14 September 2016 EMA/270645/2015 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: hydromorphone

Procedure no.: PSUSA/00001686/201511

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

MRP/DCP

authorisation country)

Authorisation

MAH of product in the

Member State where

member state

product is authorised

79781 $ 79782 $ 79783 $ 79784

Aristo Pharma Iberia, S.L.

Spain

1-28305 $ 1-28306 $ 1-28307 $

Mundipharma Gesellschaft

Austria

National Authorisation Number

number Hidromorfona Aristo

DE/H/3761/001 $ DE/H/3761/002 $ DE/H/3761/003 $ DE/H/3761/004

Hydal

DE/H/1540/001 $ DE/H/1540/002 $ DE/H/1540/003 $

1-28308

M.B.H.

DE/H/1540/004 Hydromorphon Aristo

AT/H/0494/001 $ AT/H/0494/002 $ AT/H/0494/003 $

1-31113 $ 1-31114 $ 1-31115 $

Aristo Pharma Gmbh

Austria

Aristo Pharma Gmbh

Germany

Germany

1-31116

AT/H/0494/004 Hydromorphon Aristo

AT/H/0494/001 $

90469.00.00 $ 90470.00.00 $

AT/H/0494/002 $

90471.00.00 $ 90472.00.00

AT/H/0494/003 $ AT/H/0494/004 Hydromorphon Aristo

DE/H/3761/001/DC $

89245.00.00 $ 89246.00.00 $

Aristo Pharma Gmbh (Art

Long

DE/H/3761/002/DC $

89247.00.00 $ 89248.00.00

57)

