# Official Journal C 32/30 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 32 |
| | |
| English edition | Information and Notices | Volume 5830 January 2015 |

ISSN 1977-091X

Official Journal

of the European Union

C 32

English edition

Information and Notices

Volume 5830 January 2015

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2015/C 032/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2015/C 032/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 9 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2015/C 032/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014(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

2015/C 032/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014(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)

9

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.1.2015 | EN | Official Journal of the European Union | C 32/1 |
| --- | --- | --- | --- |

30.1.2015

EN

Official Journal of the European Union

C 32/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014

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

(2015/C 032/01)

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.12.2014 | Paliperidone Janssen | Paliperidone | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/971 | Prolonged release suspension for injection | N05AX13 | 9.12.2014 |
| 8.12.2014 | Duloxetine Lilly | Duloxetine | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/14/972 | Gastro-resistant capsule, hard | N06AX21 | 10.12.2014 |
| 8.12.2014 | Moventig | Naloxegol | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/962 | Film-coated tablet | A06AH03 | 10.12.2014 |
| 16.12.2014 | DUAVIVE | Oestrogens conjugated/bazedoxifene | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/960 | Modified-release tablet | G03CX | 18.12.2014 |
| 16.12.2014 | Lynparza | Olaparib | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/959 | Capsule, hard | L01 | 18.12.2014 |
| 19.12.2014 | Cyramza | Ramucirumab | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/14/957 | Concentrate for solution for infusion | L01XC | 23.12.2014 |
| 19.12.2014 | Rixubis | Nonacog gamma | Baxter Innovations GmbH
  Industriestraße 67, A-1221 Wien, Österreich | EU/1/14/970 | Powder and solvent for solution for injection | B02BD04 | 23.12.2014 |
| 22.12.2014 | Scenesse | Afamelanotide | Clinuvel UK Limited
  c/o — Reed Smith, Broadgate Tower, Third Floor, 20 Primrose Street, London, EC2A 2RS, United Kingdom | EU/1/14/969 | Implant | D02BB02 | 29.12.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

5.12.2014

Paliperidone Janssen

Paliperidone

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/971

Prolonged release suspension for injection

N05AX13

9.12.2014

8.12.2014

Duloxetine Lilly

Duloxetine

Eli Lilly Nederland B.V.

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

EU/1/14/972

Gastro-resistant capsule, hard

N06AX21

10.12.2014

8.12.2014

Moventig

Naloxegol

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/962

Film-coated tablet

A06AH03

10.12.2014

16.12.2014

DUAVIVE

Oestrogens conjugated/bazedoxifene

Pfizer Limited

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

EU/1/14/960

Modified-release tablet

G03CX

18.12.2014

16.12.2014

Lynparza

Olaparib

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/959

Capsule, hard

L01

18.12.2014

19.12.2014

Cyramza

Ramucirumab

Eli Lilly Nederland B.V.

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

EU/1/14/957

Concentrate for solution for infusion

L01XC

23.12.2014

19.12.2014

Rixubis

Nonacog gamma

Baxter Innovations GmbH

Industriestraße 67, A-1221 Wien, Österreich

EU/1/14/970

Powder and solvent for solution for injection

B02BD04

23.12.2014

22.12.2014

Scenesse

Afamelanotide

Clinuvel UK Limited

c/o — Reed Smith, Broadgate Tower, Third Floor, 20 Primrose Street, London, EC2A 2RS, United Kingdom

EU/1/14/969

Implant

D02BB02

29.12.2014

—   Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.12.2014 | Desloratadine Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/11/732 | 3.12.2014 |
| 1.12.2014 | Ibandronic Acid Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/10/642 | 3.12.2014 |
| 1.12.2014 | Irbesartan Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/576 | 3.12.2014 |
| 1.12.2014 | Optimark | Mallinckrodt Deutschland GmbH
  Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland | EU/1/07/398 | 3.12.2014 |
| 4.12.2014 | Menveo | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/614 | 9.12.2014 |
| 4.12.2014 | Ratiograstim | Ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/08/444 | 8.12.2014 |
| 4.12.2014 | Tevagrastim | Teva GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/08/445 | 8.12.2014 |
| 5.12.2014 | Cystagon | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/97/039 | 9.12.2014 |
| 5.12.2014 | Erbitux | Merck KGaA
  64271 Darmstadt, Deutschland | EU/1/04/281 | 9.12.2014 |
| 5.12.2014 | Vectibix | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/07/423 | 9.12.2014 |
| 11.12.2014 | Bronchitol | Pharmaxis Pharmaceuticals Limited
  The Priory, Stomp Road, Burnham, Buckinghamshire SL1 7LW, United Kingdom | EU/1/12/760 | 15.12.2014 |
| 11.12.2014 | Efavirenz Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/742 | 15.12.2014 |
| 11.12.2014 | Eviplera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/11/737 | 15.12.2014 |
| 11.12.2014 | Levetiracetam Ratiopharm | Ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/702 | 15.12.2014 |
| 11.12.2014 | Removab | Neovii Biotech GmbH
  Am Haag 6-7, 82166 Graefelfing, Deutschland | EU/1/09/512 | 15.12.2014 |
| 15.12.2014 | Lantus | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/134 | 18.12.2014 |
| 15.12.2014 | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 17.12.2014 |
| 15.12.2014 | Levetiracetam Actavis Group | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/11/738 | 18.12.2014 |
| 15.12.2014 | Mircera | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/07/400 | 18.12.2014 |
| 15.12.2014 | Naglazyme | BioMarin Europe Ltd
  164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | EU/1/05/324 | 17.12.2014 |
| 15.12.2014 | Optisulin | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/133 | 18.12.2014 |
| 15.12.2014 | Revestive | NPS Pharma Holdings Limited
  Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland | EU/1/12/787 | 17.12.2014 |
| 15.12.2014 | Somatropin Biopartners | BioPartners GmbH
  Kaiserpassage 11, D-72764 Reutlingen, Deutschland | EU/1/13/849 | 17.12.2014 |
| 15.12.2014 | Tasigna | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/422 | 18.12.2014 |
| 15.12.2014 | Xeloda | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/163 | 18.12.2014 |
| 16.12.2014 | Afinitor | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/538 | 18.12.2014 |
| 16.12.2014 | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/13/891 | 18.12.2014 |
| 16.12.2014 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 17.12.2014 |
| 16.12.2014 | Fasturtec | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/00/170 | 18.12.2014 |
| 16.12.2014 | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/11/687 | 18.12.2014 |
| 16.12.2014 | HyQvia | Baxter Innovations GmbH
  Industriestraße 67, A-1221 Wien, Österreich | EU/1/13/840 | 18.12.2014 |
| 16.12.2014 | Incivo | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/720 | 18.12.2014 |
| 16.12.2014 | Lamivudine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/566 | 18.12.2014 |
| 16.12.2014 | Levetiracetam Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/11/713 | 18.12.2014 |
| 16.12.2014 | Methylthioninium chloride Proveblue | Provepharm S.A.S.
  22 Rue Marc Donadille, 13013 Marseille, France | EU/1/11/682 | 18.12.2014 |
| 16.12.2014 | NULOJIX | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/694 | 18.12.2014 |
| 16.12.2014 | Orphacol | Laboratoires CTRS
  63 rue de l'Est, F-92100 Boulogne-Billancourt, France | EU/1/13/870 | 18.12.2014 |
| 16.12.2014 | Paglitaz | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/721 | 18.12.2014 |
| 16.12.2014 | Pioglitazone Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/12/757 | 18.12.2014 |
| 16.12.2014 | Pioglitazone Teva Pharma | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/12/758 | 18.12.2014 |
| 16.12.2014 | Remsima | Celltrion Healthcare Hungary Kft.
  Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország | EU/1/13/853 | 18.12.2014 |
| 16.12.2014 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 19.12.2014 |
| 16.12.2014 | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620 | 17.12.2014 |
| 16.12.2014 | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/858 | 18.12.2014 |
| 16.12.2014 | Ultibro Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/13/862 | 18.12.2014 |
| 16.12.2014 | Ulunar Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/14/917 | 19.12.2014 |
| 16.12.2014 | Votubia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/11/710 | 18.12.2014 |
| 16.12.2014 | Xoterna Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/13/863 | 18.12.2014 |
| 16.12.2014 | Zelboraf | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/12/751 | 19.12.2014 |
| 19.12.2014 | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 23.12.2014 |
| 19.12.2014 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | EU/1/02/226 | 23.12.2014 |
| 19.12.2014 | Puregon | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/96/008 | 23.12.2014 |
| 19.12.2014 | Rilutek | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/96/010 | 23.12.2014 |
| 19.12.2014 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | EU/1/13/832 | 5.1.2015 |
| 19.12.2014 | Telmisartan Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/610 | 24.12.2014 |
| 19.12.2014 | Travatan | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/01/199 | 23.12.2014 |
| 19.12.2014 | Victoza | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/09/529 | 23.12.2014 |
| 19.12.2014 | Zoledronic acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/771 | 24.12.2014 |
| 19.12.2014 | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 24.12.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

1.12.2014

Desloratadine Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/11/732

3.12.2014

1.12.2014

Ibandronic Acid Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/642

3.12.2014

1.12.2014

Irbesartan Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/576

3.12.2014

1.12.2014

Optimark

Mallinckrodt Deutschland GmbH

Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland

EU/1/07/398

3.12.2014

4.12.2014

Menveo

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/614

9.12.2014

4.12.2014

Ratiograstim

Ratiopharm GmbH

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

EU/1/08/444

8.12.2014

4.12.2014

Tevagrastim

Teva GmbH

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

EU/1/08/445

8.12.2014

5.12.2014

Cystagon

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/97/039

9.12.2014

5.12.2014

Erbitux

Merck KGaA

64271 Darmstadt, Deutschland

EU/1/04/281

9.12.2014

5.12.2014

Vectibix

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423

9.12.2014

11.12.2014

Bronchitol

Pharmaxis Pharmaceuticals Limited

The Priory, Stomp Road, Burnham, Buckinghamshire SL1 7LW, United Kingdom

EU/1/12/760

15.12.2014

11.12.2014

Efavirenz Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/742

15.12.2014

11.12.2014

Eviplera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/11/737

15.12.2014

11.12.2014

Levetiracetam Ratiopharm

Ratiopharm GmbH

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

EU/1/11/702

15.12.2014

11.12.2014

Removab

Neovii Biotech GmbH

Am Haag 6-7, 82166 Graefelfing, Deutschland

EU/1/09/512

15.12.2014

15.12.2014

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134

18.12.2014

15.12.2014

Lemtrada

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

17.12.2014

15.12.2014

Levetiracetam Actavis Group

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/11/738

18.12.2014

15.12.2014

Mircera

Roche Registration Limited

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

EU/1/07/400

18.12.2014

15.12.2014

Naglazyme

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/05/324

17.12.2014

15.12.2014

Optisulin

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133

18.12.2014

15.12.2014

Revestive

NPS Pharma Holdings Limited

Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland

EU/1/12/787

17.12.2014

15.12.2014

Somatropin Biopartners

BioPartners GmbH

Kaiserpassage 11, D-72764 Reutlingen, Deutschland

EU/1/13/849

17.12.2014

15.12.2014

Tasigna

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/422

18.12.2014

15.12.2014

Xeloda

Roche Registration Limited

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

EU/1/00/163

18.12.2014

16.12.2014

Afinitor

Novartis Europharm Limited

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

EU/1/09/538

18.12.2014

16.12.2014

Brintellix

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/13/891

18.12.2014

16.12.2014

Cimzia

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/09/544

17.12.2014

16.12.2014

Fasturtec

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/00/170

18.12.2014

16.12.2014

Hizentra

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/11/687

18.12.2014

16.12.2014

HyQvia

Baxter Innovations GmbH

Industriestraße 67, A-1221 Wien, Österreich

EU/1/13/840

18.12.2014

16.12.2014

Incivo

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

18.12.2014

16.12.2014

Lamivudine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/566

18.12.2014

16.12.2014

Levetiracetam Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/11/713

18.12.2014

16.12.2014

Methylthioninium chloride Proveblue

Provepharm S.A.S.

22 Rue Marc Donadille, 13013 Marseille, France

EU/1/11/682

18.12.2014

16.12.2014

NULOJIX

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/694

18.12.2014

16.12.2014

Orphacol

Laboratoires CTRS

63 rue de l'Est, F-92100 Boulogne-Billancourt, France

EU/1/13/870

18.12.2014

16.12.2014

Paglitaz

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/721

18.12.2014

16.12.2014

Pioglitazone Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/757

18.12.2014

16.12.2014

Pioglitazone Teva Pharma

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/758

18.12.2014

16.12.2014

Remsima

Celltrion Healthcare Hungary Kft.

Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország

EU/1/13/853

18.12.2014

16.12.2014

Ristaben

Merck Sharp & Dohme Limited

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

EU/1/10/621

19.12.2014

16.12.2014

Ristfor

Merck Sharp & Dohme Limited

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

EU/1/10/620

17.12.2014

16.12.2014

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

18.12.2014

16.12.2014

Ultibro Breezhaler

Novartis Europharm Limited

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

EU/1/13/862

18.12.2014

16.12.2014

Ulunar Breezhaler

Novartis Europharm Limited

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

EU/1/14/917

19.12.2014

16.12.2014

Votubia

Novartis Europharm Limited

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

EU/1/11/710

18.12.2014

16.12.2014

Xoterna Breezhaler

Novartis Europharm Limited

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

EU/1/13/863

18.12.2014

16.12.2014

Zelboraf

Roche Registration Limited

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

EU/1/12/751

19.12.2014

19.12.2014

CellCept

Roche Registration Limited

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

EU/1/96/005

23.12.2014

19.12.2014

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

EU/1/02/226

23.12.2014

19.12.2014

Puregon

Merck Sharp & Dohme Limited

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

EU/1/96/008

23.12.2014

19.12.2014

Rilutek

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/96/010

23.12.2014

19.12.2014

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

EU/1/13/832

5.1.2015

19.12.2014

Telmisartan Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/610

24.12.2014

19.12.2014

Travatan

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/01/199

23.12.2014

19.12.2014

Victoza

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

23.12.2014

19.12.2014

Zoledronic acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/771

24.12.2014

19.12.2014

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/772

24.12.2014

—   Issuing of a marketing authorisation (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 | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 22.12.2014 | Bovela | Modified live BVDV-1, non-cytopathic parent strain KE-9, Modified live BVDV-2, non-cytopathic parent strain NY-93 | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/2/14/176 | Lyophilisate and solvent for suspension for injection | QI02AD02 | 29.12.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

22.12.2014

Bovela

Modified live BVDV-1, non-cytopathic parent strain KE-9, Modified live BVDV-2, non-cytopathic parent strain NY-93

Boehringer Ingelheim International GmbH

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

EU/2/14/176

Lyophilisate and solvent for suspension for injection

QI02AD02

29.12.2014

—   Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.12.2014 | Gripovac 3 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/09/102 | 8.12.2014 |
| 4.12.2014 | Porcilis AR-T DF | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/00/026 | 8.12.2014 |
| 4.12.2014 | Respiporc Flu3 | IDT Biologika GmbH
  Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland | EU/2/09/103 | 8.12.2014 |
| 11.12.2014 | Comfortis | Eli Lilly and Company Ltd, Elanco Animal Health
  Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/10/115 | 15.12.2014 |
| 11.12.2014 | Trifexis | Eli Lilly and Company Ltd, Elanco Animal Health
  Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/13/155 | 15.12.2014 |
| 16.12.2014 | Pexion | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/147 | 18.12.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.12.2014

Gripovac 3

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/09/102

8.12.2014

4.12.2014

Porcilis AR-T DF

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/00/026

8.12.2014

4.12.2014

Respiporc Flu3

IDT Biologika GmbH

Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland

EU/2/09/103

8.12.2014

11.12.2014

Comfortis

Eli Lilly and Company Ltd, Elanco Animal Health

Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/10/115

15.12.2014

11.12.2014

Trifexis

Eli Lilly and Company Ltd, Elanco Animal Health

Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/13/155

15.12.2014

16.12.2014

Pexion

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/147

18.12.2014

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 |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 30.1.2015 | EN | Official Journal of the European Union | C 32/9 |
| --- | --- | --- | --- |

30.1.2015

EN

Official Journal of the European Union

C 32/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014

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

(2015/C 032/02)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 16.12.2014 | Plendil | See Annex I | See Annex I | See Annex I | 17.12.2014 |
| 11.12.2014 | Suanovil 20 Captalin | See Annex II | See Annex II | See Annex II | 12.12.2014 |
| 22.12.2014 | Oxynal-Targin | See Annex III | See Annex III | See Annex III | 23.12.2014 |
| 5.12.2014 | Resflor | See Annex IV | See Annex IV | See Annex IV | 9.12.2014 |
| 16.12.2014 | Polymyxin | See Annex V | See Annex V | See Annex V | 17.12.2014 |
| 22.12.2014 | Docetaxel | Docetaxel and alcohol in their formulation | Not applicable | Not applicable | 23.12.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

16.12.2014

Plendil

See Annex I

See Annex I

See Annex I

17.12.2014

11.12.2014

Suanovil 20 Captalin

See Annex II

See Annex II

See Annex II

12.12.2014

22.12.2014

Oxynal-Targin

See Annex III

See Annex III

See Annex III

23.12.2014

5.12.2014

Resflor

See Annex IV

See Annex IV

See Annex IV

9.12.2014

16.12.2014

Polymyxin

See Annex V

See Annex V

See Annex V

17.12.2014

22.12.2014

Docetaxel

Docetaxel and alcohol in their formulation

Not applicable

Not applicable

23.12.2014

---

(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 form, strength of the medicinal product, route 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 | AstraZeneca Österreich GmbH
  Schwarzenbergplatz 7
  1037 Wien
  Austria | Plendil retard 2,5 mg — Filmtabletten | 2,5 mg | Prolonged-release tablet | Oral use |
| Austria | AstraZeneca Österreich GmbH
  Schwarzenbergplatz 7
  1037 Wien
  Austria | Plendil retard 5 mg — Filmtabletten | 5 mg | Prolonged-release tablet | Oral use |
| Belgium | NV AstraZeneca SA
  Rue Egide van Ophemstraat
  110, B-1180 Brussel
  Belgium | Plendil 5 mg Retard | 5 mg | Prolonged-release tablet | Oral use |
| Belgium | NV AstraZeneca SA
  Rue Egide van Ophemstraat
  110, B-1180 Brussel
  Belgium | Plendil 10 mg Retard | 10 mg | Prolonged-release tablet | Oral use |
| Bulgaria | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Плендил
  (Plendil) | 5 mg | Prolonged-release tablet | Oral use |
| Croatia | AstraZeneca d.o.o.
  Radnička cesta 80
  10 000 Zagreb
  Croatia | Plendil 5 mg
  tablete s produljenim oslobađanjem | 5 mg | Prolonged-release tablet | Oral use |
| Croatia | AstraZeneca d.o.o.
  Radnička cesta 80
  10 000 Zagreb
  Croatia | Plendil 10 mg
  tablete s produljenim oslobađanjem | 10 mg | Prolonged-release tablet | Oral use |
| Cyprus | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Plendil | 2,5 mg | Prolonged-release tablets | Oral use |
| Cyprus | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Cyprus | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Czech Republic | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | PLENDIL ER 5 mg | 5 mg | Prolonged-release tablet | Oral use |
| Czech Republic | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | PLENDIL ER 10 mg | 10 mg | Prolonged-release tablet | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Köbenhavn S.
  Denmark | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Köbenhavn S.
  Denmark | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Köbenhavn S.
  Denmark | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Estonia | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| Estonia | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Estonia | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Finland | AstraZeneca Oy
  Itsehallintokuja 4
  02600 Espoo
  Finland | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| Finland | AstraZeneca Oy
  Itsehallintokuja 4
  02600 Espoo
  Finland | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Finland | AstraZeneca Oy
  Itsehallintokuja 4
  02600 Espoo
  Finland | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| France | AstraZeneca
  1 place Renault
  92844 Rueil-Malmaison Cedex
  France | FLODIL | 5 mg | Prolonged-release tablet | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | Modip 2,5 mg | 2,5 mg | Prolonged-release tablet | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | Modip 5 mg | 5 mg | Prolonged-release tablet | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | Modip 10 mg | 10 mg | Prolonged-release tablet | Oral use |
| Greece | AstraZeneca S.A.
  Theotokopoulou & Astronafton str
  151 25 Maroussi
  Greece | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| Greece | AstraZeneca S.A.
  Theotokopoulou & Astronafton str
  151 25 Maroussi
  Greece | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Greece | AstraZeneca S.A.
  Theotokopoulou & Astronafton str
  151 25 Maroussi
  Greece | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Hungary | AstraZeneca Kft.
  H-1113 Budapest
  Bocskai út 134-146
  Hungary | Plendil 2,5 mg retard filmtabletta | 2,5 mg | Prolonged-release tablet | Oral use |
| Hungary | AstraZeneca Kft.
  H-1113 Budapest
  Bocskai út 134-146
  Hungary | Plendil 5 mg retard filmtabletta | 5 mg | Prolonged-release tablet | Oral use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Köbenhavn S.
  Denmark | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Köbenhavn S.
  Denmark | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Köbenhavn S.
  Denmark | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Ireland | AstraZeneca UK Ltd.
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Plendil 2,5 mg Prolonged-release, Film-coated Tablets | 2,5 mg | Prolonged-release tablet | Oral use |
| Ireland | AstraZeneca UK Ltd.
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Plendil 5 mg Prolonged-release, Film-coated Tablets | 5 mg | Prolonged-release tablet | Oral use |
| Ireland | AstraZeneca UK Ltd.
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Plendil 10 mg Prolonged-release, Film-coated Tablets | 10 mg | Prolonged-release tablet | Oral use |
| Italy | AstraZeneca S.p.A
  Palazzo Volta
  Via F. Sforza
  20080 Basiglio (MI)
  Italy | Plendil 5 mg
  compresse a rilascio prolungato | 5 mg | Prolonged-release tablet | Oral use |
| Italy | AstraZeneca S.p.A
  Palazzo Volta
  Via F. Sforza
  20080 Basiglio (MI)
  Italy | Plendil 10 mg compresse a rilascio prolungato | 10 mg | Prolonged-release tablet | Oral use |
| Italy | AstraZeneca S.p.A
  Palazzo Volta
  Via F. Sforza
  20080 Basiglio (MI)
  Italy | Feloday 5 mg
  compresse a rilascio prolungato | 5 mg | Prolonged-release tablet | Oral use |
| Italy | AstraZeneca S.p.A
  Palazzo Volta
  Via F. Sforza
  20080 Basiglio (MI)
  Italy | Feloday 10 mg
  compresse a rilascio prolungato | 10 mg | Prolonged-release tablet | Oral use |
| Italy | SIMESA S.p.A
  Palazzo Galileo
  Via F. Sforza
  20080 Basiglio (MI)
  Italy | Prevex 5 mg
  compresse a rilascio prolungato | 5 mg | Prolonged-release tablet | Oral use |
| Italy | SIMESA S.p.A
  Palazzo Galileo
  Via F. Sforza
  20080 Basiglio (MI)
  Italy | Prevex 10 mg
  compresse a rilascio prolungato | 10 mg | Prolonged-release tablet | Oral use |
| Latvia | AstraZeneca AB
  S-151 85, Södertälje
  Sweden | Plendil 5 mg ilgstošās darbības tabletes | 5 mg | Prolonged-release tablet | Oral use |
| Latvia | AstraZeneca AB
  S-151 85, Södertälje
  Sweden | Plendil 10 mg ilgstošās darbības tabletes | 10 mg | Prolonged-release tablet | Oral use |
| Lithuania | AstraZeneca AB
  S-151 85, Södertälje
  Sweden | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| Lithuania | AstraZeneca AB
  S-151 85, Södertälje
  Sweden | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Lithuania | AstraZeneca AB
  S-151 85, Södertälje
  Sweden | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Luxembourg | NV AstraZeneca SA
  Rue Egide van Ophemstraat
  B-1180 Brussel
  Belgium | PLENDIL 5 mg Retard | 5 mg | Prolonged-release tablet | Oral use |
| Luxembourg | NV AstraZeneca SA
  Rue Egide van Ophemstraat
  B-1180 Brussel
  Belgium | PLENDIL 10 mg Retard | 10 mg | Prolonged-release tablet | Oral use |
| Malta | Astra Zeneca AB
  Gartunavagen, S-151 85 Sodertalje, Sweden | Plendil 5 mg Prolonged-release, Film-coated Tablets | 5 mg | Prolonged-release tablet | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | Plendil 2,5 | 2,5 mg | Prolonged-release tablet | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | Plendil 5 | 5 mg | Prolonged-release tablet | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | Plendil 10 | 10 mg | Prolonged-release tablet | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050, Etterstad
  0601 Oslo
  Norway | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050, Etterstad
  0601 Oslo
  Norway | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050, Etterstad
  0601 Oslo
  Norway | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Poland | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Poland | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, 7
  Queluz de baixo
  2730-097 Barcarena
  Portugal | Preslow | 5 mg | Prolonged-release tablet | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, 7
  Queluz de baixo
  2730-097 Barcarena
  Portugal | Preslow | 10 mg | Prolonged-release tablet | Oral use |
| Romania | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| Romania | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Romania | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Slovak Republic | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil 2,5 mg | 2,5 mg | Prolonged-release tablet | Oral use |
| Slovak Republic | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil 5 mg | 5 mg | Prolonged-release tablet | Oral use |
| Slovak Republic | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil 10 mg | 10 mg | Prolonged-release tablet | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache 56
  Edificio Roble
  28033 Madrid
  Spain | Plendil 5 mg comprimidos de liberación prolongada | 5 mg | Prolonged-release tablet | Oral use |
| Sweden | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| Sweden | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| Sweden | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Plendil | 10 mg | Prolonged-release tablet | Oral use |
| Sweden | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Felodipin AstraZeneca | 2,5 mg | Prolonged-release tablet | Oral use |
| Sweden | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Felodipin AstraZeneca | 5 mg | Prolonged-release tablet | Oral use |
| Sweden | AstraZeneca AB
  S-151 85 Sodertalje
  Sweden | Felodipin AstraZeneca | 10 mg | Prolonged-release tablet | Oral use |
| United Kingdom | AstraZeneca UK Ltd.
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Plendil | 2,5 mg | Prolonged-release tablet | Oral use |
| United Kingdom | AstraZeneca UK Ltd.
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Plendil | 5 mg | Prolonged-release tablet | Oral use |
| United Kingdom | AstraZeneca UK Ltd.
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Plendil | 10 mg | Prolonged-release tablet | Oral use |

Member State

EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

1037 Wien

Austria

Plendil retard 2,5 mg — Filmtabletten

2,5 mg

Prolonged-release tablet

Oral use

Austria

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

1037 Wien

Austria

Plendil retard 5 mg — Filmtabletten

5 mg

Prolonged-release tablet

Oral use

Belgium

NV AstraZeneca SA

Rue Egide van Ophemstraat

110, B-1180 Brussel

Belgium

Plendil 5 mg Retard

5 mg

Prolonged-release tablet

Oral use

Belgium

NV AstraZeneca SA

Rue Egide van Ophemstraat

110, B-1180 Brussel

Belgium

Plendil 10 mg Retard

10 mg

Prolonged-release tablet

Oral use

Bulgaria

AstraZeneca AB

S-151 85 Södertälje

Sweden

Плендил

(Plendil)

5 mg

Prolonged-release tablet

Oral use

Croatia

AstraZeneca d.o.o.

