# Official Journal C 123/25 A

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 123 |
| | |
| English edition | Information and Notices | Volume 5725 April 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 123

English edition

Information and Notices

Volume 5725 April 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 123/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2014 to 31 March 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2014/C 123/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2014 to 31 March 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 8 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 123/01

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

2014/C 123/02

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

8

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 25.4.2014 | EN | Official Journal of the European Union | C 123/1 |
| --- | --- | --- | --- |

25.4.2014

EN

Official Journal of the European Union

C 123/1

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

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

2014/C 123/01

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.3.2014 | Sirturo | bedaquiline | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/901 | Tablet | J04A | 7.3.2014 |
| 21.3.2014 | Cometriq | cabozantinib | TMC Pharma Services Ltd.
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/13/890 | Capsule, hard | Pending | 26.3.2014 |
| 21.3.2014 | Eperzan | albiglutide | GlaxoSmithKline Trading Services Limited
  6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | EU/1/13/908 | Powder and solvent for solution for injection | A10BX13 | 26.3.2014 |
| 21.3.2014 | Latuda | lurasidone | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/913 | Film-coated tablet | N05AE05 | 27.3.2014 |
| 27.3.2014 | Adempas | riociguat | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/907 | Film-coated tablet | C02KX05 | 31.3.2014 |
| 27.3.2014 | Bemfola | follitropin alfa | FINOX Biotech AG
  Gärten 71 FL-9496 Balzers Liechtenstein | EU/1/13/909 | Solution for injection in pre-filled pen | G03GA05 | 31.3.2014 |
| 27.3.2014 | Zoledronic acid Teva Generics | Zoledronic Acid | Teva Generics B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/912 | Solution for infusion | M05BA08 | 1.4.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

5.3.2014

Sirturo

bedaquiline

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/901

Tablet

J04A

7.3.2014

21.3.2014

Cometriq

cabozantinib

TMC Pharma Services Ltd.

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/13/890

Capsule, hard

Pending

26.3.2014

21.3.2014

Eperzan

albiglutide

GlaxoSmithKline Trading Services Limited

6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland

EU/1/13/908

Powder and solvent for solution for injection

A10BX13

26.3.2014

21.3.2014

Latuda

lurasidone

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/913

Film-coated tablet

N05AE05

27.3.2014

27.3.2014

Adempas

riociguat

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/907

Film-coated tablet

C02KX05

31.3.2014

27.3.2014

Bemfola

follitropin alfa

FINOX Biotech AG

Gärten 71 FL-9496 Balzers Liechtenstein

EU/1/13/909

Solution for injection in pre-filled pen

G03GA05

31.3.2014

27.3.2014

Zoledronic acid Teva Generics

Zoledronic Acid

Teva Generics B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/912

Solution for infusion

M05BA08

1.4.2014

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 21.3.2014 | Winfuran | Toray International U.K. Limited
  Verulam Gardens, 70 Gray’s Inn Road, London, WC1X 8NH, United Kingdom | — | 25.3.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

21.3.2014

Winfuran

Toray International U.K. Limited

Verulam Gardens, 70 Gray’s Inn Road, London, WC1X 8NH, United Kingdom

—

25.3.2014

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.3.2014 | Opatanol | Alcon Laboratories (UK) Ltd.
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/02/217 | 5.3.2014 |
| 3.3.2014 | Peyona | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/09/528 | 5.3.2014 |
| 3.3.2014 | Sildenafil Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/09/595 | 5.3.2014 |
| 5.3.2014 | Azopt | Alcon Laboratories (UK) Ltd.
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/00/129 | 10.3.2014 |
| 5.3.2014 | Emadine | Alcon Laboratories (UK) Ltd.
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/98/095 | 10.3.2014 |
| 5.3.2014 | Forxiga | Bristol-Myers Squibb/AstraZeneca EEIG
  Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/12/795 | 7.3.2014 |
| 5.3.2014 | IntronA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/127 | 7.3.2014 |
| 5.3.2014 | Tasmar | Meda AB
  Pipers väg 2A, S-170 09 Solna, Sverige | EU/1/97/044 | 7.3.2014 |
| 10.3.2014 | Osigraft | Olympus Biotech International Limited
  Block 2, International Science Centre, National Technology Park, Castletroy, Limerick, Ireland | EU/1/01/179 | 12.3.2014 |
| 10.3.2014 | Pedea | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/04/284 | 12.3.2014 |
| 10.3.2014 | Ruconest | Pharming Group N.V.
  Darwinweg 24, NL-2333 CR Leiden, Nederland | EU/1/10/641 | 12.3.2014 |
| 12.3.2014 | Qutenza | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/09/524 | 14.3.2014 |
| 12.3.2014 | Tyverb | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/440 | 14.3.2014 |
| 12.3.2014 | Vibativ | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/11/705 | 14.3.2014 |
| 14.3.2014 | Cialis | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/02/237 | 18.3.2014 |
| 14.3.2014 | Pandemrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/08/452 | 18.3.2014 |
| 14.3.2014 | Zevalin | Spectrum Pharmaceuticals B.V.
  Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland | EU/1/03/264 | 18.3.2014 |
| 21.3.2014 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412 | 26.3.2014 |
| 21.3.2014 | Binocrit | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/07/410 | 26.3.2014 |
| 21.3.2014 | Ceplene | Meda AB
  Box 906, SE-170 09 Solna, Sverige | EU/1/08/477 | 26.3.2014 |
| 21.3.2014 | Clopidogrel Acino | Acino AG
  Am Windfeld 35, 83714 Miesbach, Deutschland | EU/1/09/532 | 26.3.2014 |
| 21.3.2014 | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/11/733 | 26.3.2014 |
| 21.3.2014 | DuoTrav | Alcon Laboratories (UK) Ltd.
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/06/338 | 25.3.2014 |
| 21.3.2014 | ellaOne | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/09/522 | 26.3.2014 |
| 21.3.2014 | Elonva | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/609 | 25.3.2014 |
| 21.3.2014 | Entacapone Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/10/665 | 25.3.2014 |
| 21.3.2014 | Epoetin alfa Hexal | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411 | 26.3.2014 |
| 21.3.2014 | Mabthera | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/067 | 26.3.2014 |
| 21.3.2014 | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 25.3.2014 |
| 21.3.2014 | Renvela | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/09/521 | 26.3.2014 |
| 21.3.2014 | Replagal | Shire Human Genetic Therapies AB
  Svärdvägen 11D, SE-182 33 Danderyd, Sverige | EU/1/01/189 | 26.3.2014 |
| 21.3.2014 | Soliris | Alexion Europe SAS
  25 boulevard de l'Amiral Bruix, F-75016 Paris, France | EU/1/07/393 | 28.3.2014 |
| 21.3.2014 | TachoSil | Takeda Austria GmbH
  St.-Peter-Strasse 25, A-4020 Linz, Österreich | EU/1/04/277 | 25.3.2014 |
| 21.3.2014 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/11/697 | 25.3.2014 |
| 21.3.2014 | Vedrop | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/09/533 | 26.3.2014 |
| 21.3.2014 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 25.3.2014 |
| 21.3.2014 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 25.3.2014 |
| 21.3.2014 | Ziagen | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/99/112 | 26.3.2014 |
| 27.3.2014 | Altargo | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/390 | 31.3.2014 |
| 27.3.2014 | Gardasil | Sanofi Pasteur MSD, SNC
  8 rue Jonas Salk, F-69007 Lyon, France | EU/1/06/357 | 31.3.2014 |
| 27.3.2014 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 31.3.2014 |
| 31.3.2014 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH
  Fehlandtstraße 3, D-20354 Hamburg, Deutschland | EU/1/09/605 | 2.4.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.3.2014