DE/H/2246/001 $

76825.00.00 $ 76826.00.00 $

Teva Gmbh

Germany

DE/H/2246/002 $

76827.00.00

DE/H/3761/003/DC $ DE/H/3761/004/DC Hydromorphon Awd

DE/H/2246/003 Hydromorphon Develco

DE/H/3737/001/DC

89001.00.00

Develco Pharma Gmbh

Germany

Hydromorphon Develco

DE/H/3737/002/DC

89002.00.00

Develco Pharma Gmbh

Germany

List of nationally authorised medicinal products EMA/703492/2016

Page 2/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Hydromorphon Develco

DE/H/3737/003/DC

89003.00.00

Develco Pharma Gmbh

Germany

Hydromorphon Develco

DE/H/3737/004/DC

89004.00.00

Develco Pharma Gmbh

Germany

Hydromorphon HCl-

DE/H/2246/001 $

76825.00.00 $ 76826.00.00 $

Hormosan Pharma Gmbh

Germany

Hormosan

DE/H/2246/002 $

76827.00.00 $ 76828.00.00

Hexal Pharma Gmbh

Austria

Hexal Ag

Germany

Aristo Pharma GmbH

Germany

Ratiopharm Gmbh

Germany

DE/H/2246/003 $ DE/H/2246/004 Hydromorphon Hexal

DE/H/2248/001 $

1-29429 $ 1-29430 $ 1-29431 $ 1-

DE/H/2248/002 $

29432

DE/H/2248/003 $ DE/H/2248/004 Hydromorphon Hexal

DE/H/2431/001 $

78090.00.00 $ 78091.00.00 $

Retard

DE/H/2431/002 $

78092.00.00 $ 78093.00.00 $

DE/H/2431/003 $

78094.00.00

DE/H/2431/004 $ DE/H/2431/005 Hydromorphon

DE/H/3762/001/DC $

89249.00.00 $ 89250.00.00 $

Neuraxpharm

DE/H/3762/002/DC $

89251.00.00 $ 89252.00.00

DE/H/3762/003/DC $ DE/H/3762/004/DC Hydromorphon

DE/H/2245/001 $

76821.00.00 $ 76822.00.00 $

Ratiopharm

DE/H/2245/002 $

76823.00.00 $ 76824.00.00

DE/H/2245/003 $ DE/H/2245/004

List of nationally authorised medicinal products EMA/703492/2016

Page 3/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

Ratiopharm Arzneimittel

Austria

number Hydromorphon

DE/H/2245/001 $

Ratiopharm

DE/H/2245/002

Hydromorphon

DE/H/2245/003 $

Ratiopharm

DE/H/2245/004

Hydromorphon Hexal

DE/H/2248/001 $

76833.00.00 $ 76834.00.00 $

Retard

DE/H/2248/002 $

76835.00.00 $ 76836.00.00

1-29272 $ 1-29273

Vertriebs-Gmbh 1-29274 $ 1-29275

Ratiopharm Arzneimittel

Austria

Vertriebs-Gmbh Hexal Ag

Germany

Winthrop Arzneimittel Gmbh

Germany

Teva Gmbh

Germany

1 A Pharma Gmbh

Germany

Acino Ag

Germany

Ratiopharm Gmbh

Germany

Ratiopharm Gmbh

Germany

DE/H/2248/003 $ DE/H/2248/004 Hydromorphon Winthrop

DE/H/2247/001 $

76829.00.00 $ 76830.00.00 $

DE/H/2247/002 $

76831.00.00 $ 76832.00.00

DE/H/2247/003 $ DE/H/2247/004 Hydromorphon-Awd

DE-H-2246-001-004

76825.00.00 $ 76826.00.00 $ 76827.00.00

Hydromorphon-Hcl 1 A

84814.00.00 $ 84815.00.00 $

Pharma

84817.00.00 $ 84818.00.00

Hydromorphone-HCL-

85909.00.00 $ 85910.00.00 $

Acino

85911.00.00 $ 85912.00.00 $ 85913.00.00

Hydromorphon-Hcl

84819.00.00 $ 84821.00.00 $

Ratiopharm

84823.00.00

Hydromorphon-Hcl

84820.00.00 $ 84822.00.00

Ratiopharm

List of nationally authorised medicinal products EMA/703492/2016

Page 4/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

MAH of product in the

Member State where

member state

product is authorised

Ratiopharm Gmbh

Germany

1-29272 $ 1-29273 $ 1-29274 $ 1-

Ratiopharm Arzneimittel

Austria

29275

Vertriebs-Gmbh

76821.00.00 $ 76822.00.00 $

Ratiopharm Gmbh

Germany

Martindale Pharmaceuticals

Ireland

National Authorisation Number

number Hydromorphone Hcl

84819.00.00 $ 84820.00.00 $

Ratiopharm

84821.00.00 $ 84822.00.00 $ 84823.00.00

Hydromorphone Hcl

DE-H-2245-001-004

Ratiopharm Hydromorphone Hcl

DE-H-2245-001-004

Ratiopharm

76823.00.00 $ 76824.00.00

Hydromorphone

PA 361/18/1 $ PA 361/18/2

Hydrochloride Jurnista

List of nationally authorised medicinal products EMA/703492/2016

Ltd 58351

Janssen-Cilag Ag

Liechtenstein

Page 5/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

Janssen-Cilag Spa

Italy

number Jurnista

DK/H/0869/001 $

037396013 $ 037396025 $

DK/H/0869/002 $

037396049 $ 037396064 $

DK/H/0869/003 $

037396076 $ 037396088 $

DK/H/0869/004 $

037396090 $ 037396102/M $

DK/H/0869/005

037396114 $ 037396126 $ 037396138 $ 037396140 $ 037396165 $ 037396189 $ 037396191 $ 037396203 $ 037396215 $ 037396227 $ 037396239 $ 037396241 $ 037396254 $ 037396266 $ 037396280 $ 037396304 $ 037396328 $ 037396330 $ 037396342 $ 037396355 $ 037396367 $ 037396379 $ 037396381 $ 037396405 $ 037396429 $ 037396431 $ 037396443 $ 037396456 $ 037396468 $ 037396470 $ 037396482 $ 037396494 $ 037396506 $ 037396520 $ 037396544 $ 037396557 $ 037396569 $ 037396571 $ 037396583 $ 037396595 $ 037396607

