# Official Journal C 396/27 N

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 396 |
| | |
| English edition | Information and Notices | Volume 5827 November 2015 |

ISSN 1977-091X

Official Journal

of the European Union

C 396

English edition

Information and Notices

Volume 5827 November 2015

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2015/C 396/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2015/C 396/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 2015(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 7 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2015/C 396/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2015/C 396/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 2015(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)

7

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 27.11.2015 | EN | Official Journal of the European Union | C 396/1 |
| --- | --- | --- | --- |

27.11.2015

EN

Official Journal of the European Union

C 396/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 2015

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

(2015/C 396/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.10.2015 | Cresemba | isavuconazole | Basilea Medical Ltd
  c/o Cox Costello & Horne Limited, Langwood House, 63-81
  High Street, Rickmansworth, Hertfordshire
  WD3 1EQ, United Kingdom | EU/1/15/1036 | Powder for concentrate for solution for infusion | J02AC05 | 19.10.2015 |

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

15.10.2015

Cresemba

isavuconazole

Basilea Medical Ltd

c/o Cox Costello & Horne Limited, Langwood House, 63-81

High Street, Rickmansworth, Hertfordshire

WD3 1EQ, United Kingdom

EU/1/15/1036

Powder for concentrate for solution for infusion

J02AC05

19.10.2015

—   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 |
| --- | --- | --- | --- | --- |
| 5.10.2015 | Kanuma | Synageva BioPharma Ltd
  1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom | EU/1/15/1033 | 7.10.2015 |
| 5.10.2015 | Potactasol | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/10/660 | 7.10.2015 |
| 8.10.2015 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 12.10.2015 |
| 8.10.2015 | Invanz | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216 | 12.10.2015 |
| 8.10.2015 | Mirapexin | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/051 | 12.10.2015 |
| 8.10.2015 | Orencia | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/07/389 | 12.10.2015 |
| 15.10.2015 | Adempas | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/907 | 19.10.2015 |
| 15.10.2015 | Betaferon | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/95/003 | 19.10.2015 |
| 15.10.2015 | ChondroCelect | TiGenix NV
  Romeinse straat 12/2, B-3001 Leuven, België | EU/1/09/563 | 19.10.2015 |
| 15.10.2015 | Dynastat | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/209 | 19.10.2015 |
| 15.10.2015 | Fortacin | Plethora Solutions Limited
  Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom | EU/1/13/881 | 19.10.2015 |
| 15.10.2015 | Iressa | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/09/526 | 19.10.2015 |
| 15.10.2015 | Kadcyla | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/885 | 19.10.2015 |
| 15.10.2015 | Lyxumia | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/811 | 19.10.2015 |
| 15.10.2015 | Mabthera | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/067 | 19.10.2015 |
| 15.10.2015 | Onbrez Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/593 | 19.10.2015 |
| 15.10.2015 | Pegasys | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/221 | 19.10.2015 |
| 15.10.2015 | Torisel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/424 | 19.10.2015 |
| 16.10.2015 | Corbilta | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/13/859 | 20.10.2015 |
| 16.10.2015 | Silapo | STADA Arzneimittel AG
  Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland | EU/1/07/432 | 20.10.2015 |
| 22.10.2015 | Procysbi | Raptor Pharmaceuticals Europe BV
  Naritaweg 165, NL-1043 BW Amsterdam, Nederland | EU/1/13/861 | 26.10.2015 |
| 22.10.2015 | Zalasta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/07/415 | 26.10.2015 |
| 28.10.2015 | Cerezyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/97/053 | 30.10.2015 |
| 28.10.2015 | Daliresp | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/11/668 | 30.10.2015 |
| 28.10.2015 | Daxas | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/10/636 | 30.10.2015 |
| 28.10.2015 | Eylea | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/12/797 | 30.10.2015 |
| 28.10.2015 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 30.10.2015 |
| 28.10.2015 | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | 30.10.2015 |
| 28.10.2015 | Infanrix hexa | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/00/152 | 30.10.2015 |
| 28.10.2015 | Libertek | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/11/666 | 30.10.2015 |
| 28.10.2015 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 30.10.2015 |
| 28.10.2015 | Rebetol | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/107 | 30.10.2015 |
| 28.10.2015 | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267 | 30.10.2015 |
| 28.10.2015 | Sycrest | Organon N.V.
  Kloosterstraat 6, NL-5349 AB Oss, Nederland | EU/1/10/640 | 30.10.2015 |
| 28.10.2015 | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/08/488 | 30.10.2015 |
| 28.10.2015 | Zelboraf | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/12/751 | 30.10.2015 |