Radnička cesta 80

10 000 Zagreb

Croatia

Plendil 5 mg

tablete s produljenim oslobađanjem

5 mg

Prolonged-release tablet

Oral use

Croatia

AstraZeneca d.o.o.

Radnička cesta 80

10 000 Zagreb

Croatia

Plendil 10 mg

tablete s produljenim oslobađanjem

10 mg

Prolonged-release tablet

Oral use

Cyprus

AstraZeneca AB

S-151 85 Södertälje

Sweden

Plendil

2,5 mg

Prolonged-release tablets

Oral use

Cyprus

AstraZeneca AB

S-151 85 Södertälje

Sweden

Plendil

5 mg

Prolonged-release tablet

Oral use

Cyprus

AstraZeneca AB

S-151 85 Södertälje

Sweden

Plendil

10 mg

Prolonged-release tablet

Oral use

Czech Republic

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

PLENDIL ER 5 mg

5 mg

Prolonged-release tablet

Oral use

Czech Republic

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

PLENDIL ER 10 mg

10 mg

Prolonged-release tablet

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Köbenhavn S.

Denmark

Plendil

2,5 mg

Prolonged-release tablet

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Köbenhavn S.

Denmark

Plendil

5 mg

Prolonged-release tablet

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Köbenhavn S.

Denmark

Plendil

10 mg

Prolonged-release tablet

Oral use

Estonia

AstraZeneca AB

S-151 85 Södertälje

Sweden

Plendil

2,5 mg

Prolonged-release tablet

Oral use

Estonia

AstraZeneca AB

S-151 85 Södertälje

Sweden

Plendil

5 mg

Prolonged-release tablet

Oral use

Estonia

AstraZeneca AB

S-151 85 Södertälje

Sweden

Plendil

10 mg

Prolonged-release tablet

Oral use

Finland

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Plendil

2,5 mg

Prolonged-release tablet

Oral use

Finland

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Plendil

5 mg

Prolonged-release tablet

Oral use

Finland

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Plendil

10 mg

Prolonged-release tablet

Oral use

France

AstraZeneca

1 place Renault

92844 Rueil-Malmaison Cedex

France

FLODIL

5 mg

Prolonged-release tablet

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

Modip 2,5 mg

2,5 mg

Prolonged-release tablet

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

Modip 5 mg

5 mg

Prolonged-release tablet

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

Modip 10 mg

10 mg

Prolonged-release tablet

Oral use

Greece

AstraZeneca S.A.

Theotokopoulou & Astronafton str

151 25 Maroussi

Greece

Plendil

2,5 mg

Prolonged-release tablet

Oral use

Greece

AstraZeneca S.A.

Theotokopoulou & Astronafton str

151 25 Maroussi

Greece

Plendil

5 mg

Prolonged-release tablet

Oral use

Greece

AstraZeneca S.A.

Theotokopoulou & Astronafton str

151 25 Maroussi

Greece

Plendil

10 mg

Prolonged-release tablet

Oral use

Hungary

AstraZeneca Kft.

H-1113 Budapest

Bocskai út 134-146

Hungary

Plendil 2,5 mg retard filmtabletta

2,5 mg

Prolonged-release tablet

Oral use

Hungary

AstraZeneca Kft.

H-1113 Budapest

Bocskai út 134-146

Hungary

Plendil 5 mg retard filmtabletta

5 mg

Prolonged-release tablet

Oral use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Köbenhavn S.

Denmark

Plendil

2,5 mg

Prolonged-release tablet

Oral use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Köbenhavn S.

Denmark

Plendil

5 mg

Prolonged-release tablet

Oral use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Köbenhavn S.

Denmark

Plendil

10 mg

Prolonged-release tablet

Oral use

Ireland

AstraZeneca UK Ltd.

600 Capability Green

Luton LU1 3LU

United Kingdom

Plendil 2,5 mg Prolonged-release, Film-coated Tablets

2,5 mg

Prolonged-release tablet

Oral use

Ireland

AstraZeneca UK Ltd.

600 Capability Green

Luton LU1 3LU

United Kingdom

Plendil 5 mg Prolonged-release, Film-coated Tablets

5 mg

Prolonged-release tablet

Oral use

Ireland

AstraZeneca UK Ltd.

600 Capability Green

Luton LU1 3LU

United Kingdom

Plendil 10 mg Prolonged-release, Film-coated Tablets

10 mg

Prolonged-release tablet

Oral use

Italy

AstraZeneca S.p.A

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

Plendil 5 mg

compresse a rilascio prolungato

5 mg

Prolonged-release tablet

Oral use

Italy

AstraZeneca S.p.A

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

Plendil 10 mg compresse a rilascio prolungato

10 mg

Prolonged-release tablet

Oral use

Italy

AstraZeneca S.p.A

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

Feloday 5 mg

compresse a rilascio prolungato

5 mg

Prolonged-release tablet

Oral use

Italy

AstraZeneca S.p.A

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

Feloday 10 mg

compresse a rilascio prolungato

10 mg

Prolonged-release tablet

Oral use

Italy

SIMESA S.p.A

Palazzo Galileo

Via F. Sforza

20080 Basiglio (MI)

Italy

Prevex 5 mg

compresse a rilascio prolungato

5 mg

Prolonged-release tablet

Oral use

Italy

SIMESA S.p.A

Palazzo Galileo

Via F. Sforza

20080 Basiglio (MI)

Italy

Prevex 10 mg

compresse a rilascio prolungato

10 mg

Prolonged-release tablet

Oral use

Latvia

AstraZeneca AB

S-151 85, Södertälje

Sweden

Plendil 5 mg ilgstošās darbības tabletes

5 mg

Prolonged-release tablet

Oral use

Latvia

AstraZeneca AB

S-151 85, Södertälje

Sweden

Plendil 10 mg ilgstošās darbības tabletes

10 mg

Prolonged-release tablet

Oral use

Lithuania

AstraZeneca AB

S-151 85, Södertälje

Sweden

Plendil

2,5 mg

Prolonged-release tablet

Oral use

Lithuania

AstraZeneca AB

S-151 85, Södertälje

Sweden

Plendil

5 mg

Prolonged-release tablet

Oral use

Lithuania

AstraZeneca AB

S-151 85, Södertälje

Sweden

Plendil

10 mg

Prolonged-release tablet

Oral use

Luxembourg

NV AstraZeneca SA

Rue Egide van Ophemstraat

B-1180 Brussel

Belgium

PLENDIL 5 mg Retard

5 mg

Prolonged-release tablet

Oral use

Luxembourg

NV AstraZeneca SA

Rue Egide van Ophemstraat

B-1180 Brussel

Belgium

PLENDIL 10 mg Retard

10 mg

Prolonged-release tablet

Oral use

Malta

Astra Zeneca AB

Gartunavagen, S-151 85 Sodertalje, Sweden

Plendil 5 mg Prolonged-release, Film-coated Tablets

5 mg

Prolonged-release tablet

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Plendil 2,5

2,5 mg

Prolonged-release tablet

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Plendil 5

5 mg

Prolonged-release tablet

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Plendil 10

10 mg

Prolonged-release tablet

Oral use

Norway

AstraZeneca AS

Postboks 6050, Etterstad

0601 Oslo

Norway

Plendil

2,5 mg

Prolonged-release tablet

Oral use

Norway

AstraZeneca AS

Postboks 6050, Etterstad

0601 Oslo

Norway

Plendil

5 mg

Prolonged-release tablet

Oral use

Norway

AstraZeneca AS

Postboks 6050, Etterstad

0601 Oslo

Norway

Plendil

10 mg

Prolonged-release tablet

Oral use

Poland

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil

5 mg

Prolonged-release tablet

Oral use

Poland

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil

10 mg

Prolonged-release tablet

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Queluz de baixo

2730-097 Barcarena

Portugal

Preslow

5 mg

Prolonged-release tablet

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Queluz de baixo

2730-097 Barcarena

Portugal

Preslow

10 mg

Prolonged-release tablet

Oral use

Romania

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil

2,5 mg

Prolonged-release tablet

Oral use

Romania

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil

5 mg

Prolonged-release tablet

Oral use

Romania

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil

10 mg

Prolonged-release tablet

Oral use

Slovak Republic

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil 2,5 mg

2,5 mg

Prolonged-release tablet

Oral use

Slovak Republic

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil 5 mg

5 mg

Prolonged-release tablet

Oral use

Slovak Republic

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil 10 mg

10 mg

Prolonged-release tablet

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache 56

Edificio Roble

28033 Madrid

Spain

Plendil 5 mg comprimidos de liberación prolongada

5 mg

Prolonged-release tablet

Oral use

Sweden

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil

2,5 mg

Prolonged-release tablet

Oral use

Sweden

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil

5 mg

Prolonged-release tablet

Oral use

Sweden

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Plendil

10 mg

Prolonged-release tablet

Oral use

Sweden

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Felodipin AstraZeneca

2,5 mg

Prolonged-release tablet

Oral use

Sweden

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Felodipin AstraZeneca

5 mg

Prolonged-release tablet

Oral use

Sweden

AstraZeneca AB

S-151 85 Sodertalje

Sweden

Felodipin AstraZeneca

10 mg

Prolonged-release tablet

Oral use

United Kingdom

AstraZeneca UK Ltd.

600 Capability Green

Luton LU1 3LU

United Kingdom

Plendil

2,5 mg

Prolonged-release tablet

Oral use

United Kingdom

AstraZeneca UK Ltd.

600 Capability Green

Luton LU1 3LU

United Kingdom

Plendil

5 mg

Prolonged-release tablet

Oral use

United Kingdom

AstraZeneca UK Ltd.