List of nationally authorised medicinal products EMA/703492/2016

Page 6/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

Janssen-Cilag Spa

Italy

Janssen-Cilag A/S

Denmark

Janssen-Cilag Gmbh

Germany

number Jurnista

DK/H/0869/001 $

037396037 $ 037396052 $

DK/H/0869/002 $

037396153 $ 037396177 $

DK/H/0869/003 $

037396278 $ 037396292 $

DK/H/0869/004 $

037396393 $ 037396417 $

DK/H/0869/005

037396518 $ 037396532 $ 037396316

Jurnista

DK/H/0869/001 $

32344 $ 32345 $ 32346 $ 32347 $

DK/H/0869/002 $

40775

DK/H/0869/003 $ DK/H/0869/004 $ DK/H/0869/005 Jurnista

DK/H/0869/001 $

63501.00.00 $ 63502.00.00 $

DK/H/0869/002 $

63503.00.00 $ 63504.00.00 $

DK/H/0869/003 $

68242.00.00

DK/H/0869/004 $ DK/H/0869/005

List of nationally authorised medicinal products EMA/703492/2016

Page 7/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

Janssen-Cilag Kft.

Hungary

number Jurnista

DK/H/0869/001 $

OGYI-T-20162/01 $ OGYI-T-

DK/H/0869/002 $

20162/02 $ OGYI-T-20162/03 $

DK/H/0869/003 $

OGYI-T-20162/04 $ OGYI-T-

DK/H/0869/004 $

20162/05 $ OGYI-T-20162/06 $

DK/H/0869/005

OGYI-T-20162/07 $ OGYI-T20162/08 $ OGYI-T-20162/09 $ OGYI-T-20162/10 $ OGYI-T20162/11 $ OGYI-T-20162/12 $ OGYI-T-20162/13 $ OGYI-T20162/14 $ OGYI-T-20162/15 $ OGYI-T-20162/16 $ OGYI-T20162/17 $ OGYI-T-20162/18 $ OGYI-T-20162/19 $ OGYI-T20162/20 $ OGYI-T-20162/21 $ OGYI-T-20162/22 $ OGYI-T20162/23 $ OGYI-T-20162/24 $ OGYI-T-20162/25 $ OGYI-T20162/26 $ OGYI-T-20162/27 $ OGYI-T-20162/28 $ OGYI-T20162/29 $ OGYI-T-20162/30 $ OGYI-T-20162/31 $ OGYI-T20162/32 $ OGYI-T-20162/33 $ OGYI-T-20162/34 $ OGYI-T20162/35 $ OGYI-T-20162/36 $ OGYI-T-20162/37 $ OGYI-T20162/38 $ OGYI-T-20162/39 $ OGYI-T-20162/40 $ OGYI-T20162/41 $ OGYI-T-20162/42 $ OGYI-T-20162/43 $ OGYI-T-

List of nationally authorised medicinal products EMA/703492/2016

20162/44 $ OGYI-T-20162/45 $ OGYI-T-20162/46 $ OGYI-T20162/47 $ OGYI-T-20162/48 $ OGYI-T-20162/49 $ OGYI-T20162/50 $ OGYI-T-20162/51 $

Page 8/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

Portugal

number Jurnista

DK/H/0869/001 $

5079033 $ 5079041 $ 5100318 $

Janssen-Cilag Farmacêutica,

DK/H/0869/002 $

5100326 $ 5286240 $ 5286257 $

Lda.

DK/H/0869/003 $

5296173 $ 5841481 $ 5841580 $

DK/H/0869/004 $

5841689 $ 5841788 $ 5841887 $

DK/H/0869/005 $

5841986 $ 5842083 $ 5842182

DK/H/0869/005 Jurnista

DK/H/0869/001 $

65/187/06-C $ 65/188/06-C $

DK/H/0869/002 $

65/189/06-C $ 65/723/07-C

Janssen-Cilag S.R.O

Czech Republic

68.018 $ 68.019 $ 68.020 $ 69.710

Janssen-Cilag S.A.

