Dec 1, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name. (in authorisation
01 December 2016 EMA/848711/2016 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: Quinapril
Procedure no.: PSUSA/00002591/201604
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
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© European Medicines Agency, 2016. 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
Accupril 10 mg Filmtabletten
not available
BE150954
PFIZER S.A. (BELGIUM)
BE
Accupril 10 mg Filmtabletten
not available
2003027114
PFIZER S.A. (BELGIUM)
LU
Accupril 20 mg Filmtabletten
not available
BE150981
PFIZER S.A. (BELGIUM)
BE
Accupril 20 mg Filmtabletten
not available
2003027115
PFIZER S.A. (BELGIUM)
LU
Accupril 40 mg Filmtabletten
not available
BE150963
PFIZER S.A. (BELGIUM)
BE
Accupril 40 mg Filmtabletten
not available
2003027116
PFIZER S.A. (BELGIUM)
LU
Accupril 5 mg Filmtabletten
not available
BE150972
PFIZER S.A. (BELGIUM)
BE
Accupril 5 mg Filmtabletten
not available
2003027113
PFIZER S.A. (BELGIUM)
LU
Accupril® 10 mg
not available
23665.01.00
PFIZER PHARMA GMBH
DE
Filmtabletten
List of nationally authorised medicinal products Quinapril EMA/848711/2016
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
Accupril® 20 mg
not available
23665.02.00
PFIZER PHARMA GMBH
DE
not available
23665.00.00
PFIZER PHARMA GMBH
DE
not available
027217025
PFIZER ITALIA S.R.L.
IT
not available
027217102
PFIZER ITALIA S.R.L.
IT
not available
027217037
PFIZER ITALIA S.R.L.
IT
not available
027217090
PFIZER ITALIA S.R.L.
IT
not available
027217013
PFIZER ITALIA S.R.L.
IT
not available
58/312/91-B/C
PFIZER, SPOL. S R.O.
CZ
not available
58/0312/91–C/S
PFIZER LIMITED
SK
Filmtabletten Accupril® 5 mg Filmtabletten ACCUPRIN 10 mg compresse rivestite con film ACCUPRIN 20 mg compresse rivestite con film ACCUPRIN 20 mg compresse rivestite con film ACCUPRIN 40 mg compresse rivestite con film ACCUPRIN 5 mg compresse rivestite con film ACCUPRO 10 potahované tablety ACCUPRO 10 Filmom obalené tablety
List of nationally authorised medicinal products Quinapril EMA/848711/2016
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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
ACCUPRO 10 mg apvalkotās
not available
99-0548
PFIZER LIMITED
LV
not available
7888/2006/01
PFIZER EUROPE MA EEIG
RO
not available
PA 0822/007/002
PFIZER HEALTHCARE
IE
tabletes Accupro 10 mg comprimate filmate Accupro 10 mg Film - Coated tablets Accupro 10 mg filmdragerade
IRELAND not available
10771
PFIZER OY
FI
Accupro 10 mg filmtabletta
not available
OGYI-T-4163/02
PFIZER KFT.
HU
Accupro 10 mg Filmtabletten
not available
1-19361
PFIZER CORPORATION
AT
tabletter
AUSTRIA GESELLSCHAFT M.B.H. ACCUPRO 10 mg plėvele
not available
LT/1/2000/0234/003
PFIZER LIMITED
LT
not available
LT/1/2000/0234/004
PFIZER LIMITED
LT
not available
R/7070
PFIZER EUROPE MA EEIG
PL
dengtos tablets ACCUPRO 10 mg plėvele dengtos tablets ACCUPRO 10, 10 mg, tabletki powlekane
List of nationally authorised medicinal products Quinapril EMA/848711/2016
Page 4/13
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
ACCUPRO 20 Filmom obalené
not available
58/0312/91–C/S
PFIZER LIMITED
SK
not available
99-0549
PFIZER LIMITED
LV
not available
4506/2004/01
PFIZER EUROPE MA EEIG
RO
not available
PA 0822/007/003
PFIZER HEALTHCARE
IE
tablety ACCUPRO 20 mg apvalkotās tabletes Accupro 20 mg comprimate filmate Accupro 20 mg Film - Coated tablets Accupro 20 mg filmdragerade
IRELAND not available
10772
PFIZER OY
FI
Accupro 20 mg filmtabletta
not available
OGYI-T-4163/03
PFIZER KFT.
HU
Accupro 20 mg Filmtabletten
not available
1-19363
PFIZER CORPORATION
AT
tabletter
AUSTRIA GESELLSCHAFT M.B.H. ACCUPRO 20 mg plėvele
not available
LT/1/2000/0234/006
PFIZER LIMITED
LT
not available
LT/1/2000/0234/005
PFIZER LIMITED
LT
dengtos tablets ACCUPRO 20 mg plėvele dengtos tablets
List of nationally authorised medicinal products Quinapril EMA/848711/2016
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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
ACCUPRO 20 mg plėvele
not available
LT/1/2000/0234/007
PFIZER LIMITED
LT
not available
58/312/91-C/C
PFIZER, SPOL. S R.O.
