# Official Journal C 184/2011

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2011.184.eng |
| --- | --- |
| Official Journal
  of the European Union | C 184 |
| | |
| English edition | Information and Notices | Volume 5424 June 2011 |

ISSN 1725-2423

doi:10.3000/17252423.C_2011.184.eng

Official Journal

of the European Union

C 184

English edition

Information and Notices

Volume 5424 June 2011

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2011/C 184/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 2011(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2011/C 184/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 2011(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 17 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2011/C 184/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 2011(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2011/C 184/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 2011(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

17

| EN | |
| --- | --- |

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 24.6.2011 | EN | Official Journal of the European Union | C 184/1 |
| --- | --- | --- | --- |

24.6.2011

EN

Official Journal of the European Union

C 184/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 2011

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1)
  )

2011/C 184/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.3.2011 | Ifirmacombi | Irbesartan/hydrochlorothiazide | KRKA, d. d., Novo mesto |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

4.3.2011

Ifirmacombi

Irbesartan/hydrochlorothiazide

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673/001-024

Film-coated tablet

C09DA04

8.3.2011

4.3.2011

Pumarix

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/10/664/001

Suspension and emulsion for emulsion for injection

J07BB02

8.3.2011

4.3.2011

Xeplion

paliperidone

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/672/001-006

Prolonged release suspension for injection

N05AX13

8.3.2011

10.3.2011

Leflunomide Teva

leflunomide

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/675/001-010

Film-coated tablet

L04AA13

14.3.2011

14.3.2011

Repso

leflunomide

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/674/001-010

Film-coated tablet

L04AA13

17.3.2011

14.3.2011

Teysuno

Tegafur/gimeracil/oteracil

| Taiho Pharma Europe, Limited |
| --- |
| 55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom |

Taiho Pharma Europe, Limited

55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom

EU/1/11/669/001-004

Capsule, hard

L01BC53

17.3.2011

17.3.2011

GILENYA

Fingolimod

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/677/001-004

Capsule, hard

L04AA27

22.3.2011

17.3.2011

HALAVEN

eribulin

| Eisai Limited |
| --- |
| European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom |

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom

EU/1/11/678/001-002

Solution for injection

L01XX41

22.3.2011

17.3.2011

JEVTANA

cabazitaxel

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/11/676/001

Concentrate and solvent for solution for infusion

Pending

22.3.2011

28.3.2011

Trobalt

retigabine

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/11/681/001-013

Film-coated tablet

N03AX21

31.3.2011

13.4.2011

Riprazo HCT

aliskiren hemifumarate / hydrochlorothiazide

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/11/680/001-080

Film-coated tablet

C09XA52

15.4.2011

14.4.2011

Hizentra

human normal immunoglobulin

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland |

CSL Behring GmbH

Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland

EU/1/11/687/001-012

Solution for injection

J06BA01

18.4.2011

14.4.2011

Pravafenix

fenofibrate / pravastatin

| LABORATOIRES SMB SA |
| --- |
| 26-28 rue de la Pastorale, 1080 Brussels, Belgique - 26-28 Herdersliedstraat, 1080, Brussel, Belgïe |

LABORATOIRES SMB SA

26-28 rue de la Pastorale, 1080 Brussels, Belgique - 26-28 Herdersliedstraat, 1080, Brussel, Belgïe

EU/1/11/679/001-006

Capsule, hard

C10BA03

19.4.2011

14.4.2011

Rasilamlo

aliskiren / amlodipine

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/11/686/001-056

Film-coated tablet

C09XA53

18.4.2011

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.3.2011 | Silgard | Merck Sharp & Dohme Ltd |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

4.3.2011

Silgard

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358/001-021

8.3.2011

4.3.2011

Vaniqa

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, 08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/01/173/001-003

8.3.2011

8.3.2011

Clopidogrel DURA

| Mylan dura GmbH |
| --- |
| Wittichstraße 6, D-64295 Darmstadt, Deutschland |

Mylan dura GmbH

Wittichstraße 6, D-64295 Darmstadt, Deutschland

EU/1/09/560/001-009

10.3.2011

8.3.2011

Clopidogrel Mylan

| Mylan S.A.S |
| --- |
| 117 allée des Parcs, 69 800 Saint Priest, France |

Mylan S.A.S

117 allée des Parcs, 69 800 Saint Priest, France

EU/1/09/559/001-016

10.3.2011

8.3.2011

Rebetol

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/99/107/001-005

21.3.2011

8.3.2011

Tarceva

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311/001-003

10.3.2011

10.3.2011

Abraxane

| Abraxis BioScience Limited |
| --- |
| Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom |

Abraxis BioScience Limited

Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom

EU/1/07/428/001

22.3.2011

10.3.2011

Abseamed

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37, D-58638 Iserlohn, Deutschland |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412/001-052

11.3.2011

10.3.2011

Abseamed

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37, D-58638 Iserlohn, Deutschland |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412/001-052

14.3.2011

10.3.2011

Clopidogrel Teva Pharma

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/561/001-010

14.3.2011

14.3.2011

Actrapid

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/230/001-017

17.3.2011

14.3.2011

BeneFIX

| Wyeth Europa Ltd. |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-007

18.3.2011

14.3.2011

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, Kundl 6250, Österreich |

Sandoz GmbH

Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/07/410/001-052

17.3.2011

14.3.2011

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, Kundl 6250, Österreich |

Sandoz GmbH

Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/07/410/001-052

16.3.2011

14.3.2011

Clopidogrel Acino

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, 83714 Miesbach, Deutschland |

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/532/001-007

16.3.2011

14.3.2011

Clopidogrel Hexal

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, Miesbach 83714, Deutschland |

Acino Pharma GmbH

Am Windfeld 35, Miesbach 83714, Deutschland

EU/1/09/534/001-007

21.3.2011

14.3.2011

Epoetin alfa Hexal

| Hexal AG. |
| --- |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland |

Hexal AG.

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411/001-052

17.3.2011

14.3.2011

Epoetin alfa Hexal

| Hexal AG. |
| --- |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland |

Hexal AG.

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411/001-052

18.3.2011

14.3.2011

Prometax

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/092/001-026

16.3.2011

14.3.2011

Rivastigmine HEXAL

| HEXAL AG |
| --- |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland |

HEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/09/589/001-018

21.3.2011

14.3.2011

Visudyne

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/00/140/001

21.3.2011

17.3.2011

Actraphane

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/229/001-004

EU/1/02/229/011-019

EU/1/02/229/024-037

22.3.2011

17.3.2011

Clopidogrel Sandoz

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, 83714 Miesbach, Deutschland |

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/547/001-007

22.3.2011

17.3.2011

Copalia HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/575/001-060

22.3.2011

17.3.2011

Dafiro HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/574/001-060

22.3.2011

17.3.2011

Exelon

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/066/001-026

22.3.2011

17.3.2011

HBVAXPRO

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/01/183/001

EU/1/01/183/004-005

EU/1/01/183/007-008

EU/1/01/183/011

EU/1/01/183/013

EU/1/01/183/015

EU/1/01/183/018-032

22.3.2011

17.3.2011

INOmax

| INO Therapeutics AB |
| --- |
| SE-181 81 Lidingö, Sverige |

INO Therapeutics AB

SE-181 81 Lidingö, Sverige

EU/1/01/194/001-002

22.3.2011

17.3.2011

Liprolog

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/01/195/001-027

22.3.2011

17.3.2011

Mixtard

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/231/001-037

22.3.2011

17.3.2011

NovoMix

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/142/004-005

EU/1/00/142/009-025

22.3.2011

17.3.2011

ProQuad

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/05/323/001-013

22.3.2011

17.3.2011

Protaphane

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234/001-017

22.3.2011

18.3.2011

Adrovance

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/364/001-009

23.3.2011

18.3.2011

Fosavance

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/310/001-009

23.3.2011

18.3.2011

Humira

| Abbott Laboratories Ltd |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom |

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom

EU/1/03/256/001-010

23.3.2011

18.3.2011

INOmax

| INO Therapeutics AB |
| --- |
| SE-181 81 Lidingö, Sverige |

INO Therapeutics AB

SE-181 81 Lidingö, Sverige

EU/1/01/194/001-004

22.3.2011

18.3.2011

Ivemend

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/437/001-004

23.3.2011

18.3.2011

Kaletra

| Abbott Laboratories |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom |

Abbott Laboratories

Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom

EU/1/01/172/001-008

23.3.2011

18.3.2011

Kivexa

| ViiV Healthcare UK Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/04/298/001-003

23.3.2011

18.3.2011

Luveris

| Merck Serono Europe Limited |
| --- |
| 56, Marsh Wall, London E14 9TP, United Kingdom |

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/155/001-007

23.3.2011

18.3.2011

Menveo

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, 53100 Siena, Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/614/001-002

23.3.2011

18.3.2011

Mirapexin

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051/001-006

EU/1/97/051/009-033

23.3.2011

18.3.2011

Rasilez

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405/001-040

23.3.2011

18.3.2011

Rasilez HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491/001-080

23.3.2011

18.3.2011

Riprazo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/409/001-040

23.3.2011

18.3.2011

RoActemra

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/08/492/001-006

23.3.2011

18.3.2011

Sifrol

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/050/013-033

23.3.2011

18.3.2011

Simulect

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/084/001-002

23.3.2011

18.3.2011

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-002

23.3.2011

18.3.2011

Xyrem

| UCB Pharma Ltd. |
| --- |
| 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |

UCB Pharma Ltd.

208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

EU/1/05/312/001

23.3.2011

18.3.2011

Zerit

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/96/009/001-009

23.3.2011

24.3.2011

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

29.3.2011

24.3.2011

Cayston

| Gilead Sciences International Limited |
| --- |
| Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543/001-002

29.3.2011

24.3.2011

Clopidogrel ratiopharm

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, 83714 Miesbach, Deutschland |

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/554/001-008

28.3.2011

24.3.2011

DuoTrav

| Alcon Laboratories (UK) Ltd. |
| --- |
| Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |

Alcon Laboratories (UK) Ltd.

Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom

EU/1/06/338/001-003

29.3.2011

24.3.2011

Evoltra

| Genzyme Europe BV |
| --- |
| Gooimeer 10, 1411 DD Naarden, Nederland |

Genzyme Europe BV

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/06/334/001-005

30.3.2011

24.3.2011

Exforge HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/569/001-060

30.3.2011

24.3.2011

Forsteo

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/03/247/001-002

30.3.2011

24.3.2011

Grepid

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535/001-016

29.3.2011

24.3.2011

HBVAXPRO

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/01/183/001

EU/1/01/183/004-005

EU/1/01/183/007-008

EU/1/01/183/011

EU/1/01/183/013

EU/1/01/183/015

EU/1/01/183/018-032

28.3.2011

24.3.2011

Humalog

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/96/007/002

EU/1/96/007/004-006

EU/1/96/007/008

EU/1/96/007/010

EU/1/96/007/015-021

EU/1/96/007/023-038

28.3.2011

24.3.2011

Imprida HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/570/001-060

30.3.2011

24.3.2011

Insulatard

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233/001-017

28.3.2011

24.3.2011

Levitra

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/03/248/001-020

30.3.2011

24.3.2011

Myocet

| Cephalon Europe |
| --- |
| 5 Rue Charles Martigny, Maisons Alfort 94700, France |

Cephalon Europe

5 Rue Charles Martigny, Maisons Alfort 94700, France

EU/1/00/141/001

29.3.2011

24.3.2011

Pandemrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/08/452/001

31.3.2011

24.3.2011

Revatio

| Pfizer Limited |
| --- |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited

Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/05/318/001-002

30.3.2011

24.3.2011

Reyataz

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267/001-010

30.3.2011

24.3.2011

Scintimun

| CIS bio international |
| --- |
| Boite Postale 32 - F-91192 Gif-sur-Yvette - France |

CIS bio international

Boite Postale 32 - F-91192 Gif-sur-Yvette - France

EU/1/09/602/001-002

29.3.2011

24.3.2011

Silodyx

| Recordati Ireland Ltd. |
| --- |
| Raheens East, Ringaskiddy Co. Cork, Ireland |

Recordati Ireland Ltd.

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/607/001-014

29.3.2011

24.3.2011

Soliris

| Alexion Europe S.A.S. |
| --- |
| 25, boulevard de l'Amiral Bruix, 75016 Paris, France |

Alexion Europe S.A.S.

25, boulevard de l'Amiral Bruix, 75016 Paris, France

EU/1/07/393/001

28.3.2011

24.3.2011

Sprimeo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/407/001-040

28.3.2011

24.3.2011

Toviaz

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/07/386/001-018

30.3.2011

24.3.2011

Urorec

| Recordati Ireland Ltd. |
| --- |
| Raheens East, Ringaskiddy Co. Cork, Ireland |

Recordati Ireland Ltd.

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/608/001-014

29.3.2011

24.3.2011

Vantavo

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/09/572/001-009

28.3.2011

24.3.2011

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-002

29.3.2011

24.3.2011

Zopya

| Norpharm Regulatory Services Ltd |
| --- |
| 26 Laurence Street, Drogheda, Co. Louth, Ireland |

Norpharm Regulatory Services Ltd

26 Laurence Street, Drogheda, Co. Louth, Ireland

EU/1/09/562/001-009

29.3.2011

24.3.2011

Zostavax

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/341/001-013

30.3.2011

28.3.2011

Adenuric

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/447/001-012

30.3.2011

28.3.2011

Afinitor

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/538/001-008

30.3.2011

28.3.2011

Evicel

| OMRIX biopharmaceuticals S.A. / N.V. |
| --- |
| 200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België |

OMRIX biopharmaceuticals S.A. / N.V.

200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België

EU/1/08/473/001-003

5.4.2011

28.3.2011

Levemir

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278/001-011

30.3.2011

28.3.2011

Oprymea

| KRKA, d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/469/001-025

30.3.2011

28.3.2011

Vizarsin

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551/001-012

30.3.2011

31.3.2011

Ilaris

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/564/001-002

4.4.2011

31.3.2011

Temozolomide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, DR Utrecht 3542, Nederland |

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/09/606/001-012

4.4.2011

8.4.2011

Copalia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/372/001-039

12.4.2011

8.4.2011

Dafiro

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/371/001-039

12.4.2011

8.4.2011

Invega

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 - 2340 Beerse - België |

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/07/395/001-095

12.4.2011

8.4.2011

Neulasta

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/02/227/001-004

12.4.2011

8.4.2011

NovoRapid

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-015

EU/1/99/119/017-018

12.4.2011

8.4.2011

RotaTeq

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, Lyon 69007, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

12.4.2011

8.4.2011

Tyverb

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/440/001-003

12.4.2011

12.4.2011

Aclasta

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/308/001-002

14.4.2011

12.4.2011

Emtriva

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/03/261/001-003

14.4.2011

12.4.2011

Firdapse

| BioMarin Europe Ltd |
| --- |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/09/601/001

14.4.2011

12.4.2011

Kineret

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/02/203/001-004

14.4.2011

12.4.2011

Nexavar

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/06/342/001

14.4.2011

12.4.2011

Sildenafil ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/603/001-015

14.4.2011

14.4.2011

Bondenza

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/03/266/003-006

19.4.2011

14.4.2011

Bondronat

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/012/004

EU/1/96/012/009-013

18.4.2011

14.4.2011

Bonviva

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/03/265/003-006

19.4.2011

14.4.2011

Brinavess

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/645/001-002

18.4.2011

14.4.2011

Ceplene

| EpiCept GmbH |
| --- |
| Goethestrasse 4, D-80336 München, Deutschland |

EpiCept GmbH

Goethestrasse 4, D-80336 München, Deutschland

EU/1/08/477/001

18.4.2011

14.4.2011

Integrilin

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex, UB6 ONN, United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex, UB6 ONN, United Kingdom

EU/1/99/109/001-002

20.4.2011

14.4.2011

NutropinAq

| Ipsen Pharma |
| --- |
| 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65, quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/00/164/003-005

19.4.2011

14.4.2011

Preotact

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1, DK-4000 Roskilde, Danmark |

Nycomed Danmark ApS

Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/06/339/001-002

18.4.2011

14.4.2011

Rotarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/05/330/001-011

18.4.2011

14.4.2011

Travatan

| Alcon Laboratories (UK) Ltd. |
| --- |
| Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |

Alcon Laboratories (UK) Ltd.

Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom

EU/1/01/199/001-002

18.4.2011

14.4.2011

Zopya

| Norpharm Regulatory Services Ltd |
| --- |
| 26 Laurence Street, Drogheda, Co. Louth, Ireland |

Norpharm Regulatory Services Ltd

26 Laurence Street, Drogheda, Co. Louth, Ireland

EU/1/09/562/001-009

19.4.2011

18.4.2011

Arava

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118/001-010

21.4.2011

18.4.2011

DaTSCAN

| GE Healthcare Limited |
| --- |
| Little Chalfont, Bucks HP7 9NA, United Kingdom |

GE Healthcare Limited

Little Chalfont, Bucks HP7 9NA, United Kingdom

EU/1/00/135/001-002

21.4.2011

18.4.2011

Erbitux

| Merck KGaA |
| --- |
| Frankfurter Straße 250, 64271 Darmstadt, Deutschland |

Merck KGaA

Frankfurter Straße 250, 64271 Darmstadt, Deutschland

EU/1/04/281/001-005

21.4.2011

18.4.2011

Firazyr

| Jerini AG |
| --- |
| Invalidenstr. 130, D-10115 Berlin, Deutschland |

Jerini AG

Invalidenstr. 130, D-10115 Berlin, Deutschland

EU/1/08/461/001-002

21.4.2011

18.4.2011

Humalog

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/96/007/002

EU/1/96/007/004-006

EU/1/96/007/008

EU/1/96/007/010

EU/1/96/007/015-021

EU/1/96/007/023-038

21.4.2011

18.4.2011

Kaletra

| Abbott Laboratories |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom |

Abbott Laboratories

Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom

EU/1/01/172/001-008

21.4.2011

18.4.2011

Leflunomide Winthrop

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604/001-010

21.4.2011

18.4.2011

Modigraf

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/09/523/001-002

21.4.2011

18.4.2011

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/578/001

21.4.2011

18.4.2011

Pegasys

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/221/001-010

21.4.2011

18.4.2011

Rasilez

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405/001-040

21.4.2011

18.4.2011

Somavert

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/02/240/001-004

21.4.2011

18.4.2011

Telzir

| ViiV Healthcare UK Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/04/282/001-002

21.4.2011

18.4.2011

Thalidomide Celgene

| Celgene Europe Limited |
| --- |
| Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom |

Celgene Europe Limited

Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom

EU/1/08/443/001

18.4.2011

18.4.2011

Valtropin

| BioPartners GmbH |
| --- |
| Kaiserpassage 11 - D-72764 Reutlingen, Deutschland |

BioPartners GmbH

Kaiserpassage 11 - D-72764 Reutlingen, Deutschland

EU/1/06/335/001

21.4.2011

18.4.2011

Xyrem

| UCB Pharma Ltd. |
| --- |
| 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |

UCB Pharma Ltd.

208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

EU/1/05/312/001

21.4.2011

20.4.2011

Adcirca

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, NL-3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/476/005-006

27.4.2011

20.4.2011

Advagraf

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/07/387/001-026

28.4.2011

20.4.2011

Altargo

| Glaxo Group Limited |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/390/001-004

27.4.2011

20.4.2011

Efient

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/08/503/001-016

28.4.2011

20.4.2011

Herceptin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/145/001

27.4.2011

20.4.2011

Levitra

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/03/248/001-015

27.4.2011

20.4.2011

Liprolog

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/01/195/001-027

27.4.2011

20.4.2011

Prepandrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/08/453/002

28.4.2011

20.4.2011

Remicade

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, 2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

27.4.2011

20.4.2011

Revasc

| Canyon Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row - WC1R 4JS London - United Kingdom |

Canyon Pharmaceuticals Ltd

20-22 Bedford Row - WC1R 4JS London - United Kingdom

EU/1/97/043/001-003

27.4.2011

20.4.2011

Simponi

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, CB Leiden 2333, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, CB Leiden 2333, Nederland

EU/1/09/546/001-004

27.4.2011

20.4.2011

Tolura

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/10/632/001-021

28.4.2011

20.4.2011

Tysabri

| Elan Pharma International Ltd. |
| --- |
| Monksland, Athlone, County Westmeath, Ireland |

Elan Pharma International Ltd.

Monksland, Athlone, County Westmeath, Ireland

EU/1/06/346/001

27.4.2011

20.4.2011

Vivanza

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/03/249/001-012

27.4.2011

20.4.2011

Zerit

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/96/009/001-009

27.4.2011

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 24.3.2011 | Onsenal | Pfizer Limited |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

24.3.2011

Onsenal

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/03/259/001-006

29.3.2011

31.3.2011

Clopidogrel Sandoz

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, 83714 Miesbach, Deutschland |

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/547/001-007

4.4.2011

20.4.2011

Filgrastim ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/08/449/001-008

28.4.2011

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (2)
  ): Accepted

| Date of the Décision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.3.2011 | CaniLeish | Leishmania infantum Excreted Secreted Proteins (ESP) | VIRBAC S.A. |
| 1ère Avenue 2065 m L.I.D. - 06516 Carros - France |

Date of the Décision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

14.3.2011

CaniLeish

Leishmania infantum Excreted Secreted Proteins (ESP)

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/11/121/001-009

Lyophilisate and solvent for suspension for injection

QI07AO

17.3.2011

14.3.2011

ZULVAC 1+8 Ovis

Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 / Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/2/11/120/001-003

Suspension for injection

QI04AA02

17.3.2011

12.4.2011

Veraflox

Pradofloxacin

| Bayer Animal Health GmbH |
| --- |
| 51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

51368 Leverkusen, Deutschland

EU/2/10/107/001-014

Oral suspension Tablet

QJ01MA

14.4.2011

14.4.2011

BLUEVAC BTV8

Bluetongue virus inactivated, serotype 8

| CZ Veterinaria, S.A. |
| --- |
| La Relva s/n, P.O. Box 16, Porriño 36400, ESPANA |

CZ Veterinaria, S.A.

La Relva s/n, P.O. Box 16, Porriño 36400, ESPANA

EU/2/11/122/001-003

Suspension for injection

QI02AA08

QI04AA02

18.4.2011

20.4.2011

Procox

emodepside & toltrazuril

| Bayer Animal Health GmbH |
| --- |
| 51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

51368 Leverkusen, Deutschland

EU/2/11/123/001-002

Oral suspension

QP52AX60

28.4.2011

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 10.3.2011 | Flexicam | Dechra Veterinary Products A/S |
| Mekuvej 9, 7171 Uldum, Danmark |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

10.3.2011

Flexicam

Dechra Veterinary Products A/S

Mekuvej 9, 7171 Uldum, Danmark

EU/2/06/058/004

14.3.2011

14.3.2011

Zulvac 8 Bovis

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/2/09/105/001-002

17.3.2011

18.3.2011

Zubrin

| Schering - Plough Limited |
| --- |
| Schering - Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom |

Schering - Plough Limited

Schering - Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom

EU/2/00/028/002-008

23.3.2011

28.3.2011

BTVPUR AlSap 8

| MERIAL |
| --- |
| 29 avenue Tony Garnier, 69007 LYON, France |

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/09/094/001-005

31.3.2011

12.4.2011

Zactran

| MERIAL |
| --- |
| 29 avenue Tony Garnier, 69007 LYON, France |

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/08/082/001-007

14.4.2011

14.4.2011

Convenia

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/06/059/001

20.4.2011

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4H

---

(1)  OJ L 136, 30.4.04, p. 1.

(2)  OJ L 136, 30.4.04, p. 1.

