11 October 2017 EMA/764352/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): amlodipine
Procedure No.: PSUSA/00000174/201703
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, 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
Amlobesilat-Sandoz® 10 mg Tabletten Amlodipin – 1 A Pharma 7,5 mg Tabletten N Amlodipin "1A Farma", tabletter Amlodipin "Sandoz", tabletter Amlodipin 1A Pharma 7,5 mg - Tabletten Amlodipin Hexal 7,5 mg Tabletten Amlodipin HEXAL 7,5 mg Tabletten Amlodipin Sandoz 7,5 mg – Tabletten Amlodipina Pfizer Italia 10 mg compresse Amlodipina Pfizer Italia 5 mg compresse Amlodipine 10 mg Tablets Amlodipine 10 mg tablets Amlodipine 5 mg Tablets Amlodipine 5 mg tablets Amlodipine Pfizer 10 mg Tablets AMLODIPINE PFIZER 10 mg, gélule AMLODIPINE PFIZER 10 mg, gélule AMLODIPINE PFIZER 10 mg, gélule Amlodipine Pfizer 5 mg Tablets AMLODIPINE PFIZER 5 mg, gélule
DK/H/0964/002
66353.00.00
HEXAL AG
DE
DK/H/0963/002
66350.00.00
1 A PHARMA GMBH
DE
DK/H/0963/002
36551
1A FARMA A/S
DK
DK/H/0964/002
36554
SANDOZ A/S
DK
DK/H/0963/002
1-26866
1A PHARMA GMBH
AT
DK/H/0960/002
1-26856
HEXAL PHARMA GMBH
AT
DK/H/0960/002
66344.00.00
HEXAL AG
DE
DK/H/0964/002
1-26875
SANDOZ GMBH
AT
UK/H/5127/006
027444025
PFIZER ITALIA S.R.L.
IT
UK/H/5127/005
027444013
PFIZER ITALIA S.R.L.
IT
UK/H/5127/006 not available UK/H/5127/005 not available UK/H/5127/006
PL 00057/1433 PL 30684/0224 PL 00057/1432 PL 30684/0223 PA 0019/055/002
PFIZER LIMITED DAWA LIMITED PFIZER LIMITED DAWA LIMITED PFIZER LIMITED
UK UK UK UK IE
not available
34009 382 351 2 8
FR
not available
34009 333 420 4 3
not available
34009 333 419 6 1
UK/H/5127/005
PA 0019/055/001
PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) PFIZER LIMITED
not available
34009 382 352 9 6
PFIZER HOLDING FRANCE (S.C.A.)
FR
List of nationally authorised medicinal products EMA/764352/2017
FR FR IE
Page 2/11
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
AMLODIPINE PFIZER 5 mg, gélule AMLODIPINE PFIZER 5 mg, gélule Amlohexal, tabletter Amlor 10 mg gélules Amlor 10 mg gélules Amlor 10 mg harde capsules Amlor 10 mg Hartkapseln Amlodipin Amlor 10 mg Hartkapseln Amlodipin AMLOR 10 mg, gélule
not available
34009 333 416 7 1
FR
not available
34009 333 417 3 2
DK/H/0960/002 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004
36542 BE148303 2003127931 BE148303 BE148303
PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) HEXAL A/S PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM)
UK/H/5127/004
2003127931
PFIZER S.A. (BELGIUM)
LU
UK/H/5127/004
34009 333 133 5 7
FR
AMLOR 10 mg, gélule
UK/H/5127/004
34009 372 438 8 9
Amlor 5 mg gélules Amlor 5 mg gélules Amlor 5 mg harde capsules Amlor 5 mg Hartkapseln Amlodipin Amlor 5 mg Hartkapseln Amlodipin AMLOR 5 mg, gélule
UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003
BE148041 2003127930 BE148041 BE148041
PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM)
UK/H/5127/003
2003127930
PFIZER S.A. (BELGIUM)
LU
UK/H/5127/003
34009 333 135 8 6
FR
AMLOR 5 mg, gélule
UK/H/5127/003
34009 557 706 9 5
AMLOR 5 mg, gélule
UK/H/5127/003
34009 372 437 1 1
Antacal 10 mg compresse
not available
027461021
Antacal 5 mg compresse
not available
027461019
Astudal 10 mg comprimidos Astudal 5 mg comprimidos
not available not available
59.162 59.161
PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) ERREKAPPA EUROTERAPICI SPA ERREKAPPA EUROTERAPICI SPA ALMIRALL, S.A. ALMIRALL, S.A.