Opatanol

Alcon Laboratories (UK) Ltd.

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

EU/1/02/217

5.3.2014

3.3.2014

Peyona

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/09/528

5.3.2014

3.3.2014

Sildenafil Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/09/595

5.3.2014

5.3.2014

Azopt

Alcon Laboratories (UK) Ltd.

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

EU/1/00/129

10.3.2014

5.3.2014

Emadine

Alcon Laboratories (UK) Ltd.

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

EU/1/98/095

10.3.2014

5.3.2014

Forxiga

Bristol-Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/12/795

7.3.2014

5.3.2014

IntronA

Merck Sharp & Dohme Limited

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

EU/1/99/127

7.3.2014

5.3.2014

Tasmar

Meda AB

Pipers väg 2A, S-170 09 Solna, Sverige

EU/1/97/044

7.3.2014

10.3.2014

Osigraft

Olympus Biotech International Limited

Block 2, International Science Centre, National Technology Park, Castletroy, Limerick, Ireland

EU/1/01/179

12.3.2014

10.3.2014

Pedea

Orphan Europe S.A.R.L.

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

EU/1/04/284

12.3.2014

10.3.2014

Ruconest

Pharming Group N.V.

Darwinweg 24, NL-2333 CR Leiden, Nederland

EU/1/10/641

12.3.2014

12.3.2014

Qutenza

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/09/524

14.3.2014

12.3.2014

Tyverb

Glaxo Group Ltd

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

EU/1/07/440

14.3.2014

12.3.2014

Vibativ

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

EU/1/11/705

14.3.2014

14.3.2014

Cialis

Eli Lilly Nederland B.V.

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

EU/1/02/237

18.3.2014

14.3.2014

Pandemrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/08/452

18.3.2014

14.3.2014

Zevalin

Spectrum Pharmaceuticals B.V.

Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland

EU/1/03/264

18.3.2014

21.3.2014

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412

26.3.2014

21.3.2014

Binocrit

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/07/410

26.3.2014

21.3.2014

Ceplene

Meda AB

Box 906, SE-170 09 Solna, Sverige

EU/1/08/477

26.3.2014

21.3.2014

Clopidogrel Acino

Acino AG

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/532

26.3.2014

21.3.2014

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/11/733

26.3.2014

21.3.2014

DuoTrav

Alcon Laboratories (UK) Ltd.

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

EU/1/06/338

25.3.2014

21.3.2014

ellaOne

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/09/522

26.3.2014

21.3.2014

Elonva

Merck Sharp & Dohme Limited

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

EU/1/09/609

25.3.2014

21.3.2014

Entacapone Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/665

25.3.2014

21.3.2014

Epoetin alfa Hexal

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411

26.3.2014

21.3.2014

Mabthera

Roche Registration Limited

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

EU/1/98/067

26.3.2014

21.3.2014

Nexium Control

Pfizer Consumer Healthcare Limited

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

EU/1/13/860

25.3.2014

21.3.2014

Renvela

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/521

26.3.2014

21.3.2014

Replagal

Shire Human Genetic Therapies AB

Svärdvägen 11D, SE-182 33 Danderyd, Sverige

EU/1/01/189

26.3.2014

21.3.2014

Soliris

Alexion Europe SAS

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

EU/1/07/393

28.3.2014

21.3.2014

TachoSil

Takeda Austria GmbH

St.-Peter-Strasse 25, A-4020 Linz, Österreich

EU/1/04/277

25.3.2014

21.3.2014

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/11/697

25.3.2014

21.3.2014

Vedrop

Orphan Europe S.A.R.L.

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

EU/1/09/533

26.3.2014

21.3.2014

Victrelis

Merck Sharp & Dohme Limited

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

EU/1/11/704

25.3.2014

21.3.2014

XALKORI

Pfizer Limited

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

EU/1/12/793

25.3.2014

21.3.2014

Ziagen

ViiV Healthcare UK Limited

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

EU/1/99/112

26.3.2014

27.3.2014

Altargo

Glaxo Group Ltd

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

EU/1/07/390

31.3.2014

27.3.2014

Gardasil

Sanofi Pasteur MSD, SNC

8 rue Jonas Salk, F-69007 Lyon, France

EU/1/06/357

31.3.2014

27.3.2014

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

31.3.2014

31.3.2014

Temomedac

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstraße 3, D-20354 Hamburg, Deutschland

EU/1/09/605

2.4.2014

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.3.2014 | Equisolon | Prednisolone | Le Vet B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/14/161 | Oral powder | QH02AB06 | 14.3.2014 |
| 12.3.2014 | Fungitraxx | Itraconazole | Avimedical B.V.
  Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland | EU/2/13/160 | Oral solution | QJ02AC02 | 17.3.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

12.3.2014

Equisolon

Prednisolone

Le Vet B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/14/161

Oral powder

QH02AB06

14.3.2014

12.3.2014

Fungitraxx

Itraconazole

Avimedical B.V.

Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland

EU/2/13/160

Oral solution

QJ02AC02

17.3.2014

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 12.3.2014 | BTVPUR AlSap 8 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/09/094 | 14.3.2014 |
| 12.3.2014 | Loxicom | Norbrook Laboratories Ltd
  Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | EU/2/08/090 | 14.3.2014 |
| 12.3.2014 | RevitaCAM | Abbott Laboratories Ltd
  Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | EU/2/12/138 | 14.3.2014 |
| 14.3.2014 | Bovilis BTV8 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/10/106 | 18.3.2014 |
| 14.3.2014 | Panacur AquaSol | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/11/135 | 18.3.2014 |
| 31.3.2014 | Meloxidyl | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/06/070 | 2.4.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

12.3.2014

BTVPUR AlSap 8

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/09/094

14.3.2014

12.3.2014

Loxicom

Norbrook Laboratories Ltd

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090

14.3.2014

12.3.2014

RevitaCAM

Abbott Laboratories Ltd

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

EU/2/12/138

14.3.2014

14.3.2014

Bovilis BTV8

Intervet International B.V.

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

EU/2/10/106

18.3.2014

14.3.2014

Panacur AquaSol

Intervet International B.V.

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

EU/2/11/135

18.3.2014

31.3.2014

Meloxidyl

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/06/070

2.4.2014

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 |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK — LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK — LONDON E14 4H

---

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

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

---

| 25.4.2014 | EN | Official Journal of the European Union | C 123/8 |
| --- | --- | --- | --- |

25.4.2014

EN

Official Journal of the European Union

C 123/8

---

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

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

2014/C 123/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 5.3.2014 | Tibolona Aristo | See Annex I | See Annex I | See Annex I | 6.3.2014 |
| 21.3.2014 | Norbonex | See Annex II | See Annex II | See Annex II | 25.3.2014 |
| 10.3.2014 | Valebo | See Annex III | See Annex III | See Annex III | 11.3.2014 |
| 5.3.2014 | Tibocina | See Annex IV | See Annex IV | See Annex IV | 6.3.2014 |
| 21.3.2014 | Rocephin | See Annex V | See Annex V | See Annex V | 25.3.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

5.3.2014

Tibolona Aristo

See Annex I

See Annex I

See Annex I

6.3.2014

21.3.2014

Norbonex

See Annex II

See Annex II

See Annex II

25.3.2014

10.3.2014

Valebo

See Annex III

See Annex III

See Annex III

11.3.2014

5.3.2014

Tibocina

See Annex IV

See Annex IV

See Annex IV

6.3.2014

21.3.2014

Rocephin

See Annex V

See Annex V

See Annex V

25.3.2014

—   Refusal of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 28.3.2014 | Barium selenate | See Annex VI | See Annex VI | See Annex VI | 31.3.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

28.3.2014

Barium selenate

See Annex VI

See Annex VI

See Annex VI

31.3.2014

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 28.3.2014 | Barium selenate | See Annex VI | See Annex VI | See Annex VI | 31.3.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

28.3.2014

Barium selenate

See Annex VI

See Annex VI

See Annex VI

31.3.2014

---

(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.

---

ANNEX I

List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States

| Member State EU/EEA | Applicant
  company name, address | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Germany | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  D-13435 Berlin
  Germany | Tibolon Aristo | 2,5 mg | tablet | oral use |
| Spain | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  D-13435 Berlin
  Germany | Tibolona Aristo | 2,5 mg | tablet | oral use |

Member State EU/EEA

Applicant

company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Germany

Aristo Pharma GmbH

Wallenroder Str. 8-10

D-13435 Berlin

Germany

Tibolon Aristo

2,5 mg

tablet

oral use

Spain

Aristo Pharma GmbH

Wallenroder Str. 8-10

D-13435 Berlin

Germany

Tibolona Aristo

2,5 mg

tablet

oral use

---

ANNEX II

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States

| Member State EU/EEA | Applicant | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Germany | Norbrook Laboratories Limited
  Station Works
  Camlough Road
  Newry
  Co. Down
  BT35 6JP
  Northern Ireland | Norbonex 5 mg/ml Pour-On Solution
  for Beef and Dairy Cattle | Eprinomectin | 5 mg/ml | Pour-on solution | Cattle | Topical use |
| The Netherlands | Norbrook Laboratories Limited
  Station Works
  Camlough Road
  Newry
  Co. Down
  BT35 6JP
  Northern Ireland | Norbonex 5 mg/ml Pour-On Solution
  for Beef and Dairy Cattle | Eprinomectin | 5 mg/ml | Pour-on solution | Cattle | Topical use |
| United Kingdom | Norbrook Laboratories Limited
  Station Works
  Camlough Road
  Newry
  Co. Down
  BT35 6JP
  Northern Ireland | Norbonex 5 mg/ml Pour-On Solution
  for Beef and Dairy Cattle | Eprinomectin | 5 mg/ml | Pour-on solution | Cattle | Topical use |