---

| 24.6.2011 | EN | Official Journal of the European Union | C 184/17 |
| --- | --- | --- | --- |

24.6.2011

EN

Official Journal of the European Union

C 184/17

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 2011

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
  or Article 38 of Directive 2001/82/EC
   (2)
  )

2011/C 184/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 10.3.2011 | Tienam and associated names | See Annex I | See Annex I | 11.3.2011 |
| 17.3.2011 | INOmax - II 19 | INO Therapeutics AB, SE-181 81 Lidingö, Sverige | These Decisions are addressed to the Member States | 21.3.2011 |
| 18.3.2011 | INOmax - X 21 | INO Therapeutics AB, SE-181 81 Lidingö, Sverige | These Decisions are addressed to the Member States | 22.3.2011 |
| 14.3.2011 | Repso | Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland | These Decisions are addressed to the Member States | 16.3.2011 |
| 17.3.2011 | GILENYA | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | These Decisions are addressed to the Member States | 21.3.2011 |
| 28.3.2011 | Trobalt | Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | These Decisions are addressed to the Member States | 29.3.2011 |
| 10.3.2011 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Deutschland | These Decisions are addressed to the Member States | 11.3.2011 |
| 10.3.2011 | Leflunomide Teva | Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland | These Decisions are addressed to the Member States | 11.3.2011 |
| 14.3.2011 | Binocrit | Sandoz GmbH, Biochemiestrasse 10, Kundl 6250, Österreich | These Decisions are addressed to the Member States | 16.3.2011 |
| 14.4.2011 | Brinavess | Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | These Decisions are addressed to the Member States | 15.4.2011 |
| 14.3.2011 | Epoetin alfa Hexal | Hexal AG., Industriestrasse 25, D-83607 Holzkirchen, Deutschland | These Decisions are addressed to the Member States | 17.3.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

10.3.2011

Tienam and associated names

See Annex I

See Annex I

11.3.2011

17.3.2011

INOmax - II 19

INO Therapeutics AB, SE-181 81 Lidingö, Sverige

These Decisions are addressed to the Member States

21.3.2011

18.3.2011

INOmax - X 21

INO Therapeutics AB, SE-181 81 Lidingö, Sverige

These Decisions are addressed to the Member States

22.3.2011

14.3.2011

Repso

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland

These Decisions are addressed to the Member States

16.3.2011

17.3.2011

GILENYA

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

These Decisions are addressed to the Member States

21.3.2011

28.3.2011

Trobalt

Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

These Decisions are addressed to the Member States

29.3.2011

10.3.2011

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Deutschland

These Decisions are addressed to the Member States

11.3.2011

10.3.2011

Leflunomide Teva

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland

These Decisions are addressed to the Member States

11.3.2011

14.3.2011

Binocrit

Sandoz GmbH, Biochemiestrasse 10, Kundl 6250, Österreich

These Decisions are addressed to the Member States

16.3.2011

14.4.2011

Brinavess

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

These Decisions are addressed to the Member States

15.4.2011

14.3.2011

Epoetin alfa Hexal

Hexal AG., Industriestrasse 25, D-83607 Holzkirchen, Deutschland

These Decisions are addressed to the Member States

17.3.2011

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 20.4.2011 | morphine/oxycodone/hydromorphone | See Annex II | See Annex II | 26.4.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

20.4.2011

morphine/oxycodone/hydromorphone

See Annex II

See Annex II

26.4.2011

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Merck Sharp & Dohme Ges.m.b.H. Am Euro Platz 2 |
| 1120 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Merck Sharp & Dohme Ges.m.b.H. Am Euro Platz 2

1120 Wien

Austria

Zienam 500 mg Trockensubstanz zur Infusionsbereitung

500 mg

Powder for solution for infusion

Intravenous use

Belgium

| Merck Sharp & Dohme B.V. |
| --- |
| Chaussée de Waterloo 1135 |
| 1180 Bruxelles |
| Belgium |

Merck Sharp & Dohme B.V.

Chaussée de Waterloo 1135

1180 Bruxelles

Belgium

Tienam 500 mg, poudre pour solution pour perfusion / Tienam Monovial 500 mg, poudre pour solution pour perfusion

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Bulgaria

| Merck Sharp & Dohme Bulgaria EOOD 55, Nikola Vaptzarov Blvd., Expo 2000 Sofia 1407 |
| --- |
| Bulgaria |

Merck Sharp & Dohme Bulgaria EOOD 55, Nikola Vaptzarov Blvd., Expo 2000 Sofia 1407

Bulgaria

Tienam 500/500 mg powder for solution for infusion

Тиенам 500/500 mg прах за инфузионен разтвор

500/500mg

Powder for solution for infusion

Intravenous use

Czech Republic

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, |
| 2031 BN Haarlem, |
| The Netherlands |

Merck Sharp & Dohme B.V.

Waarderweg 39,

2031 BN Haarlem,

The Netherlands

Tienam i.v.

500mg /500mg i.v.

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi St 46, 11415 Tallinn |
| Estonia |

Merck Sharp & Dohme OÜ

Peterburi St 46, 11415 Tallinn

Estonia

TIENAM I.V. 500 MG/500 MG

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, |
| 2031 BN Haarlem, |
| The Netherlands |

Merck Sharp & Dohme B.V.

Waarderweg 39,

2031 BN Haarlem,

The Netherlands

TIENAM

500 mg/500 mg

Powder for solution for infusion

Intravenous use

France

| Merck Sharp & Dohme Chibret |
| --- |
| 3 avenue Hoche |
| 75114 Paris cedex 08 |
| France |

Merck Sharp & Dohme Chibret

3 avenue Hoche

75114 Paris cedex 08

France

TIENAM 500 mg/500 mg, poudre pour perfusion avec système de transfert pour poche

500 mg/500 mg

Powder for infusion

Intravenous use

France

| Merck Sharp & Dohme Chibret |
| --- |
| 3 avenue Hoche |
| 75114 Paris cedex 08 |
| France |

Merck Sharp & Dohme Chibret

3 avenue Hoche

75114 Paris cedex 08

France

TIENAM 250 mg/250 mg, poudre pour perfusion

250 mg/250 mg

Powder for infusion

Intravenous use

France

| Merck Sharp & Dohme Chibret |
| --- |
| 3 avenue Hoche |
| 75114 Paris cedex 08 |
| France |

Merck Sharp & Dohme Chibret

3 avenue Hoche

75114 Paris cedex 08

France

TIENAM 500 mg/500 mg, poudre pour perfusion

500 mg/500 mg

Powder for infusion

Intravenous use

France

| Merck Sharp & Dohme Chibret |
| --- |
| 3 avenue Hoche |
| 75114 Paris cedex 08 |
| France |

Merck Sharp & Dohme Chibret

3 avenue Hoche

75114 Paris cedex 08

France

TIENAM 500 mg/500 mg, poudre et solution pour usage parentéral (IM)

500 mg/500 mg

Powder for suspension for parenteral use (IM)

Intramuscular use

Germany

| MSD SHARP & DOHME GMBH |
| --- |
| Lindenplatz 1 |
| D-85540 Haar |
| Germany |

MSD SHARP & DOHME GMBH

Lindenplatz 1

D-85540 Haar

Germany

ZIENAMo 500 mg

Pulver zur Herstellung einer Infusionslösung

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Greece

| Vianex S.A |
| --- |
| Tatoiou str. |
| 18th Km Athens-Lamia National Road |
| 14671 Nea Erythrea |
| Greece |

Vianex S.A

Tatoiou str.

18th Km Athens-Lamia National Road

14671 Nea Erythrea

Greece

Primaxin DR.PD.INJ (500+500)mg/Vial (IV)

500 mg

Dry Powder for injection

Intravenous use

Greece

| Vianex S.A |
| --- |
| Tatoiou str. |
| 18th Km Athens-Lamia National Road |
| 14671 Nea Erythrea |
| Greece |

Vianex S.A

Tatoiou str.

18th Km Athens-Lamia National Road

14671 Nea Erythrea

Greece

Primaxin DR.PD.INJ (250+250mg/Vial (IV)

250mg

Dry Powder for injection

Intravenous use

Hungary

| MSD Hungary Ltd. |
| --- |
| 1123 Budapest, Alkotás u. 50. |
| Hungary |

MSD Hungary Ltd.

1123 Budapest, Alkotás u. 50.

Hungary

Tienam

500 mg

Powder for solution for infusion

Intravenous infusion

Iceland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem |
| The Netherlands |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem

The Netherlands

Tienam

500 mg/500 mg

Powder for solution for infusion

Intravenous infusion

Ireland

| Merck Sharp & Dohme Ireland (Human Health) Limited |
| --- |
| Pelham House |
| South County Business Park |
| Leopardstown |
| Dublin 18 |
| Ireland |

Merck Sharp & Dohme Ireland (Human Health) Limited

Pelham House

South County Business Park

Leopardstown

Dublin 18

Ireland

Primaxin IV

500mg/500mg Powder for Solution for Infusion

500 mg/500 mg

Powder for solution for infusion

Intravenous infusion

Italy

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via Vitorchiano, 151 – 00189 Roma |
| Italy |

Merck Sharp & Dohme (Italia) S.p.A.

Via Vitorchiano, 151 – 00189 Roma

Italy

TIENAM (20 ml)

500 mg/500 mg

Powder for solution for infusion

Intravenous infusion

Italy

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via Vitorchiano, 151 – 00189 Roma |
| Italy |

Merck Sharp & Dohme (Italia) S.p.A.

Via Vitorchiano, 151 – 00189 Roma

Italy

IMIPEM (20 ml)

500 mg/500 mg

Powder for solution for infusion

Intravenous infusion

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A, |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| Italy |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A,

Viale Shakespeare, 47

00144 Roma

Italy

TENACID (20 ml)

500 mg/500 mg

Powder for solution for infusion

Intravenous infusion

Latvia

| SIA „Merck Sharp & Dohme Latvija“, Skanstes 13, Riga, LV-1013 |
| --- |
| Latvia |

SIA „Merck Sharp & Dohme Latvija“, Skanstes 13, Riga, LV-1013

Latvia

TIENAM I.V.

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Lithuania

| Merck Sharp & Dohme, UAB, |
| --- |
| Kęstučio 59/27, LT-08124 Vilnius |
| Lithuania |

Merck Sharp & Dohme, UAB,

Kęstučio 59/27, LT-08124 Vilnius

Lithuania

TIENAM I.V.

500 mg + 500 mg

Powder for solution for injection

Intravenous use

Luxembourg

| Merck Sharp & Dohme B.V. |
| --- |
| Chaussée de Waterloo 1135 |
| 1180 Bruxelles |
| Belgium |

Merck Sharp & Dohme B.V.

Chaussée de Waterloo 1135

1180 Bruxelles

Belgium

Tienam 500 mg, poudre pour solution pour perfusion / Tienam Monovial 500 mg, poudre pour solution pour perfusion

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Malta

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU

United Kingdom

Primaxin IV 500mg Injection

500mg

Powder for concentrate for solution for infusion

Intravenous use

Netherlands

| Merck Sharp & Dohme BV |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |
| The Netherlands |

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

The Netherlands

Tiënam I.V.

250 mg and 500 mg

Powder for solution for infusion

Intravenous use

Norway

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem |
| The Netherlands |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem

The Netherlands

Tienam

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Poland

| MSD Polska Sp. z o.o. |
| --- |
| ul. Chłodna 51 |
| 00-867 Warszawa |
| Poland |

MSD Polska Sp. z o.o.

ul. Chłodna 51

00-867 Warszawa

Poland

TIENAM

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| P.O. BOX 214 |
| Porto Salvo |
| 2770-192 Paço de Arcos |
| Portugal |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

P.O. BOX 214

Porto Salvo

2770-192 Paço de Arcos

Portugal

Tienam IV

500 mg / 500 mg

Powder for solution for infusion

Intravenous use

Romania

| Merck Sharp & Dohme Romania S.R.L. |
| --- |
| Bucharest Business Park, Șos. București-Ploiești Nr.1A, Clădirea C1, Etaj 3, Sector 1, București |
| Romania |

Merck Sharp & Dohme Romania S.R.L.

Bucharest Business Park, Șos. București-Ploiești Nr.1A, Clădirea C1, Etaj 3, Sector 1, București

Romania

TIENAM I.V., pulbere pentru soluție perfuzabilă

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Slovak Republic

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem |
| P.O. Box 581, 2003 PC Haarlem |
| The Netherlands |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem

P.O. Box 581, 2003 PC Haarlem

The Netherlands

TIENAM i.v.

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Slovenia

| Merck Sharp & Dohme, |
| --- |
| inovativna zdravila d.o.o. |
| Šmartinska cesta 140, |
| 1000 Ljubljana, Slovenia |

Merck Sharp & Dohme,

inovativna zdravila d.o.o.

Šmartinska cesta 140,

1000 Ljubljana, Slovenia

CONET 500 mg/500 mg prašek za raztopino za infundiranje

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Spain

| Merck Sharp & Dohme de España, S.A. |
| --- |
| C/ Josefa Valcárcel, 38 |
| 28027 Madrid |
| Spain |

Merck Sharp & Dohme de España, S.A.

C/ Josefa Valcárcel, 38

28027 Madrid

Spain

TIENAM I.V. 500 mg powder for solution for infusion

500 mg/500 mg

Powder for solution for infusion

Intravenous use

Sweden

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, |
| Haarlem, P.O.Box 581, |
| 2003 PC Haarlem |
| The Netherlands |

Merck Sharp & Dohme B.V.

Waarderweg 39,

Haarlem, P.O.Box 581,

2003 PC Haarlem

The Netherlands

Tienam

500 mg/500 mg

Powder for solution for infusion

Intravenous use

United Kingdom

| Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU |
| --- |
| United Kingdom |

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU

United Kingdom

PrimaxinIV 500mg Injection

500mg

Powder for concentrate for solution for infusion

Intravenous use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)

| Member State (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | betapharm Arzneimittel GmbH Kobelweg 95 |
| 86156 Augsburg |
| Germany |

Member State (EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

AT - Austria

betapharm Arzneimittel GmbH Kobelweg 95

86156 Augsburg

Germany

Carenox 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

AT - Austria

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

86156 Augsburg

Germany

Carenox 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

AT - Austria

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

86156 Augsburg

Germany

Merlodon 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

AT - Austria

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

86156 Augsburg

Germany

Merlodon 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

AT - Austria

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

86156 Augsburg

Germany

Merlodon 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

AT - Austria

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

86156 Augsburg

Germany

Merlodon 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

AT - Austria

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

86156 Augsburg

Germany

Merlodon 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX

France

M - dolor retard 10 mg - Kapseln

10 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX

France

M - dolor retard 100 mg - Kapseln

100 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX

France

M - dolor retard 200 mg - Kapseln

200 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX

France

M - dolor retard 30 mg - Kapseln

30 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX

France

M - dolor retard 60 mg - Kapseln

60 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Vendal retard 10 mg - Filmtabletten

10 mg

Prolonged-release tablet

Oral use

AT - Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Vendal retard 100 mg - Filmtabletten

100 mg

Prolonged-release tablet

Oral use

AT - Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Vendal retard 200 mg - Filmtabletten

200 mg

Prolonged-release tablet

Oral use

AT - Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Vendal retard 30 mg - Filmtabletten

30 mg

Prolonged-release tablet

Oral use

AT - Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Vendal retard 60 mg - Filmtabletten

60 mg

Prolonged-release tablet

Oral use

AT - Austria

| GlaxoSmithKline Pharma GmbH |
| --- |
| Albert-Schweitzer-Gasse 6 |
| 1140 Wien |
| Austria |

GlaxoSmithKline Pharma GmbH

Albert-Schweitzer-Gasse 6

1140 Wien

Austria

Kapanol CSR 100 mg - Kapseln

100 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| GlaxoSmithKline Pharma GmbH |
| --- |
| Albert-Schweitzer-Gasse 6 |
| 1140 Wien |
| Austria |

GlaxoSmithKline Pharma GmbH

Albert-Schweitzer-Gasse 6

1140 Wien

Austria

Kapanol CSR 50 mg - Kapseln

50 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 |
| --- |
| 1020 Wien |
| Austria |

Hexal Pharma GmbH Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Oxycodon Hexal 10 mg - Retardtabletten

10 mg

Prolonged-release tablet

Oral use

AT - Austria

| Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 |
| --- |
| 1020 Wien |
| Austria |

Hexal Pharma GmbH Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Oxycodon Hexal 20 mg - Retardtabletten

20 mg

Prolonged-release tablet

Oral use

AT - Austria

| Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 |
| --- |
| 1020 Wien |
| Austria |

Hexal Pharma GmbH Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Oxycodon Hexal 40 mg - Retardtabletten

40 mg

Prolonged-release tablet

Oral use

AT - Austria

| Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 |
| --- |
| 1020 Wien |
| Austria |

Hexal Pharma GmbH Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Oxycodon Hexal 5 mg - Retardtabletten

5 mg

Prolonged-release tablet

Oral use

AT - Austria

| Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 |
| --- |
| 1020 Wien |
| Austria |

Hexal Pharma GmbH Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Oxycodon Hexal 80 mg - Retardtabletten

80 mg

Prolonged-release tablet

Oral use

AT - Austria

| Janssen - Cilag Pharma GmbH Vorgartenstraße 206b |
| --- |
| 1020 Wien |
| Austria |

Janssen - Cilag Pharma GmbH Vorgartenstraße 206b

1020 Wien

Austria

Jurnista 16 mg - Retardtabletten

16 mg

Prolonged-release tablet

Oral use

AT - Austria

| Janssen - Cilag Pharma GmbH Vorgartenstraße 206b |
| --- |
| 1020 Wien |
| Austria |

Janssen - Cilag Pharma GmbH Vorgartenstraße 206b

1020 Wien

Austria

Jurnista 32 mg - Retardtabletten

32 mg

Prolonged-release tablet

Oral use

AT - Austria

| Janssen - Cilag Pharma GmbH Vorgartenstraße 206b |
| --- |
| 1020 Wien |
| Austria |

Janssen - Cilag Pharma GmbH Vorgartenstraße 206b

1020 Wien

Austria

Jurnista 4 mg - Retardtabletten

4 mg

Prolonged-release tablet

Oral use

AT - Austria

| Janssen - Cilag Pharma GmbH Vorgartenstraße 206b |
| --- |
| 1020 Wien |
| Austria |

Janssen - Cilag Pharma GmbH Vorgartenstraße 206b

1020 Wien

Austria

Jurnista 64 mg - Retardtabletten

64 mg

Prolonged-release tablet

Oral use

AT - Austria

| Janssen - Cilag Pharma GmbH Vorgartenstraße 206b |
| --- |
| 1020 Wien |
| Austria |

Janssen - Cilag Pharma GmbH Vorgartenstraße 206b

1020 Wien

Austria

Jurnista 8 mg - Retardtabletten

8 mg

Prolonged-release tablet

Oral use

AT - Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Compensan retard 100 mg - Filmtabletten

100 mg

Prolonged-release tablet

Oral use

AT - Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Compensan retard 200 mg - Filmtabletten

200 mg

Prolonged-release tablet

Oral use

AT - Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Compensan retard 300 mg - Filmtabletten

300 mg

Prolonged-release tablet

Oral use

AT - Austria

| Lannacher Heilmittel GmbH Schloßplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel GmbH Schloßplatz 1

8502 Lannach

Austria

Morphinhydrochlorid Lannacher retard 10 mg - Filmtabletten

10 mg

Prolonged-release tablet

Oral use

AT - Austria

| Lannacher Heilmittel GmbH Schloßplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel GmbH Schloßplatz 1

8502 Lannach

Austria

Morphinhydrochlorid Lannacher retard 100 mg - Filmtabletten

100 mg

Prolonged-release tablet

Oral use

AT - Austria

| Lannacher Heilmittel GmbH Schloßplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel GmbH Schloßplatz 1

8502 Lannach

Austria

Morphinhydrochlorid Lannacher retard 200 mg - Filmtabletten

200 mg

Prolonged-release tablet

Oral use

AT - Austria

| Lannacher Heilmittel GmbH Schloßplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel GmbH Schloßplatz 1

8502 Lannach

Austria

Morphinhydrochlorid Lannacher retard 30 mg - Filmtabletten

30 mg

Prolonged-release tablet

Oral use

AT - Austria

| Lannacher Heilmittel GmbH Schloßplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel GmbH Schloßplatz 1

8502 Lannach

Austria

Morphinhydrochlorid Lannacher retard 60 mg - Filmtabletten

60 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Hydal retard 16 mg - Kapseln

16 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Hydal retard 2 mg - Kapseln

2 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Hydal retard 24 mg - Kapseln

24 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Hydal retard 4 mg - Kapseln

4 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Hydal retard 8 mg - Kapseln

8 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Hydal Uno retard 12 mg - Kapseln

12 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Hydal Uno retard 16 mg - Kapseln

16 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Hydal Uno retard 24 mg - Kapseln

24 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Hydal Uno retard 32 mg - Kapseln

32 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Mundidol retard 10 mg - Filmtabletten

10 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Mundidol retard 100 mg - Filmtabletten

100 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Mundidol retard 200 mg - Filmtabletten

200 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Mundidol retard 30 mg - Filmtabletten

30 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Mundidol retard 60 mg - Filmtabletten

60 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Mundidol Uno retard 120 mg - Kapseln

120 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Mundidol Uno retard 200 mg - Kapseln

200 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Mundidol Uno retard 30 mg - Kapseln

30 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Mundidol Uno retard 60 mg - Kapseln

60 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

OxyContin retard 10 mg Filmtabletten

10 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

OxyContin retard 20 mg Filmtabletten

20 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

OxyContin retard 40 mg Filmtabletten

40 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

OxyContin retard 5 mg Filmtabletten

5 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

OxyContin retard 80 mg Filmtabletten

80 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Substitol retard 120 mg - Kapseln

120 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Substitol retard 200 mg - Kapseln

200 mg

Prolonged-release capsule, hard

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Targin 10 mg/5 mg Retardtabletten

10 mg/5 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Targin 20 mg/10 mg Retardtabletten

20 mg/10 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Targin 40 mg/20 mg Retardtabletten

40 mg/20 mg

Prolonged-release tablet

Oral use

AT - Austria

| Mundipharma GmbH Apollogasse 16-18 1070 Wien |
| --- |
| Austria |

Mundipharma GmbH Apollogasse 16-18 1070 Wien

Austria

Targin 5 mg/2,5 mg Retardtabletten

5 mg/2,5 mg

Prolonged-release tablet

Oral use

AT - Austria

| Pharmachemie B.V. |
| --- |
| Swensweg 5, P.O. Box 552 2003 RN Haarlem |
| Netherlands |

Pharmachemie B.V.