List of nationally authorised medicinal products EMA/764352/2017
FR DK BE LU BE BE
FR BE LU BE BE
FR FR IT IT ES ES
Page 3/11
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
Istin 10 mg hard capsules Istin 10 mg orodispersible tablets Istin 10 mg tablets Istin 10 mg tablets ISTIN 10 mg tablets Istin 5 mg hard capsules Istin 5 mg orodispersible tablets Istin 5 mg tablets Istin 5 mg tablets ISTIN 5 mg tablets Norvas 10 mg comprimidos Norvas 5 mg comprimidos Norvasc 10 mg capsule Norvasc 10 mg capsule Norvasc 10 mg capsule Norvasc 10 mg capsule Norvasc 10 mg capsule Norvasc 10 mg capsule Norvasc 10 mg capsule Norvasc 10 mg capsule Norvasc 10 mg capsule Norvasc 10 mg capsule Norvasc 10 mg compresse Norvasc 10 mg comprimate Norvasc 10 mg comprimate Norvasc 10 mg comprimate Norvasc 10 mg comprimate Norvasc 10 mg comprimate Norvasc 10 mg comprimate Norvasc 10 mg comprimate Norvasc 10 mg comprimate Norvasc 10 mg comprimate Norvasc 10 mg comprimate
UK/H/5127/004 UK/H/5123/002
PL 00057/1416 PL 00057/1390
PFIZER LIMITED PFIZER LIMITED
UK UK
UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/003 UK/H/5123/001
PA 19/45/2 MA505/03102 PL 00057/0298 PL 00057/1415 PL 00057/1389
PFIZER PFIZER PFIZER PFIZER PFIZER
IE MT UK UK UK
UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/002 UK/H/5127/001 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004 UK/H/5127/004 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002
PA 19/45/1 MA505/03101 PL 00057/0297 59.160 59.159 5657/2013/02 5657/2013/05 5657/2013/04 5657/2013/09 5657/2013/07 5657/2013/08 5657/2013/03 5657/2013/06 5657/2013/10 5657/2013/01 027428022 5655/2013/07 5655/2013/13 5655/2013/08 5655/2013/10 5655/2013/04 5655/2013/14 5655/2013/11 5655/2013/17 5655/2013/06 5655/2013/15
PFIZER LIMITED PFIZER HELLAS, A.E. PFIZER LIMITED PFIZER, S.L. PFIZER, S.L. PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER ITALIA S.R.L. PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG
List of nationally authorised medicinal products EMA/764352/2017
LIMITED HELLAS, A.E. LIMITED LIMITED LIMITED
IE MT UK ES ES RO RO RO RO RO RO RO RO RO RO IT RO RO RO RO RO RO RO RO RO RO
Page 4/11
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
Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc
comprimate comprimate comprimate comprimate comprimate comprimate comprimate comprimidos
UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002
5655/2013/16 5655/2013/09 5655/2013/03 5655/2013/02 5655/2013/05 5655/2013/12 5655/2013/01 8793026
MA EEIG MA EEIG MA EEIG MA EEIG MA EEIG MA EEIG MA EEIG PFIZER,
RO RO RO RO RO RO RO PT
Norvasc 10 mg comprimidos
UK/H/5127/002
5829486
PFIZER,
PT
Norvasc 10 mg comprimidos orodispersíveis Norvasc 10 mg kietosios kapsulės Norvasc 10 mg kietosios kapsulės Norvasc 10 mg kietosios kapsulės Norvasc 10 mg kietosios kapsulės Norvasc 10 mg kietosios kapsulės Norvasc 10 mg kietosios kapsulės Norvasc 10 mg kietosios kapsulės Norvasc 10 mg kietosios kapsulės Norvasc 10 mg kietosios kapsulės Norvasc 10 mg kietosios kapsulės NORVASC 10 mg tablete Norvasc 10 mg tablete
