
HU
Pariet 20 mg filmtabletta
not available
OGYI-T-7563/06
JANSSEN-CILAG KFT.
HU
List of nationally authorised medicinal products EMA/475695/2017
Page 6/13
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
Pariet 20 mg filmtabletta
not available
OGYI-T-7563/04
JANSSEN-CILAG KFT.
HU
Pariet 10 mg filmtabletta
not available
OGYI-T-7563/03
JANSSEN-CILAG KFT.
HU
PARIET 10 mg comprimidos gastrorresistentes.
UK/H/0248/001
62.461
JANSSEN-CILAG S.A.
ES
PARIET 20 mg comprimidos gastrorresistentes.
UK/H/0248/002
62.462
JANSSEN-CILAG S.A.
ES
PARIET 10 mg, comprimé gastro-résistant
UK/H/0248/002
34009 356 744 0 1
JANSSEN-CILAG
FR
PARIET 20 mg, comprimé gastro-résistant
UK/H/0248/002
34009 355 147 9 0
JANSSEN-CILAG
FR
PARIET 10 mg - Filmtabletten
UK/H/0248/001
1-22777
JANSSEN-CILAG PHARMA GMBH
AT
PARIET 20 mg - Filmtabletten
UK/H/0248/002
1-22778
JANSSEN-CILAG PHARMA GMBH
AT
PARIET 20 mg compresse gastroresistenti
UK/H/0248/002
034216186
JANSSEN-CILAG SPA
IT
List of nationally authorised medicinal products EMA/475695/2017
Page 7/13
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
PARIET 20 mg compresse gastroresistenti
UK/H/0248/002
034216212
JANSSEN-CILAG SPA
IT
PARIET 20 mg compresse gastroresistenti
UK/H/0248/002
034216200
JANSSEN-CILAG SPA
IT
PARIET 10 mg compresse gastroresistenti
UK/H/0248/001
034216073
JANSSEN-CILAG SPA
IT
PARIET 10 mg compresse gastroresistenti
UK/H/0248/001
034216010
JANSSEN-CILAG SPA
IT
PARIET 10 mg compresse gastroresistenti
UK/H/0248/001
034216034
JANSSEN-CILAG SPA
IT
PARIET 10 mg compresse gastroresistenti
UK/H/0248/001
034216059
JANSSEN-CILAG SPA
IT
PARIET 10 mg compresse gastroresistenti
UK/H/0248/001
034216085
JANSSEN-CILAG SPA
IT
PARIET 10 mg compresse gastroresistenti
UK/H/0248/001
034216061
JANSSEN-CILAG SPA
IT
PARIET 10 mg compresse gastroresistenti
UK/H/0248/001
034216022
JANSSEN-CILAG SPA
IT
List of nationally authorised medicinal products EMA/475695/2017
Page 8/13
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
PARIET 20 mg compresse gastroresistenti
UK/H/0248/002
034216174
JANSSEN-CILAG SPA
IT
PARIET 20 mg compresse gastroresistenti
UK/H/0248/002
034216224
JANSSEN-CILAG SPA
IT
PARIET 20 mg compresse gastroresistenti
UK/H/0248/002
034216236
JANSSEN-CILAG SPA
IT
PARIET 10 mg compresse gastroresistenti
UK/H/0248/001
034216046
JANSSEN-CILAG SPA
IT
PARIET 20 mg compresse gastroresistenti
UK/H/0248/002
034216198
JANSSEN-CILAG SPA
IT
PARIET 20 mg compresse gastroresistenti
UK/H/0248/002
034216248
JANSSEN-CILAG SPA
IT
PARIET® 20 mg comprimés gastro-résistants
UK/H/0248/002
BE199701
JANSSEN-CILAG NV
BE
PARIET® 10 mg maagsapresistente tabletten
UK/H/0248/001
BE199692
JANSSEN-CILAG NV
BE
PARIET® 10 mg comprimés gastro-résistants
UK/H/0248/001
BE199692
JANSSEN-CILAG NV
BE
List of nationally authorised medicinal products EMA/475695/2017
Page 9/13
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
PARIET® 20mg gastro-resistant tablet
not available
018/01902
JANSSEN-CILAG INTERNATIONAL NV
MT
PARIET® 10mg gastro-resistant tablet
not available
018/01901
JANSSEN-CILAG INTERNATIONAL NV
MT
PARIET® 20 mg maagsapresistente tabletten
UK/H/0248/002
BE199701
JANSSEN-CILAG NV
BE
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
2881381
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Pariet 20 mg comprimidos gastrorresistentes
UK/H/0248/002
2881183
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
2881084
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
2880680
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
2880284
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
2880987
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
List of nationally authorised medicinal products EMA/475695/2017
Page 10/13
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
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
3737087
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
5336383
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
2880581
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
2880482
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
2880185
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
2880086
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
3737285
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
2881282
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
2880383
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
List of nationally authorised medicinal products EMA/475695/2017
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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
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
3737384
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
5786488
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
5336482
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
2880888
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
5786389
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
2880789
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
2881589
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
2881480
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
3736980
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
List of nationally authorised medicinal products EMA/475695/2017
Page 12/13
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
PARIET 10 mg comprimidos gastrorresistentes
UK/H/0248/001
3737186
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 20 mg comprimidos gastrorresistentes
UK/H/0248/002
3736881
JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
PARIET 10 mg γαστροανθεκτικό δισκίο
UK/H/0248/001
67598
JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.
GR
PARIET 20 mg γαστροανθεκτικό δισκίο
UK/H/0248/001
67597
JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.
GR
PARIET 20 mg gastro-resistant tablet.
UK/H/0248/001
PA 748/41/2
JANSSEN-CILAG LIMITED
IE
PARIET 10 mg gastro-resistant tablet
UK/H/0248/002
PA 748/41/1
JANSSEN-CILAG LIMITED
IE
List of nationally authorised medicinal products EMA/475695/2017
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