Swensweg 5, P.O. Box 552 2003 RN Haarlem

Netherlands

Relimal 200 mg Retardtabletten

200 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

1140 Wien

Austria

Hydromorphon ratiopharm 16 mg Retardtabletten

16 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

1140 Wien

Austria

Hydromorphon ratiopharm 24 mg Retardtabletten

24 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

1140 Wien

Austria

Hydromorphon ratiopharm 4 mg Retardtabletten

4 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

1140 Wien

Austria

Hydromorphon ratiopharm 8 mg Retardtabletten

8 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

1140 Wien

Austria

Oxycodon-HCl-ratiopharm 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

1140 Wien

Austria

Oxycodon-HCl-ratiopharm 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

1140 Wien

Austria

Oxycodon-HCl-ratiopharm 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

1140 Wien

Austria

Oxycodon-HCl-ratiopharm 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

AT - Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

1140 Wien

Austria

Oxycodon-HCl-ratiopharm 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

AT - Austria

| Stada Arzneimittel GmbH Muthgasse 36 |
| --- |
| 1190 Wien |
| Austria |

Stada Arzneimittel GmbH Muthgasse 36

1190 Wien

Austria

Oxycodon-HCl STADA 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

AT - Austria

| Stada Arzneimittel GmbH Muthgasse 36 |
| --- |
| 1190 Wien |
| Austria |

Stada Arzneimittel GmbH Muthgasse 36

1190 Wien

Austria

Oxycodon-HCl STADA 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

AT - Austria

| Stada Arzneimittel GmbH Muthgasse 36 |
| --- |
| 1190 Wien |
| Austria |

Stada Arzneimittel GmbH Muthgasse 36

1190 Wien

Austria

Oxycodon-HCl STADA 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

AT - Austria

| Stada Arzneimittel GmbH Muthgasse 36 |
| --- |
| 1190 Wien |
| Austria |

Stada Arzneimittel GmbH Muthgasse 36

1190 Wien

Austria

Oxycodon-HCl STADA 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

AT - Austria

| Stada Arzneimittel GmbH Muthgasse 36 |
| --- |
| 1190 Wien |
| Austria |

Stada Arzneimittel GmbH Muthgasse 36

1190 Wien

Austria

Oxycodon-HCl STADA 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

AT - Austria

| Yes Pharmaceutical Development Services GmbH |
| --- |
| Bahnstraße 42-46 61381 Friedrichsdorf Germany |

Yes Pharmaceutical Development Services GmbH

Bahnstraße 42-46 61381 Friedrichsdorf Germany

Maridolor 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

AT - Austria

| Yes Pharmaceutical Development Services GmbH |
| --- |
| Bahnstraße 42-46 61381 Friedrichsdorf Germany |

Yes Pharmaceutical Development Services GmbH

Bahnstraße 42-46 61381 Friedrichsdorf Germany

Maridolor 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

AT - Austria

| Yes Pharmaceutical Development Services GmbH |
| --- |
| Bahnstraße 42-46 61381 Friedrichsdorf Germany |

Yes Pharmaceutical Development Services GmbH

Bahnstraße 42-46 61381 Friedrichsdorf Germany

Maridolor 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

AT - Austria

| Yes Pharmaceutical Development Services GmbH |
| --- |
| Bahnstraße 42-46 61381 Friedrichsdorf Germany |

Yes Pharmaceutical Development Services GmbH

Bahnstraße 42-46 61381 Friedrichsdorf Germany

Oxycodon-HCl ‘YES’ 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

AT - Austria

| Yes Pharmaceutical Development Services GmbH |
| --- |
| Bahnstraße 42-46 61381 Friedrichsdorf Germany |

Yes Pharmaceutical Development Services GmbH

Bahnstraße 42-46 61381 Friedrichsdorf Germany

Oxycodon-HCl ‘YES’ 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

BE - Belgium

| DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven |
| --- |
| Belgium |

DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven

Belgium

DOC MORFINE 10 MG

10 mg

Prolonged-release tablet

Oral use

BE - Belgium

| DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven |
| --- |
| Belgium |

DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven

Belgium

DOC MORFINE 100 MG

100 mg

Prolonged-release tablet

Oral use

BE - Belgium

| DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven |
| --- |
| Belgium |

DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven

Belgium

DOC MORFINE 30 MG

30 mg

Prolonged-release tablet

Oral use

BE - Belgium

| DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven |
| --- |
| Belgium |

DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven

Belgium

DOC MORFINE 60 MG

60 mg

Prolonged-release tablet

Oral use

BE - Belgium

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ETHYPHARM MORPHINE SULPHATE 10 MG

10 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ETHYPHARM MORPHINE SULPHATE 100 MG

100 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ETHYPHARM MORPHINE SULPHATE 30 MG

30 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ETHYPHARM MORPHINE SULPHATE 60 MG

60 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

OPIDUR 120 MG

120 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

OPIDUR 200 MG

200 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

OPIDUR 20 MG

20 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

OPIDUR 40 MG

40 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

OPIDUR 60 MG

60 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| GLAXOSMITHKLINE S.A. Rue Du Tilleul 13 |
| --- |
| 1332 Genval |
| Belgium |

GLAXOSMITHKLINE S.A. Rue Du Tilleul 13

1332 Genval

Belgium

KAPANOL 100 MG

100 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| GLAXOSMITHKLINE S.A. Rue Du Tilleul 13 |
| --- |
| 1332 Genval |
| Belgium |

GLAXOSMITHKLINE S.A. Rue Du Tilleul 13

1332 Genval

Belgium

KAPANOL 20 MG

20 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| GLAXOSMITHKLINE S.A. Rue Du Tilleul 13 |
| --- |
| 1332 Genval |
| Belgium |

GLAXOSMITHKLINE S.A. Rue Du Tilleul 13

1332 Genval

Belgium

KAPANOL 50 MG

50 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16 |
| --- |
| 2610 Wilrijk |
| Belgium |

I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16

2610 Wilrijk

Belgium

MORPHISIN 10

10 mg

Modified-release tablet

Oral use

BE - Belgium

| I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16 |
| --- |
| 2610 Wilrijk |
| Belgium |

I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16

2610 Wilrijk

Belgium

MORPHISIN 100

100 mg

Modified-release tablet

Oral use

BE - Belgium

| I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16 |
| --- |
| 2610 Wilrijk |
| Belgium |

I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16

2610 Wilrijk

Belgium

MORPHISIN 30

30 mg

Modified-release tablet

Oral use

BE - Belgium

| I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16 |
| --- |
| 2610 Wilrijk |
| Belgium |

I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16

2610 Wilrijk

Belgium

MORPHISIN 60

60 mg

Modified-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

MS CONTIN 10 MG

10 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

MS CONTIN 100 MG

100 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

MS CONTIN 15 MG

15 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

MS CONTIN 200 MG

200 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

MS CONTIN 30 MG

30 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

MS CONTIN 5 MG

5 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

MS CONTIN 60 MG

60 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

MS DIRECT 10 MG EX SEVREDOL

10 mg

Film-coated tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

MS DIRECT 20 MG EX SEVREDOL

20 mg

Film-coated tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 10 MG

10 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 120 MG

120 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 15 MG

15 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 160 MG

160 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 20 MG

20 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 30 MG

30 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 40 MG

40 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 5 MG

5 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 60 MG

60 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

OXYCONTIN 80 MG

80 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

TARGINACT 10 MG/5 MG

10,5 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

TARGINACT 20 MG/10 MG

21 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

TARGINACT 40 MG/20 MG

42 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

TARGINACT 5 MG/2,5 MG

5,25 mg

Prolonged-release tablet

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

PALLADONE IMMEDIATE RELEASE 1,3 MG

1,3 mg

Capsule, hard

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

PALLADONE IMMEDIATE RELEASE 2,6 MG

2,6 mg

Capsule, hard

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

PALLADONE SLOW RELEASE 16 MG*

16 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

PALLADONE SLOW RELEASE 24 MG*

24 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

PALLADONE SLOW RELEASE 4 MG

4 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 |
| --- |
| Mechelen |
| Belgium |

MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800

Mechelen

Belgium

PALLADONE SLOW RELEASE 8 MG

8 mg

Prolonged-release capsule, hard

Oral use

BE - Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens Medialaan 40 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens Medialaan 40 1800 Vilvoorde

Belgium

OXYCODON SANDOZ 10 MG

10 mg

Prolonged-release tablet

Oral use

BE - Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens Medialaan 40 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens Medialaan 40 1800 Vilvoorde

Belgium

OXYCODON SANDOZ 10 MG

10 mg

Prolonged-release tablet

Oral use

BE - Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens Medialaan 40 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens Medialaan 40 1800 Vilvoorde

Belgium

OXYCODON SANDOZ 20 MG

20 mg

Prolonged-release tablet

Oral use

BE - Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens Medialaan 40 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens Medialaan 40 1800 Vilvoorde

Belgium

OXYCODON SANDOZ 20 MG

20 mg

Prolonged-release tablet

Oral use

BE - Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens Medialaan 40 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens Medialaan 40 1800 Vilvoorde

Belgium

OXYCODON SANDOZ 5 MG

5 mg

Prolonged-release tablet

Oral use

BE - Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens Medialaan 40 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens Medialaan 40 1800 Vilvoorde

Belgium

OXYCODON SANDOZ 5 MG

5 mg

Prolonged-release tablet

Oral use

BE - Belgium

| TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk |
| --- |
| Belgium |

TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk

Belgium

MORPHINE TEVA 10 MG

10 mg

Modified-release tablet

Oral use

BE - Belgium

| TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk |
| --- |
| Belgium |

TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk

Belgium

MORPHINE TEVA 100 MG

100 mg

Modified-release tablet

Oral use

BE - Belgium

| TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk |
| --- |
| Belgium |

TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk

Belgium

MORPHINE TEVA 30 MG

30 mg

Modified-release tablet

Oral use

BE - Belgium

| TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk |
| --- |
| Belgium |

TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk

Belgium

MORPHINE TEVA 60 MG

60 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

MST-Continus

10 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

MST-Continus

30 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

MST-Continus

60 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

MST-Continus

100 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

OxyContin

10 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

OxyContin

20 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

OxyContin

40 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

OxyContin

80 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

Substitol

120 mg

Prolonged-release capsule

Oral use

BG - Bulgaria

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18, Postfach 83 |
| 1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18, Postfach 83

1072 Vienna

Austria

Substitol

200 mg

Prolonged-release capsule

Oral use

BG - Bulgaria

| Nycomed Danmark A/S |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark A/S

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

10 mg

Prolonged-release tablet

Oral use

BG - Bulgaria

| Nycomed Danmark A/S |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark A/S

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

30 mg

Prolonged-release tablet

Oral use

BG - Bulgaria

| Nycomed Danmark A/S |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark A/S

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

60 mg

Prolonged-release tablet

Oral use

BG - Bulgaria

| Nycomed Danmark A/S |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark A/S

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

100 mg

Prolonged-release tablet

Oral use

BG - Bulgaria

| Тева Фармасютикълс България ЕООД, ул. „Н.В.Гогол“ 15, ет.1 |
| --- |
| 1124 София |
| България |

Тева Фармасютикълс България ЕООД, ул. „Н.В.Гогол“ 15, ет.1

1124 София

България

Morphine Teva

10 mg

Prolonged-release tablet

Oral use

BG - Bulgaria

| Тева Фармасютикълс България ЕООД, ул. „Н.В.Гогол“ 15, ет.1 |
| --- |
| 1124 София |
| България |

Тева Фармасютикълс България ЕООД, ул. „Н.В.Гогол“ 15, ет.1

1124 София

България

Morphine Teva

30 mg

Prolonged-release tablet

Oral use

BG - Bulgaria

| Тева Фармасютикълс България ЕООД, ул. „Н.В.Гогол“ 15, ет.1 |
| --- |
| 1124 София |
| България |

Тева Фармасютикълс България ЕООД, ул. „Н.В.Гогол“ 15, ет.1

1124 София

България

Morphine Teva

60 mg

Prolonged-release tablet

Oral use

BG - Bulgaria

| Тева Фармасютикълс България ЕООД, ул. „Н.В.Гогол“ 15, ет.1 |
| --- |
| 1124 София |
| България |

Тева Фармасютикълс България ЕООД, ул. „Н.В.Гогол“ 15, ет.1

1124 София

България

Morphine Teva

100 mg

Prolonged-release tablet

Oral use

CY - Cyprus

| Mundipharma Pharmaceuticals Ltd |
| --- |
| 13 Othellos street, P.O.Box 23661 |
| 1685 Lefkosia |
| Cyprus |

Mundipharma Pharmaceuticals Ltd

13 Othellos street, P.O.Box 23661

1685 Lefkosia

Cyprus

MST CONTINUS PR TABLETS 100 mg

100 mg

Prolonged-release tablet

Oral use

CY - Cyprus

| Mundipharma Pharmaceuticals Ltd |
| --- |
| 13 Othellos street, P.O.Box 23661 |
| 1685 Lefkosia |
| Cyprus |

Mundipharma Pharmaceuticals Ltd

13 Othellos street, P.O.Box 23661

1685 Lefkosia

Cyprus

MST CONTINUS PR TABLETS 10 mg

10 mg

Prolonged-release tablet

Oral use

CY - Cyprus

| Mundipharma Pharmaceuticals Ltd |
| --- |
| 13 Othellos street, P.O.Box 23661 |
| 1685 Lefkosia |
| Cyprus |

Mundipharma Pharmaceuticals Ltd

13 Othellos street, P.O.Box 23661

1685 Lefkosia

Cyprus

MST CONTINUS PR TABLETS 30 mg

30 mg

Prolonged-release tablet

Oral use

CY - Cyprus

| Mundipharma Pharmaceuticals Ltd |
| --- |
| 13 Othellos street, P.O.Box 23661 |
| 1685 Lefkosia |
| Cyprus |

Mundipharma Pharmaceuticals Ltd

13 Othellos street, P.O.Box 23661

1685 Lefkosia

Cyprus

MST CONTINUS PR TABLETS 60 mg

60 mg

Prolonged-release tablet

Oral use

CY - Cyprus

| Mundipharma Pharmaceuticals Ltd |
| --- |
| 13 Othellos street, P.O.Box 23661 |
| 1685 Lefkosia |
| Cyprus |

Mundipharma Pharmaceuticals Ltd

13 Othellos street, P.O.Box 23661

1685 Lefkosia

Cyprus

OXYCONTIN PR TABLETS 10 mg

10 mg

Prolonged-release tablet

Oral use

CY - Cyprus

| Mundipharma Pharmaceuticals Ltd |
| --- |
| 13 Othellos street, P.O.Box 23661 |
| 1685 Lefkosia |
| Cyprus |

Mundipharma Pharmaceuticals Ltd

13 Othellos street, P.O.Box 23661

1685 Lefkosia

Cyprus

OXYCONTIN PR TABLETS 20 mg

20 mg

Prolonged-release tablet

Oral use

CY - Cyprus

| Mundipharma Pharmaceuticals Ltd |
| --- |
| 13 Othellos street, P.O.Box 23661 |
| 1685 Lefkosia |
| Cyprus |

Mundipharma Pharmaceuticals Ltd

13 Othellos street, P.O.Box 23661

1685 Lefkosia

Cyprus

OXYCONTIN PR TABLETS 40 mg

40 mg

Prolonged-release tablet

Oral use

CY - Cyprus

| Mundipharma Pharmaceuticals Ltd |
| --- |
| 13 Othellos street, P.O.Box 23661 |
| 1685 Lefkosia |
| Cyprus |

Mundipharma Pharmaceuticals Ltd

13 Othellos street, P.O.Box 23661

1685 Lefkosia

Cyprus

OXYCONTIN PR TABLETS 5 mg

5 mg

Prolonged-release tablet

Oral use

CY - Cyprus

| Mundipharma Pharmaceuticals Ltd |
| --- |
| 13 Othellos street, P.O.Box 23661 |
| 1685 Lefkosia |
| Cyprus |

Mundipharma Pharmaceuticals Ltd

13 Othellos street, P.O.Box 23661

1685 Lefkosia

Cyprus

OXYCONTIN PR TABLETS 80 mg

80 mg

Prolonged-release tablet

Oral use

CZ - Czech Republic

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1070 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1070 Viena

Austria

MST Continus 100 mg

100 mg

Modified-release tablet

Oral use

CZ - Czech Republic

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1070 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1070 Viena

Austria

MST Continus 30 mg

30 mg

Modified-release tablet

Oral use

CZ - Czech Republic

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1070 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1070 Viena

Austria

MST Continus 60 mg

60 mg

Modified-release tablet

Oral use

CZ - Czech Republic

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1070 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1070 Viena

Austria

OxyContin 10 mg

10 mg

prolonged-release tablet

Oral use

CZ - Czech Republic

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1070 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1070 Viena

Austria

OxyContin 20 mg

20 mg

prolonged-release tablet

Oral use

CZ - Czech Republic

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1070 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1070 Viena

Austria

OxyContin 40 mg

40 mg

prolonged-release tablet

Oral use

CZ - Czech Republic

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1070 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1070 Viena

Austria

OxyContin 80 mg

80 mg

prolonged-release tablet

Oral use

CZ - Czech Republic

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18, A-1070 Viena, Austria

MST Continus 10 mg

10 mg

Modified-release tablet

Oral use

DE - Germany

| 1 A Pharma GmbH Keltenring 1 + 3 |
| --- |
| D-82041 Oberhaching |
| Germany |

1 A Pharma GmbH Keltenring 1 + 3

D-82041 Oberhaching

Germany

Oxycodonhydrochlorid - 1 A Pharma 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| 1 A Pharma GmbH Keltenring 1 + 3 |
| --- |
| D-82041 Oberhaching |
| Germany |

1 A Pharma GmbH Keltenring 1 + 3

D-82041 Oberhaching

Germany

Oxycodonhydrochlorid - 1 A Pharma 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| 1 A Pharma GmbH Keltenring 1 + 3 |
| --- |
| D-82041 Oberhaching |
| Germany |

1 A Pharma GmbH Keltenring 1 + 3

D-82041 Oberhaching

Germany

Oxycodonhydrochlorid - 1 A Pharma 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| AbZ-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Morphinsulfat AbZ 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| AbZ-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Morphinsulfat AbZ 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| AbZ-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Morphinsulfat AbZ 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| AbZ-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Morphinsulfat AbZ 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 |
| --- |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Oxycodon-HCl AbZ 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 |
| --- |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Oxycodon-HCl AbZ 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 |
| --- |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Oxycodon-HCl AbZ 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 |
| --- |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Oxycodon-HCl AbZ 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 |
| --- |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Oxycodon-HCl AbZ 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| ACINO AG |
| --- |
| Am Windfeld 35 |
| D-83714 Miesbach |
| Germany |

ACINO AG

Am Windfeld 35

D-83714 Miesbach

Germany

Oxycodonhydrochlorid Acino 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| ACINO AG |
| --- |
| Am Windfeld 35 |
| D-83714 Miesbach |
| Germany |

ACINO AG

Am Windfeld 35

D-83714 Miesbach

Germany

Oxycodonhydrochlorid Acino 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| ACINO AG |
| --- |
| Am Windfeld 35 |
| D-83714 Miesbach |
| Germany |

ACINO AG

Am Windfeld 35

D-83714 Miesbach

Germany

Oxycodonhydrochlorid Acino 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| ACINO AG |
| --- |
| Am Windfeld 35 |
| D-83714 Miesbach |
| Germany |

ACINO AG

Am Windfeld 35

D-83714 Miesbach

Germany

Oxycodonhydrochlorid Acino 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| ACINO AG |
| --- |
| Am Windfeld 35 |
| D-83714 Miesbach |
| Germany |

ACINO AG

Am Windfeld 35

D-83714 Miesbach

Germany

Oxycodonhydrochlorid Acino 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld |
| --- |
| Germany |

Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld

Germany

MORPHIN-PUREN 10 mg retard

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld |
| --- |
| Germany |

Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld

Germany

MORPHIN-PUREN 100 mg retard

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld |
| --- |
| Germany |

Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld

Germany

MORPHIN-PUREN 30 mg retard

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld |
| --- |
| Germany |

Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld

Germany

MORPHIN-PUREN 60 mg retard

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-STr. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-STr. 19

D-89150 Laichingen

Germany

Hydromorphon-AL 16 mg Retardtabletten

16 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-STr. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-STr. 19

D-89150 Laichingen

Germany

Hydromorphon-AL 24 mg Retardtabletten

24 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-STr. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-STr. 19

D-89150 Laichingen

Germany

Hydromorphon-AL 4 mg Retardtabletten

4 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-STr. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-STr. 19

D-89150 Laichingen

Germany

Hydromorphon-AL 8 mg Retardtabletten

8 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen |
| --- |
| Germany |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen

Germany

Morphin AL 10 retard

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen |
| --- |
| Germany |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen

Germany

Morphin AL 100 retard

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen |
| --- |
| Germany |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen

Germany

Morphin AL 30 retard

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen |
| --- |
| Germany |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen

Germany

Morphin AL 60 retard

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen |
| --- |
| Germany |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen

Germany

Oxycodon-HCl AL 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen |
| --- |
| Germany |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen

Germany

Oxycodon-HCl AL 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen |
| --- |
| Germany |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen

Germany

Oxycodon-HCl AL 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen |
| --- |
| Germany |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen

Germany

Oxycodon-HCl AL 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen |
| --- |
| Germany |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen

Germany

Oxycodon-HCl AL 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| AWD.pharma GmbH & Co. KG Wasastr. 50 |
| --- |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG Wasastr. 50

D-01445 Radebeul

Germany

Morphin AWD 10 mg retard

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| AWD.pharma GmbH & Co. KG Wasastr. 50 |
| --- |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG Wasastr. 50

D-01445 Radebeul

Germany

Morphin AWD 100 mg retard

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| AWD.pharma GmbH & Co. KG Wasastr. 50 |
| --- |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG Wasastr. 50

D-01445 Radebeul

Germany

Morphin AWD 30 mg retard

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| AWD.pharma GmbH & Co. KG Wasastr. 50 |
| --- |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG Wasastr. 50

D-01445 Radebeul

Germany

Morphin AWD 60 mg retard

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| AWD.pharma GmbH & Co.KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Germany

Hydromorphon-AWD 16 mg Retardtabletten

16 mg

Prolonged-release tablet

Oral use

DE - Germany

| AWD.pharma GmbH & Co.KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Germany

Hydromorphon-AWD 24 mg Retardtabletten

24 mg

Prolonged-release tablet

Oral use

DE - Germany

| AWD.pharma GmbH & Co.KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Germany

Hydromorphon-AWD 4 mg Retardtabletten

4 mg

Prolonged-release tablet

Oral use

DE - Germany

| AWD.pharma GmbH & Co.KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Germany

Hydromorphon-AWD 8 mg Retardtabletten

8 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

M-beta 10

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

M-beta 100

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

M-beta 30

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

M-beta 60

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

Oxycodon-HCl beta 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

Oxycodon-HCl beta 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

Oxycodon-HCl beta 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

Oxycodon-HCl beta 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

Oxycodon-HCl beta 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

Oxycodon-HCl beta 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| betapharm Arzneimittel GmbH Kobelweg 95 |
| --- |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH Kobelweg 95

D-86156 Augsburg

Germany

Oxycodon-HCl beta 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Morphinsulfat-CT 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Morphinsulfat-CT 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Morphinsulfat-CT 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Morphinsulfat-CT 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Oxycodon-HCl-CT 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Oxycodon-HCl-CT 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Oxycodon-HCl-CT 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Oxycodon-HCl-CT 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Oxycodon-HCl-CT 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München |
| --- |
| Germany |

GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München

Germany

Kapanol 100 mg

100 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München |
| --- |
| Germany |

GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München

Germany

Kapanol 20 mg

20 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München |
| --- |
| Germany |

GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München

Germany

Kapanol 50 mg

50 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen |
| --- |
| Germany |

Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen

Germany

M-long 100 mg

100 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen |
| --- |
| Germany |

Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen

Germany

M-long 10 mg

10 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen |
| --- |
| Germany |

Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen

Germany

M-long 30 mg

30 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen |
| --- |
| Germany |

Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen

Germany

M-long 60 mg

60 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen |
| --- |
| Germany |

Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen

Germany

Morphin Grünenthal 10 mg

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen |
| --- |
| Germany |

Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen

Germany

Morphin Grünenthal 100 mg

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen |
| --- |
| Germany |

Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen

Germany

Morphin Grünenthal 30 mg

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen |
| --- |
| Germany |

Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen

Germany

Morphin Grünenthal 60 mg

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul |
| --- |
| Germany |

GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul

Germany

Morphinsulfat-GRY 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul |
| --- |
| Germany |

GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul

Germany

Morphinsulfat-GRY 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul |
| --- |
| Germany |

GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul

Germany

Morphinsulfat-GRY 200 mg Retardtabletten

200 mg

Prolonged-release tablet

Oral use

DE - Germany

| GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul |
| --- |
| Germany |

GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul

Germany

Morphinsulfat-GRY 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul |
| --- |
| Germany |

GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul

Germany

Morphinsulfat-GRY 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Morphin 10 retard Heumann

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Morphin 100 retard Heumann

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Morphin 30 retard Heumann

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Morphin 60 retard Heumann

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Hydromorphon-HEXAL retard 16 mg Retardtabletten

16 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Hydromorphon-HEXAL retard 24 mg Retardtabletten

24 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Hydromorphon-HEXAL retard 4 mg Retardtabletten

4 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Hydromorphon-HEXAL retard 8 mg Retardtabletten

8 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Kancodal HEXAL 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Kancodal HEXAL 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Morphin HEXAL 100 mg Retardkapseln

100 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Morphin HEXAL 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Morphin HEXAL 10mg Retardkapseln

10 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Morphin HEXAL 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Morphin HEXAL 30 mg Retardkapseln

30 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Morphin HEXAL 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Morphin HEXAL 60 mg Retardkapseln

60 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Morphin HEXAL 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Oxyco HEXAL 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Oxyco HEXAL 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Oxycodon-HCl HEXAL 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Oxycodon-HCl HEXAL 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Oxycodon-HCl HEXAL 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Oxycodon-HCl HEXAL 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Oxycodon-HCl HEXAL 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Oxycodon-HCl HEXAL 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Oxycodonhydrochloridl HEXAL 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| Janssen-Cilag GmbH |
| --- |
| Johnson & Johnson |
| Platz 1 D-41470 Neuss |
| Germany |