Spain

Palladon

16714 $ 16715 $ 16716 $ 16717

Norpharma A/S

Denmark

Palladon

32124 $ 32125

Norpharma A/S

Denmark

Palladon

32273 $ 32342 $ 32343

Norpharma A/S

Denmark

DE/H/1540/001 $

BE342702 $ BE342711 $ BE342727

Mundipharma Comm Va

Belgium

DE/H/1540/002 $

$ BE342736

Mundipharma Comm Va

Belgium

DK/H/0869/003 $ DK/H/0869/005 Jurnista

DK/H/0869/001 $ DK/H/0869/002 $ DK/H/0869/003 $ DK/H/0869/005

Palladone

DE/H/1540/003 $ DE/H/1540/004 Palladone Immediate

BE 256952 $ BE256961

Release

List of nationally authorised medicinal products EMA/703492/2016

Page 9/16

Product Name (in

MRP/DCP

MAH of product in the

Member State where

authorisation country)

Authorisation

member state

product is authorised

43149 $ 43150 $ 43151 $ 43152

Norpharma A/S

Denmark

DE/H/1540/001 $

IS/1/08/079/01 $ IS/1/08/079/02 $

Norpharma A/S

Iceland

DE/H/1540/002 $

IS/1/08/079/03 $ IS/1/08/079/04

National Authorisation Number

number Palladon

DE/H/1540/001 $ DE/H/1540/002 $ DE/H/1540/003 $ DE/H/1540/004

Palladon

DE/H/1540/003 $ DE/H/1540/004 Palladon

IS/1/00/056/01 $ IS/1/00/056/02

Norpharma A/S

Iceland

Palladon

980415 (IS) $ 9800416 (IS) $

Norpharma A/S

Iceland

Mundipharma Comm Va

Belgium

Mundipharma Oy

Finland

24917 $ 24918 $ 24919 $ 24920

Mundipharma Oy

Finland

34009 348 906 5 9 $ 34009

Mundipharma

France

980417 (IS) $ 980418 (IS) BE 217131 $ BE 217156 $ BE

Palladone Slow Release

217174 $ BE 217192 11978 $ 11979 $ 11980 $ 11981 $

Palladon

12924 $ 12925 Palladon

DE/H/1540/001 $ DE/H/1540/002 $ DE/H/1540/003 $ DE/H/1540/004

Sophidone L.P

348 907 1 0 $ 34009 561 203 8 3 $ 34009 561 204 4 4

List of nationally authorised medicinal products EMA/703492/2016

Page 10/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

Mundipharma

France

Mundipharma SAS

France

Mundipharma Sas

France

Mundipharma Gmbh

Germany

Medis, D.O.O.

Slovenia

Napp Pharmaceuticals Ltd

United Kingdom

Napp Pharmaceuticals Ltd

United Kingdom

number Sophidone L.P.

34009 348 901 3 0 $ 34009 348 904 2 0 $ 34009 348 908 8 8

Sophidone L.P.

NL 23993 $ NL 23994 $ NL 23995 $ NL 23996

Sophidone L.P.

34009 348 903 6 9 $ 34009 348 905 9 8 $ 34009 348 909 4 9 $ 34009 561 199 0 5 $ 34009 561 200 9 3 $ 34009 561 201 5 4 $ 34009 561 202 1 5 $ 34009 561 205 0 5 $ 34009 561 206 7 3

Palladon Injekt

59109.00.00 $ 59110.00.00 $ 59111.00.00

Palladone

5363-I-1202/09 $ 5363-I-1204/09 $ 5363-I-1206/09 $ 5363-I1207/09 $ 5363-I-1208/09 $ 5363I-1210/09 $ 5363-I-1211/09 $ 5363-I-1212/09 $ 5363-I-1214/09 $ 5363-I-1215/09 $ 5363-I1216/09 $ 5363-I-1218/09 $ 5363I-1220/09

Palladone

PL16950/0163 $ PL16950/0164 $ PL16950/0165

Palladone

List of nationally authorised medicinal products EMA/703492/2016

PL16950/0166

Page 11/16

Product Name (in

MRP/DCP

MAH of product in the

Member State where

authorisation country)

