27 October 2016 EMA/737385/2016 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: amlodipine Procedure no.: PSUSA/00000174/201603

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, 2016. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation country)

MRP/DCP Authorisation number

Amdip

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

20173 $ 20174

Delorbis Pharmaceuticals Ltd

Cyprus

Amlobesilat-Sandoz

DK/H/0964/002

66353.00.00

Hexal AG

Germany

Amlodipin 1 A Pharma

DK/H/0963

66350.00.00

1 A Pharma Gmbh

Germany

Amlodipin 1a Farma

DK/H/0963

36551

1a Farma A/S

Denmark

Amlodipin Al

DK/H/0589/001

59211.00.00 $ 59211.01.00

Aliud Pharma Gmbh

Germany

$ DK/H/0589/002 Amlodipin Hexal

DK/H/0960/002

0715/06110014

Hexal Ag

Luxembourg

Amlodipin Hexal

DK/H/0960

66344.00.00

Hexal Ag

Germany

Amlodipin Sandoz

DK/H/0964

36554

Sandoz A/S

Denmark

Amlodipin Stada

DK/H/0588/001

20270 $ 20271

Stada Arzneimittel Ag

Sweden

$ DK/H/0588/002

List of nationally authorised medicinal products EMA/737385/2016

Page 2/14

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

Amlodipin Stada

DK/H/0589/001

35770

Stada Arzneimittel Ag

Denmark

Amlodipin Stada

DK/H/0589/002

35771

Stada Arzneimittel Ag

Denmark

Norvasc

UK/H/5127/001

1-19247

Pfizer Corporation Austria

Austria

Gesellschaft M.B.H. Norvasc

UK/H/5127/002

1-19248

Pfizer Corporation Austria

Austria

Gesellschaft M.B.H. Amlodipina Stada

DK/H/0588/001

5092283 $ 5092382 $ 5092481

$ DK/H/0588/002

$ 5092580 $ 5092689 $ 5092788

Stada Lda.

Portugal

Dawa Limited

United Kingdom

$ 5092887 $ 5092986 $ 5093083 $ 5093182 $ 5093281 $ 5093380 $ 5093489 $ 5093588 $ 5093687 $ 5093885 $ 5093984 $ 5094081 $ 5094388 $ 5094487 $ 5094586 $ 5094685 $ 5094784 $ 5094982 $ 5095088 $ 5095187 $ 5095286 $ 5095385 $ 5095484 $ 5095583 $ 5095682 $ 5095781 $ 5095880 $ 5095989 $ 5096086 $ 5096185 $ 5229687 $ 5094883 Amlodipine

List of nationally authorised medicinal products EMA/737385/2016

PL 30684/0223 $ PL 30684/0224

Page 3/14

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

Amlor

UK/H/5123/001

BE437114

Pfizer S.A. (Belgium)

Belgium

Amlor

UK/H/5123/002

BE437123

Pfizer S.A. (Belgium)

Belgium

Amlor

UK/H/5127/003

BE148041

Pfizer S.A. (Belgium)

Belgium

Amlor

UK/H/5127/004

BE148303

Pfizer S.A. (Belgium)

Belgium

норваск

UK/H/5127/001

20000435 $ 20000436

Pfizer Europe Ma Eeig

Bulgaria

RVG 30223 $ RVG 30224

Centrafarm B.V.

Netherlands

$ UK/H/5127/002 Amlodipinemesilaat Cf

DK/H/0588/001 $ DK/H/0588/002

Amlohexal

DK/H/0960

36542

Hexal A/S

Denmark

Amlopharm

DK/H/0588/001

35768 $ 35769

Stada Arzneimittel Ag

Denmark

UP/I-530-09/12-02/391 $ UP/I-530-

Pfizer Croatia D.O.O.

Croatia

$ DK/H/0588/002 Norvasc

09/12-02/392

List of nationally authorised medicinal products EMA/737385/2016

Page 4/14

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

UK/H/5127/003

13774

Pfizer Hellas, A.E.

Cyprus

Norvasc

UK/H/5127/004

13775

Pfizer Hellas, A.E.

Cyprus

Zorem

UK/H/5127/005

83/374/01-C $ 83/375/01-C

Pfizer, Spol. S R.O.

Czech Republic

$ UK/H/5127/006 Norvasc

UK/H/5127/001

13334

Pfizer Aps

Denmark

Norvasc

UK/H/5127/002

13335

Pfizer Aps

Denmark

Norvasc

UK/H/5127/001

176297

Pfizer Europe Ma Eeig

Estonia

Norvasc

UK/H/5127/002

176397

Pfizer Europe Ma Eeig

Estonia

Norvasc Odt

UK/H/5123/001

807513

Pfizer Europe Ma Eeig

Estonia

Norvasc Odt

UK/H/5123/002

807413

Pfizer Europe Ma Eeig

Estonia

List of nationally authorised medicinal products EMA/737385/2016

Page 5/14

Product Name (in authorisation country)

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

ANTACAL

27461

Errekappa Euroterapici Spa

Italy

Astudal

59.161

Almirall, S.A.