CZ
not available
R/7071
PFIZER EUROPE MA EEIG
PL
not available
05-0295
PFIZER LIMITED
LV
not available
PA 0822/007/004
PFIZER HEALTHCARE
IE
dengtos tablets ACCUPRO 20 potahované tablety ACCUPRO 20, 20 mg, tabletki powlekane ACCUPRO 40 mg apvalkotās tabletes Accupro 40 mg Film - Coated tablets ACCUPRO 40 mg plėvele
IRELAND not available
LT/1/2000/0234/001
PFIZER LIMITED
LT
not available
10801
PFIZER EUROPE MA EEIG
PL
not available
58/0312/91–C/S
PFIZER LIMITED
SK
not available
4505/2004/01
PFIZER EUROPE MA EEIG
RO
dengtos tablets ACCUPRO 40, 40 mg, tabletki powlekane ACCUPRO 5 Filmom obalené tablet Accupro 5 mg comprimate filmate
List of nationally authorised medicinal products Quinapril EMA/848711/2016
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
Accupro 5 mg Film - Coated
not available
PA 0822/007/001
PFIZER HEALTHCARE
IE
tablets Accupro 5 mg filmdragerade
IRELAND not available
10770
PFIZER OY
FI
Accupro 5 mg filmtabletta
not available
OGYI-T-4163/01
PFIZER KFT.
HU
Accupro 5 mg Filmtabletten
not available
1-19359
PFIZER CORPORATION
AT
tabletter
AUSTRIA GESELLSCHAFT M.B.H. ACCUPRO 5 mg plėvele
not available
LT/1/2000/0234/002
PFIZER LIMITED
LT
not available
58/312/91-A/C
PFIZER, SPOL. S R.O.
CZ
not available
R/7069
PFIZER EUROPE MA EEIG
PL
Accupro Tablets 10 mg
not available
PL 00057/0515
PFIZER LIMITED
UK
Accupro Tablets 20 mg
not available
PL 00057/0516
PFIZER LIMITED
UK
dengtos tablets ACCUPRO 5 potahované tablety ACCUPRO 5, 5 mg, tabletki powlekane
List of nationally authorised medicinal products Quinapril EMA/848711/2016
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
Accupro Tablets 40 mg
not available
PL 00057/0517
PFIZER LIMITED
UK
Accupro Tablets 5 mg
not available
PL 00057/0514
PFIZER LIMITED
UK
Accupro, tabletter,
not available
13846
PFIZER APS
DK
not available
13429
PFIZER APS
DK
not available
13428
PFIZER APS
DK
not available
17443.01.00
PFIZER PHARMA GMBH
DE
not available
17443.02.00
PFIZER PHARMA GMBH
DE
not available
17443.00.00
PFIZER PHARMA GMBH
DE
not available
13096
PFIZER HELLAS, A.E.
CY
filmovertrukne Accupro, tabletter, filmovertrukne Accupro, tabletter, filmovertrukne Accupro® 10 10 mg Filmtabletten Accupro® 20 20 mg Filmtabletten Accupro® 5 5 mg Filmtabletten ACCUPRON®
List of nationally authorised medicinal products Quinapril EMA/848711/2016
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
ACCUPRON®
not available
13095
PFIZER HELLAS, A.E.
CY
ACCUPRON®
not available
41131/10/31-05-2011
PFIZER HELLAS, A.E.
GR
ACCUPRON®
not available
41129/10/31-05-2011
PFIZER HELLAS, A.E.
GR
ACCUPRON®
not available
41126/10/31-05-2011
PFIZER HELLAS, A.E.
GR
ACEQUIN 20 mg compresse
not available
027230097
RECORDATI INDUSTRIA
IT
rivestite con film
CHIMICA E FARMACEUTICA S.P.A.
ACEQUIN 20 mg compresse
not available
027230034
rivestite con film
RECORDATI INDUSTRIA
IT
CHIMICA E FARMACEUTICA S.P.A.
ACEQUIN 5 mg compresse
not available
027230010
rivestite con film
RECORDATI INDUSTRIA
IT
CHIMICA E FARMACEUTICA S.P.A.
ACUITEL 20 mg, comprimé
not available
34009 560 069 6 0
enrobé sécable ACUITEL 20 mg, comprimé
PFIZER HOLDING FRANCE
FR
(S.C.A.) not available
enrobé sécable
List of nationally authorised medicinal products Quinapril EMA/848711/2016
34009 372 964 1 0
PFIZER HOLDING FRANCE
FR
(S.C.A.)