600 Capability Green

Luton LU1 3LU

United Kingdom

Plendil

10 mg

Prolonged-release tablet

Oral use

---

ANNEX II

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States

| Member State EU/EEA | Applicant/Marketing Authorisation Holder | Product name | INN | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | Merial Belgium SA
  Culliganlaan 1c
  1831 Diegem
  Belgium | Captalin | Spiramycin | 1 0 00  000 IU/ml | Solution for injection | Cattle |
| Bulgaria | Ceva Animal Health Bulgaria Ltd
  26 Elemag Str., ent.B, app.1
  Sofia 1113
  Bulgaria | Spirovet 6 00  000 IU/ml инжекционен разрвор за говеда и свине/Spirovet 6 00  000 IU/ml solution for injection for cattle and pigs | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Czech Republic | Merial
  29 avenue Tony Garnier
  69007 Lyon
  France | SUANOVIL 20 injekční roztok | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Czech Republic | Ceva Sante Animale
  Z.I. La Ballastière
  Libourne
  France | SPIROVET 6 00  000 IU/ml solution for injection for cattle and pigs | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Estonia | Merial
  29 avenue Tony Garnier
  69007 Lyon
  France | Suanovil 20 | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Estonia | Ceva Sante Animale
  10 avenue de la Ballastière
  33500 Libourne
  France | Spirovet | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| France | Merial
  29 avenue Tony Garnier
  69007 Lyon
  France | Suanovil 20 | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| France | Merial
  29 avenue Tony Garnier
  69007 Lyon
  France | Captalin | Spiramycin | 1 0 00  000 IU/ml | Solution for injection | Cattle |
| France | Ceva Sante Animale
  10 avenue de la Ballastière
  33500 Libourne
  France | Spirovet | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| France | Ceva Sante Animale
  10 avenue de la Ballastière
  33500 Libourne
  France | Spiramycine CEVA 6 00  000 UI/ML solution injectable pour bovins et porcins | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Greece | Merial
  29 avenue Tony Garnier
  69007 Lyon
  France | Suanovil 20 | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Hungary | Merial
  29 avenue Tony Garnier
  69007 Lyon
  France | Suanovil 20 % injekció | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Hungary | Ceva-Phylaxia Zrt.
  Szállás u. 5
  1107 Budapest
  Hungary | Spirovet 6 00  000 NE/ml, injekció szarvasmarha és sertés részére | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Ireland | Ceva Sante Animale
  10 avenue de la Ballastière
  33500 Libourne
  France | SPIROVET 6 00  000 IU/ml solution for injection for cattle and pigs | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Italy | Merial Italia S.p.A.
  Via Vittor Pisani 16
  20124 Milano
  Italy | Captalin | Spiramycin | 1 0 00  000 IU/ml | Solution for injection | Cattle |
| Italy | Merial Italia S.p.A.
  Via Vittor Pisani 16
  20124 Milano
  Italy | Spiramin | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Italy | Ceva Salute Animale S.p.A.
  Viale Colleoni, 15
  20864 Agrate Brianza (MB)
  Italy | Spiravet 20 | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Latvia | Merial
  29 avenue Tony Garnier
  69007 Lyon
  France | Suanovil 20 | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Lithuania | Ceva Sante Animale
  Z.I. La Ballastière
  33500 Libourne
  France | SPIROVET 6 00  000 TV/ml, injekcinis tirpalas galvijams ir kiaulėms | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Portugal | Merial Portuguesa — Saúde Animal, LDA
  Av. Maria Lamas, lote 19 — BL. A Piso 2
  Parque Industrial e Comercial Serra das Minas
  2635-432 Rio de Mouro
  Portugal | Suanovil 20 | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Portugal | Ceva Saúde Animal — Produtos Farmacêuticos e Imunológicos, Lda.
  Rua Doutor António Loureiro Borges,
  9/9A, 9oA Miraflores
  1495-131 Algés
  Portugal | SPIROVET 6 00  000 UI/ml solução injetável para bovinos e suínos | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Romania | Ceva Sante Animale
  Z.I. de la Ballastière, BP 126
  33500 Libourne Cedex
  FRANCE | Spirovet | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Romania | Merial
  Rue de Bourgelat 17
  69002 Lyon
  France | Suanovil 20 | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Slovakia | Merial
  29 avenue Tony Garnier
  69007 Lyon
  France | Suanovil 20 injekčný roztok | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Slovenia | Ceva Sante Animale
  10 avenue de la Ballastière
  33500 Libourne
  France | SPIROVET 6 00  000 IU/ml raztopina za injiciranje za govedo in prašiče | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| Spain | Merial Laboratorios S.A.
  Tarragona, No 161 — Locales D/E 08820 Barcelona
  Spain | Suanovil 20 | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |
| United Kingdom | Ceva Animal Health Ltd
  Unit 3
  Anglo Office Park
  White Lion Road
  Amersham
  Buckinghamshire
  HP7 9FB
  United Kingdom | Spirovet | Spiramycin | 6 00  000 IU/ml | Solution for injection | Cattle
  Pigs |

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Belgium

Merial Belgium SA

Culliganlaan 1c

1831 Diegem

Belgium

Captalin

Spiramycin

1 0 00  000 IU/ml

Solution for injection

Cattle

Bulgaria

Ceva Animal Health Bulgaria Ltd

26 Elemag Str., ent.B, app.1

Sofia 1113

Bulgaria

Spirovet 6 00  000 IU/ml инжекционен разрвор за говеда и свине/Spirovet 6 00  000 IU/ml solution for injection for cattle and pigs

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Czech Republic

Merial

29 avenue Tony Garnier

69007 Lyon

France

SUANOVIL 20 injekční roztok

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Czech Republic

Ceva Sante Animale

Z.I. La Ballastière

Libourne

France

SPIROVET 6 00  000 IU/ml solution for injection for cattle and pigs

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Estonia

Merial

29 avenue Tony Garnier

69007 Lyon

France

Suanovil 20

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Estonia

Ceva Sante Animale

10 avenue de la Ballastière

33500 Libourne

France

Spirovet

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

France

Merial

29 avenue Tony Garnier

69007 Lyon

France

Suanovil 20

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

France

Merial

29 avenue Tony Garnier

69007 Lyon

France

Captalin

Spiramycin

1 0 00  000 IU/ml

Solution for injection

Cattle

France

Ceva Sante Animale

10 avenue de la Ballastière

33500 Libourne

France

Spirovet

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

France

Ceva Sante Animale

10 avenue de la Ballastière

33500 Libourne

France

Spiramycine CEVA 6 00  000 UI/ML solution injectable pour bovins et porcins

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Greece

Merial

29 avenue Tony Garnier

69007 Lyon

France

Suanovil 20

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Hungary

Merial

29 avenue Tony Garnier

69007 Lyon

France

Suanovil 20 % injekció

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Hungary

Ceva-Phylaxia Zrt.

Szállás u. 5

1107 Budapest

Hungary

Spirovet 6 00  000 NE/ml, injekció szarvasmarha és sertés részére

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Ireland

Ceva Sante Animale

10 avenue de la Ballastière

33500 Libourne

France

SPIROVET 6 00  000 IU/ml solution for injection for cattle and pigs

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Italy

Merial Italia S.p.A.

Via Vittor Pisani 16

20124 Milano

Italy

Captalin

Spiramycin

1 0 00  000 IU/ml

Solution for injection

Cattle

Italy

Merial Italia S.p.A.

Via Vittor Pisani 16

20124 Milano

Italy

Spiramin

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Italy

Ceva Salute Animale S.p.A.

Viale Colleoni, 15

20864 Agrate Brianza (MB)

Italy

Spiravet 20

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Latvia

Merial

29 avenue Tony Garnier

69007 Lyon

France

Suanovil 20

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Lithuania

Ceva Sante Animale

Z.I. La Ballastière

33500 Libourne

France

SPIROVET 6 00  000 TV/ml, injekcinis tirpalas galvijams ir kiaulėms

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Portugal

Merial Portuguesa — Saúde Animal, LDA

Av. Maria Lamas, lote 19 — BL. A Piso 2

Parque Industrial e Comercial Serra das Minas

2635-432 Rio de Mouro

Portugal

Suanovil 20

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Portugal

Ceva Saúde Animal — Produtos Farmacêuticos e Imunológicos, Lda.

Rua Doutor António Loureiro Borges,

9/9A, 9oA Miraflores

1495-131 Algés

Portugal

SPIROVET 6 00  000 UI/ml solução injetável para bovinos e suínos

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Romania

Ceva Sante Animale

Z.I. de la Ballastière, BP 126

33500 Libourne Cedex

FRANCE

Spirovet

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Romania

Merial

Rue de Bourgelat 17

69002 Lyon

France

Suanovil 20

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Slovakia

Merial

29 avenue Tony Garnier

69007 Lyon

France

Suanovil 20 injekčný roztok

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Slovenia

Ceva Sante Animale

10 avenue de la Ballastière

33500 Libourne

France

SPIROVET 6 00  000 IU/ml raztopina za injiciranje za govedo in prašiče

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

Spain

Merial Laboratorios S.A.

Tarragona, No 161 — Locales D/E 08820 Barcelona

Spain

Suanovil 20

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

United Kingdom

Ceva Animal Health Ltd

Unit 3

Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

United Kingdom

Spirovet

Spiramycin

6 00  000 IU/ml

Solution for injection

Cattle

Pigs

---

ANNEX III

List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the Member States

| Member State
  (in EEA) | Marketing authorisation holder | INN | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Austria | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Austria | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Austria | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Belgium | Mundipharma Comm. VA
  Blarenberglaan 3C, Mechelen
  2800
  Belgium | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 10 mg/5 mg | prolonged-release tablets | oral |
| Belgium | Mundipharma Comm. VA
  Blarenberglaan 3C, Mechelen
  2800
  Belgium | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 20 mg/10 mg | prolonged-release tablets | oral |
| Belgium | Mundipharma Comm. VA
  Blarenberglaan 3C, Mechelen
  2800
  Belgium | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Belgium | Mundipharma Comm. VA
  Blarenberglaan 3C, Mechelen
  2800
  Belgium | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 40 mg/20 mg | prolonged-release tablets | oral |
| Bulgaria | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Bulgaria | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Bulgaria | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Bulgaria | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Cyprus | Mundipharma Pharmaceuticals Ltd.
  13, Othellos Street, Dhali Industrial Zone, Nicosia
  Cyprus | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Cyprus | Mundipharma Pharmaceuticals Ltd.
  13, Othellos Street, Dhali Industrial Zone, Nicosia
  Cyprus | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 10 mg/5 mg | prolonged-release tablets | oral |
| Cyprus | Mundipharma Pharmaceuticals Ltd.
  13, Othellos Street, Dhali Industrial Zone, Nicosia
  Cyprus | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 20 mg/10 mg | prolonged-release tablets | oral |
| Cyprus | Mundipharma Pharmaceuticals Ltd.
  13, Othellos Street, Dhali Industrial Zone, Nicosia
  Cyprus | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 40 mg/20 mg | prolonged-release tablets | oral |
| Czech Republic | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride) | Targin 5 mg/2,5 mg tablety s prodlouženým uvolňováním | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Czech Republic | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride) | Targin 10 mg/5 mg tablety s prodlouženým uvolňováním | 10 mg/5 mg | prolonged-release tablets | oral |
| Czech Republic | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride) | Targin 20 mg/10 mg tablety s prodlouženým uvolňováním | 20 mg/10 mg | prolonged-release tablets | oral |
| Czech Republic | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride) | Targin 40 mg/20 mg tablety s prodlouženým uvolňováním | 40 mg/20 mg | prolonged-release tablets | oral |
| Denmark | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Denmark | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Denmark | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Denmark | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Estonia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Estonia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 10 mg/5 mg | prolonged-release tablets | oral |
| Estonia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 20 mg/10 mg | prolonged-release tablets | oral |
| Estonia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 40 mg/20 mg | prolonged-release tablets | oral |
| Finland | Mundipharma Oy
  Rajatorpantie 41 B
  01640 Vantaa
  Finland | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 10 mg/5 mg | prolonged-release tablets | oral |
| Finland | Mundipharma Oy
  Rajatorpantie 41 B
  01640 Vantaa
  Finland | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 20 mg/10 mg | prolonged-release tablets | oral |
| Finland | Mundipharma Oy
  Rajatorpantie 41 B
  01640 Vantaa
  Finland | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Finland | Mundipharma Oy
  Rajatorpantie 41 B
  01640 Vantaa
  Finland | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 40 mg/20 mg | prolonged-release tablets | oral |
| France | Mundipharma SAS
  100, avenue de Suffren, Paris
  75015
  France | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 5 mg/2,5 mg | prolonged-release tablets | oral |
| France | Mundipharma SAS
  100, avenue de Suffren Paris
  75015
  France | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 10 mg/5 mg | prolonged-release tablets | oral |
| France | Mundipharma SAS
  100, avenue de Suffren
  Paris
  75015
  France | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 20 mg/10 mg | prolonged-release tablets | oral |
| France | Mundipharma SAS
  100, avenue de Suffren
  Paris
  75015
  France | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 40 mg/20 mg | prolonged-release tablets | oral |
| Germany | Mundipharma GmbH
  Mundipharma Str. 2
  Limburg
  65549
  Germany | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Oxynal | 10 mg/5 mg | prolonged-release tablets | oral |
| Germany | Mundipharma GmbH
  Mundipharma Str. 2, Limburg
  65549
  Germany | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Oxynal | 20 mg/10 mg | prolonged-release tablets | oral |
| Germany | Mundipharma GmbH
  Mundipharma Str. 2, Limburg
  65549
  Germany | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Germany | Mundipharma GmbH
  Mundipharma Str. 2
  Limburg
  65549
  Germany | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Germany | Mundipharma GmbH
  Mundipharma Str. 2 Limburg
  65549
  Germany | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Germany | Mundipharma GmbH
  Mundipharma Str. 2 Limburg
  65549
  Germany | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Hungary | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Hungary | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 10 mg/5 mg | prolonged-release tablets | oral |
| Hungary | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 20 mg/10 mg | prolonged-release tablets | oral |
| Hungary | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 40 mg/20 mg | prolonged-release tablets | oral |
| Iceland | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Iceland | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Iceland | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Iceland | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Ireland | Mundipharma Pharmaceuticals Ltd.
  Millbank House, Arkle Road
  Sandyford, Dublin 18
  Ireland | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Ireland | Mundipharma Pharmaceuticals Ltd.
  Millbank House, Arkle Road
  Sandyford, Dublin 18
  Ireland | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Ireland | Mundipharma Pharmaceuticals Ltd.
  Millbank House, Arkle Road
  Sandyford, Dublin 18
  Ireland | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Ireland | Mundipharma Pharmaceuticals Ltd.
  Millbank House, Arkle Road
  Sandyford, Dublin 18
  Ireland | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Italy | Mundipharma Pharmaceuticals Srl
  Via G. Serbelloni 4, Milano
  20122
  Italy | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Italy | Mundipharma Pharmaceuticals Srl
  Via G. Serbelloni 4, Milano
  20122
  Italy | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Italy | Mundipharma Pharmaceuticals Srl
  Via G. Serbelloni 4, Milano
  20122
  Italy | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Italy | Mundipharma Pharmaceuticals Srl
  Via G. Serbelloni 4, Milano
  20122
  Italy | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Latvia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Latvia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Latvia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Latvia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Luxembourg | Mundipharma Comm. VA
  Blarenberglaan 3C, Mechelen
  2800
  Belgium | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 10 mg/5 mg | prolonged-release tablets | oral |
| Luxembourg | Mundipharma Comm. VA
  Blarenberglaan 3C Mechelen
  2800
  Belgium | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 20 mg/10 mg | prolonged-release tablets | oral |
| Luxembourg | Mundipharma Comm. VA
  Blarenberglaan 3C Mechelen
  2800
  Belgium | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Luxembourg | Mundipharma Comm. VA
  Blarenberglaan 3C Mechelen
  2800
  Belgium | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 40 mg/20 mg | prolonged-release tablets | oral |
| Norway | Mundipharma AS
  Dicks vei 10B, 1366
  Lysaker
  Norway | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 10 mg/5 mg | prolonged-release tablets | oral |
| Norway | Mundipharma AS
  Dicks vei 10B, 1366
  Lysaker
  Norway | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 20 mg/10 mg | prolonged-release tablets | oral |
| Norway | Mundipharma AS
  Dicks vei 10B, 1366
  Lysaker
  Norway | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Norway | Mundipharma AS
  Dicks vei 10B, 1366
  Lysaker
  Norway | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 40 mg/20 mg | prolonged-release tablets | oral |
| Poland | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Poland | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Poland | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Poland | Norpharma A/S
  Slotsmarken 15, Horsholm
  2970
  Denmark | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Portugal | Mundipharma Farmaceutica Lda
  Rua Duque de Palmela, no 23, Lisboa
  1250-097
  Portugal | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Portugal | Mundipharma Farmaceutica Lda
  Rua Duque de Palmela, no 23, Lisboa
  1250-097
  Portugal | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Portugal | Mundipharma Farmaceutica Lda
  Rua Duque de Palmela, no 23, Lisboa
  1250-097
  Portugal | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Portugal | Mundipharma Farmaceutica Lda
  Rua Duque de Palmela, no 23, Lisboa
  1250-097
  Portugal | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Romania | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Romania | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Romania | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Romania | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Slovak Republic | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Slovak Republic | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Slovak Republic | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Slovak Republic | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Slovenia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Slovenia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 10 mg/5 mg | prolonged-release tablets | oral |
| Slovenia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 20 mg/10 mg | prolonged-release tablets | oral |
| Slovenia | Mundipharma Gesellschaft m.b.H
  Apollogasse 16-18, Wien
  1070
  Austria | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 40 mg/20 mg | prolonged-release tablets | oral |
| Spain | Mundipharma Pharmaceuticals, S.L.
  C/Bahía de Pollensa, 11 Madrid
  28042
  Spain | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Spain | Mundipharma Pharmaceuticals, S.L.
  C/Bahía de Pollensa, 11
  Madrid
  28042
  Spain | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 10 mg/5 mg | prolonged-release tablets | oral |
| Spain | Mundipharma Pharmaceuticals, S.L.
  C/Bahía de Pollensa, 11, Madrid
  28042
  Spain | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 20 mg/10 mg | prolonged-release tablets | oral |
| Spain | Mundipharma Pharmaceuticals, S.L.
  C/Bahía de Pollensa, 11
  Madrid
  28042
  Spain | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targin | 40 mg/20 mg | prolonged-release tablets | oral |
| Sweden | Mundipharma AB
  Mölndalsvägen 30B
  Göteborg
  412 63
  Sweden | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 10 mg/5 mg | prolonged-release tablets | oral |
| Sweden | Mundipharma AB
  Mölndalsvägen 30B Göteborg
  412 63
  Sweden | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 20 mg/10 mg | prolonged-release tablets | oral |
| Sweden | Mundipharma AB
  Mölndalsvägen 30B Göteborg
  412 63
  Sweden | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 5 mg/2,5 mg | prolonged-release tablets | oral |
| Sweden | Mundipharma AB
  Mölndalsvägen 30B Göteborg
  412 63
  Sweden | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targiniq | 40 mg/20 mg | prolonged-release tablets | oral |
| The Netherlands | Mundipharma Pharmaceuticals B.V.
  De Wel 20, MV Hoevelaken
  3871
  The Netherlands | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 10 mg/5 mg | prolonged-release tablets | oral |
| The Netherlands | Mundipharma Pharmaceuticals B.V.
  De Wel 20, MV Hoevelaken
  3871
  The Netherlands | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 20 mg/10 mg | prolonged-release tablets | oral |
| The Netherlands | Mundipharma Pharmaceuticals B.V.
  De Wel 20, MV Hoevelaken
  3871
  The Netherlands | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 5 mg/2,5 mg | prolonged-release tablets | oral |
| The Netherlands | Mundipharma Pharmaceuticals B.V.
  De Wel 20, MV Hoevelaken
  3871
  The Netherlands | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 40 mg/20 mg | prolonged-release tablets | oral |
| United Kingdom | Napp Pharmaceuticals Ltd.
  Cambridge Science Park Milton Road
  CB4 0GW
  United Kingdom | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 10 mg/5 mg | prolonged-release tablets | oral |
| United Kingdom | Napp Pharmaceuticals Ltd.
  Cambridge Science Park Milton Road
  CB4 0GW
  United Kingdom | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 20 mg/10 mg | prolonged-release tablets | oral |
| United Kingdom | Napp Pharmaceuticals Ltd.
  Cambridge Science Park Milton Road
  CB4 0GW
  United Kingdom | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 5 mg/2,5 mg | prolonged-release tablets | oral |
| United Kingdom | Napp Pharmaceuticals Ltd.
  Cambridge Science Park Milton Road
  CB4 0GW
  United Kingdom | Oxycodone hydrochloride/Naloxone hydrochloride dihydrate | Targinact | 40 mg/20 mg | prolonged-release tablets | oral |