Spain

Astudal

59.162

Almirall, S.A.

Spain

10251 $ 10252

Pfizer Oy

Finland

Norvasc

MRP/DCP Authorisation number

UK/H/5127/001 $ UK/H/5127/002

Norvasc

UK/H/5127/001

16909.00.00

Pfizer Pharma Gmbh

Germany

Norvasc

UK/H/5127/002

16909.01.00

Pfizer Pharma Gmbh

Germany

Norvasc

UK/H/5127/003

26172/20-3-2014

Pfizer Hellas, A.E.

Greece

Norvasc

UK/H/5127/004

26173/20-3-2014

Pfizer Hellas, A.E.

Greece

Norvasc

UK/H/5127/001

OGYI-T-1934/01

Pfizer Kft.

Hungary

List of nationally authorised medicinal products EMA/737385/2016

Page 6/14

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

UK/H/5127/002

OGYI-T-1934/02

Pfizer Kft.

Hungary

Norvasc

UK/H/5127/001

880133 (IS) $ 880134 (IS)

Pfizer Aps

Iceland

$ UK/H/5127/002 Amlodipine Pfizer

UK/H/5127/005

PA/19/55/1

Pfizer Limited

Ireland

Amlodipine Pfizer

UK/H/5127/006

PA/19/55/2

Pfizer Limited

Ireland

Istin

UK/H/5127/001

PA 19/45/1

Pfizer Limited

Ireland

Istin

UK/H/5127/002

PA 19/45/2

Pfizer Limited

Ireland

Amlodipina Pfizer Italia

UK/H/5127/005

027444013

Pfizer Italia S.R.L.

Italy

Amlodipina Pfizer Italia

UK/H/5127/006

027444025

Pfizer Italia S.R.L.

Italy

Norvasc

UK/H/5127/001

027428010

Pfizer Italia S.R.L.

Italy

List of nationally authorised medicinal products EMA/737385/2016

Page 7/14

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

UK/H/5127/002

027428022

Pfizer Italia S.R.L.

Italy

Norvasc

UK/H/5127/001

97-0600 $ 97-0601

Pfizer Limited

Latvia

2013080262 $ 2013080263

Pfizer S.A. (Belgium)

Luxembourg

2003127930 $ 2003127931

Pfizer S.A. (Belgium)

Luxembourg

$ UK/H/5127/002 Amlor

UK/H/5123/001 $ UK/H/5123/002

Amlor

UK/H/5127/003 $ UK/H/5127/004

Istin

UK/H/5127/001

MA505/03101

Pfizer Hellas, A.E.

Malta

Istin

UK/H/5127/002

MA505/03102

Pfizer Hellas, A.E.

Malta

Norvasc

UK/H/5127/001

RVG 13348

Pfizer B.V.

Netherlands

Norvasc

UK/H/5127/002

RVG 13349

Pfizer B.V.

Netherlands

Norvasc

UK/H/5127/001

7526

Pfizer As

Norway

List of nationally authorised medicinal products EMA/737385/2016

Page 8/14

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

UK/H/5127/002

7527

Pfizer As

Norway

Norvasc

UK/H/5123/002

21155

Pfizer Europe Ma Eeig

Poland

Norvasc

UK/H/5127/001

R/0128

Pfizer Europe Ma Eeig

Poland

Norvasc

UK/H/5127/002

R/0129

Pfizer Europe Ma Eeig

Poland

Norvasc Odt

UK/H/5123/001

21154

Pfizer Europe Ma Eeig

Poland

Norvasc

UK/H/5127/001

5828884 $ 5829585 $ 8793000

Laboratórios Pfizer, Lda.

Portugal

$ 8793018 Norvasc

UK/H/5127/002

5829486 $ 8793026

Laboratórios Pfizer, Lda.

Portugal

Norvasc

UK/H/5127/001

5654/2013/01 $ 5654/2013/02

Pfizer Europe Ma Eeig

Romania

$ UK/H/5127/002

$ 5654/2013/03 $ 5654/2013/04 $ 5654/2013/05 $ 5654/2013/06 $ 5654/2013/07 $ 5654/2013/08 $ 5654/2013/09 $ 5654/2013/10 $ 5654/2013/11 $ 5654/2013/12 $ 5654/2013/13 $ 5654/2013/14

List of nationally authorised medicinal products EMA/737385/2016

Page 9/14

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

Pfizer Europe Ma Eeig

Romania

Pfizer Europe Ma Eeig

Romania

$ 5654/2013/15 $ 5654/2013/16 $ 5655/2013/01 $ 5655/2013/02 $ 5655/2013/03 $ 5655/2013/04 $ 5655/2013/05 $ 5655/2013/06 $ 5655/2013/07 $ 5655/2013/08 $ 5655/2013/09 $ 5655/2013/10 $ 5655/2013/11 $ 5655/2013/12 $ 5655/2013/13 $ 5655/2013/14 $ 5655/2013/15 $ 5655/2013/16 $ 5655/2013/17 Norvasc