Member State EU/EEA

Applicant

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Germany

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

Norbonex 5 mg/ml Pour-On Solution

for Beef and Dairy Cattle

Eprinomectin

5 mg/ml

Pour-on solution

Cattle

Topical use

The Netherlands

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

Norbonex 5 mg/ml Pour-On Solution

for Beef and Dairy Cattle

Eprinomectin

5 mg/ml

Pour-on solution

Cattle

Topical use

United Kingdom

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

Norbonex 5 mg/ml Pour-On Solution

for Beef and Dairy Cattle

Eprinomectin

5 mg/ml

Pour-on solution

Cattle

Topical use

---

ANNEX III

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

| Member State EU/EEA | Applicant
  company name, address | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Tevabone 70 mg Tabletten und 1
  Mikrogramm Weichkapseln | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Belgium | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Valebo 70 mg + 1 microgram
  Tabletten + capsules, zacht | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Bulgaria | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Teвабон 70 mg таблетки и 1
  микрограм меки капсули | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Denmark | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Tevabone | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| France | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Tevabone 70 mg et 1 microgramme, comprimé et capsule molle | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Germany | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Valebo 70 mg Tabletten und 1
  Mikrogramm Weichkapseln | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Hungary | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Tevabone 70 mg tabletta és 1
  mikrogramm lágy kapszula | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Ireland | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Teboneva 70 mg tablets and 1
  microgram capsules, soft | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Netherlands | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Tevabone 70 mg tabletten en 1
  microgram zachte capsules | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Portugal | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Tevabone | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Slovak Republic | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Tevabone 70 mg tablety a 1 mikrogram mäkké kapsuly | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Slovenia | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Valebo 70 mg tablete in 1
  mikrogram mehke kapsule v
  kombiniranem pakiranju | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| Spain | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Tevabone 70 mg comprimidos y 1
  mcg capsulas blandas | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |
| United Kingdom | TEVA Pharma B.V.
  Computerweg 10,
  3542DR Utrecht,
  The Netherlands | Valebo 70 mg + 1 microgram
  Tablets + Capsules, soft | 70 mg
  And
  1 mcg | Tablets
  And
  Capsules, Soft | Oral |

Member State EU/EEA

Applicant

company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Tevabone 70 mg Tabletten und 1

Mikrogramm Weichkapseln

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Belgium

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Valebo 70 mg + 1 microgram

Tabletten + capsules, zacht

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Bulgaria

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Teвабон 70 mg таблетки и 1

микрограм меки капсули

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Denmark

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Tevabone

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

France

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Tevabone 70 mg et 1 microgramme, comprimé et capsule molle

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Germany

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Valebo 70 mg Tabletten und 1

Mikrogramm Weichkapseln

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Hungary

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Tevabone 70 mg tabletta és 1

mikrogramm lágy kapszula

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Ireland

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Teboneva 70 mg tablets and 1

microgram capsules, soft

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Netherlands

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Tevabone 70 mg tabletten en 1

microgram zachte capsules

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Portugal

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Tevabone

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Slovak Republic

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Tevabone 70 mg tablety a 1 mikrogram mäkké kapsuly

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Slovenia

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Valebo 70 mg tablete in 1

mikrogram mehke kapsule v

kombiniranem pakiranju

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

Spain

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Tevabone 70 mg comprimidos y 1

mcg capsulas blandas

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

United Kingdom

TEVA Pharma B.V.

Computerweg 10,

3542DR Utrecht,

The Netherlands

Valebo 70 mg + 1 microgram

Tablets + Capsules, soft

70 mg

And

1 mcg

Tablets

And

Capsules, Soft

Oral

---

ANNEX IV

List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States

| Member State EU/EEA | Applicant
  company name, address | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  D-13435 Berlin
  Germany | Tibolinia | 2,5 mg | tablet | oral use |
| Germany | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  D-13435 Berlin
  Germany | Tibolon Aristo Doublette | 2,5 mg | tablet | oral use |
| Netherlands | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  D-13435 Berlin
  Germany | Tibolinia | 2,5 mg | tablet | oral use |
| Spain | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  D-13435 Berlin
  Germany | Tibocina | 2,5 mg | tablet | oral use |