Janssen-Cilag GmbH

Johnson & Johnson

Platz 1 D-41470 Neuss

Germany

JURNISTA 16 mg Retardtabletten

16 mg

Prolonged-release tablet

Oral use

DE - Germany

| Janssen-Cilag GmbH |
| --- |
| Johnson & Johnson |
| Platz 1 D-41470 Neuss |
| Germany |

Janssen-Cilag GmbH

Johnson & Johnson

Platz 1 D-41470 Neuss

Germany

JURNISTA 32 mg Retardtabletten

32 mg

Prolonged-release tablet

Oral use

DE - Germany

| Janssen-Cilag GmbH |
| --- |
| Johnson & Johnson |
| Platz 1 D-41470 Neuss |
| Germany |

Janssen-Cilag GmbH

Johnson & Johnson

Platz 1 D-41470 Neuss

Germany

JURNISTA 4 mg Retardtabletten

4 mg

Prolonged-release tablet

Oral use

DE - Germany

| Janssen-Cilag GmbH |
| --- |
| Johnson & Johnson |
| Platz 1 D-41470 Neuss |
| Germany |

Janssen-Cilag GmbH

Johnson & Johnson

Platz 1 D-41470 Neuss

Germany

JURNISTA 64 mg Retardtabletten

64 mg

Prolonged-release tablet

Oral use

DE - Germany

| Janssen-Cilag GmbH |
| --- |
| Johnson & Johnson |
| Platz 1 D-41470 Neuss |
| Germany |

Janssen-Cilag GmbH

Johnson & Johnson

Platz 1 D-41470 Neuss

Germany

JURNISTA 8 mg Retardtabletten

8 mg

Prolonged-release tablet

Oral use

DE - Germany

| Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg |
| --- |
| Germany |

Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg

Germany

Morphanton 100mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg |
| --- |
| Germany |

Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg

Germany

Morphanton 10mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg |
| --- |
| Germany |

Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg

Germany

Morphanton 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg |
| --- |
| Germany |

Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg

Germany

Morphanton 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf |
| --- |
| Germany |

Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf

Germany

Morphin-HCl Krewel 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf |
| --- |
| Germany |

Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf

Germany

Morphin-HCl Krewel 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf |
| --- |
| Germany |

Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf

Germany

Morphin-HCl Krewel 200 mg Retardtabletten

200 mg

Prolonged-release tablet

Oral use

DE - Germany

| Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf |
| --- |
| Germany |

Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf

Germany

Morphin-HCl Krewel 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf |
| --- |
| Germany |

Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf

Germany

Morphin-HCl Krewel 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| medac Gesellschaft für klinische |
| --- |
| Spezialpräparate mbH Fehlandtstr. 3 |
| D-20354 Hamburg |
| Germany |

medac Gesellschaft für klinische

Spezialpräparate mbH Fehlandtstr. 3

D-20354 Hamburg

Germany

Capros 1 x täglich 120 mg Hartkapseln, retardiert

120 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| medac Gesellschaft für klinische |
| --- |
| Spezialpräparate mbH Fehlandtstr. 3 |
| D-20354 Hamburg |
| Germany |

medac Gesellschaft für klinische

Spezialpräparate mbH Fehlandtstr. 3

D-20354 Hamburg

Germany

Capros 1 x täglich 20 mg Hartkapseln, retardiert

20 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| medac Gesellschaft für klinische |
| --- |
| Spezialpräparate mbH Fehlandtstr. 3 |
| D-20354 Hamburg |
| Germany |

medac Gesellschaft für klinische

Spezialpräparate mbH Fehlandtstr. 3

D-20354 Hamburg

Germany

Capros 1 x täglich 200 mg Hartkapseln, retardiert

200 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| medac Gesellschaft für klinische |
| --- |
| Spezialpräparate mbH Fehlandtstr. 3 |
| D-20354 Hamburg |
| Germany |

medac Gesellschaft für klinische

Spezialpräparate mbH Fehlandtstr. 3

D-20354 Hamburg

Germany

Capros 1 x täglich 60 mg Hartkapseln, retardiert

60 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| medac Gesellschaft für klinische |
| --- |
| Spezialpräparate mbH Fehlandtstr. 3 |
| D-20354 Hamburg |
| Germany |

medac Gesellschaft für klinische

Spezialpräparate mbH Fehlandtstr. 3

D-20354 Hamburg

Germany

Capros 100 mg

100 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| medac Gesellschaft für klinische |
| --- |
| Spezialpräparate mbH Fehlandtstr. 3 |
| D-20354 Hamburg |
| Germany |

medac Gesellschaft für klinische

Spezialpräparate mbH Fehlandtstr. 3

D-20354 Hamburg

Germany

Capros 10 mg

10 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| medac Gesellschaft für klinische |
| --- |
| Spezialpräparate mbH Fehlandtstr. 3 |
| D-20354 Hamburg |
| Germany |

medac Gesellschaft für klinische

Spezialpräparate mbH Fehlandtstr. 3

D-20354 Hamburg

Germany

Capros 30 mg

30 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| medac Gesellschaft für klinische |
| --- |
| Spezialpräparate mbH Fehlandtstr. 3 |
| D-20354 Hamburg |
| Germany |

medac Gesellschaft für klinische

Spezialpräparate mbH Fehlandtstr. 3

D-20354 Hamburg

Germany

Capros 60 mg

60 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MST 10 mg Mundipharma

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MST 100 mg Mundipharma

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MST 200 mg Mundipharma

200 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MST 30 mg Mundipharma

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MST 60 mg Mundipharma

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MST Continus 100 mg

100 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MST Continus 200 mg

200 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MST Continus 30 mg

30 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MST Continus 60 mg

60 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MSTW 10 mg Krugmann

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MSTW 100 mg Krugmann

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MSTW 200 mg Krugmann

200 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MSTW 30 mg Krugmann

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

MSTW 60 mg Krugmann

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OXYGESIC 10 mg

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OXYGESIC 20 mg

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OXYGESIC 40 mg

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OXYGESIC 5 mg

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OXYGESIC 80 mg

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OxyContin 10 mg

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OxyContin 20 mg

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OxyContin 40 mg

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OxyContin 5 mg

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

OxyContin 80 mg

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Oxynal 10/5 mg Retardtabletten

10 mg

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Oxynal 20/10 mg Retardtabletten

20 mg

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Palladon retard 16 mg

16 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Palladon retard 24 mg

24 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Palladon retard 4 mg

4 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Palladon retard 8 mg

8 mg

Prolonged-release capsule, hard

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Targin 10 mg/5 mg Retardtabletten

10 mg

5,45

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Targin 10 mg/5 mg Retardtabletten

10 mg

5,45

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Targin 20 mg/10 mg Retardtabletten

20 mg

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Targin 40 mg/20 mg Retardtabletten

40 mg

21,8 mg

Prolonged-release tablet

Oral use

DE - Germany

| Mundipharma GmbH |
| --- |
| Mundipharma Str. 2 |
| D-65549 Limburg |
| Germany |

Mundipharma GmbH

Mundipharma Str. 2

D-65549 Limburg

Germany

Targin 5 mg/2,5 mg Retardtabletten

5 mg

2,73

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin EINS PS Pharma 10 mg retard

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin EINS PS Pharma 100 mg retard

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin EINS PS Pharma 200 mg retard

200 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin EINS PS Pharma 30 mg retard

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin EINS PS Pharma 60 mg retard

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin PS Pharma 200 mg retard

200 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin VIER PS Pharma 10 mg retard

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin VIER PS Pharma 100 mg retard

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin VIER PS Pharma 30 mg retard

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin VIER PS Pharma 60 mg retard

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin ZWEI PS Pharma 10 mg retard

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin ZWEI PS Pharma 100 mg retard

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin ZWEI PS Pharma 200 mg retard

200 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin ZWEI PS Pharma 30 mg retard

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| PS Pharma Service GmbH Lise-Meitner-Str. 10 |
| --- |
| D-40670 Meerbusch |
| Germany |

PS Pharma Service GmbH Lise-Meitner-Str. 10

D-40670 Meerbusch

Germany

Morphin ZWEI PS Pharma 60 mg retard

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Hydromorphon-ratiopharm 16 mg Retardtabletten

16 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Hydromorphon-ratiopharm 24 mg Retardtabletten

24 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Hydromorphon-ratiopharm 4 mg Retardtabletten

4 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Hydromorphon-ratiopharm 8 mg Retardtabletten

8 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Morphin-ratiopharm 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Morphin-ratiopharm 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Morphin-ratiopharm 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Morphin-ratiopharm 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodon-HCl-ratiopharm 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodon-HCl-ratiopharm 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodon-HCl-ratiopharm 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodon-HCl-ratiopharm 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodon-HCl-ratiopharm 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodonhydrochlorid-ratiopharm 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodonhydrochlorid-ratiopharm 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodonhydrochlorid-ratiopharm 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodonhydrochlorid-ratiopharm 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodonhydrochlorid-ratiopharm 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Oxycodonhydrochlorid-ratiopharm 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Morph Sandoz 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Morph Sandoz 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Morph Sandoz 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Morph Sandoz 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Oxycodon-HCl Sandoz 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Oxycodon-HCl Sandoz 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Oxycodon-HCl Sandoz 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Oxycodon-HCl Sandoz 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Oxycodon-HCl Sandoz 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Oxycodon-HCl Sandoz 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DE - Germany

| Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen |
| --- |
| Germany |

Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen

Germany

Oxycodon-HCl Sandoz 10 mg

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Hydromorphon-Stada 16 mg Retardtabletten

16 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Hydromorphon-Stada 24 mg Retardtabletten

24 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Hydromorphon-Stada 4 mg Retardtabletten

4 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Hydromorphon-Stada 8 mg Retardtabletten

8 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

M-Stada 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

M-Stada 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

M-Stada 200 mg Retardtabletten

200 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

M-Stada 30 mg Retardtabletten

30 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

M-Stada 60 mg Retardtabletten

60 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Oxycodon-HCl STADA 10 mg Retardtabletten

10 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Oxycodon-HCl STADA 20 mg Retardtabletten

20 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Oxycodon-HCl STADA 40 mg Retardtabletten

40 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Oxycodon-HCl STADA 5 mg Retardtabletten

5 mg

Prolonged-release tablet

Oral use

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Oxycodon-HCl STADA 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Acino AG |
| --- |
| Am Windfeld 35 |
| DE-83714 Miesbach |
| Germany |

Acino AG

Am Windfeld 35

DE-83714 Miesbach

Germany

Oxycodonhydrochlorid ‘Acino’

5 mg

Prolonged release tablet

Oral use

DK - Denmark

| Acino AG |
| --- |
| Am Windfeld 35 |
| DE-83714 Miesbach |
| Germany |

Acino AG

Am Windfeld 35

DE-83714 Miesbach

Germany

Oxycodonhydrochlorid ‘Acino’

10 mg

Prolonged release tablet

Oral use

DK - Denmark

| Acino AG |
| --- |
| Am Windfeld 35 |
| DE-83714 Miesbach |
| Germany |

Acino AG

Am Windfeld 35

DE-83714 Miesbach

Germany

Oxycodonhydrochlorid ‘Acino’

20 mg

Prolonged release tablet

Oral use

DK - Denmark

| Acino AG |
| --- |
| Am Windfeld 35 |
| DE-83714 Miesbach |
| Germany |

Acino AG

Am Windfeld 35

DE-83714 Miesbach

Germany

Oxycodonhydrochlorid ‘Acino’

40 mg

Prolonged release tablet

Oral use

DK - Denmark

| Acino AG |
| --- |
| Am Windfeld 35 |
| DE-83714 Miesbach |
| Germany |

Acino AG

Am Windfeld 35

DE-83714 Miesbach

Germany

Oxycodonhydrochlorid ‘Acino’

80 mg

Prolonged release tablet

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Ethirfin

20 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Ethirfin

40 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Ethirfin

60 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Ethirfin

120 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Ethirfin

200 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Morphinsulfat ‘Ethypharm’

20 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Morphinsulfat ‘Ethypharm’

40 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Morphinsulfat ‘Ethypharm’

60 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Morphinsulfat ‘Ethypharm’

120 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Morphinsulfat ‘Ethypharm’

200 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Zomorph

20 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Zomorph

40 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Zomorph

60 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Zomorph

120 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| Ethypharm |
| --- |
| 17-21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

17-21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

Zomorph

200 mg

Prolonged-release capsule, hard

Oral use

DK - Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK 2650 Hvidovre |
| Denmark |

HEXAL A/S

Kanalholmen 8-12

DK 2650 Hvidovre

Denmark

Oxycodonhydrochlorid ‘Hexal’

5 mg

Prolonged-release tablet

Oral use

DK - Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK 2650 Hvidovre |
| Denmark |

HEXAL A/S

Kanalholmen 8-12

DK 2650 Hvidovre

Denmark

Oxycodonhydrochlorid ‘Hexal’

10 mg

Prolonged-release tablet

Oral use

DK - Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK 2650 Hvidovre |
| Denmark |

HEXAL A/S

Kanalholmen 8-12

DK 2650 Hvidovre

Denmark

Oxycodonhydrochlorid ‘Hexal’

20 mg

Prolonged-release tablet

Oral use

DK - Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK 2650 Hvidovre |
| Denmark |

HEXAL A/S

Kanalholmen 8-12

DK 2650 Hvidovre

Denmark

Oxycodonhydrochlorid ‘Hexal’

40 mg

Prolonged-release tablet

Oral use

DK - Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK 2650 Hvidovre |
| Denmark |

HEXAL A/S

Kanalholmen 8-12

DK 2650 Hvidovre

Denmark

Oxycodonhydrochlorid ‘Hexal’

80 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) |
| --- |
| Hammerbakken 19 |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC)

Hammerbakken 19

DK-3460 Birkerød

Denmark

Jurnista

4 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) |
| --- |
| Hammerbakken 19 |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC)

Hammerbakken 19

DK-3460 Birkerød

Denmark

Jurnista

8 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) |
| --- |
| Hammerbakken 19 |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC)

Hammerbakken 19

DK-3460 Birkerød

Denmark

Jurnista

16 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) |
| --- |
| Hammerbakken 19 |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC)

Hammerbakken 19

DK-3460 Birkerød

Denmark

Jurnista

32 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) |
| --- |
| Hammerbakken 19 |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC)

Hammerbakken 19

DK-3460 Birkerød

Denmark

Jurnista

64 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Fidestor

4 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Fidestor

8 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Fidestor

16 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Fidestor

32 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Fidestor

64 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Spanzar

4 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Spanzar

8 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Spanzar

16 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Spanzar

32 mg

Prolonged release tablet

Oral use

DK - Denmark

| Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 |
| --- |
| DK-3460 Birkerød |
| Denmark |

Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19

DK-3460 Birkerød

Denmark

Spanzar

64 mg

Prolonged release tablet

Oral use

DK - Denmark

| Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1

A-8502 Lannach

Austria

Depolan

10 mg

Prolonged release tablet

Oral use

DK - Denmark

| Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1

A-8502 Lannach

Austria

Depolan

30 mg

Prolonged release tablet

Oral use

DK - Denmark

| Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1

A-8502 Lannach

Austria

Depolan

60 mg

Prolonged release tablet

Oral use

DK - Denmark

| Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1

A-8502 Lannach

Austria

Depolan

100 mg

Prolonged release tablet

Oral use

DK - Denmark

| Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1

A-8502 Lannach

Austria

Depolan

200 mg

Prolonged release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

80 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

15 mg

Prolonged-release tablet

Oral use

DK – Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

60 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

120 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

5 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

10 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

20 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

40 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

80 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

OxyContin

160 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

Palladon

4 mg

Prolonges release capsule, hard

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

Palladon

8 mg

Prolonges release capsule, hard

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

Palladon

16 mg

Prolonges release capsule, hard

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

Palladon

24 mg

Prolonges release capsule, hard

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

Targin

5 + 2,5 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

Targin

10 + 5 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

Targin

20 + 10 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| DK-2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

DK-2970 Hørsholm

Denmark

Targin

40 + 20 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

10 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

30 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

60 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

100 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

5 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

10 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

30 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

60 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

100 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

200 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

20 mg

Prolonged-release granules, for oral suspension

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

30 mg

Prolonged-release granules, for oral suspension

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

60 mg

Prolonged-release granules, for oral suspension

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

100 mg

Prolonged-release granules, for oral suspension

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin

200 mg

Prolonged-release granules, for oral suspension

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin Uno

30 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin Uno

60 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin Uno

90 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin Uno

120 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin Uno

150 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Contalgin Uno

200 mg

Prolonged-release capsule

Oral use

DK - Denmark

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodonhydrochlorid ‘ratiopharm’

5 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodonhydrochlorid ‘ratiopharm’

10 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodonhydrochlorid ‘ratiopharm’

20 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodonhydrochlorid ‘ratiopharm’

40 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodonhydrochlorid ‘ratiopharm’

80 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Oxicos

5 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Oxicos

10 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Oxicos

20 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Oxycodonhydrochlorid ‘1A Farma’

5 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Oxycodonhydrochlorid ‘1A Farma’

10 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Oxycodonhydrochlorid ‘1A Farma’

20 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Teva Denmark A/S |
| --- |
| Parallelvej 10 |
| DK-2800 Kongens Lyngby |
| Denmark |

Teva Denmark A/S

Parallelvej 10

DK-2800 Kongens Lyngby

Denmark

Malfin

10 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Teva Denmark A/S |
| --- |
| Parallelvej 10 |
| DK-2800 Kongens Lyngby |
| Denmark |

Teva Denmark A/S

Parallelvej 10

DK-2800 Kongens Lyngby

Denmark

Malfin

30 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Teva Denmark A/S |
| --- |
| Parallelvej 10 |
| DK-2800 Kongens Lyngby |
| Denmark |

Teva Denmark A/S

Parallelvej 10

DK-2800 Kongens Lyngby

Denmark

Malfin

60 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Teva Denmark A/S |
| --- |
| Parallelvej 10 |
| DK-2800 Kongens Lyngby |
| Denmark |

Teva Denmark A/S

Parallelvej 10

DK-2800 Kongens Lyngby

Denmark

Malfin

100 mg

Prolonged-release tablet

Oral use

DK - Denmark

| Teva Denmark A/S |
| --- |
| Parallelvej 10 |
| DK-2800 Kongens Lyngby |
| Denmark |

Teva Denmark A/S

Parallelvej 10

DK-2800 Kongens Lyngby

Denmark

Malfin

200 mg

Prolonged-release tablet

Oral use

EL-Greece

| LAVIPHARM HELLAS AE Agias Marinas Str. |
| --- |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS AE Agias Marinas Str.

Paiania Attikis 19002

Greece

MORFICONTIN

10 mg

Prolonged release tablet

Oral use

EL-Greece

| LAVIPHARM HELLAS AE Agias Marinas Str. |
| --- |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS AE Agias Marinas Str.

Paiania Attikis 19002

Greece

MORFICONTIN

30 mg

Prolonged release tablet

Oral use

EL-Greece

| LAVIPHARM HELLAS AE Agias Marinas Str. |
| --- |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS AE Agias Marinas Str.

Paiania Attikis 19002

Greece

MORFICONTIN

60 mg

Prolonged release tablet

Oral use

EL-Greece

| LAVIPHARM HELLAS AE Agias Marinas Str. |
| --- |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS AE Agias Marinas Str.

Paiania Attikis 19002

Greece

MORFICONTIN

100 mg

Prolonged release tablet

Oral use

EL-Greece

| LAVIPHARM HELLAS AE Agias Marinas Str. |
| --- |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS AE Agias Marinas Str.

Paiania Attikis 19002

Greece

MORFICONTIN

30 mg

Prolonged release tablet

Oral use

EL-Greece

| LAVIPHARM HELLAS AE Agias Marinas Str. |
| --- |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS AE Agias Marinas Str.

Paiania Attikis 19002

Greece

MORFICONTIN

60 mg

Prolonged release tablet

Oral use

EL-Greece

| LAVIPHARM HELLAS AE Agias Marinas Str. |
| --- |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS AE Agias Marinas Str.

Paiania Attikis 19002

Greece

MORFICONTIN

100 mg

Prolonged release tablet

Oral use

EL-Greece

| LAVIPHARM HELLAS AE Agias Marinas Str. |
| --- |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS AE Agias Marinas Str.

Paiania Attikis 19002

Greece

MORFICONTIN

5 mg

Modified release tablet

Oral use

EL-Greece

| LAVIPHARM HELLAS AE Agias Marinas Str. |
| --- |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS AE Agias Marinas Str.

Paiania Attikis 19002

Greece

MORFICONTIN

15 mg

Modified release tablet

Oral use

EL-Greece

| MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620 |
| --- |
| Limbirg D-6270 |
| Germany |

MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620

Limbirg D-6270

Germany

OXYCONTIN

10 mg

Prolonged-release tablet

Oral use

EL-Greece

| MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620 |
| --- |
| Limbirg D-6270 |
| Germany |

MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620

Limbirg D-6270

Germany

OXYCONTIN

20 mg

Prolonged-release tablet

Oral use

EL-Greece

| MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620 |
| --- |
| Limbirg D-6270 |
| Germany |

MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620

Limbirg D-6270

Germany

OXYCONTIN

40 mg

Prolonged-release tablet

Oral use

EL-Greece

| MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620 |
| --- |
| Limbirg D-6270 |
| Germany |

MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620

Limbirg D-6270

Germany

OXYCONTIN

80 mg

Prolonged-release tablet

Oral use

EL-Greece

| P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. |
| --- |
| 145 68, Kryoneri Athens |
| Greece |

P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str.

145 68, Kryoneri Athens

Greece

MONGOL

10 mg

Modified-release capsule

Oral use

EL-Greece

| P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. |
| --- |
| 145 68, Kryoneri Athens |
| Greece |

P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str.

145 68, Kryoneri Athens

Greece

MONGOL

30 mg

Modified-release capsule

Oral use

EL-Greece

| P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. |
| --- |
| 145 68, Kryoneri Athens |
| Greece |

P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str.

145 68, Kryoneri Athens

Greece

MONGOL

60 mg

Modified-release capsule

Oral use

EL-Greece

| P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. |
| --- |
| 145 68, Kryoneri Athens |
| Greece |

P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str.

145 68, Kryoneri Athens

Greece

MONGOL

100 mg

Modified-release capsule

Oral use

EL-Greece

| P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. |
| --- |
| 145 68, Kryoneri Athens |
| Greece |

P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str.

145 68, Kryoneri Athens

Greece

MONGOL

200 mg

Prolonged-release capsule

Oral use

ES - Spain

| ARCHIMEDES PHARMA IBERICA S.L. |
| --- |
| C/ Jorge Juan 139 |
| Madrid |
| Spain |

ARCHIMEDES PHARMA IBERICA S.L.

C/ Jorge Juan 139

Madrid

Spain

ZOMORPH10 MG Cápsulas

10 mg

Prolonged-release capsule

Oral use

ES - Spain

| ARCHIMEDES PHARMA IBERICA S.L. |
| --- |
| C/ Jorge Juan 139 |
| Madrid |
| Spain |

ARCHIMEDES PHARMA IBERICA S.L.

C/ Jorge Juan 139

Madrid

Spain

ZOMORPH100 mg Cápsulas

100 mg

Prolonged-release capsule

Oral use

ES - Spain

| ARCHIMEDES PHARMA IBERICA S.L. |
| --- |
| C/ Jorge Juan 139 |
| Madrid |
| Spain |

ARCHIMEDES PHARMA IBERICA S.L.

C/ Jorge Juan 139

Madrid

Spain

ZOMORPH30 mg Cápsulas

30 mg

Prolonged-release capsule

Oral use

ES - Spain

| ARCHIMEDES PHARMA IBERICA S.L. |
| --- |
| C/ Jorge Juan 139 |
| Madrid |
| Spain |

ARCHIMEDES PHARMA IBERICA S.L.

