# Official Journal C 282/2013

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2013.282.eng |
| --- | --- |
| Official Journal
  of the European Union | C 282 |
| | |
| English edition | Information and Notices | Volume 5627 September 2013 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2013.282.eng

Official Journal

of the European Union

C 282

English edition

Information and Notices

Volume 5627 September 2013

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2013/C 282/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 1 |
| 2013/C 282/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 6 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2013/C 282/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013(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

2013/C 282/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013(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

)

6

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 27.9.2013 | EN | Official Journal of the European Union | C 282/1 |
| --- | --- | --- | --- |

27.9.2013

EN

Official Journal of the European Union

C 282/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013

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

2013/C 282/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.8.2013 | Pomalidomide Celgene | Pomalidomide | Celgene Europe Limited |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |

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

5.8.2013

Pomalidomide Celgene

Pomalidomide

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

Capsule, hard

L04AX06

8.8.2013

5.8.2013

Somatropin Biopartners

somatropin

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

BioPartners GmbH

Kaiserpassage 11, D-72764 Reutlingen, Deutschland

EU/1/13/849

Powder and solvent for prolonged-release suspension for injection

H01AC01

8.8.2013

12.8.2013

Voncento

human coagulation factor VIII/human von Willebrand factor

CSL Behring GmbH

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

EU/1/13/857

Powder and solvent for solution for injection/infusion

B02BD06

14.8.2013

26.8.2013

AUBAGIO

Teriflunomide

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/13/838

Film-coated tablet

L04AA31

29.8.2013

26.8.2013

Cholib

fenofibrate/simvastatin

Abbott Healthcare Products Ltd

Mansbridge Road, West End Southampton, SO18 3JD, United Kingdom

EU/1/13/866

Film-coated tablet

C10BA04

28.8.2013

26.8.2013

Nexium Control

esomeprazole

| AstraZeneca AB |
| --- |
| SE-151 85 Södertälje, Sverige |

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/860

Gastro-resistant tablet

A02BC05

29.8.2013

26.8.2013

Stivarga

regorafenib

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

Film-coated tablet

L01XE21

29.8.2013

26.8.2013

Tafinlar

DABRAFENIB

| GlaxoSmithKline Trading Services Limited |
| --- |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland |

GlaxoSmithKline Trading Services Limited

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

EU/1/13/865

Capsule, hard

L01XE23

29.8.2013

—   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 |
| --- | --- | --- | --- | --- |
| 5.8.2013 | Icandra | Novartis Europharm Limited |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

5.8.2013

Icandra

Novartis Europharm Limited

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

EU/1/08/484

8.8.2013

5.8.2013

Marixino

| Consilient Health Ltd. |
| --- |
| Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland |

Consilient Health Ltd.

Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/13/820

8.8.2013

5.8.2013

Rasilamlo

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

Novartis Europharm Limited

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

EU/1/11/686

8.8.2013

5.8.2013

Xarelto

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

8.8.2013

5.8.2013

Zomarist

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

Novartis Europharm Limited

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

EU/1/08/483

8.8.2013

12.8.2013

Circadin

| RAD Neurim Pharmaceuticals EEC Limited |
| --- |
| One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom |

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom

EU/1/07/392

14.8.2013

12.8.2013

Pixuvri

| CTI Life Sciences Ltd |
| --- |
| Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom |

CTI Life Sciences Ltd

Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom

EU/1/12/764

14.8.2013

12.8.2013

Signifor

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

Novartis Europharm Limited

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

EU/1/12/753

14.8.2013

12.8.2013

Twynsta

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

Boehringer Ingelheim International GmbH

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

EU/1/10/648

14.8.2013

12.8.2013

Zavesca

| Actelion Registration Ltd |
| --- |
| Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom |

Actelion Registration Ltd

Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom

EU/1/02/238

14.8.2013

14.8.2013

Conbriza

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

Pfizer Limited

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

EU/1/09/511

19.8.2013

14.8.2013

FLUENZ

| MedImmune, LLC |
| --- |
| Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland |

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/10/661

19.8.2013

14.8.2013

IOA

| Organon N.V. |
| --- |
| Kloosterstraat 6, NL-5349 AB Oss, Nederland |

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

EU/1/11/689

19.8.2013

26.8.2013

ADCETRIS

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, London WC2B 4AE, United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/12/794

28.8.2013

26.8.2013

Azarga

| Alcon Laboratories (UK) Ltd. |
| --- |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |

Alcon Laboratories (UK) Ltd.

