# Official Journal C 290/29 A

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 290 |
| | |
| English edition | Information and Notices | Volume 5729 August 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 290

English edition

Information and Notices

Volume 5729 August 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 290/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 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 290/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 10 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 290/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 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 290/02

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

10

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.8.2014 | EN | Official Journal of the European Union | C 290/1 |
| --- | --- | --- | --- |

29.8.2014

EN

Official Journal of the European Union

C 290/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 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 290/01

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.7.2014 | Envarsus | tacrolimus | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/935 | Prolonged-release tablet | L04AD02 | 22.7.2014 |
| 18.7.2014 | Plegridy | peginterferon beta-1a | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/14/934 | Solution for injection | L03AB13 | 23.7.2014 |
| 18.7.2014 | Simbrinza | Brinzolamide/Brimonidine tartrate | Alcon Laboratories (UK) Ltd.
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/14/933 | Ear drops, suspension | Pending | 23.7.2014 |
| 22.7.2014 | Nuwiq | simoctocog alfa | Octapharma AB
  Elersvägen 40 Stockholm 11275 Sweden | EU/1/14/936 | Powder and solvent for solution for injection | B02BD02 | 24.7.2014 |
| 23.7.2014 | Gazyvaro | obinutuzumab | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/14/937 | Concentrate for solution for infusion | L01 | 24.7.2014 |
| 31.7.2014 | Translarna | ataluren | PTC Therapeutics, Limited
  Lakeside House, Office G33a, 1 Furzeground Way, Stockley Park E. Uxbridge, UB11 1BD, United Kingdom | EU/1/13/902 | Granules for oral suspension | Pending | 5.8.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

18.7.2014

Envarsus

tacrolimus

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/935

Prolonged-release tablet

L04AD02

22.7.2014

18.7.2014

Plegridy

peginterferon beta-1a

Biogen Idec Limited

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

EU/1/14/934

Solution for injection

L03AB13

23.7.2014

18.7.2014

Simbrinza

Brinzolamide/Brimonidine tartrate

Alcon Laboratories (UK) Ltd.

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

EU/1/14/933

Ear drops, suspension

Pending

23.7.2014

22.7.2014

Nuwiq

simoctocog alfa

Octapharma AB

Elersvägen 40 Stockholm 11275 Sweden

EU/1/14/936

Powder and solvent for solution for injection

B02BD02

24.7.2014

23.7.2014

Gazyvaro

obinutuzumab

Roche Registration Limited

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

EU/1/14/937

Concentrate for solution for infusion

L01

24.7.2014

31.7.2014

Translarna

ataluren

PTC Therapeutics, Limited

Lakeside House, Office G33a, 1 Furzeground Way, Stockley Park E. Uxbridge, UB11 1BD, United Kingdom

EU/1/13/902

Granules for oral suspension

Pending

5.8.2014

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.7.2014 | Masican | AB Science S.A.
  3 avenue George V, F-75008 Paris, France | | 8.7.2014 |
| 23.7.2014 | Masiviera | AB Science S.A.
  3 avenue George V, F-75008 Paris, France | | 24.7.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.7.2014

Masican

AB Science S.A.

3 avenue George V, F-75008 Paris, France

8.7.2014

23.7.2014

Masiviera

AB Science S.A.

