# C_2014123EN.01000101.xml

| 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

---

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))

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

Issuing of a marketing authorization

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

Issuing of a marketing authorization

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

Modification of a marketing authorization

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

Issuing of a marketing authorization

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

Modification of a marketing authorization

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

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

1

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

2

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