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
ACUITEL 20 mg, comprimé
not available
34009 331 722 3 7
PFIZER HOLDING FRANCE
FR
enrobé sécable ACUITEL 20 mg, comprimé
(S.C.A.) not available
34009 560 070 4 2
enrobé sécable ACUITEL 20 mg, comprimé
not available
34009 331 724 6 6
not available
34009 331 725 2 7
not available
34009 331 726 9 5
not available
34009 560 072 7 1
not available
34009 560 071 0 3
PFIZER HOLDING FRANCE
FR
PFIZER HOLDING FRANCE
FR
PFIZER HOLDING FRANCE
FR
(S.C.A.) not available
34009 372 963 5 9
coated tablets Acuprel 20 mg comprimidos
FR
(S.C.A.)
enrobé sécable ACUITEL 5 mg, scored film-
PFIZER HOLDING FRANCE
(S.C.A.)
enrobé sécable ACUITEL 5 mg, comprimé
FR
(S.C.A.)
enrobé sécable ACUITEL 5 mg, comprimé
PFIZER HOLDING FRANCE (S.C.A.)
enrobé sécable ACUITEL 5 mg, comprimé
FR
(S.C.A.)
enrobé sécable ACUITEL 5 mg, comprimé
PFIZER HOLDING FRANCE
PFIZER HOLDING FRANCE
FR
(S.C.A.) not available
59.082
PARKE-DAVIS, S.L.
ES
recubiertos con película
List of nationally authorised medicinal products Quinapril EMA/848711/2016
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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
Acuprel 40 mg comprimidos
not available
61.710
PARKE-DAVIS, S.L.
ES
not available
59.081
PARKE-DAVIS, S.L.
ES
Acupril 10, tabletten 10 mg
not available
RVG 13602
PFIZER B.V.
NL
Acupril 20 mg Comprimidos
not available
2195683
LABORATÓRIOS PFIZER,
PT
recubiertos con película Acuprel 5 mg comprimidos recubiertos con película
revestidos por película Acupril 20 mg Comprimidos
LDA. not available
2195584
revestidos por película
LABORATÓRIOS PFIZER,
PT
LDA.
Acupril 20, tabletten 20 mg
not available
RVG 13603
PFIZER B.V.
NL
Acupril 40 mg Comprimidos
not available
5829684
LABORATÓRIOS PFIZER,
PT
revestidos por película Acupril 40 mg Comprimidos
LDA. not available
2504785
revestidos por película Acupril 40, tabletten 40 mg
LABORATÓRIOS PFIZER,
PT
LDA. not available
List of nationally authorised medicinal products Quinapril EMA/848711/2016
RVG 19839
PFIZER B.V.
NL
Page 11/13
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
Acupril 5 mg Comprimidos
not available
2141583
LABORATÓRIOS PFIZER,
PT
revestidos por película Acupril 5 mg Comprimidos
LDA. not available
2191484
revestidos por película Acupril 5 mg Comprimidos
LABORATÓRIOS PFIZER,
PT
LDA. not available
4590980
revestidos por película
LABORATÓRIOS PFIZER,
PT
LDA.
Acupril 5, tabletten 5 mg
not available
RVG 13601
PFIZER B.V.
NL
Ectren 20 mg comprimidos
not available
59.191
LABORATORIOS MENARINI,
ES
recubiertos con película Ectren 40 mg comprimidos
S.A. not available
61.733
recubiertos con película QUINAZIL 20 mg compresse
LABORATORIOS MENARINI,
ES
S.A. not available
027225034
rivestite con film
MALESCI ISTITUTO
IT
FARMACOBIOLOGICO S.P.A.
QUINAZIL 20 mg compresse
not available
027225097
rivestite con film
MALESCI ISTITUTO
IT
FARMACOBIOLOGICO S.P.A.
QUINAZIL 5 mg compresse
not available
rivestite con film
027225010
MALESCI ISTITUTO
IT
FARMACOBIOLOGICO S.P.A.
List of nationally authorised medicinal products Quinapril EMA/848711/2016
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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
Quinhexal 10 mg Film-coated
UK/H/0660/002
PL 10880/0067
HEXAL AG
UK
UK/H/0660/003
PL 10880/0068
HEXAL AG
UK
UK/H/0660/004
PL 10880/0069
HEXAL AG
UK
UK/H/0660/001
PL 10880/0066
HEXAL AG
UK
not available
20010922
PFIZER EUROPE MA EEIG
BG
not available
20010923
PFIZER EUROPE MA EEIG
BG
Tablets Quinhexal 20 mg Film-coated Tablets Quinhexal 40 mg Film-coated Tablets Quinhexal 5 mg Film-coated Tablets Акупро 10 mg филмирани таблетки Акупро 20 mg филмирани таблетки
List of nationally authorised medicinal products Quinapril EMA/848711/2016
Page 13/13