Member State

(in EEA)

Marketing authorisation holder

INN

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Austria

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Austria

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Austria

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Belgium

Mundipharma Comm. VA

Blarenberglaan 3C, Mechelen

2800

Belgium

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

10 mg/5 mg

prolonged-release tablets

oral

Belgium

Mundipharma Comm. VA

Blarenberglaan 3C, Mechelen

2800

Belgium

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

20 mg/10 mg

prolonged-release tablets

oral

Belgium

Mundipharma Comm. VA

Blarenberglaan 3C, Mechelen

2800

Belgium

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

5 mg/2,5 mg

prolonged-release tablets

oral

Belgium

Mundipharma Comm. VA

Blarenberglaan 3C, Mechelen

2800

Belgium

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

40 mg/20 mg

prolonged-release tablets

oral

Bulgaria

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Bulgaria

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Bulgaria

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Bulgaria

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Cyprus

Mundipharma Pharmaceuticals Ltd.

13, Othellos Street, Dhali Industrial Zone, Nicosia

Cyprus

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

5 mg/2,5 mg

prolonged-release tablets

oral

Cyprus

Mundipharma Pharmaceuticals Ltd.

13, Othellos Street, Dhali Industrial Zone, Nicosia

Cyprus

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

10 mg/5 mg

prolonged-release tablets

oral

Cyprus

Mundipharma Pharmaceuticals Ltd.

13, Othellos Street, Dhali Industrial Zone, Nicosia

Cyprus

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

20 mg/10 mg

prolonged-release tablets

oral

Cyprus

Mundipharma Pharmaceuticals Ltd.

13, Othellos Street, Dhali Industrial Zone, Nicosia

Cyprus

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

40 mg/20 mg

prolonged-release tablets

oral

Czech Republic

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride)

Targin 5 mg/2,5 mg tablety s prodlouženým uvolňováním

5 mg/2,5 mg

prolonged-release tablets

oral

Czech Republic

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride)

Targin 10 mg/5 mg tablety s prodlouženým uvolňováním

10 mg/5 mg

prolonged-release tablets

oral

Czech Republic

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride)

Targin 20 mg/10 mg tablety s prodlouženým uvolňováním

20 mg/10 mg

prolonged-release tablets

oral

Czech Republic

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride)

Targin 40 mg/20 mg tablety s prodlouženým uvolňováním

40 mg/20 mg

prolonged-release tablets

oral

Denmark

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Denmark

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Denmark

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Denmark

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Estonia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

5 mg/2,5 mg

prolonged-release tablets

oral

Estonia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

10 mg/5 mg

prolonged-release tablets

oral

Estonia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

20 mg/10 mg

prolonged-release tablets

oral

Estonia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

40 mg/20 mg

prolonged-release tablets

oral

Finland

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

10 mg/5 mg

prolonged-release tablets

oral

Finland

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

20 mg/10 mg

prolonged-release tablets

oral

Finland

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

5 mg/2,5 mg

prolonged-release tablets

oral

Finland

Mundipharma Oy

Rajatorpantie 41 B

01640 Vantaa

Finland

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

40 mg/20 mg

prolonged-release tablets

oral

France

Mundipharma SAS

100, avenue de Suffren, Paris

75015

France

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

5 mg/2,5 mg

prolonged-release tablets

oral

France

Mundipharma SAS

100, avenue de Suffren Paris

75015

France

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

10 mg/5 mg

prolonged-release tablets

oral

France

Mundipharma SAS

100, avenue de Suffren

Paris

75015

France

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

20 mg/10 mg

prolonged-release tablets

oral

France

Mundipharma SAS

100, avenue de Suffren

Paris

75015

France

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

40 mg/20 mg

prolonged-release tablets

oral

Germany

Mundipharma GmbH

Mundipharma Str. 2

Limburg

65549

Germany

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Oxynal

10 mg/5 mg

prolonged-release tablets

oral

Germany

Mundipharma GmbH

Mundipharma Str. 2, Limburg

65549

Germany

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Oxynal

20 mg/10 mg

prolonged-release tablets

oral

Germany

Mundipharma GmbH

Mundipharma Str. 2, Limburg

65549

Germany

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Germany

Mundipharma GmbH

Mundipharma Str. 2

Limburg

65549

Germany

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Germany

Mundipharma GmbH

Mundipharma Str. 2 Limburg

65549

Germany

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Germany

Mundipharma GmbH

Mundipharma Str. 2 Limburg

65549

Germany

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Hungary

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

5 mg/2,5 mg

prolonged-release tablets

oral

Hungary

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

10 mg/5 mg

prolonged-release tablets

oral

Hungary

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

20 mg/10 mg

prolonged-release tablets

oral

Hungary

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

40 mg/20 mg

prolonged-release tablets

oral

Iceland

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Iceland

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Iceland

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Iceland

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Ireland

Mundipharma Pharmaceuticals Ltd.

Millbank House, Arkle Road

Sandyford, Dublin 18

Ireland

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Ireland

Mundipharma Pharmaceuticals Ltd.

Millbank House, Arkle Road

Sandyford, Dublin 18

Ireland

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Ireland

Mundipharma Pharmaceuticals Ltd.

Millbank House, Arkle Road

Sandyford, Dublin 18

Ireland

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Ireland

Mundipharma Pharmaceuticals Ltd.

Millbank House, Arkle Road

Sandyford, Dublin 18

Ireland

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Italy

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni 4, Milano

20122

Italy

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Italy

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni 4, Milano

20122

Italy

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Italy

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni 4, Milano

20122

Italy

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Italy

Mundipharma Pharmaceuticals Srl

Via G. Serbelloni 4, Milano

20122

Italy

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Latvia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Latvia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride

Targin

10 mg/5 mg

prolonged-release tablets

oral

Latvia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride

Targin

20 mg/10 mg

prolonged-release tablets

oral

Latvia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride

Targin

40 mg/20 mg

prolonged-release tablets

oral

Luxembourg

Mundipharma Comm. VA

Blarenberglaan 3C, Mechelen

2800

Belgium

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

10 mg/5 mg

prolonged-release tablets

oral

Luxembourg

Mundipharma Comm. VA

Blarenberglaan 3C Mechelen

2800

Belgium

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

20 mg/10 mg

prolonged-release tablets

oral

Luxembourg

Mundipharma Comm. VA

Blarenberglaan 3C Mechelen

2800

Belgium

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

5 mg/2,5 mg

prolonged-release tablets

oral

Luxembourg

Mundipharma Comm. VA

Blarenberglaan 3C Mechelen

2800

Belgium

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

40 mg/20 mg

prolonged-release tablets

oral

Norway

Mundipharma AS

Dicks vei 10B, 1366

Lysaker

Norway

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

10 mg/5 mg

prolonged-release tablets

oral

Norway

Mundipharma AS

Dicks vei 10B, 1366

Lysaker

Norway

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

20 mg/10 mg

prolonged-release tablets

oral

Norway

Mundipharma AS

Dicks vei 10B, 1366

Lysaker

Norway

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

5 mg/2,5 mg

prolonged-release tablets

oral

Norway

Mundipharma AS

Dicks vei 10B, 1366

Lysaker

Norway

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

40 mg/20 mg

prolonged-release tablets

oral

Poland

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Poland

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Poland

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Poland

Norpharma A/S

Slotsmarken 15, Horsholm

2970

Denmark

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Portugal

Mundipharma Farmaceutica Lda

Rua Duque de Palmela, no 23, Lisboa

1250-097

Portugal

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Portugal

Mundipharma Farmaceutica Lda

Rua Duque de Palmela, no 23, Lisboa

1250-097

Portugal

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Portugal

Mundipharma Farmaceutica Lda

Rua Duque de Palmela, no 23, Lisboa

1250-097

Portugal

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Portugal

Mundipharma Farmaceutica Lda

Rua Duque de Palmela, no 23, Lisboa

1250-097

Portugal

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Romania

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Romania

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Romania

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Romania

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Slovak Republic

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Slovak Republic

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Slovak Republic

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Slovak Republic

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Slovenia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

5 mg/2,5 mg

prolonged-release tablets

oral

Slovenia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

10 mg/5 mg

prolonged-release tablets

oral

Slovenia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

20 mg/10 mg

prolonged-release tablets

oral

Slovenia

Mundipharma Gesellschaft m.b.H

Apollogasse 16-18, Wien

1070

Austria

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

40 mg/20 mg

prolonged-release tablets

oral

Spain

Mundipharma Pharmaceuticals, S.L.