UK/H/5123/002
5575816
PFIZER,
PT
UK/H/5127/004
LT/1/96/1466/045
PFIZER EUROPE PFIZER EUROPE PFIZER EUROPE PFIZER EUROPE PFIZER EUROPE PFIZER EUROPE PFIZER EUROPE LABORATÓRIOS LDA. LABORATÓRIOS LDA. LABORATÓRIOS LDA. PFIZER EUROPE
MA EEIG
LT
UK/H/5127/004
LT/1/96/1466/048
PFIZER EUROPE MA EEIG
LT
UK/H/5127/004
LT/1/96/1466/006
PFIZER EUROPE MA EEIG
LT
UK/H/5127/004
LT/1/96/1466/046
PFIZER EUROPE MA EEIG
LT
UK/H/5127/004
LT/1/96/1466/049
PFIZER EUROPE MA EEIG
LT
UK/H/5127/004
LT/1/96/1466/047
PFIZER EUROPE MA EEIG
LT
UK/H/5127/004
LT/1/96/1466/008
PFIZER EUROPE MA EEIG
LT
UK/H/5127/004
LT/1/96/1466/052
PFIZER EUROPE MA EEIG
LT
UK/H/5127/004
LT/1/96/1466/050
PFIZER EUROPE MA EEIG
LT
UK/H/5127/004
LT/1/96/1466/051
PFIZER EUROPE MA EEIG
LT
not available UK/H/5127/002
UP/I-530-09/12-02/392 H/99/01131/022
PFIZER CROATIA D.O.O. PFIZER LUXEMBOURG SARL
HR SI
10 10 10 10 10 10 10 10
mg mg mg mg mg mg mg mg
List of nationally authorised medicinal products EMA/764352/2017
Page 5/11
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
Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tablete Norvasc 10 mg tabletes Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės Norvasc 10 mg tabletės NORVASC 10 mg tabletit
UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002
H/99/01131/024 H/99/01131/026 H/99/01131/028 H/99/01131/018 H/99/01131/032 H/99/01131/020 H/99/01131/023 H/99/01131/021 H/99/01131/017 H/99/01131/025 H/99/01131/019 H/99/01131/029 H/99/01131/027 H/99/01131/031 H/99/01131/033 H/99/01131/030 97-0601 LT/1/96/1466/054 LT/1/96/1466/033 LT/1/96/1466/026 LT/1/96/1466/035 LT/1/96/1466/034 LT/1/96/1466/028 LT/1/96/1466/024 LT/1/96/1466/027 LT/1/96/1466/036 LT/1/96/1466/030 LT/1/96/1466/032 LT/1/96/1466/004 LT/1/96/1466/025 LT/1/96/1466/029 LT/1/96/1466/023 LT/1/96/1466/022 LT/1/96/1466/031 10252
PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER
SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI LV LT LT LT LT LT LT LT LT LT LT LT LT LT LT LT LT LT FI
List of nationally authorised medicinal products EMA/764352/2017
LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LIMITED EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG OY
Page 6/11
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
Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc σκληρά Norvasc σκληρά Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc Norvasc
tabletta tabletter tabletter tabletter tablety töflur καψάκια
UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/002 UK/H/5127/004
OGYI-T-1934/02 10252 7527 11288 83/0437/12–S 880133 (IS) 13775
PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER
HU FI NO SE SK IS CY
10 mg καψάκια
UK/H/5127/004
26173/20-3-2014
PFIZER HELLAS, A.E.