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

5.10.2015

Kanuma

Synageva BioPharma Ltd

1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom

EU/1/15/1033

7.10.2015

5.10.2015

Potactasol

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/10/660

7.10.2015

8.10.2015

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

12.10.2015

8.10.2015

Invanz

Merck Sharp & Dohme Limited

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

EU/1/02/216

12.10.2015

8.10.2015

Mirapexin

Boehringer Ingelheim International GmbH

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

EU/1/97/051

12.10.2015

8.10.2015

Orencia

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/389

12.10.2015

15.10.2015

Adempas

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/907

19.10.2015

15.10.2015

Betaferon

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/95/003

19.10.2015

15.10.2015

ChondroCelect

TiGenix NV

Romeinse straat 12/2, B-3001 Leuven, België

EU/1/09/563

19.10.2015

15.10.2015

Dynastat

Pfizer Limited

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

EU/1/02/209

19.10.2015

15.10.2015

Fortacin

Plethora Solutions Limited

Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom

EU/1/13/881

19.10.2015

15.10.2015

Iressa

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/526

19.10.2015

15.10.2015

Kadcyla

Roche Registration Limited

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

EU/1/13/885

19.10.2015

15.10.2015

Lyxumia

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/811

19.10.2015

15.10.2015

Mabthera

Roche Registration Limited

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

EU/1/98/067

19.10.2015

15.10.2015

Onbrez Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/593

19.10.2015

15.10.2015

Pegasys

Roche Registration Limited

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

EU/1/02/221

19.10.2015

15.10.2015

Torisel

Pfizer Limited

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

EU/1/07/424

19.10.2015

16.10.2015

Corbilta

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/13/859

20.10.2015

16.10.2015

Silapo

STADA Arzneimittel AG

Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland

EU/1/07/432

20.10.2015

22.10.2015

Procysbi

Raptor Pharmaceuticals Europe BV

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

EU/1/13/861

26.10.2015

22.10.2015

Zalasta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415

26.10.2015

28.10.2015

Cerezyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/97/053

30.10.2015

28.10.2015

Daliresp

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/668

30.10.2015

28.10.2015

Daxas

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/10/636

30.10.2015

28.10.2015

Eylea

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/12/797

30.10.2015

28.10.2015

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

30.10.2015

28.10.2015

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

30.10.2015

28.10.2015

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/00/152

30.10.2015

28.10.2015

Libertek

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/666

30.10.2015

28.10.2015

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

30.10.2015

28.10.2015

Rebetol

Merck Sharp & Dohme Limited

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

EU/1/99/107

30.10.2015

28.10.2015

Reyataz

Bristol-Myers Squibb Pharma EEIG

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

EU/1/03/267

30.10.2015

28.10.2015

Sycrest

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

EU/1/10/640

30.10.2015

28.10.2015

Vidaza

Celgene Europe Limited

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

EU/1/08/488

30.10.2015

28.10.2015

Zelboraf

Roche Registration Limited

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

EU/1/12/751

30.10.2015

—   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 |
| --- | --- | --- | --- | --- |
| 5.10.2015 | RevitaCAM | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/138 | 7.10.2015 |
| 8.10.2015 | NexGard | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/13/159 | 12.10.2015 |
| 8.10.2015 | SevoFlo | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/02/035 | 12.10.2015 |
| 15.10.2015 | Aivlosin | ECO Animal Health Ltd
  78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom | EU/2/04/044 | 19.10.2015 |
| 15.10.2015 | Zulvac SBV | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/178 | 19.10.2015 |
| 22.10.2015 | MS-H vaccine | Pharmsure Ltd
  Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom | EU/2/11/126 | 26.10.2015 |

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

5.10.2015

RevitaCAM

Zoetis Belgium S.A.

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

EU/2/12/138

7.10.2015

8.10.2015

NexGard

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/159

12.10.2015

8.10.2015

SevoFlo

Zoetis Belgium S.A.

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

EU/2/02/035

12.10.2015

15.10.2015

Aivlosin

ECO Animal Health Ltd

78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom

EU/2/04/044

19.10.2015

15.10.2015

Zulvac SBV

Zoetis Belgium S.A.

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

EU/2/14/178

19.10.2015

22.10.2015

MS-H vaccine

Pharmsure Ltd

Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom

EU/2/11/126

26.10.2015

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 28.10.2015 | Dicural | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/97/003 | 30.10.2015 |

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

28.10.2015

Dicural

Pfizer Limited

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

EU/2/97/003

30.10.2015

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.

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| 27.11.2015 | EN | Official Journal of the European Union | C 396/7 |
| --- | --- | --- | --- |

27.11.2015

EN

Official Journal of the European Union

C 396/7

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 2015

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

(2015/C 396/02)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 22.10.2015 | Gutal | See Annex | See Annex | See Annex | 23.10.2015 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

22.10.2015

Gutal

See Annex

See Annex

See Annex

23.10.2015

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

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

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ANNEX

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 | Product name | INN | Strength | Pharmaceutical
  form | Animal species | Route of
  administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Belgium | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Bulgaria | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Cyprus | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Czech Republic | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Denmark | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Estonia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| France | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Germany | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Greece | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Hungary | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Ireland | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Italy | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Latvia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Lithuania | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Luxembourg | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Malta | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| The Netherlands | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Poland | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Portugal | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Romania | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Slovakia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Slovenia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Spain | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| United Kingdom | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1  000 g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1  000 g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |

Member State

(EU/EEA)

Applicant

Product name

INN

Strength

Pharmaceutical

form

Animal species

Route of

administration

Austria

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Belgium

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Bulgaria

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Cyprus

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Czech Republic

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Denmark

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Estonia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

France

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Germany

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Greece

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Hungary

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Ireland

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Italy

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Latvia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Lithuania

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Luxembourg

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Malta

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

The Netherlands

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Poland

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Portugal

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Romania

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Slovakia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Slovenia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Spain

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

United Kingdom

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1  000 g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1  000 g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

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