C/Bahía de Pollensa, 11 Madrid

28042

Spain

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

5 mg/2,5 mg

prolonged-release tablets

oral

Spain

Mundipharma Pharmaceuticals, S.L.

C/Bahía de Pollensa, 11

Madrid

28042

Spain

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

10 mg/5 mg

prolonged-release tablets

oral

Spain

Mundipharma Pharmaceuticals, S.L.

C/Bahía de Pollensa, 11, Madrid

28042

Spain

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

20 mg/10 mg

prolonged-release tablets

oral

Spain

Mundipharma Pharmaceuticals, S.L.

C/Bahía de Pollensa, 11

Madrid

28042

Spain

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targin

40 mg/20 mg

prolonged-release tablets

oral

Sweden

Mundipharma AB

Mölndalsvägen 30B

Göteborg

412 63

Sweden

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

10 mg/5 mg

prolonged-release tablets

oral

Sweden

Mundipharma AB

Mölndalsvägen 30B Göteborg

412 63

Sweden

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

20 mg/10 mg

prolonged-release tablets

oral

Sweden

Mundipharma AB

Mölndalsvägen 30B Göteborg

412 63

Sweden

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

5 mg/2,5 mg

prolonged-release tablets

oral

Sweden

Mundipharma AB

Mölndalsvägen 30B Göteborg

412 63

Sweden

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targiniq

40 mg/20 mg

prolonged-release tablets

oral

The Netherlands

Mundipharma Pharmaceuticals B.V.

De Wel 20, MV Hoevelaken

3871

The Netherlands

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

10 mg/5 mg

prolonged-release tablets

oral

The Netherlands

Mundipharma Pharmaceuticals B.V.

De Wel 20, MV Hoevelaken

3871

The Netherlands

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

20 mg/10 mg

prolonged-release tablets

oral

The Netherlands

Mundipharma Pharmaceuticals B.V.

De Wel 20, MV Hoevelaken

3871

The Netherlands

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

5 mg/2,5 mg

prolonged-release tablets

oral

The Netherlands

Mundipharma Pharmaceuticals B.V.

De Wel 20, MV Hoevelaken

3871

The Netherlands

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

40 mg/20 mg

prolonged-release tablets

oral

United Kingdom

Napp Pharmaceuticals Ltd.

Cambridge Science Park Milton Road

CB4 0GW

United Kingdom

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

10 mg/5 mg

prolonged-release tablets

oral

United Kingdom

Napp Pharmaceuticals Ltd.

Cambridge Science Park Milton Road

CB4 0GW

United Kingdom

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

20 mg/10 mg

prolonged-release tablets

oral

United Kingdom

Napp Pharmaceuticals Ltd.

Cambridge Science Park Milton Road

CB4 0GW

United Kingdom

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

5 mg/2,5 mg

prolonged-release tablets

oral

United Kingdom

Napp Pharmaceuticals Ltd.

Cambridge Science Park Milton Road

CB4 0GW

United Kingdom

Oxycodone hydrochloride/Naloxone hydrochloride dihydrate

Targinact

40 mg/20 mg

prolonged-release tablets

oral

---

ANNEX IV

List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States

| Member State EU/EEA | Marketing authorisation holder | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Intervet GesmbH
  Siemensstrasse 107
  1210 Wien
  Austria | RESFLOR 300/16,5 mg/mL Lösung zur Injektion für Rinder | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Belgium | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor 300, 16,5 mg/mL solution injectable pour bovines | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Bulgaria | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | РЕСФЛОР 300/16,5 мг/мл Разтвор за инжективно приложение при eдри преживни животни | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Cyprus | Schering-Plough S.A.
  63, Agiou Dimitriou street
  17456 Alimos
  Greece | RESFLOR 300/16,5 mg/mL Ενέσιμο Διάλυμα για βοοειδή | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Czech Republic | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor injekční roztok pro skot | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Denmark | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor vet. injection, solution for Injection for Cattle | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Estonia | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor vet. injection, solution for Injection for Cattle | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Finland | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor vet. injection, solution for Injection for Cattle | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| France | Intervet MSD Santé Animale
  7 Rue Olivier de Serres
  Angers Technopole
  CS 17144
  49071 Beaucouzé
  France | RESFLOR SOLUTION INJECTABLE | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Germany | Intervet Deutschland GmbH
  Feldstraße 1a
  D-85716 Unterschleißheim
  Germany | RESFLOR 300/16,5 mg/mL Lösung zur Injektion für Rinder | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Greece | Intervet Hellas S.A.
  63, Agiou Dimitriou street
  17456 Alimos
  Greece | RESFLOR 300/16,5 mg/mL Ενέσιμο Διάλυμα για βοοειδή | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Hungary | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | RESFLOR INJEKCIÓS OLDAT | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Ireland | Intervet Ireland Ltd.
  Magna Drive
  Magna Business Park
  Citywest Rd.
  Dublin 24
  Ireland | RESFLOR 300/16,5 mg/mL Solution for Injection for Cattle | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Italy | Intervet MSD Santé Animale
  7 Rue Olivier de Serres
  Angers Technopole
  CS 17144
  49071 Beaucouzé
  France | RESFLOR 300/16,5 mg/mL SOLUZIONE INIETTABILE per bovini | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Latvia | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor vet. injection, solution for Injection for Cattle | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Lithuania | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor vet. injection, solution for Injection for Cattle | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Luxembourg | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor 300, 16,5 mg/mL solution injectable pour bovines | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| The Netherlands | Intervet Nederland B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor 300, 16,5 mg/mL oplossing voor injectie voor runderen | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Norway | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor vet. injection, solution for Injection for Cattle | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Poland | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor 300/16,5 mg/mL roztwór do wstrzykiwań dla bydła | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Portugal | MSD Animal Health, Lda.
  Quinta da Fonte
  Edifício Vasco da Gama 19
  2770-192 Paço de Arcos
  Portugal | RESFLOR 300/16,5 mg/mL Solução Injectável para Bovinos | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Romania | Intervet Romania s.r.l.
  Soseua de Centura no. 13A
  Comuna Chiajna
  Judet Ilfov
  Romania | RESFLOR 300/16,5 mg/mL solutie injectabila pentru bovine | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Slovakia | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor injekčný roztok pre hovädzí dobytok | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Slovenia | Intervet International B.V.
  Wim de Koerverstraat 35
  5831 AN Boxmeer
  The Netherlands | Resflor 300/16,5 mg/mL raztopina za injiciranje za govedo | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| Spain | Merck Sharp & Dohme Animal Health S.L.
  Polígono Industrial El Montalvo I
  c/Zeppelín no 6, parcela 38
  37008 Carbajosa de la Sagrada — Salamanca
  Spain | RESFLOR SOLUCIÓN INYECTABLE | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |
| United Kingdom | Intervet UK Ltd.
  Walton Manor, Walton
  Milton Keynes MK7 7AJ
  United Kingdom | RESFLOR 300/16,5 mg/mL Solution for Injection for Cattle | Florfenicol, flunixin | Solution for injection | 300 mg/ml 16,5 mg/ml | Cattle | Subcutaneous |

Member State EU/EEA

Marketing authorisation holder

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Intervet GesmbH

Siemensstrasse 107

1210 Wien

Austria

RESFLOR 300/16,5 mg/mL Lösung zur Injektion für Rinder

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Belgium

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor 300, 16,5 mg/mL solution injectable pour bovines

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Bulgaria

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

РЕСФЛОР 300/16,5 мг/мл Разтвор за инжективно приложение при eдри преживни животни

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Cyprus

Schering-Plough S.A.

63, Agiou Dimitriou street

17456 Alimos

Greece

RESFLOR 300/16,5 mg/mL Ενέσιμο Διάλυμα για βοοειδή

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Czech Republic

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor injekční roztok pro skot

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Denmark

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor vet. injection, solution for Injection for Cattle

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Estonia

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor vet. injection, solution for Injection for Cattle

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Finland

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor vet. injection, solution for Injection for Cattle

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

France

Intervet MSD Santé Animale

7 Rue Olivier de Serres

Angers Technopole

CS 17144

49071 Beaucouzé

France

RESFLOR SOLUTION INJECTABLE

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Germany

Intervet Deutschland GmbH

Feldstraße 1a

D-85716 Unterschleißheim

Germany

RESFLOR 300/16,5 mg/mL Lösung zur Injektion für Rinder

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Greece

Intervet Hellas S.A.

63, Agiou Dimitriou street

17456 Alimos

Greece

RESFLOR 300/16,5 mg/mL Ενέσιμο Διάλυμα για βοοειδή

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Hungary

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

RESFLOR INJEKCIÓS OLDAT

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Ireland

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Rd.

Dublin 24

Ireland

RESFLOR 300/16,5 mg/mL Solution for Injection for Cattle

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Italy

Intervet MSD Santé Animale

7 Rue Olivier de Serres

Angers Technopole

CS 17144

49071 Beaucouzé

France

RESFLOR 300/16,5 mg/mL SOLUZIONE INIETTABILE per bovini

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Latvia

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor vet. injection, solution for Injection for Cattle

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Lithuania

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor vet. injection, solution for Injection for Cattle

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Luxembourg

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor 300, 16,5 mg/mL solution injectable pour bovines

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

The Netherlands

Intervet Nederland B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor 300, 16,5 mg/mL oplossing voor injectie voor runderen

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Norway

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor vet. injection, solution for Injection for Cattle

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Poland

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor 300/16,5 mg/mL roztwór do wstrzykiwań dla bydła

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Portugal

MSD Animal Health, Lda.

Quinta da Fonte

Edifício Vasco da Gama 19

2770-192 Paço de Arcos

Portugal

RESFLOR 300/16,5 mg/mL Solução Injectável para Bovinos

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Romania

Intervet Romania s.r.l.

Soseua de Centura no. 13A

Comuna Chiajna

Judet Ilfov

Romania

RESFLOR 300/16,5 mg/mL solutie injectabila pentru bovine

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Slovakia

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor injekčný roztok pre hovädzí dobytok

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Slovenia

Intervet International B.V.

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Resflor 300/16,5 mg/mL raztopina za injiciranje za govedo

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

Spain

Merck Sharp & Dohme Animal Health S.L.

Polígono Industrial El Montalvo I

c/Zeppelín no 6, parcela 38

37008 Carbajosa de la Sagrada — Salamanca

Spain

RESFLOR SOLUCIÓN INYECTABLE

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

United Kingdom

Intervet UK Ltd.

Walton Manor, Walton

Milton Keynes MK7 7AJ

United Kingdom

RESFLOR 300/16,5 mg/mL Solution for Injection for Cattle

Florfenicol, flunixin

Solution for injection

300 mg/ml 16,5 mg/ml

Cattle

Subcutaneous

---

ANNEX V

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration and marketing authorisation holders in the Member States