Authorisation

member state

product is authorised

Napp Pharmaceuticals Ltd

United Kingdom

PL16950/0049 $ PL16950/0050

Napp Pharmaceuticals Ltd

United Kingdom

DE/H/1540/001 $

72196.00.00 $ 72197.00.00 $

Mundipharma Gmbh

Germany

DE/H/1540/002 $

72198.00.00 $ 72199.00.00

Mundipharma Gmbh

Germany

59112.00.00 $ 59112.01.00

Mundipharma Gmbh

Germany

IE/H/0131/005 $

PA 1688/007/001 $ PA

Mundipharma

Ireland

IE/H/0131/006

1688/007/002

Pharmaceuticals Limited

IE/H/0131/001 $

PA 1688/007/007 $ PA

Mundipharma

IE/H/0131/002 $

1688/007/008 $ PA 1688/007/009

Pharmaceuticals Limited

IE/H/0131/003 $

$ PA 1688/007/010 $ PA

IE/H/0131/004

1688/007/011

DE/H/1540/001 $

1495/09120028 $ 1495/09120029

DE/H/1540/002 $

$ 1495/09120030 $

DE/H/1540/003 $

1495/09120031

National Authorisation Number

number PL16950/0051 $ PL16950/0052 $

Palladone SR

PL16950/0053 $ PL16950/0054 $ PL169/0055 Palladone Palladon Injekt

DE/H/1540/003 $ DE/H/1540/004 33162.00.00 $ 33162.01.00 $

Palladon retard

33162.02.00 $ 33162.03.00 Palladon

IE/H/0131/005/MR $ IE/H/0131/006/MR

Palladone

Palladone Sr

Palladone

Mundipharma Comm Va

Ireland

Luxembourg

DE/H/1540/004

List of nationally authorised medicinal products EMA/703492/2016

Page 12/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

MAH of product in the

Member State where

member state

product is authorised

1495/04030125 $ 1495/04030126

Mundipharma Comm Va

Luxembourg

1495/01070020 $ 1495/01070021

Mundipharma Comm Va

Luxembourg

RVG 104833 $ RVG 104836 $ RVG

Mundipharma

Netherlands

104837 $ RVG 104838

Pharmaceuticals Bv

RVG 26549 $ RVG 26550

Mundipharma

National Authorisation Number

number Palladone Immediate Release Palladone Slow Release

$ 1495/01070022 $ 1495/01070023 Palladon Injectie

Palladon-Ir

Netherlands

Pharmaceuticals Bv RVG 22162 $ RVG 22163 $ RVG

Mundipharma

22164 $ RVG 22165 $ RVG 29655

Pharmaceuticals Bv

DE/H/1540/001 $

08-5876 $ 08-5877 $ 08-5878 $

Mundipharma As.

Norway

DE/H/1540/002 $

08-5879

Mundipharma As.

Norway

03-2290 $ 03-2291

Mundipharma As.

Norway

65/0248/03-S $ 65/0249/03-S $

Mundipharma Ges.M.B.H

Slovakia

Palladon-Sr Capsules

Palladon

Netherlands

DE/H/1540/003 $ DE/H/1540/004 Palladon

IE/H/0131/001 $

03-2293 $ 03-2294 $ 03-2295 $

IE/H/0131/002 $

03-2296

IE/H/0131/003 $ IE/H/0131/004 Palladon

IE/H/0131/005 $ IE/H/0131/006

Palladone-Sr

65/0250/03-S $ 65/0251/03-S

List of nationally authorised medicinal products EMA/703492/2016

Page 13/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

Acino Ag

Germany

Mundipharma

Spain

number 85919.00.00 $ 85920.00.00 $

Rexaphon

85921.00.00 $ 85922.00.00 $ 85923.00.00 Palladone

DE/H/1540/001 $

71471 $ 71813 $ 71814 $ 71815

DE/H/1540/002 $

Pharmaceuticals Sl

DE/H/1540/003 $ DE/H/1540/004 Palladone Continus

63.885 $ 63.886 $ 63.887 $ 63.888

Mundipharma

Spain

Pharmaceuticals Sl Palladon

DE/H/1540/001 $

26898 $ 26899 $ 26900 $ 26901

Mundipharma Ab

Sweden

DE/H/2432/002-005

78096.00.00

ACTAVIS GROUP PTC EHF.