C/ Jorge Juan 139

Madrid

Spain

ZOMORPH60 mg Cápsulas

60 mg

Prolonged-release capsule

Oral use

ES - Spain

| JANSSEN-CILAG |
| --- |
| S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID |
| Spain |

JANSSEN-CILAG

S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID

Spain

JURNISTA

64 mg

Prolonged-release tablet

Oral use

ES - Spain

| JANSSEN-CILAG |
| --- |
| S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID |
| Spain |

JANSSEN-CILAG

S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID

Spain

JURNISTA

32 mg

Prolonged-release tablet

Oral use

ES - Spain

| JANSSEN-CILAG |
| --- |
| S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID |
| Spain |

JANSSEN-CILAG

S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID

Spain

JURNISTA

16 mg

Prolonged-release tablet

Oral use

ES - Spain

| JANSSEN-CILAG |
| --- |
| S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID |
| Spain |

JANSSEN-CILAG

S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID

Spain

JURNISTA

8 mg

Prolonged-release tablet

Oral use

ES - Spain

| JANSSEN-CILAG |
| --- |
| S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID |
| Spain |

JANSSEN-CILAG

S.A.Po de Las Doce Estrellas, 5 – 7 28042 MADRID

Spain

JURNISTA

4 mg

Prolonged-release tablet

Oral use

ES - Spain

| LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 |
| --- |
| Lannach A-9502 |
| Austria |

LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1

Lannach A-9502

Austria

MORFINA LANNACHER 10 MG

10 mg

coated tablet

Oral use

ES - Spain

| LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 |
| --- |
| Lannach A-9502 |
| Austria |

LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1

Lannach A-9502

Austria

MORFINA LANNACHER 100 MG

100 mg

coated tablet

Oral use

ES - Spain

| LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 |
| --- |
| Lannach A-9502 |
| Austria |

LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1

Lannach A-9502

Austria

MORFINA LANNACHER 200 MG Comprimidos

200 mg

coated tablet

Oral use

ES - Spain

| LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 |
| --- |
| Lannach A-9502 |
| Austria |

LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1

Lannach A-9502

Austria

MORFINA LANNACHER 30 MG

30 mg

coated tablet

Oral use

ES - Spain

| LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 |
| --- |
| Lannach A-9502 |
| Austria |

LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1

Lannach A-9502

Austria

MORFINA LANNACHER 60 MG

60 mg

coated tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

MST 10 CONTINUS

10 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

MST 100 CONTINUS

100 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

MST 15 CONTINUS

15 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

MST 200 CONTINUS

200 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

MST 30 CONTINUS

30 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

MST 5 CONTINUS

5 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

MST 60 CONTINUS

60 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

OXYCONTIN 10 mg comprimidos de liberación modificada

10 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

OXYCONTIN 20 mg comprimidos de liberación modificada

20 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

OXYCONTIN 40 mg comprimidos de liberación modificada

40 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

OXYCONTIN 5 mg comprimidos de liberación prolongada

5 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

OXYCONTIN 80 mg comprimidos de liberacion modificada

80 mg

Prolonged-release tablet

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

PALLADONE CONTINUS

4 mg

Prolonged-release capsule

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

PALLADONE CONTINUS

8 mg

Prolonged-release capsule

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

PALLADONE CONTINUS

16 mg

Prolonged-release capsule

Oral use

ES - Spain

| MUNDIPHARMA PHARMACEUTICALS |
| --- |
| S.L.Edificio Alvento (Torre D) |
| Vía de los Poblados, 1 |
| 28033 Madrid |
| Spain |

MUNDIPHARMA PHARMACEUTICALS

S.L.Edificio Alvento (Torre D)

Vía de los Poblados, 1

28033 Madrid

Spain

PALLADONE CONTINUS

24 mg

Prolonged-release capsule

Oral use

ET - Estonia

| Johnson & Johnson UAB |
| --- |
| Gelezinio Vilko g. 18A LT-08104 Vilnius |
| Lithuania |

Johnson & Johnson UAB

Gelezinio Vilko g. 18A LT-08104 Vilnius

Lithuania

JURNISTA

4 mg

Prolonged-release tablet

Oral use

ET - Estonia

| Johnson & Johnson UAB |
| --- |
| Gelezinio Vilko g. 18A LT-08104 Vilnius |
| Lithuania |

Johnson & Johnson UAB

Gelezinio Vilko g. 18A LT-08104 Vilnius

Lithuania

JURNISTA

8 mg

Prolonged-release tablet

Oral use

ET - Estonia

| Johnson & Johnson UAB |
| --- |
| Gelezinio Vilko g. 18A LT-08104 Vilnius |
| Lithuania |

Johnson & Johnson UAB

Gelezinio Vilko g. 18A LT-08104 Vilnius

Lithuania

JURNISTA

16 mg

Prolonged-release tablet

Oral use

ET - Estonia

| Johnson & Johnson UAB |
| --- |
| Gelezinio Vilko g. 18A LT-08104 Vilnius |
| Lithuania |

Johnson & Johnson UAB

Gelezinio Vilko g. 18A LT-08104 Vilnius

Lithuania

JURNISTA

32 mg

Prolonged-release tablet

Oral use

ET - Estonia

| Johnson & Johnson UAB |
| --- |
| Gelezinio Vilko g. 18A LT-08104 Vilnius |
| Lithuania |

Johnson & Johnson UAB

Gelezinio Vilko g. 18A LT-08104 Vilnius

Lithuania

JURNISTA

64 mg

Prolonged-release tablet

Oral use

ET - Estonia

| LANNACHER HEILMITTEL GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

LANNACHER HEILMITTEL GmbH

Schlossplatz 1

A-8502 Lannach

Austria

VENDAL RETARD 10 MG

10 mg

Prolonged-release tablet

Oral use

ET - Estonia

| LANNACHER HEILMITTEL GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

LANNACHER HEILMITTEL GmbH

Schlossplatz 1

A-8502 Lannach

Austria

VENDAL RETARD 100 MG

100 mg

Prolonged-release tablet

Oral use

ET - Estonia

| LANNACHER HEILMITTEL GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

LANNACHER HEILMITTEL GmbH

Schlossplatz 1

A-8502 Lannach

Austria

VENDAL RETARD 200 MG

200 mg

Prolonged-release tablet

Oral use

ET - Estonia

| LANNACHER HEILMITTEL GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

LANNACHER HEILMITTEL GmbH

Schlossplatz 1

A-8502 Lannach

Austria

VENDAL RETARD 30 MG

30 mg

Prolonged-release tablet

Oral use

ET - Estonia

| LANNACHER HEILMITTEL GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

LANNACHER HEILMITTEL GmbH

Schlossplatz 1

A-8502 Lannach

Austria

VENDAL RETARD 60 MG

60 mg

Prolonged-release tablet

Oral use

ET - Estonia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 A-1072 Wien |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18 A-1072 Wien

Austria

MST CONTINUS 30 MG

30 mg

Prolonged-release granules for oral suspension

Oral use

ET - Estonia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 A-1072 Wien |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18 A-1072 Wien

Austria

MXL 120 MG

120 mg

Prolonged-release capsule, hard

Oral use

ET - Estonia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 A-1072 Wien |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18 A-1072 Wien

Austria

MXL 30 MG

30 mg

Prolonged-release capsule, hard

Oral use

ET - Estonia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 A-1072 Wien |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18 A-1072 Wien

Austria

OXYCONTIN 10 MG

10 mg

Prolonged-release tablet

Oral use

ET - Estonia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 A-1072 Wien |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18 A-1072 Wien

Austria

OXYCONTIN 20 MG

20 mg

Prolonged-release tablet

Oral use

ET - Estonia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 A-1072 Wien |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18 A-1072 Wien

Austria

OXYCONTIN 40 MG

40 mg

Prolonged-release tablet

Oral use

ET - Estonia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 A-1072 Wien |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18 A-1072 Wien

Austria

OXYCONTIN 80 MG

80 mg

Prolonged-release tablet

Oral use

ET - Estonia

| Nycomed Sefa AS |
| --- |
| Jaama 55B |
| 63308 Põlva |
| Estonia |

Nycomed Sefa AS

Jaama 55B

63308 Põlva

Estonia

DOLTARD

30 mg

Prolonged-release tablet

Oral use

ET - Estonia

| Nycomed Sefa AS |
| --- |
| Jaama 55B |
| 63308 Põlva |
| Estonia |

Nycomed Sefa AS

Jaama 55B

63308 Põlva

Estonia

DOLTARD

60 mg

Prolonged-release tablet

Oral use

FI - Finland

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| 2650 HVIDOVRE |
| Denmark |

Hexal A/S

Kanalholmen 8-12

2650 HVIDOVRE

Denmark

Oxycodone Hexal

20 mg

Prolonged-release tablet

Oral use

FI - Finland

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| 2650 HVIDOVRE |
| Denmark |

Hexal A/S

Kanalholmen 8-12

2650 HVIDOVRE

Denmark

Oxycodone Hexal

40 mg

Prolonged-release tablet

Oral use

FI - Finland

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| 2650 HVIDOVRE |
| Denmark |

Hexal A/S

Kanalholmen 8-12

2650 HVIDOVRE

Denmark

Oxycodone Hexal

80 mg

Prolonged-release tablet

Oral use

FI - Finland

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1

8502 Lannach

Austria

Depolan

10 mg

Prolonged-release tablet

Oral use

FI - Finland

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1

8502 Lannach

Austria

Depolan

30 mg

Prolonged-release tablet

Oral use

FI - Finland

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1

8502 Lannach

Austria

Depolan

60 mg

Prolonged-release tablet

Oral use

FI - Finland

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1

8502 Lannach

Austria

Depolan

100 mg

Prolonged-release tablet

Oral use

FI - Finland

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1

8502 Lannach

Austria

Depolan

200 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Docontin Unotard

30 mg

Prolonged-release capsule

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Docontin Unotard

60 mg

Prolonged-release capsule

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Docontin Unotard

90 mg

Prolonged-release capsule

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Docontin Unotard

120 mg

Prolonged-release capsule

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Docontin Unotard

150 mg

Prolonged-release capsule

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Docontin Unotard

200 mg

Prolonged-release capsule

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

20 mg

Modified-release granules for oral suspension

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

30 mg

Modified-release granules for oral suspension

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

60 mg

Modified-release granules for oral suspension

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

100 mg

Modified-release granules for oral suspension

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

200 mg

Modified-release granules for oral suspension

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

10 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

30 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

60 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

100 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Dolcontin

200 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

5 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

10 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

15 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

20 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

30 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

40 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

60 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

80 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

120 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycontin

160 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Palladon

4 mg

Prolonged-release capsule, hard

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Palladon

8 mg

Prolonged-release capsule, hard

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Palladon

16 mg

Prolonged-release capsule, hard

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Palladon

24 mg

Prolonged-release capsule, hard

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Targiniq

10 mg/ 5 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Targiniq

20 mg/ 10 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Targiniq

40 mg/ 20 mg

Prolonged-release tablet

Oral use

FI - Finland

| Mundipharma Oy |
| --- |
| Rajatorpantie 41 B |
| 01640 Vantaa |
| Finland |

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Targiniq

5 mg/ 2,5 mg

Prolonged-release tablet

Oral use

FI - Finland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 ULM |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 ULM

Germany

Oxycodone ratiopharm

5 mg

Prolonged-release tablet

Oral use

FI - Finland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 ULM |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 ULM

Germany

Oxycodone ratiopharm

10 mg

Prolonged-release tablet

Oral use

FI - Finland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 ULM |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 ULM

Germany

Oxycodone ratiopharm

20 mg

Prolonged-release tablet

Oral use

FI - Finland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 ULM |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 ULM

Germany

Oxycodone ratiopharm

40 mg

Prolonged-release tablet

Oral use

FI - Finland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 ULM |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 ULM

Germany

Oxycodone ratiopharm

80 mg

Prolonged-release tablet

Oral use

FI - Finland

| Sandoz A/S |
| --- |
| C. F. Tietgens Boulevard 40 |
| 5220 ODENSE SØ |
| Denmark |

Sandoz A/S

C. F. Tietgens Boulevard 40

5220 ODENSE SØ

Denmark

Oxycodone Hydrocloride Sandoz

20 mg

Prolonged-release tablet

Oral use

FR - France

| ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie |
| --- |
| France |

ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie

France

ZOMORPH L.P. 120 mg, gélule à libération prolongée

120 mg

Prolonged-release capsule, hard

Oral use

FR - France

| ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie |
| --- |
| France |

ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie

France

ZOMORPH L.P. 20 mg, gélule à libération prolongée

20 mg

Prolonged-release capsule, hard

Oral use

FR - France

| ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie |
| --- |
| France |

ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie

France

ZOMORPH L.P. 200 mg, gélule à libération prolongée

200 mg

Prolonged-release capsule, hard

Oral use

FR - France

| ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie |
| --- |
| France |

ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie

France

ZOMORPH L.P. 40 mg, gélule à libération prolongée

40 mg

Prolonged-release capsule, hard

Oral use

FR - France

| ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie |
| --- |
| France |

ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie

France

ZOMORPH L.P. 60 mg, gélule à libération prolongée

60 mg

Prolonged-release capsule, hard

Oral use

FR - France

| BRISTOL - MYERS SQUIBB 3, rue Joseph Monier |
| --- |
| 92500 Rueil-Malmaison |
| France |

BRISTOL - MYERS SQUIBB 3, rue Joseph Monier

92500 Rueil-Malmaison

France

SKENAN L.P. 10 mg, microgranules à libération prolongée en gélule

10 mg

Prolonged-release micropillules in hard capsule

Oral use

FR - France

| BRISTOL - MYERS SQUIBB 3, rue Joseph Monier |
| --- |
| 92500 Rueil-Malmaison |
| France |

BRISTOL - MYERS SQUIBB 3, rue Joseph Monier

92500 Rueil-Malmaison

France

SKENAN L.P. 100 mg, microgranules à libération prolongée en gélule

100 mg

Prolonged-release micropillules in hard capsule

Oral use

FR - France

| BRISTOL - MYERS SQUIBB 3, rue Joseph Monier |
| --- |
| 92500 Rueil-Malmaison |
| France |

BRISTOL - MYERS SQUIBB 3, rue Joseph Monier

92500 Rueil-Malmaison

France

SKENAN L.P. 200 mg, microgranules à libération prolongée en gélule

200 mg

Prolonged-release micropillules in hard capsule

Oral use

FR - France

| BRISTOL - MYERS SQUIBB 3, rue Joseph Monier |
| --- |
| 92500 Rueil-Malmaison |
| France |

BRISTOL - MYERS SQUIBB 3, rue Joseph Monier

92500 Rueil-Malmaison

France

SKENAN L.P. 30 mg, microgranules à libération prolongée en gélule

30 mg

Prolonged-release micropillules in hard capsule

Oral use

FR - France

| BRISTOL - MYERS SQUIBB 3, rue Joseph Monier |
| --- |
| 92500 Rueil-Malmaison |
| France |

BRISTOL - MYERS SQUIBB 3, rue Joseph Monier

92500 Rueil-Malmaison

France

SKENAN L.P. 60 mg, microgranules à libération prolongée en gélule

60 mg

Prolonged-release micropillules in hard capsule

Oral use

FR - France

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex |
| France |

ETHYPHARM

194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex

France

SULFATE DE MORPHINE ETHYPHARM L.P. 10 mg, gélule à libération prolongée

10 mg

Prolonged-release capsule, hard

Oral use

FR - France

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex |
| France |

ETHYPHARM

194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex

France

SULFATE DE MORPHINE ETHYPHARM L.P. 100 mg, gélule à libération prolongée

100 mg

Prolonged-release capsule, hard

Oral use

FR - France

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex |
| France |

ETHYPHARM

194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex

France

SULFATE DE MORPHINE ETHYPHARM L.P. 30 mg, gélule à libération prolongée

30 mg

Prolonged-release capsule, hard

Oral use

FR - France

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex |
| France |

ETHYPHARM

194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex

France

SULFATE DE MORPHINE ETHYPHARM L.P. 60 mg, gélule à libération prolongée

60 mg

Prolonged-release capsule, hard

Oral use

FR - France

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex |
| France |

ETHYPHARM

194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex

France

SULFATE DE MORPHINE ETHYPHARM LP 200 mg, gélule à libération prolongée

200 mg

Prolonged-release capsule, hard

Oral use

FR - France

| Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex |
| --- |
| France |

Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex

France

KAPANOL L.P. 100 mg, gélule à libération prolongée

100 mg

Prolonged-release capsule, hard

Oral use

FR - France

| Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex |
| --- |
| France |

Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex

France

KAPANOL L.P. 20 mg, gélule à libération prolongée

20 mg

Prolonged-release capsule, hard

Oral use

FR - France

| Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex |
| --- |
| France |

Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex

France

KAPANOL L.P. 50 mg, gélule à libération prolongée

50 mg

Prolonged-release capsule, hard

Oral use

FR - France

Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany

MORPHINE STADA L.P. 10 mg, comprimé pelliculé à libération prolongée

10 mg

Prolonged-release film-coated tablet

Oral use

FR - France

Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany

MORPHINE STADA L.P. 100 mg, comprimé pelliculé à libération prolongée

100 mg

Prolonged-release film-coated tablet

Oral use

FR - France

Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany

MORPHINE STADA L.P. 200 mg, comprimé pelliculé à libération prolongée

200 mg

Prolonged-release film-coated tablet

Oral use

FR - France

Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany

MORPHINE STADA L.P. 30 mg, comprimé pelliculé à libération prolongée

30 mg

Prolonged-release film-coated tablet

Oral use

FR - France

Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany

MORPHINE STADA L.P. 60 mg, comprimé pelliculé à libération prolongée

60 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

MOSCONTIN 10 mg, comprimé enrobé à libération prolongée

10 mg

Prolonged-release coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

MOSCONTIN 100 mg, comprimé enrobé à libération prolongée

100 mg

Prolonged-release coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

MOSCONTIN 15 mg, comprimé pelliculé à libération prolongée

15 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

MOSCONTIN 30 mg, comprimé enrobé à libération prolongée

30 mg

Prolonged-release coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

MOSCONTIN 5 mg, comprimé pelliculé à liberation prolongée

5 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

MOSCONTIN 60 mg, comprimé enrobé à libération prolongée

60 mg

Prolonged-release coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

MOSCONTIN L.P. 200 mg, comprimé pelliculé à libération prolongée

200 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN L.P. 5 mg, comprimé pelliculé à libération prolongée

5 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN LP 10 mg, comprimé pelliculé à libération prolongée

10 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN LP 120 mg, comprimé pelliculé à libération prolongée

120 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN LP 15 mg, comprimé pelliculé à libération prolongée

5 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN LP 160 mg, comprimé pelliculé à libération prolongée

160 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN LP 20 mg, comprimé pelliculé à libération prolongée

20 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN LP 30 mg, comprimé pelliculé à libération prolongée

30 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN LP 40 mg, comprimé pelliculé à libération prolongée

40 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN LP 60 mg, comprimé pelliculé à libération prolongée

60 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

OXYCONTIN LP 80 mg, comprimé pelliculé à libération prolongée

80 mg

Prolonged-release film-coated tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

SOPHIDONE L.P. 16 mg, gélule à libération prolongée

16 mg

Prolonged-release capsule, hard

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

SOPHIDONE L.P. 24 mg, gélule à libération prolongée

24 mg

Prolonged-release capsule, hard

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

SOPHIDONE L.P. 4 mg, gélule à libération prolongée

4 mg

Prolonged-release capsule, hard

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

SOPHIDONE L.P. 8 mg, gélule à libération prolongée

8 mg

Prolonged-release capsule, hard

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

TARGINACT 10 mg/5 mg, comprimé à libération prolongée

10 mg/5 mg

prolonged-release tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

TARGINACT 20 mg/10 mg, comprimé à libération prolongée

20 mg/10 mg

prolonged-release tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

TARGINACT 40 mg/20 mg, comprimé à libération prolongée

40 mg/20 mg

prolonged-release tablet

Oral use

FR - France

| MUNDIPHARMA |
| --- |
| 2, rue du Docteur Lombard 92130 |
| Issy-les-Moulineaux |
| France |

MUNDIPHARMA

2, rue du Docteur Lombard 92130

Issy-les-Moulineaux

France

TARGINACT 5 mg/2,5 mg, comprimé à libération prolongée

5 mg/2,5 mg

prolonged-release tablet

Oral use

FR - France

| NAPP Laboratories Limited Cambridge |
| --- |
| Science Park |
| Milton Road |
| CB4 4GW Cambridge |
| United Kingdom |

NAPP Laboratories Limited Cambridge

Science Park

Milton Road

CB4 4GW Cambridge

United Kingdom

PALLADONE L.P. 16 mg, gélule à libération prolongée

16 mg

Prolonged-release capsule, hard

Oral use

FR - France

| NAPP Laboratories Limited Cambridge |
| --- |
| Science Park |
| Milton Road |
| CB4 4GW Cambridge |
| United Kingdom |

NAPP Laboratories Limited Cambridge

Science Park

Milton Road

CB4 4GW Cambridge

United Kingdom

PALLADONE L.P. 24 mg, gélule à libération prolongée

24 mg

Prolonged-release capsule, hard

Oral use

FR - France

| NAPP Laboratories Limited Cambridge |
| --- |
| Science Park |
| Milton Road |
| CB4 4GW Cambridge |
| United Kingdom |

NAPP Laboratories Limited Cambridge

Science Park

Milton Road

CB4 4GW Cambridge

United Kingdom

PALLADONE L.P. 4 mg, gélule à libération prolongée

4 mg

Prolonged-release capsule, hard

Oral use

FR - France

| NAPP Laboratories Limited Cambridge |
| --- |
| Science Park |
| Milton Road |
| CB4 4GW Cambridge |
| United Kingdom |

NAPP Laboratories Limited Cambridge

Science Park

Milton Road

CB4 4GW Cambridge

United Kingdom

PALLADONE L.P. 8 mg, gélule à libération prolongée

8 mg

Prolonged-release capsule, hard

Oral use

HU - Hungary

| EGIS Gyógyszergyár nyrt. |
| --- |
| Keresztúri út 30-38. |
| 1106, Budapest |
| Hungary |

EGIS Gyógyszergyár nyrt.

Keresztúri út 30-38.

1106, Budapest

Hungary

M-ESLON

30 mg

Prolonged-release capsule, hard

Oral use

HU - Hungary

| EGIS Gyógyszergyár nyrt. |
| --- |
| Keresztúri út 30-38., 1106, Budapest Hungary |

EGIS Gyógyszergyár nyrt.

Keresztúri út 30-38., 1106, Budapest Hungary

M-ESLON

60 mg

Prolonged-release capsule, hard

Oral use

HU - Hungary

| EGIS Gyógyszergyár nyrt. |
| --- |
| Keresztúri út 30-38., 1106, Budapest Hungary |

EGIS Gyógyszergyár nyrt.

Keresztúri út 30-38., 1106, Budapest Hungary

M-ESLON

100 mg

Prolonged-release capsule, hard

Oral use

HU - Hungary

| EGIS Gyógyszergyár nyrt. |
| --- |
| Keresztúri út 30-38., 1106, Budapest Hungary |

EGIS Gyógyszergyár nyrt.

Keresztúri út 30-38., 1106, Budapest Hungary

M-ESLON

200 mg

Prolonged-release capsule, hard

Oral use

HU - Hungary

| Janssen-Cilag Kft. |
| --- |
| H-2045 Törökbálint, Tó Park |
| Hungary |

Janssen-Cilag Kft.

H-2045 Törökbálint, Tó Park

Hungary

Jurnista

4 mg

Prolonged-release tablet

Oral use

HU - Hungary

| Janssen-Cilag Kft. |
| --- |
| H-2045 Törökbálint, Tó Park |
| Hungary |

Janssen-Cilag Kft.

H-2045 Törökbálint, Tó Park

Hungary

Jurnista

8 mg

Prolonged-release tablet

Oral use

HU - Hungary

| Janssen-Cilag Kft. |
| --- |
| H-2045 Törökbálint, Tó Park |
| Hungary |

Janssen-Cilag Kft.

H-2045 Törökbálint, Tó Park

Hungary

Jurnista

16 mg

Prolonged-release tablet

Oral use

HU - Hungary

| Janssen-Cilag Kft. |
| --- |
| H-2045 Törökbálint, Tó Park |
| Hungary |

Janssen-Cilag Kft.

H-2045 Törökbálint, Tó Park

Hungary

Jurnista

32 mg

Prolonged-release tablet

Oral use

HU - Hungary

| Janssen-Cilag Kft. |
| --- |
| H-2045 Törökbálint, Tó Park |
| Hungary |

Janssen-Cilag Kft.