3 avenue George V, F-75008 Paris, France

24.7.2014

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.7.2014 | Copalia HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/575 | 11.7.2014 |
| 4.7.2014 | Dafiro HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/574 | 11.7.2014 |
| 4.7.2014 | Efavirenz Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/11/742 | 9.7.2014 |
| 4.7.2014 | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa | EU/1/07/404 | 8.7.2014 |
| 4.7.2014 | Fuzeon | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/252 | 8.7.2014 |
| 4.7.2014 | Optison | GE Healthcare AS
  Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norge | EU/1/98/065 | 8.7.2014 |
| 11.7.2014 | Riluzole Zentiva | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/12/768 | 15.7.2014 |
| 11.7.2014 | Rivastigmine HEXAL | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/09/589 | 15.7.2014 |
| 11.7.2014 | Rivastigmine Sandoz | Sandoz Pharmaceuticals GmbH
  Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | EU/1/09/599 | 15.7.2014 |
| 14.7.2014 | Docetaxel Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/611 | 17.7.2014 |
| 14.7.2014 | Viagra | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077 | 16.7.2014 |
| 18.7.2014 | Adjupanrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/578 | 22.7.2014 |
| 18.7.2014 | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 22.7.2014 |
| 18.7.2014 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792 | 23.7.2014 |
| 18.7.2014 | Glivec | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/198 | 22.7.2014 |
| 18.7.2014 | Irbesartan Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/576 | 23.7.2014 |
| 18.7.2014 | Nimenrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/12/767 | 22.7.2014 |
| 18.7.2014 | Omnitrope | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/06/332 | 22.7.2014 |
| 18.7.2014 | Onglyza | Bristol-Myers Squibb/AstraZeneca EEIG
  Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/09/545 | 22.7.2014 |
| 18.7.2014 | SANCUSO | ProStrakan Limited
  Galabank Business Park, Galashiels TD1 1QH, United Kingdom | EU/1/12/766 | 23.7.2014 |
| 18.7.2014 | Savene | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/06/350 | 22.7.2014 |
| 18.7.2014 | Tasmar | Meda AB
  Pipers väg 2A, S-170 09 Solna, Sverige | EU/1/97/044 | 22.7.2014 |
| 18.7.2014 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH
  Fehlandtstraße 3, D-20354 Hamburg, Deutschland | EU/1/09/605 | 22.7.2014 |
| 18.7.2014 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 22.7.2014 |
| 18.7.2014 | Ventavis | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/255 | 22.7.2014 |
| 18.7.2014 | Votubia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/11/710 | 23.7.2014 |
| 18.7.2014 | Xagrid | Shire Pharmaceutical Contracts Ltd
  Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295 | 23.7.2014 |
| 18.7.2014 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/714 | 23.7.2014 |
| 22.7.2014 | Rapiscan | Rapidscan Pharma Solutions EU Ltd.
  Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom | EU/1/10/643 | 24.7.2014 |
| 23.7.2014 | Fabrazyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/01/188 | 24.7.2014 |
| 28.7.2014 | Arzerra | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/10/625 | 30.7.2014 |
| 28.7.2014 | Byetta | AstraZeneca AB
  S-151 85 Södertälje, Sverige | EU/1/06/362 | 30.7.2014 |
| 28.7.2014 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/691 | 30.7.2014 |
| 28.7.2014 | Enbrel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/126 | 29.7.2014 |
| 28.7.2014 | Kalydeco | Vertex Pharmaceuticals (U.K.) Limited
  Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom | EU/1/12/782 | 30.7.2014 |
| 28.7.2014 | Menveo | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/614 | 29.7.2014 |
| 28.7.2014 | Olanzapine Apotex | Apotex Europe B.V.
  Darwinweg 20, NL- 2333 CR Leiden, Nederland | EU/1/10/635 | 29.7.2014 |
| 28.7.2014 | Pandemrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/08/452 | 30.7.2014 |
| 28.7.2014 | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/858 | 30.7.2014 |
| 28.7.2014 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 29.7.2014 |
| 31.7.2014 | Avastin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300 | 4.8.2014 |
| 31.7.2014 | BYDUREON | Bristol-Myers Squibb/AstraZeneca EEIG
  Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/696 | 4.8.2014 |
| 31.7.2014 | Colobreathe | Forest Laboratories UK Ltd
  Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom | EU/1/11/747 | 1.8.2014 |
| 31.7.2014 | Xarelto | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/08/472 | 4.8.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.7.2014

Copalia HCT

Novartis Europharm Limited

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

EU/1/09/575

11.7.2014

4.7.2014

Dafiro HCT

Novartis Europharm Limited

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

EU/1/09/574

11.7.2014

4.7.2014

Efavirenz Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/11/742

9.7.2014

4.7.2014

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa

EU/1/07/404

8.7.2014

4.7.2014

Fuzeon

Roche Registration Limited

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

EU/1/03/252

8.7.2014

4.7.2014

Optison

GE Healthcare AS

Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norge

EU/1/98/065

8.7.2014

11.7.2014

Riluzole Zentiva

Aventis Pharma S.A.