Member State EU/EEA

Applicant

company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Belgium

Aristo Pharma GmbH

Wallenroder Str. 8-10

D-13435 Berlin

Germany

Tibolinia

2,5 mg

tablet

oral use

Germany

Aristo Pharma GmbH

Wallenroder Str. 8-10

D-13435 Berlin

Germany

Tibolon Aristo Doublette

2,5 mg

tablet

oral use

Netherlands

Aristo Pharma GmbH

Wallenroder Str. 8-10

D-13435 Berlin

Germany

Tibolinia

2,5 mg

tablet

oral use

Spain

Aristo Pharma GmbH

Wallenroder Str. 8-10

D-13435 Berlin

Germany

Tibocina

2,5 mg

tablet

oral use

---

ANNEX V

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States

| Member State
  EU/EEA | Marketing authorisation holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | N.V. Roche S.A.
  Rue Dante 75
  1070 Bruxelles
  Belgium | Rocephine | 2 g | Powder for solution for infusion | Intravenous use | 2 g |
| Belgium | N.V. Roche S.A.
  Rue Dante 75
  1070 Bruxelles
  Belgium | Rocephine | 1 g | Powder and solvent for solution for IM injection | Intramuscular use | 1 g |
| Belgium | N.V. Roche S.A.
  Rue Dante 75
  1070 Bruxelles
  Belgium | Rocephine | 1 g | Powder and solvent for solution for IV injection | Intravenous use | 1 g |
| Denmark | Roche a/s
  Industriholmen 59,
  DK-2650 Hvidovre,
  Danmark | Rocephalin | 2 g | Concentrate for solution for infusion | Intravenous use | 2 g |
| Denmark | Roche a/s
  Industriholmen 59,
  DK-2650 Hvidovre,
  Danmark | Rocephalin | 1 g | Powder and solvent for solution for injection | Intramuscular or intravenous use | 1 g |
| Denmark | Roche a/s
  Industriholmen 59,
  DK-2650 Hvidovre,
  Danmark | Rocephalin | 500 mg | Powder and solvent for solution for injection | Intramuscular or intravenous use | 500 mg |
| Finland | Roche Oy
  Klovinpellontie 3
  PL 12
  02181 Espoo
  Finland | Rocephalin cum lidocain | 1 g | Powder and solvent for solution for injection | Intramuscular use or intravenous use | 1 g |
| Finland | Roche Oy
  Klovinpellontie 3
  PL 12
  02181 Espoo
  Finland | Rocephalin cum lidocain | 500 mg | Powder and solvent for solution for injection | Intramuscular use or intravenous use | 500 mg |
| France | Roche
  52 Boulevard du Parc
  92521 NEUILLY SUR SEINE cedex
  France | Rocephine 1g/10 ml, powder and solvent for solution for injection (IV, SC) | 1 g/10 ml | Powder and solvent for solution for injection | Intravenous use or subcutaneous use | 1 g |
| France | Roche
  52 Boulevard du Parc
  92521 NEUILLY SUR SEINE cedex
  France | Rocephine 1 g/3.5 ml, powder and solvent for solution for injection (IM, SC) | 1 g/3.5 ml | Powder and solvent for solution for injection | Intramuscular use or subcutaneous use | 1 g |
| France | Roche
  52 Boulevard du Parc
  92521 NEUILLY SUR SEINE cedex
  France | Rocephine 500 mg/2ml, powder and solvent for solution for injection (IM, SC) | 500 mg/2 ml | Powder and solvent for solution for injection | Intramuscular use or subcutaneous use | 500 mg |
| France | Roche
  52 Boulevard du Parc
  92521 NEUILLY SUR SEINE cedex
  France | Rocephine 500 mg/5ml, powder and solvent for solution for injection (IV, SC) | 500 mg/5 ml | Powder and solvent for solution for injection | Intravenous use or subcutaneous use | 500 mg |
| Germany | Roche Pharma AG
  Emil-Barell-Str. 1
  79639 Grenzach-Wyhlen
  Germany | Rocephin zur Infusion 2 g | 2 g | Powder for solution for infusion | Intravenous use | 2 g |
| Germany | Roche Pharma AG
  Emil-Barell-Str. 1
  79639 Grenzach-Wyhlen
  Germany | Rocephin i.v. 1g | 1 g | Powder and solvent for solution for injection | Intravenous use | 1 g |
| Germany | Roche Pharma AG
  Emil-Barell-Str. 1
  79639 Grenzach-Wyhlen
  Germany | Rocephin 500 mg | 500 mg | Powder and solvent for solution for injection | Intramuscular or intravenous use | 500 mg |
| Greece | Roche (Hellas) SA
  4, Alamanas & Delfon Str.,
  Maroussi 15125,
  Attiki
  Greece | Rocephin | 2 g | Powder for solution for Infusion | Intravenous use | 2 g |
| Greece | Roche (Hellas) SA
  4, Alamanas & Delfon Str.,
  Maroussi 15125,
  Attiki
  Greece | Rocephin | 1 g | Powder and solvent for solution for Injection | intravenous use | 1 g |
| Greece | Roche (Hellas) SA
  4, Alamanas & Delfon Str.,
  Maroussi 15125,
  Attiki
  Greece | Rocephin | 1 g | Powder and solvent for solution for Injection | Intramuscular use | 1 g |
| Hungary | Roche (Hungary) Ltd.
  Edison utca 1
  Budaörs
  H-2040
  Hungary | Rocephin | 1 g | Powder and solvent for solution for injection | Intravenous use | 1000 mg |
| Hungary | Roche (Hungary) Ltd.
  Edison utca 1
  Budaörs
  H-2040
  Hungary | Rocephin | 500 mg | Powder and solvent for solution for injection | Intramuscular use | 500 mg |
| Hungary | Roche (Hungary) Ltd.
  Edison utca 1
  Budaörs
  H-2040
  Hungary | Rocephin | 250 mg | Powder and solvent for solution for injection | Intramuscular use | 250 mg |
| Iceland | Roche a/s
  Industriholmen 59,
  DK-2650 Hvidovre,
  Danmark | Rocephalin | 2 g | Concentrate for solution for infusion | Intravenous use | 2 g |
| Iceland | Roche a/s
  Industriholmen 59,
  DK-2650 Hvidovre,
  Danmark | Rocephalin | 1 g | Powder and solvent for solution for injection | Intramuscular or intravenous use | 1 g |
| Ireland | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Rocephin | 1 g | Powder for solution for injection or infusion | Intramuscular or intravenous use | 1 g |
| Ireland | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Rocephin | 1 g | Powder and solvent for solution for IM injection | Intramuscular use | 1 g |
| Italy | Roche S.p.A.
  Piazza Durante 11
  20131 Milano
  Italy | Rocefin | 2 g | Powder for solution for infusion | Intravenous use | 2 g |
| Italy | Roche S.p.A.
  Piazza Durante 11
  20131 Milano
  Italy | Rocefin | 1 g | Powder and solvent for solution for injection | intravenous use | 1 g |
| Italy | Roche S.p.A.
  Piazza Durante 11
  20131 Milano
  Italy | Rocefin | 1 g | Powder and solvent for solution for injection | Intramuscular use | 1 g |
| Italy | Roche S.p.A.
  Piazza Durante 11
  20131 Milano
  Italy | Rocefin | 500 mg | Powder and solvent for solution for injection | Intramuscular use | 500 mg |
| Italy | Roche S.p.A.
  Piazza Durante 11
  20131 Milano
  Italy | Rocefin | 250 mg | Powder and solvent for solution for injection | Intramuscular use | 250 mg |
| Latvia | Roche Latvija SIA
  8b G.Astras Street, Riga, LV1082,
  Latvia | Rocephin 1 g pulveris injekciju šķīduma pagatavošanai | 1 g | Powder for solution for injection | Intramuscular or intravenous use | 1 g |
| Luxembourg | N.V. Roche S.A.
  Rue Dante 75
  1070 Bruxelles
  Belgium | Rocephine | 2 g | Powder for solution for infusion | Intravenous use | 2 g |
| Luxembourg | N.V. Roche S.A.
  Rue Dante 75
  1070 Bruxelles
  Belgium | Rocephine | 1 g | Powder and solvent for solution for IV injection | Intravenous use | 1 g |
| Luxembourg | N.V. Roche S.A.
  Rue Dante 75
  1070 Bruxelles
  Belgium | Rocephine | 1 g | Powder and solvent for solution for IM injection | Intramuscular use | 1 g |
| Malta | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Rocephin | 2 g | Powder for solution for infusion | Intravenous use | 2 g |
| Malta | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Rocephin | 1 g | Powder for solution for injection | Intramuscular or intravenous use | 1 g |
| Malta | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Rocephin | 250 mg | Powder for solution for injection | Intramuscular or intravenous use | 250 mg |
| Netherlands | Roche Nederland B.V.
  Beneluxlaan 2a,
  3446 GR Woerden
  Netherlands | Rocephin 2 i.v. | 2 g | Powder for solution for infusion | Intravenous use | 2 g |
| Netherlands | Roche Nederland B.V.
  Beneluxlaan 2a,
  3446 GR Woerden
  Netherlands | Rocephin 1 i.m. | 1 g | Powder for solution for injection | Intramuscular use | 1 g |
| Netherlands | Roche Nederland B.V.
  Beneluxlaan 2a,
  3446 GR Woerden
  Netherlands | Rocephin 1 i.v. | 1 g | Powder for solution for injection | Intravenous use | 1 g |
| Netherlands | Roche Nederland B.V.
  Beneluxlaan 2a,
  3446 GR Woerden
  Netherlands | Rocephin 0,5 i.v. | 500 mg | Powder for solution for injection | Intravenous use | 500 mg |
| Netherlands | Roche Nederland B.V.
  Beneluxlaan 2a,
  3446 GR Woerden
  Netherlands | Rocephin 0,25 i.m. | 250 mg | Powder for solution for injection | Intramuscular use | 250 mg |
| Portugal | Roche Farmacêutica Química, Lda.,
  Estrada Nacional 249-1,
  2720-413 Amadora,
  Portugal | Rocephin | 2 g | Powder for solution for infusion | Intravenous use | 2 g |
| Portugal | Roche Farmacêutica Química, Lda.,
  Estrada Nacional 249-1,
  2720-413 Amadora,
  Portugal | Rocephin | 1000 mg/10 ml | Powder and solvent for solution for injection | intravenous use | 1 g |
| Portugal | Roche Farmacêutica Química, Lda.,
  Estrada Nacional 249-1,
  2720-413 Amadora,
  Portugal | Rocephin | 1000 mg/3,5 ml | Powder and solvent for solution for injection | Intramuscular use | 1 g |
| Portugal | Roche Farmacêutica Química, Lda.,
  Estrada Nacional 249-1,
  2720-413 Amadora,
  Portugal | Rocephin | 500 mg/2 ml | Powder and solvent for solution for injection | Intramuscular use | 500 mg |
| Portugal | Roche Farmacêutica Química, Lda.,
  Estrada Nacional 249-1,
  2720-413 Amadora,
  Portugal | Rocephin | 250 mg/2 ml | Powder and solvent for solution for injection | Intramuscular use | 250 mg |
| Romania | Roche România SRL
  Piaţa Presei Libere, Nr. 3-5,
  Clădirea City Gate–Turnul de Sud, Etajele 4A, 5 şi 6,
  Sector 1, Bucureşti,
  România | Rocephin 2 g pulbere pentru soluţie perfuzabilă | 2 g | Powder for solution for infusion | Intravenous use | 2 g |
| Sweden | Roche AB
  Box 47327
  100 74 Stockholm
  Sweden | Rocephalin | 2 g | Powder for solution for infusion | Intravenous use | 2 g |
| Sweden | Roche AB
  Box 47327
  100 74 Stockholm
  Sweden | Rocephalin | 1 g | Powder and solvent for solution for injection | Intramuscular or intravenous use | 1 g |
| Sweden | Roche AB
  Box 47327
  100 74 Stockholm
  Sweden | Rocephalin | 1 g | Powder and solvent for solution for injection | Intramuscular use | 1 g |
| United Kingdom | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Rocephin | 2 g | Powder for solution for injection/infusion | Intramuscular or intravenous use | 2 g |
| United Kingdom | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Rocephin | 1 g | Powder for solution for injection | Intramuscular or intravenous use | 1 g |
| United Kingdom | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Rocephin | 250 mg | Powder for solution for injection | Intramuscular or intravenous use | 250 mg |