H-2045 Törökbálint, Tó Park

Hungary

Jurnista

64 mg

Prolonged-release tablet

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

MST Continus

10 mg

Prolonged-release film coated tablet

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

MST Continus

30 mg

Prolonged-release tablet

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

MST Continus

60 mg

Prolonged-release tablet

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

MST Continus

100 mg

Prolonged-release tablet

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Oxycontin

10 mg

Prolonged-release film coated tablet

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Oxycontin

20 mg

Prolonged-release film coated tablet

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Oxycontin

40 mg

Prolonged-release film coated tablet

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Oxycontin

80 mg

Prolonged-release film coated tablet

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Palladone-SR

4 mg

Prolonged-release capsule

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Palladone-SR

8 mg

Prolonged-release capsule

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Palladone-SR

16 mg

Prolonged-release capsule

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Palladone-SR

24 mg

Prolonged-release capsule

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Palladone-XL

12 mg

Prolonged-release capsule

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Palladone-XL

16 mg

Prolonged-release capsule

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Palladone-XL

24 mg

Prolonged-release capsule

Oral use

HU - Hungary

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18., A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18., A-1072 Vienna

Austria

Palladone-XL

32 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

ETHIRFIN 120 mg prolonged-release capsules, hard

120 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

ETHIRFIN 20 mg prolonged-release capsules, hard

20 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

ETHIRFIN 200 mg prolonged-release capsules, hard

200 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

ETHIRFIN 40 mg prolonged-release capsules, hard

40 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

ETHIRFIN 60 mg prolonged-release capsules, hard

60 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS

10 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS

100 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 15 MG PROLONGED-RELEASE TABLETS

15 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 200 MG PROLONGED-RELEASE TABLETS

200 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS

30 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 5 MG PROLONGED-RELEASE TABLETS

5 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 60 MG PROLONGED-RELEASE TABLETS

60 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS suspension 100 mg

100 mg

Prolonged-release granules

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS suspension 20 mg

20 mg

Prolonged-release granules

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS suspension 200 mg

200 mg

Prolonged-release granules

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS suspension 30 mg

30 mg

Prolonged-release granules

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS suspension 60 mg

60 mg

Prolonged-release granules

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Oxycontin 10 mg Prolonged-release tablets

10 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Oxycontin 20 mg Prolonged-release tablets

20 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Oxycontin 40 mg Prolonged-release tablets

40 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Oxycontin 5 mg Prolonged-release tablets

5 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Oxycontin 80 mg Prolonged-release tablets

80 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Palladone SR Capsules 16 mg

16 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Palladone SR Capsules 2 mg

2 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Palladone SR Capsules 24 mg

24 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Palladone SR Capsules 4 mg

4 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Palladone SR Capsules 8mg

8 mg

Prolonged-release capsule

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Targin 10mg/5 mg Prolonged-release tablets

10mg/5mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Targin 20mg/10 mg Prolonged-release tablets

20mg/10mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Targin 40 mg/20 mg Prolonged-release tablets

40 mg/20 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Ltd. |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd.

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

Targin 5 mg/2,5 mg Prolonged-release tablets

5 mg/2,5 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Rowex Ltd. |
| --- |
| Bantry, Co.Cork |
| Ireland |

Rowex Ltd.

Bantry, Co.Cork

Ireland

DANCEX SR 10 mg Prolonged-release tablets

10 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Rowex Ltd. |
| --- |
| Bantry, Co.Cork |
| Ireland |

Rowex Ltd.

Bantry, Co.Cork

Ireland

DANCEX SR 20 mg Prolonged-release tablets

20 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Rowex Ltd. |
| --- |
| Bantry, Co.Cork |
| Ireland |

Rowex Ltd.

Bantry, Co.Cork

Ireland

DANCEX SR 5 mg Prolonged-release tablets

5 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Rowex Ltd. |
| --- |
| Bantry, Co.Cork |
| Ireland |

Rowex Ltd.

Bantry, Co.Cork

Ireland

Oxydon 10 mg Prolonged-release tablets

10 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Rowex Ltd. |
| --- |
| Bantry, Co.Cork |
| Ireland |

Rowex Ltd.

Bantry, Co.Cork

Ireland

Oxydon 20 mg Prolonged-release tablets

20 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Rowex Ltd. |
| --- |
| Bantry, Co.Cork |
| Ireland |

Rowex Ltd.

Bantry, Co.Cork

Ireland

Oxydon 40 mg Prolonged-release tablets

40 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Rowex Ltd. |
| --- |
| Bantry, Co.Cork |
| Ireland |

Rowex Ltd.

Bantry, Co.Cork

Ireland

Oxydon 5 mg Prolonged-release tablets

5 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Rowex Ltd. |
| --- |
| Bantry, Co.Cork |
| Ireland |

Rowex Ltd.

Bantry, Co.Cork

Ireland

Oxydon 80 mg Prolonged-release tablets

80 mg

Prolonged-release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Limited Cambridge Science Park, |
| --- |
| Milton Road |
| Cambridge, CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited Cambridge Science Park,

Milton Road

Cambridge, CB4 0GW

United Kingdom

OxyContin 60 mg prolonged release tablets

60 mg

Prolonged release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Limited Cambridge Science Park, |
| --- |
| Milton Road |
| Cambridge, CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited Cambridge Science Park,

Milton Road

Cambridge, CB4 0GW

United Kingdom

OxyContin 120 mg prolonged release tablets

120 mg

Prolonged release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Limited Cambridge Science Park, |
| --- |
| Milton Road |
| Cambridge, CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited Cambridge Science Park,

Milton Road

Cambridge, CB4 0GW

United Kingdom

OxyContin 160 mg prolonged release tablets

160 mg

Prolonged release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Limited Cambridge Science Park, |
| --- |
| Milton Road |
| Cambridge, CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited Cambridge Science Park,

Milton Road

Cambridge, CB4 0GW

United Kingdom

OxyContin 15 mg prolonged release tablets

15 mg

Prolonged release tablet

Oral use

IE - Ireland

| Napp Pharmaceuticals Limited Cambridge Science Park, |
| --- |
| Milton Road |
| Cambridge, CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited Cambridge Science Park,

Milton Road

Cambridge, CB4 0GW

United Kingdom

OxyContin 30 mg prolonged release tablets

30 mg

Prolonged release tablet

Oral use

IS - Iceland

| Ethypharm |
| --- |
| 194 Bureaux de la Colline Batiment |
| D 92213 Saint-Cloud Cedex |
| France |

Ethypharm

194 Bureaux de la Colline Batiment

D 92213 Saint-Cloud Cedex

France

Oxycodone Ethypharm

10 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Ethypharm |
| --- |
| 194 Bureaux de la Colline Batiment |
| D 92213 Saint-Cloud Cedex |
| France |

Ethypharm

194 Bureaux de la Colline Batiment

D 92213 Saint-Cloud Cedex

France

Oxycodone Ethypharm

20 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Ethypharm |
| --- |
| 194 Bureaux de la Colline Batiment |
| D 92213 Saint-Cloud Cedex |
| France |

Ethypharm

194 Bureaux de la Colline Batiment

D 92213 Saint-Cloud Cedex

France

Oxycodone Ethypharm

40 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Ethypharm |
| --- |
| 194 Bureaux de la Colline Batiment |
| D 92213 Saint-Cloud Cedex |
| France |

Ethypharm

194 Bureaux de la Colline Batiment

D 92213 Saint-Cloud Cedex

France

Oxycodone Ethypharm

80 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

5 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

10 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

20 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

40 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

80 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

Palladon

4 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

Palladon

8 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

Palladon

16 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

Palladon

24 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

Targin

5/2,5 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

Targin

10/5 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

Targin

20/10 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Norpharma |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma

Slotsmarken 15

2970 Hørsholm

Denmark

Targin

40/20 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin

5 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin

10 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin

30 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin

60 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin

100 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin

200 mg

Prolonged-release tablet

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin Uno

30 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin Uno

60 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin Uno

90 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin Uno

120 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin Uno

150 mg

Prolonged-release capsule, hard

Oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Contalgin Uno

200 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70 00181 Roma |
| Italy |

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Viale Amelia 70 00181 Roma

Italy

ETHIRFIN

20 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70 00181 Roma |
| Italy |

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Viale Amelia 70 00181 Roma

Italy

ETHIRFIN

40 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70 00181 Roma |
| Italy |

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Viale Amelia 70 00181 Roma

Italy

ETHIRFIN

60 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70 00181 Roma |
| Italy |

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Viale Amelia 70 00181 Roma

Italy

ETHIRFIN

120 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70 00181 Roma |
| Italy |

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Viale Amelia 70 00181 Roma

Italy

ETHIRFIN

200 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70 00181 Roma |
| Italy |

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Viale Amelia 70 00181 Roma

Italy

TWICE

10 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70 00181 Roma |
| Italy |

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Viale Amelia 70 00181 Roma

Italy

TWICE

30 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70 00181 Roma |
| Italy |

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Viale Amelia 70 00181 Roma

Italy

TWICE

60 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70 00181 Roma |
| Italy |

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Viale Amelia 70 00181 Roma

Italy

TWICE

100 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| BRUNO FARMACEUTICI S.P.A. |
| --- |
| Via delle Ande, 15 00100 Roma |
| Italy |

BRUNO FARMACEUTICI S.P.A.

Via delle Ande, 15 00100 Roma

Italy

UNIMORF

20 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| BRUNO FARMACEUTICI S.P.A. |
| --- |
| Via delle Ande, 15 00100 Roma |
| Italy |

BRUNO FARMACEUTICI S.P.A.

Via delle Ande, 15 00100 Roma

Italy

UNIMORF

40 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| BRUNO FARMACEUTICI S.P.A. |
| --- |
| Via delle Ande, 15 00100 Roma |
| Italy |

BRUNO FARMACEUTICI S.P.A.

Via delle Ande, 15 00100 Roma

Italy

UNIMORF

60 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| BRUNO FARMACEUTICI S.P.A. |
| --- |
| Via delle Ande, 15 00100 Roma |
| Italy |

BRUNO FARMACEUTICI S.P.A.

Via delle Ande, 15 00100 Roma

Italy

UNIMORF

120 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| BRUNO FARMACEUTICI S.P.A. |
| --- |
| Via delle Ande, 15 00100 Roma |
| Italy |

BRUNO FARMACEUTICI S.P.A.

Via delle Ande, 15 00100 Roma

Italy

UNIMORF

200 mg

Prolonged-release capsule, hard

Oral use

IT - Italy

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

SKENAN

10 mg

Prolonged-release capsule

Oral use

IT - Italy

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

SKENAN

30 mg

Prolonged-release capsule

Oral use

IT - Italy

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

SKENAN

60 mg

Prolonged-release capsule

Oral use

IT - Italy

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

SKENAN

100 mg

Prolonged-release capsule

Oral use

IT - Italy

| JANSSEN-CILAG SpA |
| --- |
| Via M. Buonarroti, 23 |
| 20093 Cologno Monzese (MI) |
| Italy |

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 Cologno Monzese (MI)

Italy

JURNISTA

4 mg

Prolonged-release tablet

Oral use

IT - Italy

| JANSSEN-CILAG SpA |
| --- |
| Via M. Buonarroti, 23 |
| 20093 Cologno Monzese (MI) |
| Italy |

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 Cologno Monzese (MI)

Italy

JURNISTA

8 mg

Prolonged-release tablet

Oral use

IT - Italy

| JANSSEN-CILAG SpA |
| --- |
| Via M. Buonarroti, 23 |
| 20093 Cologno Monzese (MI) |
| Italy |

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 Cologno Monzese (MI)

Italy

JURNISTA

16 mg

Prolonged-release tablet

Oral use

IT - Italy

| JANSSEN-CILAG SpA |
| --- |
| Via M. Buonarroti, 23 |
| 20093 Cologno Monzese (MI) |
| Italy |

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 Cologno Monzese (MI)

Italy

JURNISTA

32 mg

Prolonged-release tablet

Oral use

IT - Italy

| JANSSEN-CILAG SpA |
| --- |
| Via M. Buonarroti, 23 |
| 20093 Cologno Monzese (MI) |
| Italy |

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 Cologno Monzese (MI)

Italy

JURNISTA

64 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

10 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

30 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

60 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

100 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

200 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

20 mg

Controlled release granules for oral suspension

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

30 mg

Controlled release granules for oral suspension

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

60 mg

Controlled release granules for oral suspension

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

100 mg

Controlled release granules for oral suspension

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

MS CONTIN

200 mg

Controlled release granules for oral suspension

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

OXYCONTIN

5 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

OXYCONTIN

10 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

OXYCONTIN

20 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

OXYCONTIN

40 mg

Prolonged-release tablet

Oral use

IT - Italy

| Mundipharma Pharmaceuticals Srl |
| --- |
| Via G. Serbelloni, 4 |
| 20122 Milano |
| Italy |

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni, 4

20122 Milano

Italy

OXYCONTIN

80 mg

Prolonged-release tablet

Oral use

LT - Lithuania

| Lannacher Heilmittel Ges. m. b. H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges. m. b. H

Schlossplatz 1

8502 Lannach

Austria

Vendal retard

10 mg

Prolonged-release tablet

Oral use

LT - Lithuania

| Lannacher Heilmittel Ges. m. b. H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges. m. b. H

Schlossplatz 1

8502 Lannach

Austria

Vendal retard

30 mg

Prolonged-release tablet

Oral use

LT - Lithuania

| Lannacher Heilmittel Ges. m. b. H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges. m. b. H

Schlossplatz 1

8502 Lannach

Austria

Vendal retard

60 mg

Prolonged-release tablet

Oral use

LT - Lithuania

| Lannacher Heilmittel Ges. m. b. H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges. m. b. H

Schlossplatz 1

8502 Lannach

Austria

Vendal retard

100 mg

Prolonged-release tablet

Oral use

LT - Lithuania

| Lannacher Heilmittel Ges. m. b. H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges. m. b. H

Schlossplatz 1

8502 Lannach

Austria

Vendal retard

200 mg

Prolonged-release tablet

Oral use

LT - Lithuania

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

30 mg

Prolonged-release tablet

Oral use

LT - Lithuania

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |
| Denmark |

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Denmark

Doltard

60 mg

Prolonged-release tablet

Oral use

LU - Luxembourg

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

France

Morphine Sulfate LP Ethypharm

200 mg

Prolonged-release capsule, hard

Oral use

LU - Luxembourg

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

France

Zomorph L.P.

40 mg

Prolonged-release capsule, soft

Oral use

LU - Luxembourg

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

France

Zomorph L.P.

60 mg

Prolonged-release capsule, soft

Oral use

LU - Luxembourg

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

France

Zomorph L.P.

120 mg

Prolonged-release capsule, soft

Oral use

LU - Luxembourg

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

France

Zomorph L.P.

200 mg

Prolonged-release capsule, soft

Oral use

LU - Luxembourg

| Mundipharma C.V.A. |
| --- |
| Schalienhoevedreef 20H |
| B- 2800 Mechelen |
| Belgium |

Mundipharma C.V.A.

Schalienhoevedreef 20H

B- 2800 Mechelen

Belgium

Palladone Slow Release

4 mg

Capsule

Oral use

LU - Luxembourg

| Mundipharma C.V.A. |
| --- |
| Schalienhoevedreef 20H |
| B- 2800 Mechelen |
| Belgium |

Mundipharma C.V.A.

Schalienhoevedreef 20H

B- 2800 Mechelen

Belgium

Palladone Slow Release

8 mg

Capsule

Oral use

LU - Luxembourg

| Mundipharma C.V.A. |
| --- |
| Schalienhoevedreef 20H |
| B- 2800 Mechelen |
| Belgium |

Mundipharma C.V.A.

Schalienhoevedreef 20H

B- 2800 Mechelen

Belgium

Palladone Slow Release

16 mg

Capsule

Oral use

LU - Luxembourg

| Mundipharma C.V.A. |
| --- |
| Schalienhoevedreef 20H |
| B- 2800 Mechelen |
| Belgium |

Mundipharma C.V.A.

Schalienhoevedreef 20H

B- 2800 Mechelen

Belgium

Palladone Slow Release

24 mg

Capsule

Oral use

LU - Luxembourg

| Mundipharma C.V.A. |
| --- |
| Schalienhoevedreef 20H |
| B- 2800 Mechelen |
| Belgium |

Mundipharma C.V.A.

Schalienhoevedreef 20H

B- 2800 Mechelen

Belgium

Targinact-10/15

10/5mg

prolonged-release tablet

Oral use

LU - Luxembourg

| Mundipharma C.V.A. |
| --- |
| Schalienhoevedreef 20H |
| B- 2800 Mechelen |
| Belgium |

Mundipharma C.V.A.

Schalienhoevedreef 20H

B- 2800 Mechelen

Belgium

Targinact-20/10

20/10mg

prolonged-release tablet

Oral use

LV - Latvia

| Lannacher Heilmittel Ges.mbH Schloβplatz 1 |
| --- |
| A-8502, Lannach |
| Austria |

Lannacher Heilmittel Ges.mbH Schloβplatz 1

A-8502, Lannach

Austria

Vendal retard 10 mg prolonged-release tablets

10 mg

Prolonged-release tablet

Oral use

LV - Latvia

| Lannacher Heilmittel Ges.mbH Schloβplatz 1 |
| --- |
| A-8502, Lannach |
| Austria |

Lannacher Heilmittel Ges.mbH Schloβplatz 1

A-8502, Lannach

Austria

Vendal retard 100 mg prolonged-release tablets

100 mg

Prolonged-release tablet

Oral use

LV - Latvia

| Lannacher Heilmittel Ges.mbH Schloβplatz 1 |
| --- |
| A-8502, Lannach |
| Austria |

Lannacher Heilmittel Ges.mbH Schloβplatz 1

A-8502, Lannach

Austria

Vendal retard 30 mg prolonged-release tablets

30 mg

Prolonged-release tablet

Oral use

LV - Latvia

| Lannacher Heilmittel Ges.mbH Schloβplatz 1 |
| --- |
| A-8502, Lannach |
| Austria |

Lannacher Heilmittel Ges.mbH Schloβplatz 1

A-8502, Lannach

Austria

Vendal retard 60 mg prolonged-release tablets

60 mg

Prolonged-release tablet

Oral use

LV - Latvia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18

A-1072 Viena

Austria

OxyContin 10 mg prolonged release tablets

10 mg

Prolonged-release tablet

Oral use

LV - Latvia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18

A-1072 Viena

Austria

OxyContin 20 mg prolonged release tablets

20 mg

Prolonged-release tablet

Oral use

LV - Latvia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18

A-1072 Viena

Austria

OxyContin 40 mg prolonged release tablets

40 mg

Prolonged-release tablet

Oral use

LV - Latvia

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18

A-1072 Viena

Austria

OxyContin 80 mg prolonged release tablets

80 mg

Prolonged-release tablet

Oral use

LV - Latvia

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| DK – 4000 Roskilde |
| Denmark |

Nycomed Danmark ApS

Langebjerg 1

DK – 4000 Roskilde

Denmark

Doltard 30 mg prolonged-release tablets

30 mg

Prolonged-release tablet

Oral use

LV - Latvia

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| DK – 4000 Roskilde |
| Denmark |

Nycomed Danmark ApS

Langebjerg 1

DK – 4000 Roskilde

Denmark

Doltard 60 mg prolonged-release tablets

60 mg

prolonged-release tablet

Oral use

MT - Malta

| Napp Pharmaceuticals Ltd |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 10 mg tablets

10 mg

Prolonged-release tablet

Oral use

MT - Malta

| Napp Pharmaceuticals Ltd |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 30 mg tablets

30 mg

Prolonged-release tablet

Oral use

MT - Malta

| Napp Pharmaceuticals Ltd |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS 60mg tablets

60 mg

Prolonged-release tablet

Oral use

NL - Netherlands

| Apothecon B.V. |
| --- |
| Nijverheidsweg 3 |
| NL-3771 ME Barneveld |
| The Netherlands |

Apothecon B.V.

Nijverheidsweg 3

NL-3771 ME Barneveld

The Netherlands

Morfine HCl retard 10 A, tabletten met verlengde afgifte 10 mg

10 mg

Prolonged-release tablet

Oral use

NL - Netherlands

| Apothecon B.V. |
| --- |
| Nijverheidsweg 3 |
| NL-3771 ME Barneveld |
| The Netherlands |

Apothecon B.V.

Nijverheidsweg 3

NL-3771 ME Barneveld

The Netherlands

Morfine HCl retard 100 A, tabletten met verlengde afgifte 10 mg

100 mg

Prolonged-release tablet

Oral use

NL - Netherlands

| Apothecon B.V. |
| --- |
| Nijverheidsweg 3 |
| NL-3771 ME Barneveld |
| The Netherlands |

Apothecon B.V.

Nijverheidsweg 3

NL-3771 ME Barneveld

The Netherlands

Morfine HCl retard 200 A, tabletten met verlengde afgifte 10 mg

200 mg

Prolonged-release tablet

Oral use

NL - Netherlands

| Apothecon B.V. |
| --- |
| Nijverheidsweg 3 |
| NL-3771 ME Barneveld |
| The Netherlands |

Apothecon B.V.

Nijverheidsweg 3

NL-3771 ME Barneveld

The Netherlands

Morfine HCl retard 30 A, tabletten met verlengde afgifte 10 mg

30 mg

Prolonged-release tablet

Oral use

NL - Netherlands

| Apothecon B.V. |
| --- |
| Nijverheidsweg 3 |
| NL-3771 ME Barneveld |
| The Netherlands |

Apothecon B.V.

Nijverheidsweg 3

NL-3771 ME Barneveld

The Netherlands

Morfine HCl retard 60 A, tabletten met verlengde afgifte 10 mg

60 mg

Prolonged-release tablet

Oral use

NL - Netherlands

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| NL-4879 AC Etten-Leur |
| The Netherlands |

Centrafarm Services BV

Nieuwe Donk 9

NL-4879 AC Etten-Leur

The Netherlands

Morfine HCl retard CF 10 mg, tabletten met gereguleerde afgifte

10 mg

Modified-release tablet

Oral use

NL - Netherlands

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| NL-4879 AC Etten-Leur |
| The Netherlands |

Centrafarm Services BV

Nieuwe Donk 9

NL-4879 AC Etten-Leur

The Netherlands

Morfine HCl retard CF 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

NL - Netherlands

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| NL-4879 AC Etten-Leur |
| The Netherlands |

Centrafarm Services BV

Nieuwe Donk 9

NL-4879 AC Etten-Leur

The Netherlands

Morfine HCl retard CF 200 mg, tabletten met gereguleerde afgifte

200 mg

Modified-release tablet

Oral use

NL - Netherlands

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| NL-4879 AC Etten-Leur |
| The Netherlands |

Centrafarm Services BV

Nieuwe Donk 9

NL-4879 AC Etten-Leur

The Netherlands

Morfine HCl retard CF 30 mg, tabletten met gereguleerde afgifte

30 mg

Modified-release tablet

Oral use

NL - Netherlands

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| NL-4879 AC Etten-Leur |
| The Netherlands |

Centrafarm Services BV

Nieuwe Donk 9

NL-4879 AC Etten-Leur

The Netherlands

Morfine HCl retard CF 60 mg, tabletten met gereguleerde afgifte

60 mg

Modified-release tablet

Oral use

NL - Netherlands

| GlaxoSmithKline B.V. |
| --- |
| Huis ter Heideweg 62 |
| NL-3705 LZ Zeist |
| The Netherlands |

GlaxoSmithKline B.V.

Huis ter Heideweg 62

NL-3705 LZ Zeist

The Netherlands

Kapanol 100, capsules met gereguleerde afgifte 20 mg

100 mg

Prolonged-release capsule

Oral use

NL - Netherlands

| GlaxoSmithKline B.V. |
| --- |
| Huis ter Heideweg 62 |
| NL-3705 LZ Zeist |
| The Netherlands |

GlaxoSmithKline B.V.

Huis ter Heideweg 62

NL-3705 LZ Zeist

The Netherlands

Kapanol 20, capsules met gereguleerde afgifte 20 mg

20 mg

Prolonged-release capsule

Oral use

NL - Netherlands

| GlaxoSmithKline B.V. |
| --- |
| Huis ter Heideweg 62 |
| NL-3705 LZ Zeist |
| The Netherlands |

GlaxoSmithKline B.V.