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

EU/1/12/768

15.7.2014

11.7.2014

Rivastigmine HEXAL

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/09/589

15.7.2014

11.7.2014

Rivastigmine Sandoz

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland

EU/1/09/599

15.7.2014

14.7.2014

Docetaxel Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/611

17.7.2014

14.7.2014

Viagra

Pfizer Limited

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

EU/1/98/077

16.7.2014

18.7.2014

Adjupanrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/578

22.7.2014

18.7.2014

CellCept

Roche Registration Limited

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

EU/1/96/005

22.7.2014

18.7.2014

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792

23.7.2014

18.7.2014

Glivec

Novartis Europharm Limited

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

EU/1/01/198

22.7.2014

18.7.2014

Irbesartan Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/576

23.7.2014

18.7.2014

Nimenrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/12/767

22.7.2014

18.7.2014

Omnitrope

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/06/332

22.7.2014

18.7.2014

Onglyza

Bristol-Myers Squibb/AstraZeneca EEIG

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

EU/1/09/545

22.7.2014

18.7.2014

SANCUSO

ProStrakan Limited

Galabank Business Park, Galashiels TD1 1QH, United Kingdom

EU/1/12/766

23.7.2014

18.7.2014

Savene

Clinigen Healthcare Limited

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

EU/1/06/350

22.7.2014

18.7.2014

Tasmar

Meda AB

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

EU/1/97/044

22.7.2014

18.7.2014

Temomedac

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstraße 3, D-20354 Hamburg, Deutschland

EU/1/09/605

22.7.2014

18.7.2014

Tesavel

Merck Sharp & Dohme Limited

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

EU/1/07/435

22.7.2014

18.7.2014

Ventavis

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/255

22.7.2014

18.7.2014

Votubia

Novartis Europharm Limited

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

EU/1/11/710

23.7.2014

18.7.2014

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295

23.7.2014

18.7.2014

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714

23.7.2014

22.7.2014

Rapiscan

Rapidscan Pharma Solutions EU Ltd.

Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom

EU/1/10/643

24.7.2014

23.7.2014

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/188

24.7.2014

28.7.2014

Arzerra

Glaxo Group Ltd

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

EU/1/10/625

30.7.2014

28.7.2014

Byetta

AstraZeneca AB

S-151 85 Södertälje, Sverige

EU/1/06/362

30.7.2014

28.7.2014

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

30.7.2014

28.7.2014

Enbrel

Pfizer Limited

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

EU/1/99/126

29.7.2014

28.7.2014

Kalydeco

Vertex Pharmaceuticals (U.K.) Limited

Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom

EU/1/12/782

30.7.2014

28.7.2014

Menveo

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/614

29.7.2014

28.7.2014

Olanzapine Apotex

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden, Nederland

EU/1/10/635

29.7.2014

28.7.2014

Pandemrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/08/452

30.7.2014

28.7.2014

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

30.7.2014

28.7.2014

Xelevia

Merck Sharp & Dohme Limited

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

EU/1/07/382

29.7.2014

31.7.2014

Avastin

Roche Registration Limited

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

EU/1/04/300

4.8.2014

31.7.2014

BYDUREON

Bristol-Myers Squibb/AstraZeneca EEIG

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

EU/1/11/696

4.8.2014

31.7.2014

Colobreathe

Forest Laboratories UK Ltd

Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom

EU/1/11/747

1.8.2014

31.7.2014

Xarelto

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

4.8.2014

—   Withdrawal of a marketing authorisation (Article 13 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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.7.2014 | Olanzapine Cipla | Cipla (EU) Limited
  Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom | EU/1/07/426 | 10.7.2014 |
| 31.7.2014 | Doribax | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/467 | 4.8.2014 |
| 31.7.2014 | IOA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/689 | 4.8.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