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

EU/1/08/482

29.8.2013

26.8.2013

Ceplene

| Meda AB |
| --- |
| Box 906, SE-170 09 Solna, Sverige |

Meda AB

Box 906, SE-170 09 Solna, Sverige

EU/1/08/477

28.8.2013

26.8.2013

Eliquis

| Bristol-Myers Squibb/Pfizer EEIG |
| --- |
| Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

29.8.2013

26.8.2013

Eylea

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/12/797

28.8.2013

26.8.2013

Herceptin

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

Roche Registration Limited

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

EU/1/00/145

28.8.2013

26.8.2013

Hirobriz Breezhaler

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

Novartis Europharm Limited

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

EU/1/09/594

29.8.2013

26.8.2013

Ifirmasta

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

Krka, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480

29.8.2013

26.8.2013

Ilaris

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

Novartis Europharm Limited

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

EU/1/09/564

28.8.2013

26.8.2013

Inlyta

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

Pfizer Limited

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

EU/1/12/777

29.8.2013

26.8.2013

Invega

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/07/395

28.8.2013

26.8.2013

Keppra

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

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

EU/1/00/146

29.8.2013

26.8.2013

Onbrez Breezhaler

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

Novartis Europharm Limited

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

EU/1/09/593

29.8.2013

26.8.2013

Oslif Breezhaler

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

Novartis Europharm Limited

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

EU/1/09/586

28.8.2013

26.8.2013

Pramipexole Teva

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/08/490

29.8.2013

26.8.2013

Tarceva

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

Roche Registration Limited

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

EU/1/05/311

29.8.2013

26.8.2013

Tysabri

| Biogen Idec Limited |
| --- |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/06/346

29.8.2013

26.8.2013

Ventavis

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/255

29.8.2013

26.8.2013

XALKORI

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

Pfizer Limited

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

EU/1/12/793

29.8.2013

26.8.2013

Zypadhera

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

Eli Lilly Nederland B.V.

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

EU/1/08/479

29.8.2013

—   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 |
| --- | --- | --- | --- | --- |
| 5.8.2013 | Econor | Novartis Animal Health Austria GmbH |
| Biochemiestrasse 10, A-6250 Kundl, Österreich |

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

5.8.2013

Econor

Novartis Animal Health Austria GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/2/98/010

9.8.2013

12.8.2013

Trocoxil

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/08/084

14.8.2013

14.8.2013

Cerenia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/06/062

19.8.2013

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, 30.4.2004, p. 1.

---

| 27.9.2013 | EN | Official Journal of the European Union | C 282/6 |
| --- | --- | --- | --- |

27.9.2013

EN

Official Journal of the European Union

C 282/6

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013

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

2013/C 282/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 12.8.2013 | Soludox | See Annex I | See Annex I | 13.8.2013 |
| 12.8.2013 | STRENZEN | See Annex II | See Annex II | 14.8.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

12.8.2013

Soludox

See Annex I

See Annex I

13.8.2013

12.8.2013

STRENZEN

See Annex II

See Annex II

14.8.2013

---

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

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

---

ANNEX I

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 | Eurovet Animal Health BV |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Member State

EU/EEA

Marketing authorisation holder

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Czech Republic

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Estonia

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g suukaudse lahuse pulber sigadele ja kanadele

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Finland

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille ja kanoille

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

France

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 433 mg/g poudre pour administration dans l'eau de boisson des porcs et des poulets

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Germany

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Greece

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g υπό μορφή σκόνης για χρήση σε πόσιμο νερό για χοίρους και κοτόπουλα

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Italy

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g polvere da somministrare nell’acqua da bere per suini e polli

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Italy

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Acquadox 500 mg/g polvere da somministrare nell’acqua da bere per suini e polli

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Latvia

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni cūkām un vistām

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

The Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g poeder voor toediening via het drinkwater voor varkens en kippen

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Slovakia

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g prášok na použitie v pitnej vode pre ošípané

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Spain

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g polvo para administración en agua de bebida para porcino y pollos

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

United Kingdom

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g powder for use in drinking water for pigs and chickens

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

---

ANNEX II

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Novartis Animal Health Inc. |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Member State

EU/EEA

Applicant

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Czech Republic

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g prášek pro podání v pitné vodě pro prasata

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Denmark

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg pulver til anvendelse i drikkevand til svin

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

France

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g poudre pour eau de boisson porcs

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Germany

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Ireland

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g powder for use in drinking water for pigs

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Italy

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g polvere per somministrazione in acqua da bere per suini

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

The Netherlands

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g poeder voor gebruik in drinkwater voor varkens.

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Portugal

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g pó para utilização na água de bebida em suínos

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Spain

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g polvo para uso en agua de bebida para porcino

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

United Kingdom

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g powder for use in drinking water for pigs

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

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