GR
10, tabletten 10 mg 5 mg capsule 5 mg capsule 5 mg capsule 5 mg capsule 5 mg capsule 5 mg capsule 5 mg capsule 5 mg capsule 5 mg capsule 5 mg capsule 5 mg capsule 5 mg compresse 5 mg comprimate 5 mg comprimate 5 mg comprimate 5 mg comprimate 5 mg comprimate 5 mg comprimate 5 mg comprimate 5 mg comprimate 5 mg comprimate 5 mg comprimate 5 mg comprimate 5 mg comprimate
UK/H/5127/002 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/003 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001
RVG 13349 5656/2013/02 5656/2013/04 5656/2013/05 5656/2013/03 5656/2013/06 5656/2013/07 5656/2013/10 5656/2013/09 5656/2013/08 5656/2013/11 5656/2013/01 027428010 5654/2013/08 5654/2013/14 5654/2013/12 5654/2013/15 5654/2013/09 5654/2013/05 5654/2013/06 5654/2013/02 5654/2013/11 5654/2013/03 5654/2013/10 5654/2013/04
PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER
NL RO RO RO RO RO RO RO RO RO RO RO IT RO RO RO RO RO RO RO RO RO RO RO RO
10 10 10 10 10 10 10
mg mg mg mg mg mg mg
List of nationally authorised medicinal products EMA/764352/2017
KFT. OY AS AB EUROPE MA EEIG APS HELLAS, A.E.
B.V. EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG ITALIA S.R.L. EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG
Page 7/11
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
Norvasc Norvasc Norvasc Norvasc Norvasc
comprimate comprimate comprimate comprimate comprimidos
UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001
5654/2013/16 5654/2013/13 5654/2013/07 5654/2013/01 8793000
MA EEIG MA EEIG MA EEIG MA EEIG PFIZER,
RO RO RO RO PT
Norvasc 5 mg comprimidos
UK/H/5127/001
8793018
PFIZER,
PT
Norvasc 5 mg comprimidos
UK/H/5127/001
5828884
PFIZER,
PT
Norvasc 5 mg comprimidos
UK/H/5127/001
5829585
PFIZER,
PT
Norvasc 5 mg comprimidos orodispersíveis Norvasc 5 mg comprimidos orodispersíveis Norvasc 5 mg kietosios kapsulės Norvasc 5 mg kietosios kapsulės Norvasc 5 mg kietosios kapsulės Norvasc 5 mg kietosios kapsulės Norvasc 5 mg kietosios kapsulės Norvasc 5 mg kietosios kapsulės Norvasc 5 mg kietosios kapsulės Norvasc 5 mg kietosios kapsulės Norvasc 5 mg kietosios kapsulės
UK/H/5123/001
5575618
PFIZER,
PT
UK/H/5123/001
5575600
PFIZER,
PT
UK/H/5127/003
LT/1/96/1466/053
PFIZER EUROPE PFIZER EUROPE PFIZER EUROPE PFIZER EUROPE LABORATÓRIOS LDA. LABORATÓRIOS LDA. LABORATÓRIOS LDA. LABORATÓRIOS LDA. LABORATÓRIOS LDA. LABORATÓRIOS LDA. PFIZER EUROPE
MA EEIG
LT
UK/H/5127/003
LT/1/96/1466/039
PFIZER EUROPE MA EEIG
LT
UK/H/5127/003
LT/1/96/1466/037
PFIZER EUROPE MA EEIG
LT
UK/H/5127/003
LT/1/96/1466/038
PFIZER EUROPE MA EEIG
LT
UK/H/5127/003
LT/1/96/1466/042
PFIZER EUROPE MA EEIG
LT
UK/H/5127/003
LT/1/96/1466/044
PFIZER EUROPE MA EEIG
LT
UK/H/5127/003
LT/1/96/1466/043
PFIZER EUROPE MA EEIG
LT
UK/H/5127/003
LT/1/96/1466/041
PFIZER EUROPE MA EEIG
LT
UK/H/5127/003
LT/1/96/1466/040
PFIZER EUROPE MA EEIG
LT
5 5 5 5 5
mg mg mg mg mg
List of nationally authorised medicinal products EMA/764352/2017
Page 8/11
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
Norvasc 5 kapsulės Norvasc 5 kapsulės NORVASC Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5 Norvasc 5
mg kietosios
UK/H/5127/003
LT/1/96/1466/007
PFIZER EUROPE MA EEIG
LT
mg kietosios