8.7.2014

Olanzapine Cipla

Cipla (EU) Limited

Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom

EU/1/07/426

10.7.2014

31.7.2014

Doribax

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/467

4.8.2014

31.7.2014

IOA

Merck Sharp & Dohme Limited

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

EU/1/11/689

4.8.2014

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.7.2014 | ERYSENG | Inactivated Erysipelothrix rhusiopathiae, strain R32E11 | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/14/166 | Suspension for injection | QI09AB03 | 8.7.2014 |
| 4.7.2014 | Versican Plus DHPPi | Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza type 2 virus | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/169 | Lyophilisate and solvent for suspension for injection | QI07AD04 | 8.7.2014 |
| 4.7.2014 | Versican Plus Pi | Canine parainfluenza type 2 virus | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/168 | Lyophilisate and solvent for suspension for injection | QI07AD08 | 8.7.2014 |
| 8.7.2014 | ERYSENG PARVO | Inactivated porcine parvovirus, strain NADL-2/Inactivated Erysipelothrix rhusiopathiae, strain R32E11 | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/14/167 | Suspension for injection | QI09AL01 | 10.7.2014 |
| 31.7.2014 | Osurnia | terbinafine/florfenicol/betamethasone acetate | Novartis Santé Animale S.A.S.
  10 Rue Blériot, 92 500 Rueil-Malmaison, France | EU/2/14/170 | Ear gel | QS02CA90 | 1.8.2014 |
| 31.7.2014 | Versican Plus L4 | Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089
  Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090
  Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091
  Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/171 | Suspension for injection | QI07AB01 | 5.8.2014 |
| 31.7.2014 | Versican Plus Pi/L4 | Canine parainfluenza type 2 virus
  Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089
  Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090
  Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091
  Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/172 | Lyophilisate for suspension for spray vaccination | QI07AI08 | 4.8.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

4.7.2014

ERYSENG

Inactivated Erysipelothrix rhusiopathiae, strain R32E11

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170- Amer (Girona), España

EU/2/14/166

Suspension for injection

QI09AB03

8.7.2014

4.7.2014

Versican Plus DHPPi

Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza type 2 virus

Zoetis Belgium S.A.

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

EU/2/14/169

Lyophilisate and solvent for suspension for injection

QI07AD04

8.7.2014

4.7.2014

Versican Plus Pi

Canine parainfluenza type 2 virus

Zoetis Belgium S.A.

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

EU/2/14/168

Lyophilisate and solvent for suspension for injection

QI07AD08

8.7.2014

8.7.2014

ERYSENG PARVO

Inactivated porcine parvovirus, strain NADL-2/Inactivated Erysipelothrix rhusiopathiae, strain R32E11

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170- Amer (Girona), España

EU/2/14/167

Suspension for injection

QI09AL01

10.7.2014

31.7.2014

Osurnia

terbinafine/florfenicol/betamethasone acetate

Novartis Santé Animale S.A.S.

10 Rue Blériot, 92 500 Rueil-Malmaison, France

EU/2/14/170

Ear gel

QS02CA90

1.8.2014

31.7.2014

Versican Plus L4

Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089

Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090

Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091

Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088

Zoetis Belgium S.A.

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

EU/2/14/171

Suspension for injection

QI07AB01

5.8.2014

31.7.2014

Versican Plus Pi/L4

Canine parainfluenza type 2 virus

Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089

Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090

Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091

Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088

Zoetis Belgium S.A.

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

EU/2/14/172

Lyophilisate for suspension for spray vaccination

QI07AI08

4.8.2014

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.7.2014 | Draxxin | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/03/041 | 10.7.2014 |
| 8.7.2014 | SevoFlo | Abbott Laboratories Ltd
  Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom | EU/2/02/035 | 10.7.2014 |
| 11.7.2014 | ProteqFlu | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/03/037 | 15.7.2014 |
| 11.7.2014 | ProteqFlu-Te | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/03/038 | 15.7.2014 |
| 28.7.2014 | Poulvac E. coli | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/12/140 | 29.7.2014 |
| 31.7.2014 | Palladia | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/09/100 | 4.8.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

8.7.2014

Draxxin

Zoetis Belgium S.A.

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

EU/2/03/041

10.7.2014

8.7.2014

SevoFlo

Abbott Laboratories Ltd

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

EU/2/02/035

10.7.2014

11.7.2014

ProteqFlu

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/03/037

15.7.2014

11.7.2014

ProteqFlu-Te

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/03/038

15.7.2014

28.7.2014

Poulvac E. coli

Zoetis Belgium S.A.