Huis ter Heideweg 62

NL-3705 LZ Zeist

The Netherlands

Kapanol 50, capsules met gereguleerde afgifte 20 mg

50 mg

Prolonged-release capsule

Oral use

NL - Netherlands

| Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton |
| --- |
| FR-92500 Rueil Malmaison |
| France |

Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton

FR-92500 Rueil Malmaison

France

Skenan SR 10 mg, capsules met gereguleerde afgifte

10 mg

Modified-release capsule

Oral use

NL - Netherlands

| Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton |
| --- |
| FR-92500 Rueil Malmaison |
| France |

Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton

FR-92500 Rueil Malmaison

France

Skenan SR 100 mg, capsules met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

NL - Netherlands

| Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton |
| --- |
| FR-92500 Rueil Malmaison |
| France |

Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton

FR-92500 Rueil Malmaison

France

Skenan SR 200 mg, capsules met gereguleerde afgifte

200 mg

Modified-release tablet

Oral use

NL - Netherlands

| Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton |
| --- |
| FR-92500 Rueil Malmaison |
| France |

Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton

FR-92500 Rueil Malmaison

France

Skenan SR 30 mg, capsules met gereguleerde afgifte

30 mg

Modified-release tablet

Oral use

NL - Netherlands

| Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton |
| --- |
| FR-92500 Rueil Malmaison |
| France |

Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton

FR-92500 Rueil Malmaison

France

Skenan SR 60 mg, capsules met gereguleerde afgifte

60 mg

Modified-release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

MS Contin 10 mg, tabletten met gereguleerde afgifte

10 mg

Modified-release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

MS Contin 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

MS Contin 15 mg, tabletten met gereguleerde afgifte

15 mg

Modified-release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

MS Contin 200 mg, tabletten met gereguleerde afgifte

2 000 mg

Modified-release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

MS Contin 30 mg, tabletten met gereguleerde afgifte

30 mg

Modified-release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

MS Contin 5 mg, tabletten met gereguleerde afgifte

5 mg

Modified-release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

MS Contin 60 mg, tabletten met gereguleerde afgifte

60 mg

Modified-release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

OxyContin 10 mg, tabletten met gereguleerde afgifte

10 mg

Modified release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

OxyContin 20 mg, tabletten met gereguleerde afgifte

20 mg

Modified release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

OxyContin 40 mg, tabletten met gereguleerde afgifte

40 mg

Modified release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

OxyContin 5 mg, tabletten met gereguleerde afgifte

5 mg

Modified release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

OxyContin 80 mg, tabletten met gereguleerde afgifte

80 mg

Modified release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

Palladon-SR capsule 16 mg, capsules met verlengde afgifte

16 mg

Prolonged release capsule

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

Palladon-SR capsule 2 mg, capsules met verlengde afgifte

2 mg

Prolonged release capsule

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

Palladon-SR capsule 24 mg, capsules met verlengde afgifte

24 mg

Prolonged release capsule

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

Palladon-SR capsule 4 mg, capsules met verlengde afgifte

4 mg

Prolonged release capsule

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

Palladon-SR capsule 8 mg, capsules met verlengde afgifte

8 mg

Prolonged release capsule

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

Targinact 10 mg/ 5 mg, tabletten met verlengde afgifte

10 and 5 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

Targinact 20 mg/ 10 mg, tabletten met verlengde afgifte

20 and 10 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

Targinact 40 mg/ 20 mg, tabletten met verlengde afgifte

40 and 20 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Mundipharma Pharmaceuticals B.V. |
| --- |
| De Weil 20 |
| NL-3871 MV Hoevelaken |
| The Netherlands |

Mundipharma Pharmaceuticals B.V.

De Weil 20

NL-3871 MV Hoevelaken

The Netherlands

Targinact 5 mg/ 2,5 mg, tabletten met verlengde afgifte

5 and 2,5 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2031 GA Haarlem |
| The Netherlands |

Pharmachemie BV

Swensweg 5

NL-2031 GA Haarlem

The Netherlands

Morfinesulfaat retard 10 PCH, tabletten met gereguleerde afgifte 10 mg

10 mg

Modified-release tablet

Oral use

NL - Netherlands

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2031 GA Haarlem |
| The Netherlands |

Pharmachemie BV

Swensweg 5

NL-2031 GA Haarlem

The Netherlands

Morfinesulfaat retard 100 PCH, tabletten met gereguleerde afgifte 10 mg

100 mg

Modified-release tablet

Oral use

NL - Netherlands

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2031 GA Haarlem |
| The Netherlands |

Pharmachemie BV

Swensweg 5

NL-2031 GA Haarlem

The Netherlands

Morfinesulfaat retard 30 PCH, tabletten met gereguleerde afgifte 10 mg

30 mg

Modified-release tablet

Oral use

NL - Netherlands

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2031 GA Haarlem |
| The Netherlands |

Pharmachemie BV

Swensweg 5

NL-2031 GA Haarlem

The Netherlands

Morfinesulfaat retard 60 PCH, tabletten met gereguleerde afgifte 10 mg

60 mg

Modified-release tablet

Oral use

NL - Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam Florapark 4

2012 HK Haarlem

The Netherlands

Oxycodon HCl ratiopharm 10 mg, tabletten met verlengde afgifte

10 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam Florapark 4

2012 HK Haarlem

The Netherlands

Oxycodon HCl ratiopharm 20 mg, tabletten met verlengde afgifte

20 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam Florapark 4

2012 HK Haarlem

The Netherlands

Oxycodon HCl ratiopharm 40 mg, tabletten met verlengde afgifte

40 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam Florapark 4

2012 HK Haarlem

The Netherlands

Oxycodon HCl ratiopharm 50 mg, tabletten met verlengde afgifte

5 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam Florapark 4

2012 HK Haarlem

The Netherlands

Oxycodon HCl ratiopharm 80 mg, tabletten met verlengde afgifte

80 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Oxycodon HCl Sandoz 10 mg, tabletten met verlengde afgifte

10 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Oxycodon HCl Sandoz 20 mg, tabletten met verlengde afgifte

20 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Oxycodon HCl Sandoz 40 mg, tabletten met verlengde afgifte

40 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Oxycodon HCl Sandoz 5 mg, tabletten met verlengde afgifte

5 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Oxycodon HCl Sandoz 80 mg, tabletten met verlengde afgifte

80 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Oxycodon HCl Sandoz retard 10 mg, tabletten met verlengde afgifte

10 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Oxycodon HCl Sandoz retard 20 mg, tabletten met verlengde afgifte

20 mg

Prolonged release tablet

Oral use

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Oxycodon HCl Sandoz retard 5 mg, tabletten met verlengde afgifte

5 mg

Prolonged release tablet

Oral use

NO - Norway

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

20 mg

Prolonged release tablet

Oral use

NO - Norway

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

40 mg

Prolonged release tablet

Oral use

NO - Norway

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

80 mg

Prolonged release tablet

Oral use

NO - Norway

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

10 mg

Prolonged release tablet

Oral use

NO - Norway

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

5 mg

Prolonged release tablet

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

OXYCONTIN

5 mg

Prolonged-release tablet

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

OXYCONTIN

10 mg

Prolonged-release tablet

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

OXYCONTIN

20 mg

Prolonged-release tablet

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

OXYCONTIN

40 mg

Prolonged-release tablet

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

OXYCONTIN

80 mg

Prolonged-release tablet

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

PALLADON

4 mg

Prolonged-release capsule, hard

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

PALLADON

8 mg

Prolonged-release capsule, hard

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

PALLADON

16 mg

Prolonged-release capsule, hard

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

PALLADON

24 mg

Prolonged-release capsule, hard

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

PALLADON

1,3 mg

capsule, hard

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

PALLADON

2,6 mg

capsule, hard

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

Targiniq

5 mg/2,5 mg

Prolonged-release tablet

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

Targiniq

40 mg/20 mg

Prolonged-release tablet

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

Targiniq

10 mg/5 mg

Prolonged-release tablet

Oral use

NO - Norway

| Mundipharma As Vollsveien 13c 1366 Lysaker |
| --- |
| Norway |

Mundipharma As Vollsveien 13c 1366 Lysaker

Norway

Targiniq

20 mg/10 mg

Prolonged-release tablet

Oral use

NO - Norway

| Pfizer As |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norway |

Pfizer As

Postboks 3

1324 Lysaker

Norway

DOLCONTIN

20 mg/dose

Prolonged-release granules for oral suspension

Oral use

NO - Norway

| Pfizer As |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norway |

Pfizer As

Postboks 3

1324 Lysaker

Norway

DOLCONTIN

5 mg

Prolonged-release tablet

Oral use

NO - Norway

| Pfizer As |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norway |

Pfizer As

Postboks 3

1324 Lysaker

Norway

DOLCONTIN

10 mg

Prolonged-release tablet

Oral use

NO - Norway

| Pfizer As |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norway |

Pfizer As

Postboks 3

1324 Lysaker

Norway

DOLCONTIN

30 mg

Prolonged-release tablet

Oral use

NO - Norway

| Pfizer As |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norway |

Pfizer As

Postboks 3

1324 Lysaker

Norway

DOLCONTIN

60 mg

Prolonged-release tablet

Oral use

NO - Norway

| Pfizer As |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norway |

Pfizer As

Postboks 3

1324 Lysaker

Norway

DOLCONTIN

100 mg

Prolonged-release tablet

Oral use

NO - Norway

| Pfizer As |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norway |

Pfizer As

Postboks 3

1324 Lysaker

Norway

DOLCONTIN

200 mg

Prolonged-release tablet

Oral use

NO - Norway

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89070 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

89070 Ulm

Germany

Oxycodone ratiopharm

20 mg

Prolonged-release tablet

Oral use

NO - Norway

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89070 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

89070 Ulm

Germany

Oxycodone ratiopharm

40 mg

Prolonged-release tablet

Oral use

NO - Norway

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89070 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

89070 Ulm

Germany

Oxycodone ratiopharm

80 mg

Prolonged-release tablet

Oral use

NO - Norway

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89070 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

89070 Ulm

Germany

Oxycodone ratiopharm

5 mg

Prolonged-release tablet

Oral use

NO - Norway

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89070 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

89070 Ulm

Germany

Oxycodone ratiopharm

10 mg

Prolonged-release tablet

Oral use

NO - Norway

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Oxycodone Sandoz

5 mg

Prolonged release tablet

Oral use

NO - Norway

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Oxycodone Sandoz

10 mg

Prolonged release tablet

Oral use

NO - Norway

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Oxycodone Sandoz

20 mg

Prolonged release tablet

Oral use

PL - Poland

| G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach |
| --- |
| Austria |

G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach

Austria

Vendal retard

10 mg

Prolonged-release film-coated tablet

Oral use

PL - Poland

| G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach |
| --- |
| Austria |

G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach

Austria

Vendal retard

30 mg

Prolonged-release film-coated tablet

Oral use

PL - Poland

| G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach |
| --- |
| Austria |

G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach

Austria

Vendal retard

60 mg

Prolonged-release film-coated tablet

Oral use

PL - Poland

| G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach |
| --- |
| Austria |

G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach

Austria

Vendal retard

100 mg

Prolonged-release film-coated tablet

Oral use

PL - Poland

| G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach |
| --- |
| Austria |

G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach

Austria

Vendal retard

200 mg

Prolonged-release film-coated tablet

Oral use

PL - Poland

| Molteni Farmaceutici Polska Sp. z o.o. |
| --- |
| 3 Obroncow Modlina St. |
| 30-733, Cracow |
| Poland |

Molteni Farmaceutici Polska Sp. z o.o.

3 Obroncow Modlina St.

30-733, Cracow

Poland

Oramorph O.D. 20

20 mg

Prolonged-release capsule, hard

Oral use

PL - Poland

| Molteni Farmaceutici Polska Sp. z o.o. |
| --- |
| 3 Obroncow Modlina St. |
| 30-733, Cracow |
| Poland |

Molteni Farmaceutici Polska Sp. z o.o.

3 Obroncow Modlina St.

30-733, Cracow

Poland

Oramorph O.D. 200

200 mg

Prolonged-release capsule, hard

Oral use

PL - Poland

| Molteni Farmaceutici Polska Sp. z o.o. |
| --- |
| 3 Obroncow Modlina St. |
| 30-733, Cracow |
| Poland |

Molteni Farmaceutici Polska Sp. z o.o.

3 Obroncow Modlina St.

30-733, Cracow

Poland

Oramorph O.D. 40

40 mg

Prolonged-release capsule, hard

Oral use

PL - Poland

| Molteni Farmaceutici Polska Sp. z o.o. |
| --- |
| 3 Obroncow Modlina St. |
| 30-733, Cracow |
| Poland |

Molteni Farmaceutici Polska Sp. z o.o.

3 Obroncow Modlina St.

30-733, Cracow

Poland

Oramorph O.D. 60

60 mg

Prolonged-release capsule, hard

Oral use

PL - Poland

| Molteni Farmaceutici Polska Sp. z o.o. |
| --- |
| 3 Obroncow Modlina St. |
| 30-733, Cracow |
| Poland |

Molteni Farmaceutici Polska Sp. z o.o.

3 Obroncow Modlina St.

30-733, Cracow

Poland

Oramorph O.D.120

120 mg

Prolonged-release capsule, hard

Oral use

PL - Poland

| Mundipharma Ges.m.b.H Apollogase 16-18 |
| --- |
| A-1072 Wien |
| Austria |

Mundipharma Ges.m.b.H Apollogase 16-18

A-1072 Wien

Austria

Palladone-XL 12 mg

12 mg

Prolonged-release capsule, hard

Oral use

PL - Poland

| Mundipharma Ges.m.b.H Apollogase 16-18 |
| --- |
| A-1072 Wien |
| Austria |

Mundipharma Ges.m.b.H Apollogase 16-18

A-1072 Wien

Austria

Palladone-XL 16 mg

16 mg

Prolonged-release capsule, hard

Oral use

PL - Poland

| Mundipharma Ges.m.b.H Apollogase 16-18 |
| --- |
| A-1072 Wien |
| Austria |

Mundipharma Ges.m.b.H Apollogase 16-18

A-1072 Wien

Austria

Palladone-XL 24 mg

24 mg

Prolonged-release capsule, hard

Oral use

PL - Poland

| Mundipharma Ges.m.b.H Apollogase 16-18 |
| --- |
| A-1072 Wien |
| Austria |

Mundipharma Ges.m.b.H Apollogase 16-18

A-1072 Wien

Austria

Palladone-XL 32 mg

32 mg

Prolonged-release capsule, hard

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

MST Continus

10 mg

Modified-release film-coated tablet

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

MST Continus

30 mg

Modified-release film-coated tablet

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

MST Continus

60 mg

Modified-release film-coated tablet

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

MST Continus

100 mg

Modified-release film-coated tablet

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

MST Continus

200 mg

Modified-release film-coated tablet

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

5 mg

Prolonged-release tablet

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

10 mg

Prolonged-release tablet

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

20 mg

Prolonged-release tablet

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

40 mg

Prolonged-release tablet

Oral use

PL - Poland

| Norpharma A/S |
| --- |
| Slotsmarken 15 |
| 2970 Hørsholm |
| Denmark |

Norpharma A/S

Slotsmarken 15

2970 Hørsholm

Denmark

OxyContin

80 mg

Prolonged-release tablet

Oral use

PL - Poland

| Nycomed Pharma Sp. z o.o. |
| --- |
| Al. Jerozoimskie 146A 02-305 Warsaw, |
| Poland |

Nycomed Pharma Sp. z o.o.

Al. Jerozoimskie 146A 02-305 Warsaw,

Poland

Doltard

10 mg

Prolonged-release tablet

Oral use

PL - Poland

| Nycomed Pharma Sp. z o.o. |
| --- |
| Al. Jerozoimskie 146A 02-305 Warsaw, |
| Poland |

Nycomed Pharma Sp. z o.o.

Al. Jerozoimskie 146A 02-305 Warsaw,

Poland

Doltard

30 mg

Prolonged-release tablet

Oral use

PL - Poland

| Nycomed Pharma Sp. z o.o. |
| --- |
| Al. Jerozoimskie 146A 02-305 Warsaw, |
| Poland |

Nycomed Pharma Sp. z o.o.

Al. Jerozoimskie 146A 02-305 Warsaw,

Poland

Doltard

60 mg

Prolonged-release tablet

Oral use

PL - Poland

| Nycomed Pharma Sp. z o.o. |
| --- |
| Al. Jerozoimskie 146A 02-305 Warsaw, |
| Poland |

Nycomed Pharma Sp. z o.o.

Al. Jerozoimskie 146A 02-305 Warsaw,

Poland

Doltard

100 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Grünenthal, S.A. |
| --- |
| Rua Alfredo da Silva, 16 |
| 2610-016 Amadora |
| Portugal |

Grünenthal, S.A.

Rua Alfredo da Silva, 16

2610-016 Amadora

Portugal

Grumorph

10 mg

Prolonged-release capsule

Oral use

PT - Portugal

| Grünenthal, S.A. |
| --- |
| Rua Alfredo da Silva, 16 |
| 2610-016 Amadora |
| Portugal |

Grünenthal, S.A.

Rua Alfredo da Silva, 16

2610-016 Amadora

Portugal

Grumorph

30 mg

Prolonged-release capsule

Oral use

PT - Portugal

| Grünenthal, S.A. |
| --- |
| Rua Alfredo da Silva, 16 |
| 2610-016 Amadora |
| Portugal |

Grünenthal, S.A.

Rua Alfredo da Silva, 16

2610-016 Amadora

Portugal

Grumorph

60 mg

Prolonged-release capsule

Oral use

PT - Portugal

| Grünenthal, S.A. |
| --- |
| Rua Alfredo da Silva, 16 |
| 2610-016 Amadora |
| Portugal |

Grünenthal, S.A.

Rua Alfredo da Silva, 16

2610-016 Amadora

Portugal

Grumorph

100 mg

Prolonged-release capsule

Oral use

PT - Portugal

| Janssen-Cilag Farmacêutica, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 |
| A - Queluz de Baixo |
| 2734-503 Barcarena |
| Portugal |

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69

A - Queluz de Baixo

2734-503 Barcarena

Portugal

Jurnista

8 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Janssen-Cilag Farmacêutica, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 |
| A - Queluz de Baixo |
| 2734-503 Barcarena |
| Portugal |

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69

A - Queluz de Baixo

2734-503 Barcarena

Portugal

Jurnista

16 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Janssen-Cilag Farmacêutica, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 |
| A - Queluz de Baixo |
| 2734-503 Barcarena |
| Portugal |

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69

A - Queluz de Baixo

2734-503 Barcarena

Portugal

Jurnista

32 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Janssen-Cilag Farmacêutica, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 |
| A - Queluz de Baixo |
| 2734-503 Barcarena |
| Portugal |

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69

A - Queluz de Baixo

2734-503 Barcarena

Portugal

Jurnista

64 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Janssen-Cilag Farmacêutica, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 |
| A - Queluz de Baixo |
| 2734-503 Barcarena |
| Portugal |

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69

A - Queluz de Baixo

2734-503 Barcarena

Portugal

Jurnista

4 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma Farmacêutica, Lda. |
| --- |
| Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa |
| Portugal |

Mundipharma Farmacêutica, Lda.

Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa

Portugal

Mst 1

10 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma Farmacêutica, Lda. |
| --- |
| Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa |
| Portugal |

Mundipharma Farmacêutica, Lda.

Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa

Portugal

Mst 10

100 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma Farmacêutica, Lda. |
| --- |
| Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa |
| Portugal |

Mundipharma Farmacêutica, Lda.

Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa

Portugal

Mst 20

200 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma Farmacêutica, Lda. |
| --- |
| Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa |
| Portugal |

Mundipharma Farmacêutica, Lda.

Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa

Portugal

Mst 3

30 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma Farmacêutica, Lda. |
| --- |
| Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa |
| Portugal |

Mundipharma Farmacêutica, Lda.

Praça Duque de Saldanha, 1 - 6o - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa

Portugal

Mst 6

60 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma GmbH Mundipharma |
| --- |
| Strasse 2 |
| D-65549, Limburg |
| Germany |

Mundipharma GmbH Mundipharma

Strasse 2

D-65549, Limburg

Germany

Oxycontin

10 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma GmbH Mundipharma |
| --- |
| Strasse 2 |
| D-65549, Limburg |
| Germany |

Mundipharma GmbH Mundipharma

Strasse 2

D-65549, Limburg

Germany

Oxycontin

20 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma GmbH Mundipharma |
| --- |
| Strasse 2 |
| D-65549, Limburg |
| Germany |

Mundipharma GmbH Mundipharma

Strasse 2

D-65549, Limburg

Germany

Oxycontin

40 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma GmbH Mundipharma |
| --- |
| Strasse 2 |
| D-65549, Limburg |
| Germany |

Mundipharma GmbH Mundipharma

Strasse 2

D-65549, Limburg

Germany

Oxycontin

80 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma GmbH Mundipharma |
| --- |
| Strasse 2 |
| D-65549, Limburg |
| Germany |

Mundipharma GmbH Mundipharma

Strasse 2

D-65549, Limburg

Germany

Oxycontin

5 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma GmbH Mundipharma |
| --- |
| Strasse 2 |
| D-65549, Limburg |
| Germany |

Mundipharma GmbH Mundipharma

Strasse 2

D-65549, Limburg

Germany

Targin

9 mg + 4,5 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma GmbH Mundipharma |
| --- |
| Strasse 2 |
| D-65549, Limburg |
| Germany |

Mundipharma GmbH Mundipharma

Strasse 2

D-65549, Limburg

Germany

Targin

18 mg + 9 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma GmbH Mundipharma |
| --- |
| Strasse 2 |
| D-65549, Limburg |
| Germany |

Mundipharma GmbH Mundipharma

Strasse 2

D-65549, Limburg

Germany

Targin

36 mg + 18 mg

Prolonged-release tablet

Oral use

PT - Portugal

| Mundipharma GmbH Mundipharma |
| --- |
| Strasse 2 |
| D-65549, Limburg |
| Germany |

Mundipharma GmbH Mundipharma

Strasse 2

D-65549, Limburg

Germany

Targin

4,5 mg + 2,25 mg

Prolonged-release tablet

Oral use

RO - Romania

| Lannacher Heilmittel Ges.mbH Schloβplatz 1 |
| --- |
| A-8502, Lannach |
| Austria |

Lannacher Heilmittel Ges.mbH Schloβplatz 1

A-8502, Lannach

Austria

VENDAL RETARD 10 mg, comprimate cu eliberare prelungită

10 mg

Prolonged-release tablet

Oral use

RO - Romania

| Lannacher Heilmittel Ges.mbH Schloβplatz 1 |
| --- |
| A-8502, Lannach |
| Austria |

Lannacher Heilmittel Ges.mbH Schloβplatz 1

A-8502, Lannach

Austria

VENDAL RETARD 100 mg, comprimate cu eliberare prelungită

100 mg

Prolonged-release tablet

Oral use

RO - Romania

| Lannacher Heilmittel Ges.mbH Schloβplatz 1 |
| --- |
| A-8502, Lannach |
| Austria |

Lannacher Heilmittel Ges.mbH Schloβplatz 1

A-8502, Lannach

Austria

VENDAL RETARD 30 mg, comprimate cu eliberare prelungită

30 mg

Prolonged-release tablet

Oral use

RO - Romania

| Lannacher Heilmittel Ges.mbH Schloβplatz 1 |
| --- |
| A-8502, Lannach |
| Austria |

Lannacher Heilmittel Ges.mbH Schloβplatz 1

A-8502, Lannach

Austria

VENDAL RETARD 60 mg, comprimate cu eliberare prelungită

60 mg

Prolonged-release tablet

Oral use

RO - Romania

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1072 Viena

Austria

MST CONTINUS 10 mg, comprimate cu eliberare modificată

10 mg

Modified-release tablet

Oral use

RO - Romania

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1072 Viena

Austria

MST CONTINUS 100 mg, comprimate cu eliberare modificată

100 mg

Modified-release tablet

Oral use

RO - Romania

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1072 Viena

Austria

MST CONTINUS 200 mg, comprimate cu eliberare modificată

200 mg

Modified-release tablet

Oral use

RO - Romania

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1072 Viena

Austria

MST CONTINUS 30 mg, comprimate fcu eliberare modificată

30 mg

Modified-release tablet

Oral use

RO - Romania

| MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 |
| --- |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H Apollogasse 16-18

A-1072 Viena

Austria

MST CONTINUS 60 mg, comprimate cu eliberare modificată

60 mg

Modified-release tablet

Oral use

RO - Romania

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18

A-1072 Viena

Austria

OXYCONTIN 10 mg, comprimate cu eliberare modificată

10 mg

Modified-release tablet

Oral use

RO - Romania

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18

A-1072 Viena

Austria

OXYCONTIN 20 mg, comprimate cu eliberare modificată

20 mg

Modified-release tablet

Oral use

RO - Romania

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18

A-1072 Viena

Austria

OXYCONTIN 40 mg, comprimate cu eliberare modificată

40 mg

Modified-release tablet

Oral use

RO - Romania

| MUNDIPHARMA Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Viena |
| Austria |

MUNDIPHARMA Ges.m.b.H.