Germany

DE/H/2432/002-005

78097.00.00

ACTAVIS GROUP PTC EHF.

Germany

DE/H/1540/002 $ DE/H/1540/003 $ DE/H/1540/004 HYDROMORPHON-HCIACTAVIS 4 MG HARTKAPSELN, RETARDIERT HYDROMORPHON-HCIACTAVIS 8 MG HARTKAPSELN, RETARDIERT

List of nationally authorised medicinal products EMA/703492/2016

Page 14/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number HYDROMORPHON-HCI-

DE/H/2432/002-005

78098.00.00

ACTAVIS GROUP PTC EHF.

Germany

DE/H/2432/002-005

78099.00.00

ACTAVIS GROUP PTC EHF.

Germany

13782 $ 13783 $ 13784 $ 13785 $

Mundipharma Ab

Sweden

ACTAVIS 16 MG HARTKAPSELN, RETARDIERT HYDROMORPHON-HCIACTAVIS 24 MG HARTKAPSELN, RETARDIERT Palladon

13786 $ 13787 HYDROMORPHON-

DE/H/2326/004

77420.00.00

STADAPHARM GMBH

Germany

DE/H/2326/002

1-29529

STADA ARZNEIMITTEL

Austria

STADA® 24 MG RETARDTABLETTEN HYDROMORPHON STADA 8 MG RETARDTABLETTEN HYDROMORPHON STADA

GMBH DE/H/2326/003

1-29530

16 MG

STADA ARZNEIMITTEL

Austria

GMBH

RETARDTABLETTEN HYDROMORPHON-

DE/H/2326/003

77419.00.00

STADAPHARM GMBH

Germany

DE/H/2326/001

1-29528

STADA ARZNEIMITTEL

Austria

STADA® 16 MG RETARDTABLETTEN HYDROMORPHON STADA 4 MG RETARDTABLETTEN

List of nationally authorised medicinal products EMA/703492/2016

GMBH

Page 15/16

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

STADA ARZNEIMITTEL

Austria

number HYDROMORPHON STADA

DE/H/2326/004

1-29531

24 MG

GMBH

RETARDTABLETTEN HYDROMORPHON-

DE/H/2326/002

77418.00.00

STADAPHARM GMBH

Germany

DE/H/2326/001

77417.00.00

STADAPHARM GMBH

Germany

DE/H/2327/004

77424.00.00

ALIUD PHARMA GMBH

Germany

DE/H/2327/002

77422.00.00

ALIUD PHARMA GMBH

Germany

DE/H/2327/003

77423.00.00

ALIUD PHARMA GMBH

Germany

DE/H/2327/001

77421.00.00

ALIUD PHARMA GMBH

Germany

Hydromorphon Develco

2014040022

Develco Pharma Gmbh

Luxembourg

Hydromorphon Develco

2014040023

Develco Pharma Gmbh

Luxembourg

Hydromorphon Develco

2014040024

Develco Pharma Gmbh

Luxembourg

Hydromorphon Develco

2014040025

Develco Pharma Gmbh

Luxembourg

STADA® 8 MG RETARDTABLETTEN HYDROMORPHONSTADA® 4 MG RETARDTABLETTEN HYDROMORPHON-AL 24 MG RETARDTABLETTEN HYDROMORPHON-AL 8 MG RETARDTABLETTEN HYDROMORPHON-AL 16 MG RETARDTABLETTEN HYDROMORPHON-AL 4 MG RETARDTABLETTEN

List of nationally authorised medicinal products EMA/703492/2016

Page 16/16

PSUSA/00001686/201511 - European Medicines Agency - Europa EU

Sep 14, 2016 - MRP/DCP. Authorisation number. National Authorisation Number. MAH of product in the .... 20162/02 $ OGYI-T-20162/03 $. OGYI-T-20162/04 ...
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