Member State

EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Belgium

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Rocephine

2 g

Powder for solution for infusion

Intravenous use

2 g

Belgium

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Rocephine

1 g

Powder and solvent for solution for IM injection

Intramuscular use

1 g

Belgium

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Rocephine

1 g

Powder and solvent for solution for IV injection

Intravenous use

1 g

Denmark

Roche a/s

Industriholmen 59,

DK-2650 Hvidovre,

Danmark

Rocephalin

2 g

Concentrate for solution for infusion

Intravenous use

2 g

Denmark

Roche a/s

Industriholmen 59,

DK-2650 Hvidovre,

Danmark

Rocephalin

1 g

Powder and solvent for solution for injection

Intramuscular or intravenous use

1 g

Denmark

Roche a/s

Industriholmen 59,

DK-2650 Hvidovre,

Danmark

Rocephalin

500 mg

Powder and solvent for solution for injection

Intramuscular or intravenous use

500 mg

Finland

Roche Oy

Klovinpellontie 3

PL 12

02181 Espoo

Finland

Rocephalin cum lidocain

1 g

Powder and solvent for solution for injection

Intramuscular use or intravenous use

1 g

Finland

Roche Oy

Klovinpellontie 3

PL 12

02181 Espoo

Finland

Rocephalin cum lidocain

500 mg

Powder and solvent for solution for injection

Intramuscular use or intravenous use

500 mg

France

Roche

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Rocephine 1g/10 ml, powder and solvent for solution for injection (IV, SC)

1 g/10 ml

Powder and solvent for solution for injection

Intravenous use or subcutaneous use

1 g

France

Roche

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Rocephine 1 g/3.5 ml, powder and solvent for solution for injection (IM, SC)

1 g/3.5 ml

Powder and solvent for solution for injection

Intramuscular use or subcutaneous use

1 g

France

Roche

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Rocephine 500 mg/2ml, powder and solvent for solution for injection (IM, SC)

500 mg/2 ml

Powder and solvent for solution for injection

Intramuscular use or subcutaneous use

500 mg

France

Roche

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Rocephine 500 mg/5ml, powder and solvent for solution for injection (IV, SC)