| Member State
  (in EEA) | Marketing authorisation holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Forest Pharma B.V.
  Newtonlaan 115
  3584 BH Utrecht
  The Netherlands | Colistin Forest — Trockenstechampullen mit Lösungsmittel | 1 0 00  000 I.U. | powder and solvent for suspension for injection, nebuliser solution | intramuscular use,
  intravenous use,
  inhalation use |
| Austria | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung | 1 0 00  000 I.U. | powder for solution for infusion | intravenous use |
| Austria | Xellia Pharmaceuticals ApS
  Dalslandsgade 11
  DK-2300 Copenhagen S
  Denmark | Colistin Xellia 1 Million I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| Austria | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Tadim 1 Million I.E. Pulver zur Herstellung einer Lösung für einen Vernebler | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Austria | PARI Pharma GmbH
  Moosstrasse 3
  82319 Starnberg
  Germany | ColiFin 1 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Austria | PARI Pharma GmbH
  Moosstrasse 3
  82319 Starnberg
  Germany | ColiFin 2 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler | 2 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Belgium | Forest Laboratories UK Ltd.
  Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford
  Kent DA2 6SL
  United Kingdom | Colistineb 1 0 00  000 IE | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use,
  inhalation use |
| Belgium | Forest Laboratories UK Ltd. Riverbridge House
  Anchor Boulevard
  Crossways Business Park Dartford
  Kent DA2 6SL
  United Kingdom | Colistineb 2 0 00  000 IE | 2 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use,
  inhalation use |
| Bulgaria | Alvogen IPCo.S.ar. I.
  5 Rue Heienhaff
  Senningerberg
  L-1736
  Luxembourg | Colistin Alvogen | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| Bulgaria | Alvogen IPCo.S.ar. I.
  5 Rue Heienhaff
  Senningerberg
  L-1736
  Luxembourg | Colistin Alvogen | 2 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| Croatia | Altamedics d.o.o.
  Karlovačka cesta 24a, Zagreb
  10020
  Croatia | Colixin 1 milijun IU prašak za otopinu za injekciju | 1 0 00  000 I.U. | powder for solution for injection | intravenous use |
| Czech Republic | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford
  Kent DA2 6SL
  United Kingdom | Colomycin injekce 1 0 00  000 IU | 1 0 00  000 I.U. | powder for solution for injection/infusion or nebuliser solution | intravenous use,
  inhalation use |
| Denmark | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin | 1 0 00  000 I.U. | nebuliser solution | inhalation use |
| Denmark | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin | 1 0 0 00  000I.U. | powder for solution for infusion | intravenous use |
| Denmark | Xellia Pharmaceuticals ApS Dalslandsgade 11
  DK-2300
  Copenhagen S
  Denmark | Colistimethatnatrium ‘Xellia’ | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| France | Sanofi-Aventis France
  1-13 boulevard R. Rolland
  75014 Paris
  France | COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur | 1 0 00  000 I.U. | powder and solvent for nebuliser solution | inhalation use |
| France | Sanofi-Aventis France
  1-13 boulevard R. Rolland
  75014 Paris
  France | COLIMYCINE 1 0 00  000 U.I., poudre et solvant pour solution injectable | 1 0 00  000 I.U. | powder and solvent for solution for injection | intravenous use |
| France | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | TADIM 1 million d'unités internationales (UI) poudre pour solution pour inhalation par nébuliseur | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Germany | Forest Laboratories Nederland B.V.
  Newtonlaan 115
  3584 BH Utrecht
  The Netherlands | Colistin CF | 1 0 00  000 I.U. | powder and solvent for nebuliser solution | inhalation use |
| Germany | InfectoPharm Arzneimittel und Consilium GmbH
  Von-Humboldt-Straße 1
  64646
  Heppenheim
  Germany | Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektions- oder Infusionslösung | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| Germany | InfectoPharm Arzneimittel und Consilium GmbH
  Von-Humboldt-Straße 1
  64646 Heppenheim
  Germany | Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektions- oder Infusionslösung | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| Germany | Profile Pharma Limited Bicentennial Building
  Southern Gate
  Chichester
  PO19 8EZ
  United Kingdom | Promixin 1 MI.E. Pulver zur Herstellung einer Lösung für einen Vernebler | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Germany | Profile Pharma Limited
  Bicentennial Building
  Southern Gate
  Chichester
  PO19 8EZ
  United Kingdom | Promixin 1 MI.E. Pulver zur Herstellung einer Lösung für einer Infusionslösung | 1 0 00  000 I.U. | powder for solution for infusion | intravenous use |
| Greece | NORMA HELLAS AE
  54 Menandrou str
  10431 Athens
  Greece | COLISTIN/NORMA | 1 0 00  000 I.U. | powder for solution for injection | intramuscular use |
| Greece | NORMA HELLAS AE
  54 Menandrou str
  10431 Athens
  Greece | COLISTIN/NORMA | 1 0 00  000 I.U. | powder and solvent for nebuliser solution | inhalation use |
| Greece | NORMA HELLAS AE
  54 Menandrou str
  10431 Athens
  Greece | COLISTIN/NORMA | 1 0 00  000 I.U. | powder for solution for infusion | intravenous use |
| Greece | NORMA HELLAS AE
  54 Menandrou str
  10431 Athens
  Greece | COLISTIN/NORMA | 2 0 00  000 I.U. | powder for solution for infusion | intravenous use |
| Greece | ALLERTEC HELLAS AE
  74 Karamanli str.
  55134, Kalamaria, Thessaloniki
  Greece | TADIM | 1 0 00  000 I.U. | powder and solvent for nebuliser solution | inhalation use |
| Hungary | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park Dartford, Kent
  DA2 6SL
  United Kingdom | COLOMYCIN | 1 0 00  000 I.U. | powder for solution for injection/infusion,
  powder for nebuliser solution | intravenous use,
  inhalation use |
| Hungary | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford, Kent
  DA2 6SL
  United Kingdom | COLOMYCIN | 2 0 00  000 I.U. | powder for solution for injection/infusion,
  powder for nebuliser solution | intravenous use,
  inhalation use |
| Iceland | Alvogen IPCo S.à.r.l.,
  5 Rue Heienhaff,
  L-1736
  Senningerberg
  Luxembourg | Colistimethate Alvogen | 1 0 00  000 I.U. | powder for solution for injection or infusion | intravenous use |
| Iceland | Alvogen IPCo S.à.r.l.,
  5 Rue Heienhaff,
  L-1736
  Senningerberg
  Luxembourg | Colistimethate Alvogen | 2 0 00  000 I.U. | powder for solution for injection or infusion | intravenous use |
| Ireland | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford, Kent
  DA2 6SL
  United Kingdom | Colomycin Injection 1 million International Units.
  Powder for solution for injection, infusion or inhalation | 1 0 00  000 I.U. | powder for solution for injection, infusion or inhalation | intravenous use,
  inhalation use |
| Ireland | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford, Kent
  DA2 6SL
  United Kingdom | Colomycin Injection 2 million International Units.
  Powder for solution for injection, infusion or inhalation | 2 0 00  000 I.U. | powder for solution for injection, infusion or inhalation | intravenous use,
  inhalation use |
| Ireland | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin, 1 million International Units (IU), Powder for Nebuliser Solution | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Italy | UCB Pharma S.p.A. Via Gadames
  5720151 —
  Milano (MI)
  Italy | COLIMICINA | 1 0 00  000 I.U. | powder and solvent for solution for injection | intramuscular use |
| Italy | PARI Pharma GmbH
  Moosstrasse 3
  82319 Starnberg
  Germany | COLFINAIR | 1 0 00  0000 I.U. | powder for nebuliser solution | inhalation use |
| Italy | PARI Pharma GmbH
  Moosstrasse 3
  82319 Starnberg
  Germany | COLFINAIR | 2 0 00  000 I.U. | powder for nebuliser solution | Inhalation use |
| Italy | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | PROMIXIN | 1 0 0 00  000 I.U. | powder for nebuliser solution | Inhalation use |
| Luxembourg | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Tadim | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Malta | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford, Kent
  DA2 6SL
  United Kingdom | Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation | 1 0 00  000 I.U. | powder for solution for injection/infusion/inhalation | intravenous use,
  inhalation use |
| Norway | Xellia Pharmaceuticals ApS
  Dalslandsgade 11
  DK-2300 Copenhagen S
  Denmark | Colistimethate Xellia | 1 0 00  000 I.U. | powder for solution for infusion | intravenous use |
| Norway | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin | 1 0 00  000 I.U. | powder for nebuliser solution | nasal use |
| Norway | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin | 1 0 00  000 I.U. | powder for solution for infusion | intravenous use |
| Poland | Tarchomińskie Zakłady Farmaceutyczne ‘Polfa’ S.A.
  2, A. Fleminga Str.
  03-176 Warsaw
  Poland | Colistin TZF | 1 0 00  000 I.U. | powder for solution for injection, injection or inhalation | intramuscular use,
  intravenous use,
  inhalation use |
| Poland | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus 19
  2700-487 Amadora
  Portugal | Colistina Generis | 1 0 00  000 I.U. | powder for solution for injection or for nebuliser solution | intravenous use,
  inhalation use |
| Portugal | Pharmis Biofarmacêutica, Lda.
  Praceta do Farol, lote 101
  Cascais 2750-341
  Portugal | Colixin | 2 0 00  000 I.U. | powder for solution for injection or for nebuliser solution | intravenous use,
  inhalation use |
| Portugal | Pharmis Biofarmacêutica, Lda.
  Praceta do Farol, lote 101
  Cascais 2750-341
  Portugal | Colixin | 1 0 00  000 I.U. | powder for solution for injection or for nebuliser solution | intravenous use,
  inhalation use |
| Portugal | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Romania | S.C. ANTIBIOTICE S.A.,
  Str. Valea Lupului nr. 1
  707410 Iaşi
  România | COLISTINĂ ANTIBIOTICE
  1 0 00  000 UI, | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| Romania | Xellia Pharmaceuticals ApS
  Dalslandsgade 11
  DK-2300 Copenhagen S
  Denmark | Colistimetat sodic Xellia 1 milion unităţi internaţionale (U.I.) | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| Slovak Republic | Sanofi-Aventis Slovakia s.r.o.
  Einsteinova 24
  851 01 Bratislava
  Slovak Republic | Colimycine | 1 0 00  000 I.U. | powder for solution for injection | intravenous use,
  intramuscular use |
| Slovak Republic | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford, Kent DA2 6SL
  United Kingdom | KOLOMYCÍN INJEKCIA 1 milión IU | 1 0 00  000 I.U. | powder for solution for injection/infusion/
  inhalation | intravenous use,
  inhalation use |
| Slovak Republic | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford, Kent DA2 6SL
  United Kingdom | KOLOMYCÍN INJEKCIA 2 milión IU | 2 0 00  000 I.U. | powder for solution for injection/infusion/
  inhalation | intravenous use,
  inhalation use |
| Spain | GES GENÉRICOS ESPAÑOLES LABORATORIO, S.A.
  Cólquide, 6 — Portal 2,
  1o-Oficina F
  28230 Las Rozas (Madrid)
  Spain | Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador | 1 0 00  000 I.U. | powder for solution for injection,
  powder for nebuliser solution | intravenous use,
  inhalation use |
| Spain | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin 1 millón de Unidades Internacionales (UI) polvo para solución para inhalación por nebulizador | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Spain | Pharmis Biofarmacêutica, Lda.
  Praceta do Farol, lote 101
  Cascais 2750-341
  Portugal | Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador | 1 0 00  000 I.U. | powder for solution for injection,
  powder for nebuliser solution | intravenous use,
  inhalation use |
| Sweden | Profile Pharma Limited
  Bicentennial Building
  Southern Gate
  Chichester
  West Sussex
  PO19 8EZ
  United Kingdom | Tadim | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| Sweden | Profile Pharma Limited
  Bicentennial Building
  Southern Gate
  Chichester
  West Sussex
  PO19 8EZ
  United Kingdom | Tadim | 1 0 00  000 I.U. | powder for solution for infusion | intravenous use |
| Sweden | Xellia Pharmaceuticals ApS
  Dalslandsgade 11
  DK-2300 Copenhagen S
  Denmark | Colistin Xellia | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| The Netherlands | Forest Pharma B.V.
  Newtonlaan 115
  3584 BH Utrecht
  The Netherlands | Colistin, poeder voor verneveloplossing met oplosmiddel 1.000.000 IE | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| United Kingdom | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford, Kent DA2 6SL
  United Kingdom | Colomycin Injection 2 million international units powder for solution for injection, infusion or inhalation | 2 0 00  000 I.U. | powder for solution for injection | intravenous use |
| United Kingdom | Forest Laboratories UK Limited Riverbridge House
  Anchor Boulevard
  Crossways Business Park
  Dartford, Kent DA2 6SL
  United Kingdom | Colomycin Injection 1 million international units powder for solution for injection, infusion or inhalation | 1 0 00  000 I.U. | powder for solution for injection, infusion or inhalation | intramuscular use, intravenous use,
  inhalation use |
| United Kingdom | Xellia Pharmaceuticals ApS
  Dalslandsgade 11
  DK-2300 Copenhagen S
  Denmark | Colistimethate sodium 1 million international units powder for solution for injection or infusion | 1 0 00  000 I.U. | powder for solution for injection/infusion | intravenous use |
| United Kingdom | Beacon Pharmaceuticals Limited,
  Tunbridge Wells, Kent
  TN1 1YG
  United Kingdom | Colistimethate sodium 1 million I.U. powder for solution for injection | 1 0 00  000 I.U. | powder for solution for injection | intravenous use,
  inhalation use |
| United Kingdom | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin 1 million international units (IU) powder for nebuliser solution | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| United Kingdom | Profile Pharma Limited
  Chichester Business Park
  City Fields Way
  Tangmere, Chichester
  West Sussex
  PO20 2FT
  United Kingdom | Promixin 1 million international units (IU) powder for solution for infusion | 1 0 00  000 I.U. | powder for solution for injection | intramuscular use,
  intravenous use |
| United Kingdom | PARI Pharma GmbH
  Moosstrasse 3
  82319 Starnberg
  Germany | Colifin 1 MIU powder for nebuliser solutions | 1 0 00  000 I.U. | powder for nebuliser solution | inhalation use |
| United Kingdom | PARI Pharma GmbH
  Moosstrasse 3
  82319 Starnberg
  Germany | Colifin 2 MIU powder for nebuliser solutions | 2 0 00  000 I.U. | powder for nebuliser solution | inhalation use |

Member State

(in EEA)

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Forest Pharma B.V.