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

EU/2/12/140

29.7.2014

31.7.2014

Palladia

Zoetis Belgium S.A.

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

EU/2/09/100

4.8.2014

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

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

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

---

| 29.8.2014 | EN | Official Journal of the European Union | C 290/10 |
| --- | --- | --- | --- |

29.8.2014

EN

Official Journal of the European Union

C 290/10

---

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

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

2014/C 290/02

—   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 |
| --- | --- | --- | --- | --- | --- |
| 11.7.2014 | Linco-Spectin 100 | See Annex I | See Annex I | See Annex I | 22.7.2014 |
| 22.7.2014 | Domperidone | See Annex II | See Annex II | See Annex II | 23.7.2014 |
| 31.7.2014 | Tylosin | See Annex III | See Annex III | See Annex III | 4.8.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

11.7.2014

Linco-Spectin 100

See Annex I

See Annex I

See Annex I

22.7.2014

22.7.2014

Domperidone

See Annex II

See Annex II

See Annex II

23.7.2014

31.7.2014

Tylosin

See Annex III

See Annex III

See Annex III

4.8.2014

—   Refusal 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 |
| --- | --- | --- | --- | --- | --- |
| 14.7.2014 | Fiprex | See Annex V | See Annex V | See Annex V | 15.7.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

14.7.2014

Fiprex

See Annex V

See Annex V

See Annex V

15.7.2014

—   Suspension 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 |
| --- | --- | --- | --- | --- | --- |
| 14.7.2014 | Fiprex | See Annex V | See Annex V | See Annex V | 15.7.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

14.7.2014

Fiprex

See Annex V

See Annex V

See Annex V

15.7.2014

—   Revocation 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 |
| --- | --- | --- | --- | --- | --- |
| 22.7.2014 | Domperidone | See Annex II | See Annex II | See Annex II | 23.7.2014 |
| 11.7.2014 | Caustinerf arsenical, Yranicid arsenical and other associated names | See Annex IV | See Annex IV | See Annex IV | 14.7.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