Apollogasse 16-18

A-1072 Viena

Austria

OXYCONTIN 80 mg, comprimate cu eliberare modificată

80 mg

Modified-release tablet

Oral use

SE - Sweden

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

20 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

40 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

80 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

5 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Oxycodone Hexal

10 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Depolan

10 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Depolan

30 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Depolan

60 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Depolan

100 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Depolan

200 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Oxycodone Lannacher

5 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Oxycodone Lannacher

10 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Oxycodone Lannacher

20 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Oxycodone Lannacher

40 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach |
| --- |
| Austria |

Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach

Austria

Oxycodone Lannacher

80 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

OxyContin

5 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

OxyContin

10 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

OxyContin

20 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

OxyContin

40 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

OxyContin

80 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

OxyContin

160 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

Palladon

4 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

Palladon

8 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

Palladon

16 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

Palladon

24 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

Targiniq

40 mg/20 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

Targiniq

5 mg/2,5 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

Targiniq

10 mg/5 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Mundipharma AB |
| --- |
| Mölndalsvägen 30 B |
| 412 63 Göteborg |
| Sweden |

Mundipharma AB

Mölndalsvägen 30 B

412 63 Göteborg

Sweden

Targiniq

20 mg/10 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

20 mg

Modified-release granules for oral suspension

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

30 mg

Modified-release granules for oral suspension

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

60 mg

Modified-release granules for oral suspension

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

100 mg

Modified-release granules for oral suspension

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

10 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

30 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

60 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

100 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

200 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin

5 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin Unotard

30 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin Unotard

60 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin Unotard

90 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin Unotard

120 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin Unotard

150 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Dolcontin Unotard

200 mg

Prolonged-release capsule, hard

Oral use

SE - Sweden

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodone ratiopharm

5 mg

Prolonged-release tablet

Oral use

SE - Sweden

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodone ratiopharm

10 mg

Prolonged-release tablet

Oral use

SE - Sweden

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodone ratiopharm

20 mg

Prolonged-release tablet

Oral use

SE - Sweden

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodone ratiopharm

40 mg

Prolonged-release tablet

Oral use

SE - Sweden

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Oxycodone ratiopharm

80 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Oxycodone Sandoz

5 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Oxycodone Sandoz

10 mg

Prolonged-release tablet

Oral use

SE - Sweden

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Oxycodone Sandoz

20 mg

Prolonged-release tablet

Oral use

SI - Slovenia

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

M-eslon 10 mg trde kapsule s podaljšanim sproščanjem

10 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

M-eslon 100 mg trde kapsule s podaljšanim sproščanjem

100 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

M-eslon 30 mg trde kapsule s podaljšanim sproščanjem

30 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex

France

M-eslon 60 mg trde kapsule s podaljšanim sproščanjem

60 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska 53 |
| SI- 1000 Ljubljana |
| Slovenia |

Johnson & Johnson d.o.o.

Šmartinska 53

SI- 1000 Ljubljana

Slovenia

JURNISTA 16 mg tablete s podaljšanim sproščanjem

16 mg

prolonged-release tablet

Oral use

SI - Slovenia

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska 53 |
| SI- 1000 Ljubljana |
| Slovenia |

Johnson & Johnson d.o.o.

Šmartinska 53

SI- 1000 Ljubljana

Slovenia

JURNISTA 32 mg tablete s podaljšanim sproščanjem

32 mg

prolonged-release tablet

Oral use

SI - Slovenia

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska 53 |
| SI- 1000 Ljubljana |
| Slovenia |

Johnson & Johnson d.o.o.

Šmartinska 53

SI- 1000 Ljubljana

Slovenia

JURNISTA 4 mg tablete s podaljšanim sproščanjem

4 mg

prolonged-release tablet

Oral use

SI - Slovenia

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska 53 |
| SI- 1000 Ljubljana |
| Slovenia |

Johnson & Johnson d.o.o.

Šmartinska 53

SI- 1000 Ljubljana

Slovenia

JURNISTA 64 mg tablete s podaljšanim sproščanjem

64 mg

prolonged-release tablet

Oral use

SI - Slovenia

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska 53 |
| SI- 1000 Ljubljana |
| Slovenia |

Johnson & Johnson d.o.o.

Šmartinska 53

SI- 1000 Ljubljana

Slovenia

JURNISTA 8 mg tablete s podaljšanim sproščanjem

8 mg

prolonged-release tablet

Oral use

SI - Slovenia

| LEK farmacevtska družba d.d. Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

LEK farmacevtska družba d.d. Verovškova 57

SI-1000 Ljubljana

Slovenia

Carexil 10 mg tablete s podaljšanim sproščanjem

10 mg

prolonged-release tablet

Oral use

SI - Slovenia

| LEK farmacevtska družba d.d. Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

LEK farmacevtska družba d.d. Verovškova 57

SI-1000 Ljubljana

Slovenia

Carexil 20 mg tablete s podaljšanim sproščanjem

20 mg

prolonged-release tablet

Oral use

SI - Slovenia

| LEK farmacevtska družba d.d. Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

LEK farmacevtska družba d.d. Verovškova 57

SI-1000 Ljubljana

Slovenia

Carexil 5 mg tablete s podaljšanim sproščanjem

5 mg

prolonged-release tablet

Oral use

SI - Slovenia

| LEK farmacevtska družba d.d., Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

LEK farmacevtska družba d.d., Verovškova 57

SI-1000 Ljubljana

Slovenia

Oksikodon Lek 10 mg tablete s podaljšanim sproščanjem

10 mg

prolonged-release tablet

Oral use

SI - Slovenia

| LEK farmacevtska družba d.d., Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

LEK farmacevtska družba d.d., Verovškova 57

SI-1000 Ljubljana

Slovenia

Oksikodon Lek 20 mg tablete s podaljšanim sproščanjem

20 mg

prolonged-release tablet

Oral use

SI - Slovenia

| LEK farmacevtska družba d.d., Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

LEK farmacevtska družba d.d., Verovškova 57

SI-1000 Ljubljana

Slovenia

Oksikodon Lek 40 mg tablete s podaljšanim sproščanjem

40 mg

prolonged-release tablet

Oral use

SI - Slovenia

| LEK farmacevtska družba d.d., Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

LEK farmacevtska družba d.d., Verovškova 57

SI-1000 Ljubljana

Slovenia

Oksikodon Lek 5 mg tablete s podaljšanim sproščanjem

5 mg

prolonged-release tablet

Oral use

SI - Slovenia

| LEK farmacevtska družba d.d., Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

LEK farmacevtska družba d.d., Verovškova 57

SI-1000 Ljubljana

Slovenia

Oksikodon Lek 80 mg tablete s podaljšanim sproščanjem

80 mg

prolonged-release tablet

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem

10 mg

film-coated prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem

100 mg

film-coated prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem

30 mg

film-coated prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

MST Continus 60 mg filmsko obložene tablete s podaljšanim sproščanjem

60 mg

film-coated prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

OxyContin 10 mg filmsko obložene tablete s podaljšanim sproščanjem

10 mg

prolonged-release tablet

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

OxyContin 20 mg filmsko obložene tablete s podaljšanim sproščanjem

20 mg

prolonged-release tablet

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

OxyContin 40 mg filmsko obložene tablete s podaljšanim sproščanjem

40 mg

prolonged-release tablet

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

OxyContin 80 mg filmsko obložene tablete s podaljšanim sproščanjem

80 mg

prolonged-release tablet

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

PALLADONE 16 mg trde kapsule s podaljšanim sproščanjem

16 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

PALLADONE 2 mg trde kapsule s podaljšanim sproščanjem

2 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

PALLADONE 24 mg trde kapsule s podaljšanim sproščanjem

24 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem

4 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

PALLADONE 8 mg trde kapsule s podaljšanim sproščanjem

8 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

SUBSTITOL 120 mg trde kapsule s podaljšanim sproščanjem

120 mg

Prolonged-release capsule, hard

Oral use

SI - Slovenia

| Medis, d.o.o. |
| --- |
| Brnčičeva 1 |
| SI-1001 Ljubljana |
| Slovenia |

Medis, d.o.o.

Brnčičeva 1

SI-1001 Ljubljana

Slovenia

SUBSTITOL 200 mg trde kapsule s podaljšanim sproščanjem

200 mg

Prolonged-release capsule, hard

Oral use

SK - Slovakia

| Johnson & Johnson s.r.o. |
| --- |
| Plynárenská 7/B |
| Bratislava 82478 |
| Slovak Republic |

Johnson & Johnson s.r.o.

Plynárenská 7/B

Bratislava 82478

Slovak Republic

Jurnista 16 mg tablety s predĺženým uvoľňovaním

16 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Johnson & Johnson s.r.o. |
| --- |
| Plynárenská 7/B |
| Bratislava 82478 |
| Slovak Republic |

Johnson & Johnson s.r.o.

Plynárenská 7/B

Bratislava 82478

Slovak Republic

Jurnista 32 mg tablety s predĺženým uvoľňovaním

32 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Johnson & Johnson s.r.o. |
| --- |
| Plynárenská 7/B |
| Bratislava 82478 |
| Slovak Republic |

Johnson & Johnson s.r.o.

Plynárenská 7/B

Bratislava 82478

Slovak Republic

Jurnista 4 mg tablety s predĺženým uvoľňovaním

4 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Johnson & Johnson s.r.o. |
| --- |
| Plynárenská 7/B |
| Bratislava 82478 |
| Slovak Republic |

Johnson & Johnson s.r.o.

Plynárenská 7/B

Bratislava 82478

Slovak Republic

Jurnista 64 mg tablety s predĺženým uvoľňovaním

64 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Johnson & Johnson s.r.o. |
| --- |
| Plynárenská 7/B |
| Bratislava 82478 |
| Slovak Republic |

Johnson & Johnson s.r.o.

Plynárenská 7/B

Bratislava 82478

Slovak Republic

Jurnista 8 mg tablety s predĺženým uvoľňovaním

8 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1, 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1, 8502 Lannach

Austria

Oxypro 10 mg tablety s predĺženým uvoľňovaním

10 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1, 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1, 8502 Lannach

Austria

Oxypro 20 mg tablety s predĺženým uvoľňovaním

20 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1, 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1, 8502 Lannach

Austria

Oxypro 40 mg tablety s predĺženým uvoľňovaním

40 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1, 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1, 8502 Lannach

Austria

Oxypro 5 mg tablety s predĺženým uvoľňovaním

5 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Lannacher Heilmittel Ges.m.b.H. |
| --- |
| Schlossplatz 1, 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H.

Schlossplatz 1, 8502 Lannach

Austria

Oxypro 80 mg tablety s predĺženým uvoľňovaním

80 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

MST Continus 100 mg

100 mg

Modified-release tablet

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

MST Continus 30 mg

30 mg

Modified-release tablet

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

MST Continus 10 mg

10 mg

Modified-release tablet

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

MST Continus 60 mg

60 mg

Modified-release tablet

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

OxyContin 10 mg

10 mg

Modified-release tablet

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

OxyContin 20 mg

20 mg

Modified-release tablet

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

OxyContin 40 mg

40 mg

Modified-release tablet

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

OxyContin 80 mg

80 mg

Modified-release tablet

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

PALLADONE - SR capsules 16 mg

16 mg

Prolonged-release capsule, hard

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

PALLADONE - SR capsules 2 mg

2 mg

Prolonged-release capsule, hard

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

PALLADONE - SR capsules 4 mg

4 mg

Prolonged-release capsule, hard

Oral use

SK - Slovakia

| Mundipharma Ges.m.b.H. |
| --- |
| Apollogasse 16-18 |
| A-1072 Vienna |
| Austria |

Mundipharma Ges.m.b.H.

Apollogasse 16-18

A-1072 Vienna

Austria

PALLADONE - SR capsules 8 mg

8 mg

Prolonged-release capsule, hard

Oral use

SK - Slovakia

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Slovenia

Oxykodón Sandoz 20 mg tablety s predĺženým uvoľňovaním

20 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Slovenia

Oxykodón Sandoz 40 mg tablety s predĺženým uvoľňovaním

40 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Slovenia

Oxykodón Sandoz 80 mg tablety s predĺženým uvoľňovaním

80 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Slovenia

Oxykosan 10 mg tablety s predĺženým uvoľňovaním

10 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Slovenia

Oxykosan 20 mg tablety s predĺženým uvoľňovaním

20 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| YES Pharmaceutical Devel. |
| --- |
| Services GmbH |
| Bahnstrasse 42-46 D-61381, Friedrichsdorf |
| Germany |

YES Pharmaceutical Devel.

Services GmbH

Bahnstrasse 42-46 D-61381, Friedrichsdorf

Germany

Oxykodón YES 10 mg tablety s predĺženým uvoľňovaním

10 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| YES Pharmaceutical Devel. |
| --- |
| Services GmbH |
| Bahnstrasse 42-46 D-61381, Friedrichsdorf |
| Germany |

YES Pharmaceutical Devel.

Services GmbH

Bahnstrasse 42-46 D-61381, Friedrichsdorf

Germany

Oxykodón YES 20 mg tablety s predĺženým uvoľňovaním

20 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| YES Pharmaceutical Devel. |
| --- |
| Services GmbH |
| Bahnstrasse 42-46 D-61381, Friedrichsdorf |
| Germany |

YES Pharmaceutical Devel.

Services GmbH

Bahnstrasse 42-46 D-61381, Friedrichsdorf

Germany

Oxykodón YES 40 mg tablety s predĺženým uvoľňovaním

40 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| YES Pharmaceutical Devel. |
| --- |
| Services GmbH |
| Bahnstrasse 42-46 D-61381, Friedrichsdorf |
| Germany |

YES Pharmaceutical Devel.

Services GmbH

Bahnstrasse 42-46 D-61381, Friedrichsdorf

Germany

Oxykodón YES 5 mg tablety s predĺženým uvoľňovaním

5 mg

Prolonged-release tablet

Oral use

SK - Slovakia

| YES Pharmaceutical Devel. |
| --- |
| Services GmbH |
| Bahnstrasse 42-46 D-61381, Friedrichsdorf |
| Germany |

YES Pharmaceutical Devel.

Services GmbH

Bahnstrasse 42-46 D-61381, Friedrichsdorf

Germany

Oxykodón YES 80 mg tablety s predĺženým uvoľňovaním

80 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH 100 MG

100 mg

Modified-release capsule

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH 200 MG

200 mg

Modified-release capsule

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH 30 MG

30 mg

Modified-release capsule

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH 60 MG

60 mg

Modified-release capsule

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH CAPSULES 10 MG

10 mg

Modified-release capsule

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH CAPSULES XL 120 MG PROLONGED-RELEASE CAPSULES

120 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH CAPSULES XL 200 MG PROLONGED-RELEASE CAPSULES

200 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH CAPSULES XL 20 MG PROLONGED-RELEASE CAPSULES

20 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH CAPSULES XL 40 MG PROLONGED-RELEASE CAPSULES

40 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| Ethypharm |
| --- |
| 21, rue St. Mathieu (Z.I.) |
| F- 78550 Houdan |
| 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex |
| France |

Ethypharm

21, rue St. Mathieu (Z.I.)

F- 78550 Houdan

194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex

France

ZOMORPH CAPSULES XL 60 MG PROLONGED-RELEASE CAPSULES

60 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS SUSPENSION 100 MG

100 mg

Prolonged-release granules

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS SUSPENSION 200 MG

200 mg

Prolonged-release granules

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS SUSPENSION 20 MG

20 mg

Prolonged-release granules

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS SUSPENSION 30 MG

30 mg

Prolonged-release granules

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS SUSPENSION 60 MG

60 mg

Prolonged-release granules

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS TABLETS 100 MG

100 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS TABLETS 10 MG

10 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS TABLETS 15 MG

15 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS TABLETS 200 MG

200 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS TABLETS 30 MG

30 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS TABLETS 5 MG

5 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MST CONTINUS TABLETS 60 MG

60 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MXL 120 MG PROLONGED RELEASE CAPSULES

120 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MXL 150 MG PROLONGED RELEASE CAPSULES

150 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MXL 200 MG PROLONGED RELEASE CAPSULES

200 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MXL 30 MG PROLONGED RELEASE CAPSULES

30 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MXL 60 MG PROLONGED RELEASE CAPSULES

60 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED |
| --- |
| Cambridge Science Park, Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED

Cambridge Science Park, Milton Road

Cambridge CB4 0GW

United Kingdom

MXL 90 MG PROLONGED RELEASE CAPSULES

90 mg

Prolonged-release capsule, hard

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

LONGTEC 10 MG FILM-COATED, PROLONGED RELEASE TABLETS

10 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

LONGTEC 20 MG FILM-COATED, PROLONGED RELEASE TABLETS

20 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

LONGTEC 40 MG FILM-COATED, PROLONGED RELEASE TABLETS

40 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

LONGTEC 5 MG FILM-COATED, PROLONGED RELEASE TABLETS

5 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

LONGTEC 80 MG FILM-COATED, PROLONGED RELEASE TABLETS

80 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

OXYCONTIN 10 MG FILM-COATED, PROLONGED RELEASE TABLETS

10 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

OXYCONTIN 20 MG FILM-COATED, PROLONGED RELEASE TABLETS

20 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

OXYCONTIN 40 MG FILM-COATED, PROLONGED RELEASE TABLETS

40 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

OXYCONTIN 5 MG FILM-COATED, PROLONGED RELEASE TABLETS

5 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

OXYCONTIN 80 MG FILM-COATED, PROLONGED RELEASE TABLETS

80 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

PALLADONE SR CAPSULES 16 MG

16 mg

Modified-release capsule

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

PALLADONE SR CAPSULES 24 MG

24 mg

Modified-release capsule

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

PALLADONE SR CAPSULES 2 MG

2 mg

Modified-release capsule

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

PALLADONE SR CAPSULES 4 MG

4 mg

Modified-release capsule

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

PALLADONE SR CAPSULES 8 MG

8 mg

Modified-release capsule

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

TARGINACT 10 MG/5 MG PROLONGED-RELEASE TABLETS

10 mg + 5 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

TARGINACT 20 MG/10 MG PROLONGED-RELEASE TABLETS

20 mg + 10 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

TARGINACT 40 MG/20 MG PROLONGED-RELEASE TABLETS

40 mg + 20 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW |
| --- |
| United Kingdom |

NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW

United Kingdom

TARGINACT 5 MG/2,5 MG PROLONGED-RELEASE TABLETS

5 mg + 2,5 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| RATIOPHARM GMBH |
| --- |
| Graf-Arco Strasse 3 |
| Ulm, D-89079 |
| Germany |

RATIOPHARM GMBH

Graf-Arco Strasse 3

Ulm, D-89079

Germany

CANDOX 10 MG PROLONGED-RELEASE TABLETS

10 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| RATIOPHARM GMBH |
| --- |
| Graf-Arco Strasse 3 |
| Ulm, D-89079 |
| Germany |

RATIOPHARM GMBH

Graf-Arco Strasse 3

Ulm, D-89079

Germany

CANDOX 20 MG PROLONGED-RELEASE TABLETS

20 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| RATIOPHARM GMBH |
| --- |
| Graf-Arco Strasse 3 |
| Ulm, D-89079 |
| Germany |

RATIOPHARM GMBH

Graf-Arco Strasse 3

Ulm, D-89079

Germany

CANDOX 40 MG PROLONGED-RELEASE TABLETS

40 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| RATIOPHARM GMBH |
| --- |
| Graf-Arco Strasse 3 |
| Ulm, D-89079 |
| Germany |

RATIOPHARM GMBH

Graf-Arco Strasse 3

Ulm, D-89079

Germany

CANDOX 5 MG PROLONGED-RELEASE TABLETS

5 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| RATIOPHARM GMBH |
| --- |
| Graf-Arco Strasse 3 |
| Ulm, D-89079 |
| Germany |

RATIOPHARM GMBH

Graf-Arco Strasse 3

Ulm, D-89079

Germany

CANDOX 80 MG PROLONGED-RELEASE TABLETS

80 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ LIMITED

37 Woolmer Way, Borden

Hampshire GU35 9QE

United Kingdom

CAREXIL 10 MG PROLONGED-RELEASE TABLETS

10 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ LIMITED

37 Woolmer Way, Borden

Hampshire GU35 9QE

United Kingdom

CAREXIL 20 MG PROLONGED-RELEASE TABLETS

20 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ LIMITED

37 Woolmer Way, Borden

Hampshire GU35 9QE

United Kingdom

CAREXIL 5 MG PROLONGED-RELEASE TABLETS

5 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ LIMITED

37 Woolmer Way, Borden

Hampshire GU35 9QE

United Kingdom

CONTIROXIN 10 MG PROLONGED-RELEASE TABLETS

10 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ LIMITED

37 Woolmer Way, Borden

Hampshire GU35 9QE

United Kingdom

CONTIROXIN 20 MG PROLONGED-RELEASE TABLETS

20 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ LIMITED

37 Woolmer Way, Borden

Hampshire GU35 9QE

United Kingdom

CONTIROXIN 40 MG PROLONGED-RELEASE TABLETS

40 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ LIMITED

37 Woolmer Way, Borden

Hampshire GU35 9QE

United Kingdom

CONTIROXIN 5 MG PROLONGED-RELEASE TABLETS

5 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ LIMITED

37 Woolmer Way, Borden

Hampshire GU35 9QE

United Kingdom

CONTIROXIN 80 MG PROLONGED-RELEASE TABLETS

80 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| Teva Uk Limited |
| --- |
| Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG |
| United Kingdom |

Teva Uk Limited

Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG

United Kingdom

FILNARINE SR 100 MG PROLONGED RELEASE TABLETS

100 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| Teva Uk Limited |
| --- |
| Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG |
| United Kingdom |

Teva Uk Limited

Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG

United Kingdom

FILNARINE SR 10 MG PROLONGED RELEASE TABLETS

10 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| Teva Uk Limited |
| --- |
| Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG |
| United Kingdom |

Teva Uk Limited

Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG

United Kingdom

FILNARINE SR 200 MG PROLONGED RELEASE TABLETS

200 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| Teva Uk Limited |
| --- |
| Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG |
| United Kingdom |

Teva Uk Limited

Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG

United Kingdom

FILNARINE SR 30 MG PROLONGED RELEASE TABLETS

30 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| Teva Uk Limited |
| --- |
| Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG |
| United Kingdom |

Teva Uk Limited

Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG

United Kingdom

FILNARINE SR 60 MG PROLONGED RELEASE TABLETS

60 mg

Prolonged-release tablet

Oral use

UK - United Kingdom

| WAYMADE PLC |
| --- |
| Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR |
| United Kingdom |

WAYMADE PLC

Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR

United Kingdom

MORPHGESIC SR 100 MG TABLETS

100 mg

Modified-release tablet

Oral use

UK - United Kingdom

| WAYMADE PLC |
| --- |
| Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR |
| United Kingdom |

WAYMADE PLC

Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR

United Kingdom

MORPHGESIC SR 10 MG TABLETS

10 mg

Modified-release tablet

Oral use

UK - United Kingdom

| WAYMADE PLC |
| --- |
| Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR |
| United Kingdom |

WAYMADE PLC

Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR

United Kingdom

MORPHGESIC SR 30 MG TABLETS

30 mg

Modified-release tablet

Oral use

UK - United Kingdom

| WAYMADE PLC |
| --- |
| Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR |
| United Kingdom |

WAYMADE PLC

Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR

United Kingdom

MORPHGESIC SR 60 MG TABLETS

60 mg

Modified-release tablet

Oral use

---