UK/H/5127/003

5656/2013/01 $ 5656/2013/02 $ 5656/2013/03 $ 5656/2013/04 $ 5656/2013/05 $ 5656/2013/06 $ 5656/2013/07 $ 5656/2013/08 $ 5656/2013/09 $ 5656/2013/10 $ 5656/2013/11

Norvasc

UK/H/5127/004

5657/2013/01 $ 5657/2013/02 $ 5657/2013/03 $ 5657/2013/04 $ 5657/2013/05 $ 5657/2013/06 $ 5657/2013/07 $ 5657/2013/08 $ 5657/2013/09 $ 5657/2013/10

Norvasc

UK/H/5127/001

83/0871/92–C/S

Pfizer Europe Ma Eeig

Slovakia

Norvasc

UK/H/5127/002

83/0437/12–S

Pfizer Europe Ma Eeig

Slovakia

List of nationally authorised medicinal products EMA/737385/2016

Page 10/14

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

UK/H/5127/001

H/99/01131/001 $ H/99/01131/002

Pfizer Luxembourg Sarl

Slovenia

$ UK/H/5127/002

$ H/99/01131/003 $ H/99/01131/004 $ H/99/01131/005 $ H/99/01131/006 $ H/99/01131/007 $ H/99/01131/008 $ H/99/01131/009 $ H/99/01131/010 $ H/99/01131/011 $ H/99/01131/012 $ H/99/01131/013 $ H/99/01131/014 $ H/99/01131/015 $ H/99/01131/016 $ H/99/01131/017 $ H/99/01131/018 $ H/99/01131/019 $ H/99/01131/020 $ H/99/01131/021 $ H/99/01131/022 $ H/99/01131/023 $ H/99/01131/024 $ H/99/01131/025 $ H/99/01131/026 $ H/99/01131/027 $ H/99/01131/028 $ H/99/01131/029 $ H/99/01131/030

List of nationally authorised medicinal products EMA/737385/2016

Page 11/14

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

$ H/99/01131/031 $ H/99/01131/032 $ H/99/01131/033 Norvas

UK/H/5127/001

59.159

Pfizer, S.L.

Spain

Norvas

UK/H/5127/002

59.160

Pfizer, S.L.

Spain

Norvasc

UK/H/5127/001

11287

Pfizer Ab

Sweden

Norvasc

UK/H/5127/002

11288

Pfizer Ab

Sweden

Amlodipine

UK/H/5127/005

PL 00057/1432

Pfizer Limited

United Kingdom

Amlodipine

UK/H/5127/006

PL 00057/1433

Pfizer Limited

United Kingdom

Istin

UK/H/5123/001

PL 00057/1389 $ PL 00057/1390

Pfizer Limited

United Kingdom

PL 00057/0297

Pfizer Limited

United Kingdom

$ UK/H/5123/002 Istin

UK/H/5127/001

List of nationally authorised medicinal products EMA/737385/2016

Page 12/14

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

UK/H/5127/002

PL 00057/0298

Pfizer Limited

United Kingdom

Istin

UK/H/5127/003

PL 00057/1415

Pfizer Limited

United Kingdom

Istin

UK/H/5127/004

PL 00057/1416

Pfizer Limited

United Kingdom

Amlodipin Hexal

DK/H/0960

0445424 $ 0445438 $ 0445441

Hexal AG

Luxembourg

Pfizer Europe Ma Eeig

Lithuania

Pfizer Holding France

France

$0445455 $0445469 $ 0445472 $ 0445486 $ 0445505 $ 0445519 $ 0445522 $ 0445536 $ 0445583 $ 0445567 $0445571 $ 0445584 $ 0445598 $ 0445603 $ 0445619 Norvasc

Amlor

UK/H/5127/001 -

LT/1/96/1466/001 -

UK/H/5127/004

LT/1/96/1466/054

UK/H/5127/003 -

NL 16 219 $ NL 16 220

UK/H/5127/004 Amlodipine Pfizer

(S.C.A.) NL 17218 $ NL 17219

Pfizer Holding France

France

(S.C.A.) Norvasc

UK/H/5123/001

List of nationally authorised medicinal products EMA/737385/2016

5575600 $ 5575618

Laboratórios Pfizer, Lda.

Portugal

Page 13/14

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

UK/H/5123/002

5575816

Laboratórios Pfizer, Lda.

Portugal

Amlodipin 1A Pharma 7,5

DK/H/0963

1-26866

1A Pharma GmbH

Austria

DK/H/0960

1-26856

Hexal Pharma GmbH

Austria

DK/H/0964

1-26875

Sandoz GmbH

Austria

mg - Tabletten Amlodipin Hexal 7,5 mg Tabletten Amlodipin Sandoz 7,5 mg - Tabletten

List of nationally authorised medicinal products EMA/737385/2016

Page 14/14

amlodipine - European Medicines Agency - Europa EU

Oct 27, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency ... Product Name (in authorisation country). MRP/ ...

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