22.7.2014

Domperidone

See Annex II

See Annex II

See Annex II

23.7.2014

11.7.2014

Caustinerf arsenical, Yranicid arsenical and other associated names

See Annex IV

See Annex IV

See Annex IV

14.7.2014

---

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

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

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Zoetis Österreich GmbH
  Floridsdorfer Hauptstraße 1
  1210 Vienna
  Austria | Linco-Spectin forte-lösliches Pulver für Tiere | Lincomycin (as lincomycin-hydrochlorid-monohydrat) and spectinomycin (as spectinomycin sulfate) | 22,2 g lincomycin and 44,5 g spectinomycin per 100 g | Powder for oral solution | Pigs
  Chickens | Oral |
| Belgium | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 100 | Lincomycin (as lincomycin hydrochloride) and Spectinomycin (as spectinomycin sulphate) | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Pigs
  Chickens | Oral |
| Bulgaria | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | Линко-Спектин 100 разтворим прах/Linco-Spectin 100 Soluble Powder | Lincomycin (as lincomycin hydrochloride), Spectinomycin (as spectinomycin sulphate) | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Pigs
  Poultry — hens, chickens and turkeys | Oral |
| Cyprus | Zoetis Hellas SA
  L. Mesogion 253- 255
  15451, N. Psichico
  Athens
  Greece | Linco-Spectin 100 SP, Powder for oral solution for chickens | Lincomycin
  Spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Chickens | Oral |
| Czech Republic | Zoetis Česká republika, s.r.o.
  Stroupežnického 17
  Praha 5 150 00
  Czech Republic | LINCO SPECTIN 100 plv. sol. | Lincomycin and spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Pigs
  Poultry | Oral |
| Denmark | Zoetis Finland Oy
  Tietokuja 4
  FI 00330 Helsinki
  Finland | Linco-Spectin Vet. | Lincomycin and spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for solution in drinking water | Pigs
  Chickens | Oral |
| Estonia | Pfizer Manufacturing Belgium N.V.
  Rijksweg 12
  B-2870 Puurs
  Belgium | Linco-Spectin 100 Soluble Powder | Lincomycin/Spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Pigs
  Poultry (broilers) | Oral |
| France | Zoetis
  23/25 Avenue Du Docteur Lannelongue
  75014 Paris
  France | LINCO-SPECTIN 100 | Lincomycin
  spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Pigs | Oral |
| Germany | Zoetis Deutschland GmbH
  Schellingstraße 1,
  D-10785 Berlin
  Germany | Lincospectin Pulver zum Eingeben über das Trinkwasser für Schweine, Hühner (Broiler, Junghennen) und Puten | Lincomycin and spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder | Pigs
  Chicken (broiler, pullet)
  Turkey | Oral |
| Greece | Zoetis Hellas SA
  L. Mesogion 253- 255
  15451, N. Psichico
  Athens
  Greece | LINCO SPECTIN 100 | Lincomycin and spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Pouder for oral solution | Chickens (broilers) | Oral |
| Hungary | Zoetis Hungary Kft.
  Alkotás u. 53.
  H-1123 Budapest
  Hungary | Linco-Spectin 100 por belsőleges oldathoz A.U.V. | Lincomycin hydrochloride and spectinomycin sulphate | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Pigs
  Chickens
  Turkeys | Oral |
| Ireland | Pfizer Healthcare Ireland Trading as Pfizer Animal Health,
  Ringaskiddy,
  Co. Cork
  Ireland | Linco-Spectin 100 Soluble Powder | Lincomycin (as Lincomycin Hydrochloride) and Spectinomycin (as spectinomycin sulphate) | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution. Pale yellow to light tan soluble powder | Pigs and poultry (non-layers) | Pigs: Linco-Spectin 100 Soluble Powder is formulated for administration via drinking water. A fresh solution should be prepared each day.
  Poultry: For dosing via the drinking water. |
| Italy | ZOETIS ITALIA S.r.l.
  Via Andrea Doria, 41 M
  00192 Roma
  Italy | LINCOSPECTIN Polvere orale per uso in acqua da bere per polli da carne e suini | LINCOMYCIN (as Hydrochloride) SPECTINOMYCIN (as Sulfate) | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Oral powder for use in drinking water | Pigs
  Chickens | Oral |
| Latvia | Pfizer Animal Health MA EEIG
  Ramsgate Road
  Sandwich, Kent
  CT13 9NJ
  United Kingdom | Linco-Spectin 100 | Lincomycin hydrochloride, spectinomycin sulfate | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Soluble powder for oral solution | Pigs
  Poultry | Oral |
| Lithuania | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 100 | Lincomycin hydrochloride
  Spectinomycin sulphate | 33,3 g
  66,7 g | Soluble Powder | Pigs
  Poultry (non-layers) | Oral |
| Luxembourg | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | LINCO-SPECTIN 100 | Lincomycin and spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Pigs
  Poultry | Oral |
| The Netherlands | Zoetis BV
  Rivium Westlaan 74,
  2909 LD Capelle a/d Ijssel
  The Netherlands | Linco-Spectin 100 | Lincomycin and spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Oral powder | Pigs
  Poultry, not eggs for human consumption | oral |
| Poland | Zoetis Polska Sp. z o.o.
  ul. Postępu 17B
  02-676 Warszawa
  Poland | Linco-Spectin 100 (222 g + 444 g)/1000 g, proszek do sporządzania roztworu doustnego dla świń, kur, indyków, kaczek i gołębi | Lincomycin and spectinomycin | 222 g lincomycin and 444 g spectinomycin per 1  000 g | Powder for oral solution | Pigs
  Chickens
  Turkeys
  Duck
  Pigeon | Oral |
| Portugal | Zoetis Portugal, Lda
  Lagoas Park, Edifício 10
  2740-271 Porto Salvo
  Portugal | LINCO-SPECTIN 100 | Lincomycin and Spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Oral Powder | Pigs
  Poultry (broilers, pullets and turkeys) | Oral |
| Romania | Pfizer Animal Health MA EEIG
  Ramsgate Road
  Sandwich, Kent
  CT13 9NJ
  United Kingdom | LINCO-SPECTIN 100 | Lincomycin and spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Soluble powder | Pigs
  Chickens Turkeys | Oral |
| Slovakia | Zoetis Česká republika, s.r.o.
  Stroupežnického 17
  Praha 5 150 00
  Czech Republic | Linco-Spectin 100 | Lincomycinum (ut Lincomycini hydrochloridum, Spectinomycinum (ut Spectinomycini sulfas tetrahydricus) | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Pigs
  Poultry | Oral |
| Slovenia | Zoetis Belgium SA,
  Rue Laid Burniat 1,
  1348 Louvain-la-Neuve
  Belgium | LincoSpectin 100 prašek za peroralno raztopino za prašiče in perutnino | Lincomycin, Spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for oral solution | Pigs
  Poultry | Oral |
| Spain | Zoetis Spain, S.L.
  Avda. de Europa 20B Parque empresarial La Moraleja
  28108 Alcobendas, Madrid
  Spain | LINCO-SPECTIN 100 | Lincomycin and spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Oral powder | Pigs
  Poultry | Oral |
| United Kingdom | Zoetis UK Limited
  5th Floor, 6 St. Andrew Street
  EC4A 3AE London
  United Kingdom | Linco-Spectin 100 Soluble Powder, Powder for Oral Solution | Lincomycin Spectinomycin | 33,3 g lincomycin and 66,7 g spectinomycin per 150 g | Powder for Oral Solution | Pigs
  Poultry | Pigs: for administration via drinking water.
  Poultry: for administration as the sole daily source of drinking water until consumed, followed by non-medicated water for the rest of the day, if necessary |