500 mg/5 ml

Powder and solvent for solution for injection

Intravenous use or subcutaneous use

500 mg

Germany

Roche Pharma AG

Emil-Barell-Str. 1

79639 Grenzach-Wyhlen

Germany

Rocephin zur Infusion 2 g

2 g

Powder for solution for infusion

Intravenous use

2 g

Germany

Roche Pharma AG

Emil-Barell-Str. 1

79639 Grenzach-Wyhlen

Germany

Rocephin i.v. 1g

1 g

Powder and solvent for solution for injection

Intravenous use

1 g

Germany

Roche Pharma AG

Emil-Barell-Str. 1

79639 Grenzach-Wyhlen

Germany

Rocephin 500 mg

500 mg

Powder and solvent for solution for injection

Intramuscular or intravenous use

500 mg

Greece

Roche (Hellas) SA

4, Alamanas & Delfon Str.,

Maroussi 15125,

Attiki

Greece

Rocephin

2 g

Powder for solution for Infusion

Intravenous use

2 g

Greece

Roche (Hellas) SA

4, Alamanas & Delfon Str.,

Maroussi 15125,

Attiki

Greece

Rocephin

1 g

Powder and solvent for solution for Injection

intravenous use

1 g

Greece

Roche (Hellas) SA

4, Alamanas & Delfon Str.,

Maroussi 15125,

Attiki

Greece

Rocephin

1 g

Powder and solvent for solution for Injection

Intramuscular use

1 g

Hungary

Roche (Hungary) Ltd.

Edison utca 1

Budaörs

H-2040

Hungary

Rocephin

1 g

Powder and solvent for solution for injection

Intravenous use

1000 mg

Hungary

Roche (Hungary) Ltd.

Edison utca 1

Budaörs

H-2040

Hungary

Rocephin

500 mg

Powder and solvent for solution for injection

Intramuscular use

500 mg

Hungary

Roche (Hungary) Ltd.

Edison utca 1

Budaörs

H-2040

Hungary

Rocephin

250 mg

Powder and solvent for solution for injection

Intramuscular use

250 mg

Iceland

Roche a/s

Industriholmen 59,

DK-2650 Hvidovre,

Danmark

Rocephalin

2 g

Concentrate for solution for infusion

Intravenous use

2 g

Iceland

Roche a/s

Industriholmen 59,

DK-2650 Hvidovre,

Danmark

Rocephalin

1 g

Powder and solvent for solution for injection

Intramuscular or intravenous use

1 g

Ireland

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Rocephin

1 g

Powder for solution for injection or infusion

Intramuscular or intravenous use

1 g

Ireland

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Rocephin

1 g

Powder and solvent for solution for IM injection

Intramuscular use

1 g

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Rocefin

2 g

Powder for solution for infusion

Intravenous use

2 g

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Rocefin

1 g

Powder and solvent for solution for injection

intravenous use

1 g

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Rocefin

1 g

Powder and solvent for solution for injection

Intramuscular use

1 g

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Rocefin

500 mg

Powder and solvent for solution for injection

Intramuscular use

500 mg

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Rocefin

250 mg

Powder and solvent for solution for injection

Intramuscular use

250 mg

Latvia

Roche Latvija SIA

8b G.Astras Street, Riga, LV1082,

Latvia

Rocephin 1 g pulveris injekciju šķīduma pagatavošanai

1 g

Powder for solution for injection

Intramuscular or intravenous use

1 g

Luxembourg

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Rocephine

2 g

Powder for solution for infusion

Intravenous use

2 g

Luxembourg

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Rocephine

1 g

Powder and solvent for solution for IV injection

Intravenous use

1 g

Luxembourg

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Rocephine

1 g

Powder and solvent for solution for IM injection

Intramuscular use

1 g

Malta

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Rocephin

2 g

Powder for solution for infusion

Intravenous use

2 g

Malta

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Rocephin

1 g

Powder for solution for injection

Intramuscular or intravenous use

1 g

Malta

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Rocephin

250 mg

Powder for solution for injection

Intramuscular or intravenous use

250 mg

Netherlands

Roche Nederland B.V.

Beneluxlaan 2a,

3446 GR Woerden

Netherlands

Rocephin 2 i.v.

2 g

Powder for solution for infusion

Intravenous use

2 g

Netherlands

Roche Nederland B.V.

Beneluxlaan 2a,

3446 GR Woerden

Netherlands

Rocephin 1 i.m.

1 g

Powder for solution for injection

Intramuscular use

1 g

Netherlands

Roche Nederland B.V.

Beneluxlaan 2a,

3446 GR Woerden

Netherlands

Rocephin 1 i.v.

1 g

Powder for solution for injection

Intravenous use

1 g

Netherlands

Roche Nederland B.V.

Beneluxlaan 2a,

3446 GR Woerden

Netherlands

Rocephin 0,5 i.v.

500 mg

Powder for solution for injection

Intravenous use

500 mg

Netherlands

Roche Nederland B.V.

Beneluxlaan 2a,

3446 GR Woerden

Netherlands

Rocephin 0,25 i.m.