UK/H/5127/003
LT/1/96/1466/005
PFIZER EUROPE MA EEIG
LT
5 mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tablete mg tabletes mg tabletės mg tabletės mg tabletės mg tabletės mg tabletės mg tabletės mg tabletės mg tabletės mg tabletės mg tabletės mg tabletės mg tabletės mg tabletės
not available UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001
UP/I-530-09/12-02/391 H/99/01131/002 H/99/01131/008 H/99/01131/014 H/99/01131/015 H/99/01131/004 H/99/01131/009 H/99/01131/016 H/99/01131/010 H/99/01131/013 H/99/01131/005 H/99/01131/007 H/99/01131/011 H/99/01131/003 H/99/01131/012 H/99/01131/006 H/99/01131/001 97-0600 LT/1/96/1466/016 LT/1/96/1466/020 LT/1/96/1466/015 LT/1/96/1466/013 LT/1/96/1466/009 LT/1/96/1466/018 LT/1/96/1466/011 LT/1/96/1466/014 LT/1/96/1466/003 LT/1/96/1466/021 LT/1/96/1466/001 LT/1/96/1466/019 LT/1/96/1466/010
PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER
HR SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI LV LT LT LT LT LT LT LT LT LT LT LT LT LT
List of nationally authorised medicinal products EMA/764352/2017
CROATIA D.O.O. LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LUXEMBOURG SARL LIMITED EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG
Page 9/11
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
Norvasc 5 mg tabletės Norvasc 5 mg tabletės Norvasc 5 mg tabletės NORVASC 5 mg tabletit Norvasc 5 mg tabletta Norvasc 5 mg tabletter Norvasc 5 mg tabletter Norvasc 5 mg tabletter Norvasc 5 mg tablety Norvasc 5 mg töflur Norvasc 5 mg καψάκια σκληρά Norvasc 5 mg καψάκια σκληρά Norvasc 5, tabletten 5 mg NORVASC, 10 mg tabletid Norvasc, 10 mg, tabletki NORVASC, 5 mg tabletid Norvasc, 5 mg, tabletki Norvasc, tabletter Norvasc, tabletter Norvasc® 10 mg Tabletten
UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/001 UK/H/5127/003
LT/1/96/1466/002 LT/1/96/1466/017 LT/1/96/1466/012 10251 OGYI-T-1934/01 10251 7526 11287 83/0871/92–C/S 880134 (IS) 13774
PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER
LT LT LT FI HU FI NO SE SK IS CY
UK/H/5127/003
26172/20-3-2014
PFIZER HELLAS, A.E.
GR
UK/H/5127/001 UK/H/5127/002 UK/H/5127/002 UK/H/5127/001 UK/H/5127/001 UK/H/5127/002 UK/H/5127/001 UK/H/5127/002
RVG 13348 176397 R/0129 176297 R/0128 13335 13334 1-19248
NL EE PL EE PL DK DK AT
Norvasc® 10 mg Tabletten Norvasc® 5 mg Tabletten
UK/H/5127/002 UK/H/5127/001
16909.01.00 1-19247
Norvasc® 5 mg Tabletten ZOREM 10 mg tablety ZOREM 5 mg tablety Норваск 10 mg таблетки Норваск 5 mg таблетки
UK/H/5127/001 UK/H/5127/006 UK/H/5127/005 UK/H/5127/002 UK/H/5127/001
16909.00.00 83/375/01-C 83/374/01-C 20000436 20000435
PFIZER B.V. PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER APS PFIZER APS PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER PHARMA PFE GMBH PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER PHARMA PFE GMBH PFIZER, SPOL. S R.O. PFIZER, SPOL. S R.O. PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG
List of nationally authorised medicinal products EMA/764352/2017
EUROPE MA EEIG EUROPE MA EEIG EUROPE MA EEIG OY KFT. OY AS AB EUROPE MA EEIG APS HELLAS, A.E.
DE AT DE CZ CZ BG BG
Page 10/11
List of nationally authorised medicinal products EMA/764352/2017
Page 11/11