Newtonlaan 115

3584 BH Utrecht

The Netherlands

Colistin Forest — Trockenstechampullen mit Lösungsmittel

1 0 00  000 I.U.

powder and solvent for suspension for injection, nebuliser solution

intramuscular use,

intravenous use,

inhalation use

Austria

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung

1 0 00  000 I.U.

powder for solution for infusion

intravenous use

Austria

Xellia Pharmaceuticals ApS

Dalslandsgade 11

DK-2300 Copenhagen S

Denmark

Colistin Xellia 1 Million I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

Austria

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Tadim 1 Million I.E. Pulver zur Herstellung einer Lösung für einen Vernebler

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Austria

PARI Pharma GmbH

Moosstrasse 3

82319 Starnberg

Germany

ColiFin 1 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Austria

PARI Pharma GmbH

Moosstrasse 3

82319 Starnberg

Germany

ColiFin 2 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler

2 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Belgium

Forest Laboratories UK Ltd.

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent DA2 6SL

United Kingdom

Colistineb 1 0 00  000 IE

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use,

inhalation use

Belgium

Forest Laboratories UK Ltd. Riverbridge House

Anchor Boulevard

Crossways Business Park Dartford

Kent DA2 6SL

United Kingdom

Colistineb 2 0 00  000 IE

2 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use,

inhalation use

Bulgaria

Alvogen IPCo.S.ar. I.

5 Rue Heienhaff

Senningerberg

L-1736

Luxembourg

Colistin Alvogen

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

Bulgaria

Alvogen IPCo.S.ar. I.

5 Rue Heienhaff

Senningerberg

L-1736

Luxembourg

Colistin Alvogen

2 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

Croatia

Altamedics d.o.o.

Karlovačka cesta 24a, Zagreb

10020

Croatia

Colixin 1 milijun IU prašak za otopinu za injekciju

1 0 00  000 I.U.

powder for solution for injection

intravenous use

Czech Republic

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent DA2 6SL

United Kingdom

Colomycin injekce 1 0 00  000 IU

1 0 00  000 I.U.

powder for solution for injection/infusion or nebuliser solution

intravenous use,

inhalation use

Denmark

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin

1 0 00  000 I.U.

nebuliser solution

inhalation use

Denmark

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin

1 0 0 00  000I.U.

powder for solution for infusion

intravenous use

Denmark

Xellia Pharmaceuticals ApS Dalslandsgade 11

DK-2300

Copenhagen S

Denmark

Colistimethatnatrium ‘Xellia’

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

France

Sanofi-Aventis France

1-13 boulevard R. Rolland

75014 Paris

France

COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur

1 0 00  000 I.U.

powder and solvent for nebuliser solution

inhalation use

France

Sanofi-Aventis France

1-13 boulevard R. Rolland

75014 Paris

France

COLIMYCINE 1 0 00  000 U.I., poudre et solvant pour solution injectable

1 0 00  000 I.U.

powder and solvent for solution for injection

intravenous use

France

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

TADIM 1 million d'unités internationales (UI) poudre pour solution pour inhalation par nébuliseur

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Germany

Forest Laboratories Nederland B.V.

Newtonlaan 115

3584 BH Utrecht

The Netherlands

Colistin CF

1 0 00  000 I.U.

powder and solvent for nebuliser solution

inhalation use

Germany

InfectoPharm Arzneimittel und Consilium GmbH

Von-Humboldt-Straße 1

64646

Heppenheim

Germany

Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektions- oder Infusionslösung

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

Germany

InfectoPharm Arzneimittel und Consilium GmbH

Von-Humboldt-Straße 1

64646 Heppenheim

Germany

Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektions- oder Infusionslösung

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

Germany

Profile Pharma Limited Bicentennial Building

Southern Gate

Chichester

PO19 8EZ

United Kingdom

Promixin 1 MI.E. Pulver zur Herstellung einer Lösung für einen Vernebler

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Germany

Profile Pharma Limited

Bicentennial Building

Southern Gate

Chichester

PO19 8EZ

United Kingdom

Promixin 1 MI.E. Pulver zur Herstellung einer Lösung für einer Infusionslösung

1 0 00  000 I.U.

powder for solution for infusion

intravenous use

Greece

NORMA HELLAS AE

54 Menandrou str

10431 Athens

Greece

COLISTIN/NORMA

1 0 00  000 I.U.

powder for solution for injection

intramuscular use

Greece

NORMA HELLAS AE

54 Menandrou str

10431 Athens

Greece

COLISTIN/NORMA

1 0 00  000 I.U.

powder and solvent for nebuliser solution

inhalation use

Greece

NORMA HELLAS AE

54 Menandrou str

10431 Athens

Greece

COLISTIN/NORMA

1 0 00  000 I.U.

powder for solution for infusion

intravenous use

Greece

NORMA HELLAS AE

54 Menandrou str

10431 Athens

Greece

COLISTIN/NORMA

2 0 00  000 I.U.

powder for solution for infusion

intravenous use

Greece

ALLERTEC HELLAS AE

74 Karamanli str.

55134, Kalamaria, Thessaloniki

Greece

TADIM

1 0 00  000 I.U.

powder and solvent for nebuliser solution

inhalation use

Hungary

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park Dartford, Kent

DA2 6SL

United Kingdom

COLOMYCIN

1 0 00  000 I.U.

powder for solution for injection/infusion,

powder for nebuliser solution

intravenous use,

inhalation use

Hungary

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford, Kent

DA2 6SL

United Kingdom

COLOMYCIN

2 0 00  000 I.U.

powder for solution for injection/infusion,

powder for nebuliser solution

intravenous use,

inhalation use

Iceland

Alvogen IPCo S.à.r.l.,

5 Rue Heienhaff,

L-1736

Senningerberg

Luxembourg

Colistimethate Alvogen

1 0 00  000 I.U.

powder for solution for injection or infusion

intravenous use

Iceland

Alvogen IPCo S.à.r.l.,

5 Rue Heienhaff,

L-1736

Senningerberg

Luxembourg

Colistimethate Alvogen

2 0 00  000 I.U.

powder for solution for injection or infusion

intravenous use

Ireland

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford, Kent

DA2 6SL

United Kingdom

Colomycin Injection 1 million International Units.

Powder for solution for injection, infusion or inhalation

1 0 00  000 I.U.

powder for solution for injection, infusion or inhalation

intravenous use,

inhalation use

Ireland

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford, Kent

DA2 6SL

United Kingdom

Colomycin Injection 2 million International Units.

Powder for solution for injection, infusion or inhalation

2 0 00  000 I.U.

powder for solution for injection, infusion or inhalation

intravenous use,

inhalation use

Ireland

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin, 1 million International Units (IU), Powder for Nebuliser Solution

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Italy

UCB Pharma S.p.A. Via Gadames

5720151 —

Milano (MI)

Italy

COLIMICINA

1 0 00  000 I.U.

powder and solvent for solution for injection

intramuscular use

Italy

PARI Pharma GmbH

Moosstrasse 3

82319 Starnberg

Germany

COLFINAIR

1 0 00  0000 I.U.

powder for nebuliser solution

inhalation use

Italy

PARI Pharma GmbH

Moosstrasse 3

82319 Starnberg

Germany

COLFINAIR

2 0 00  000 I.U.

powder for nebuliser solution

Inhalation use

Italy

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

PROMIXIN

1 0 0 00  000 I.U.

powder for nebuliser solution

Inhalation use

Luxembourg

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Tadim

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Malta

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford, Kent

DA2 6SL

United Kingdom

Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation

1 0 00  000 I.U.

powder for solution for injection/infusion/inhalation

intravenous use,

inhalation use

Norway

Xellia Pharmaceuticals ApS

Dalslandsgade 11

DK-2300 Copenhagen S

Denmark

Colistimethate Xellia

1 0 00  000 I.U.

powder for solution for infusion

intravenous use

Norway

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin

1 0 00  000 I.U.

powder for nebuliser solution

nasal use

Norway

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin

1 0 00  000 I.U.

powder for solution for infusion

intravenous use

Poland

Tarchomińskie Zakłady Farmaceutyczne ‘Polfa’ S.A.

2, A. Fleminga Str.

03-176 Warsaw

Poland

Colistin TZF

1 0 00  000 I.U.

powder for solution for injection, injection or inhalation

intramuscular use,

intravenous use,

inhalation use

Poland

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus 19

2700-487 Amadora

Portugal

Colistina Generis

1 0 00  000 I.U.

powder for solution for injection or for nebuliser solution

intravenous use,

inhalation use

Portugal

Pharmis Biofarmacêutica, Lda.

Praceta do Farol, lote 101

Cascais 2750-341

Portugal

Colixin

2 0 00  000 I.U.

powder for solution for injection or for nebuliser solution

intravenous use,

inhalation use

Portugal

Pharmis Biofarmacêutica, Lda.

Praceta do Farol, lote 101

Cascais 2750-341

Portugal

Colixin

1 0 00  000 I.U.

powder for solution for injection or for nebuliser solution

intravenous use,

inhalation use

Portugal

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Romania

S.C. ANTIBIOTICE S.A.,

Str. Valea Lupului nr. 1

707410 Iaşi

România

COLISTINĂ ANTIBIOTICE

1 0 00  000 UI,

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

Romania

Xellia Pharmaceuticals ApS

Dalslandsgade 11

DK-2300 Copenhagen S

Denmark

Colistimetat sodic Xellia 1 milion unităţi internaţionale (U.I.)

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

Slovak Republic

Sanofi-Aventis Slovakia s.r.o.

Einsteinova 24

851 01 Bratislava

Slovak Republic

Colimycine

1 0 00  000 I.U.

powder for solution for injection

intravenous use,

intramuscular use

Slovak Republic

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford, Kent DA2 6SL

United Kingdom

KOLOMYCÍN INJEKCIA 1 milión IU

1 0 00  000 I.U.

powder for solution for injection/infusion/

inhalation

intravenous use,

inhalation use

Slovak Republic

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford, Kent DA2 6SL

United Kingdom

KOLOMYCÍN INJEKCIA 2 milión IU

2 0 00  000 I.U.

powder for solution for injection/infusion/

inhalation

intravenous use,

inhalation use

Spain

GES GENÉRICOS ESPAÑOLES LABORATORIO, S.A.

Cólquide, 6 — Portal 2,

1o-Oficina F

28230 Las Rozas (Madrid)

Spain

Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador

1 0 00  000 I.U.

powder for solution for injection,

powder for nebuliser solution

intravenous use,

inhalation use

Spain

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin 1 millón de Unidades Internacionales (UI) polvo para solución para inhalación por nebulizador

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Spain

Pharmis Biofarmacêutica, Lda.

Praceta do Farol, lote 101

Cascais 2750-341

Portugal

Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador

1 0 00  000 I.U.

powder for solution for injection,

powder for nebuliser solution

intravenous use,

inhalation use

Sweden

Profile Pharma Limited

Bicentennial Building

Southern Gate

Chichester

West Sussex

PO19 8EZ

United Kingdom

Tadim

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

Sweden

Profile Pharma Limited

Bicentennial Building

Southern Gate

Chichester

West Sussex

PO19 8EZ

United Kingdom

Tadim

1 0 00  000 I.U.

powder for solution for infusion

intravenous use

Sweden

Xellia Pharmaceuticals ApS

Dalslandsgade 11

DK-2300 Copenhagen S

Denmark

Colistin Xellia

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

The Netherlands

Forest Pharma B.V.

Newtonlaan 115

3584 BH Utrecht

The Netherlands

Colistin, poeder voor verneveloplossing met oplosmiddel 1.000.000 IE

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

United Kingdom

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford, Kent DA2 6SL

United Kingdom

Colomycin Injection 2 million international units powder for solution for injection, infusion or inhalation

2 0 00  000 I.U.

powder for solution for injection

intravenous use

United Kingdom

Forest Laboratories UK Limited Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford, Kent DA2 6SL

United Kingdom

Colomycin Injection 1 million international units powder for solution for injection, infusion or inhalation

1 0 00  000 I.U.

powder for solution for injection, infusion or inhalation

intramuscular use, intravenous use,

inhalation use

United Kingdom

Xellia Pharmaceuticals ApS

Dalslandsgade 11

DK-2300 Copenhagen S

Denmark

Colistimethate sodium 1 million international units powder for solution for injection or infusion

1 0 00  000 I.U.

powder for solution for injection/infusion

intravenous use

United Kingdom

Beacon Pharmaceuticals Limited,

Tunbridge Wells, Kent

TN1 1YG

United Kingdom

Colistimethate sodium 1 million I.U. powder for solution for injection

1 0 00  000 I.U.

powder for solution for injection

intravenous use,

inhalation use

United Kingdom

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin 1 million international units (IU) powder for nebuliser solution

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

United Kingdom

Profile Pharma Limited

Chichester Business Park

City Fields Way

Tangmere, Chichester

West Sussex

PO20 2FT

United Kingdom

Promixin 1 million international units (IU) powder for solution for infusion

1 0 00  000 I.U.

powder for solution for injection

intramuscular use,

intravenous use

United Kingdom

PARI Pharma GmbH

Moosstrasse 3

82319 Starnberg

Germany

Colifin 1 MIU powder for nebuliser solutions

1 0 00  000 I.U.

powder for nebuliser solution

inhalation use

United Kingdom

PARI Pharma GmbH

Moosstrasse 3

82319 Starnberg

Germany

Colifin 2 MIU powder for nebuliser solutions

2 0 00  000 I.U.

powder for nebuliser solution

inhalation use

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