250 mg

Powder for solution for injection

Intramuscular use

250 mg

Portugal

Roche Farmacêutica Química, Lda.,

Estrada Nacional 249-1,

2720-413 Amadora,

Portugal

Rocephin

2 g

Powder for solution for infusion

Intravenous use

2 g

Portugal

Roche Farmacêutica Química, Lda.,

Estrada Nacional 249-1,

2720-413 Amadora,

Portugal

Rocephin

1000 mg/10 ml

Powder and solvent for solution for injection

intravenous use

1 g

Portugal

Roche Farmacêutica Química, Lda.,

Estrada Nacional 249-1,

2720-413 Amadora,

Portugal

Rocephin

1000 mg/3,5 ml

Powder and solvent for solution for injection

Intramuscular use

1 g

Portugal

Roche Farmacêutica Química, Lda.,

Estrada Nacional 249-1,

2720-413 Amadora,

Portugal

Rocephin

500 mg/2 ml

Powder and solvent for solution for injection

Intramuscular use

500 mg

Portugal

Roche Farmacêutica Química, Lda.,

Estrada Nacional 249-1,

2720-413 Amadora,

Portugal

Rocephin

250 mg/2 ml

Powder and solvent for solution for injection

Intramuscular use

250 mg

Romania

Roche România SRL

Piaţa Presei Libere, Nr. 3-5,

Clădirea City Gate–Turnul de Sud, Etajele 4A, 5 şi 6,

Sector 1, Bucureşti,

România

Rocephin 2 g pulbere pentru soluţie perfuzabilă

2 g

Powder for solution for infusion

Intravenous use

2 g

Sweden

Roche AB

Box 47327

100 74 Stockholm

Sweden

Rocephalin

2 g

Powder for solution for infusion

Intravenous use

2 g

Sweden

Roche AB

Box 47327

100 74 Stockholm

Sweden

Rocephalin

1 g

Powder and solvent for solution for injection

Intramuscular or intravenous use

1 g

Sweden

Roche AB

Box 47327

100 74 Stockholm

Sweden

Rocephalin

1 g

Powder and solvent for solution for injection

Intramuscular use

1 g

United Kingdom

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Rocephin

2 g

Powder for solution for injection/infusion

Intramuscular or intravenous use

2 g

United Kingdom

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Rocephin

1 g

Powder for solution for injection

Intramuscular or intravenous use

1 g

United Kingdom

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Rocephin

250 mg

Powder for solution for injection

Intramuscular or intravenous use

250 mg

---

ANNEX VI

List of the names, pharmaceutical forms, strength of the veterinary medicinal products, animal species, route of administration, withdrawal period and applicant/marketing authorisation holders in the member states

| Member State EU/EEA | Applicant/Marketing Authorisation Holder | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration | Recommended dose | Withdrawal period |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Belgium | Cross Vetpharm Group Limited
  Broomhill Road Tallaght,
  Dublin 24
  Ireland | Selenate Long Acting 50 mg/ml, suspension injectable pour bovins | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Czech Republic | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | SELENATE Long Acting 50 mg/ml injekční suspenze pro skot | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Germany (1) | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Selenate LA 5% | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Denmark | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Selongatum Long Acting, Suspension til injektion | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Estonia | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Selenate Long Acting, 50 mg/ml, süstesuspensioon veistele | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Spain | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Dalmasel L.A. 50 mg/ml, suspensión inyectable para bovino | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| France | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | SELENATE LA SUSPENSION INJECTABLE 50 MG/ML POUR BOVINS | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Ireland | Tairgi Tread-Lia Baile na Sceilge Teo Ballinskelligs
  Killarney
  Co. Kerry
  Ireland | B.V.P. Barium Selenate Injection | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 mg Se/kg body weight corresponding to the following: Cattle (adult): 6-10 ml Cattle (young): 3-8 ml Calves: 1-2 ml | Meat and offal: 31 days
  Milk: Zero days |
| Ireland | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Selenate Long Acting 50 mg/ml Suspension for Injection for Cattle | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Lithuania | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | SELENATE LONG ACTING 50 mg/ml injekcinė suspensija galvijams | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Latvia | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Selenate Long Acting 50 mg/ml suspensija injekcijām liellopiem | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Poland | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Selenate Long Acting 50 mg/ml zawiesina do wstrzykiwań dla bydła | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Romania | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Selenate Long Acting 50 mg/ml Suspensie injectabilă pentru bovine | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Slovakia | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | SELENATE Long Acting 50 mg/ml injekcná suspenzia pre hovädzí dobytok | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| Sweden | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Selongatum vet. 50 mg/ml injektionsvätska, suspension för nötkreatur | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg body weight | Meat and offal: 31 days
  Milk: Zero days |
| United Kingdom | Cross Vetpharm Group Limited
  Broomhill Road Tallaght
  Dublin 24
  Ireland | Selenate Long Acting 50 mg/ml Suspension for Injection for Cattle | Barium selenate | Suspension for injection | 50 mg/ml | Cattle | Subcutaneous injection | 1 ml per 50 kg bodyweight | Meat and offal: 31 days
  Milk: Zero days |

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Recommended dose

Withdrawal period

Belgium

Cross Vetpharm Group Limited

Broomhill Road Tallaght,

Dublin 24

Ireland

Selenate Long Acting 50 mg/ml, suspension injectable pour bovins

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Czech Republic

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

SELENATE Long Acting 50 mg/ml injekční suspenze pro skot

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Germany (1)

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Selenate LA 5%

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Denmark

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Selongatum Long Acting, Suspension til injektion

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Estonia

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Selenate Long Acting, 50 mg/ml, süstesuspensioon veistele

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Spain

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Dalmasel L.A. 50 mg/ml, suspensión inyectable para bovino

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

France

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

SELENATE LA SUSPENSION INJECTABLE 50 MG/ML POUR BOVINS

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Ireland

Tairgi Tread-Lia Baile na Sceilge Teo Ballinskelligs

Killarney

Co. Kerry

Ireland

B.V.P. Barium Selenate Injection

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 mg Se/kg body weight corresponding to the following: Cattle (adult): 6-10 ml Cattle (young): 3-8 ml Calves: 1-2 ml

Meat and offal: 31 days

Milk: Zero days

Ireland

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Selenate Long Acting 50 mg/ml Suspension for Injection for Cattle

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Lithuania

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

SELENATE LONG ACTING 50 mg/ml injekcinė suspensija galvijams

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Latvia

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Selenate Long Acting 50 mg/ml suspensija injekcijām liellopiem

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Poland

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Selenate Long Acting 50 mg/ml zawiesina do wstrzykiwań dla bydła

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Romania

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Selenate Long Acting 50 mg/ml Suspensie injectabilă pentru bovine

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Slovakia

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

SELENATE Long Acting 50 mg/ml injekcná suspenzia pre hovädzí dobytok

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

Sweden

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Selongatum vet. 50 mg/ml injektionsvätska, suspension för nötkreatur

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg body weight

Meat and offal: 31 days

Milk: Zero days

United Kingdom

Cross Vetpharm Group Limited

Broomhill Road Tallaght

Dublin 24

Ireland

Selenate Long Acting 50 mg/ml Suspension for Injection for Cattle

Barium selenate

Suspension for injection

50 mg/ml

Cattle

Subcutaneous injection

1 ml per 50 kg bodyweight

Meat and offal: 31 days

Milk: Zero days

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