Member State

EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Zoetis Österreich GmbH

Floridsdorfer Hauptstraße 1

1210 Vienna

Austria

Linco-Spectin forte-lösliches Pulver für Tiere

Lincomycin (as lincomycin-hydrochlorid-monohydrat) and spectinomycin (as spectinomycin sulfate)

22,2 g lincomycin and 44,5 g spectinomycin per 100 g

Powder for oral solution

Pigs

Chickens

Oral

Belgium

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 100

Lincomycin (as lincomycin hydrochloride) and Spectinomycin (as spectinomycin sulphate)

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Pigs

Chickens

Oral

Bulgaria

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Линко-Спектин 100 разтворим прах/Linco-Spectin 100 Soluble Powder

Lincomycin (as lincomycin hydrochloride), Spectinomycin (as spectinomycin sulphate)

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Pigs

Poultry — hens, chickens and turkeys

Oral

Cyprus

Zoetis Hellas SA

L. Mesogion 253- 255

15451, N. Psichico

Athens

Greece

Linco-Spectin 100 SP, Powder for oral solution for chickens

Lincomycin

Spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Chickens

Oral

Czech Republic

Zoetis Česká republika, s.r.o.

Stroupežnického 17

Praha 5 150 00

Czech Republic

LINCO SPECTIN 100 plv. sol.

Lincomycin and spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Pigs

Poultry

Oral

Denmark

Zoetis Finland Oy

Tietokuja 4

FI 00330 Helsinki

Finland

Linco-Spectin Vet.

Lincomycin and spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for solution in drinking water

Pigs

Chickens

Oral

Estonia

Pfizer Manufacturing Belgium N.V.

Rijksweg 12

B-2870 Puurs

Belgium

Linco-Spectin 100 Soluble Powder

Lincomycin/Spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Pigs

Poultry (broilers)

Oral

France

Zoetis

23/25 Avenue Du Docteur Lannelongue

75014 Paris

France

LINCO-SPECTIN 100

Lincomycin

spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Pigs

Oral

Germany

Zoetis Deutschland GmbH

Schellingstraße 1,

D-10785 Berlin

Germany

Lincospectin Pulver zum Eingeben über das Trinkwasser für Schweine, Hühner (Broiler, Junghennen) und Puten

Lincomycin and spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder

Pigs

Chicken (broiler, pullet)

Turkey

Oral

Greece

Zoetis Hellas SA

L. Mesogion 253- 255

15451, N. Psichico

Athens

Greece

LINCO SPECTIN 100

Lincomycin and spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Pouder for oral solution

Chickens (broilers)

Oral

Hungary

Zoetis Hungary Kft.

Alkotás u. 53.

H-1123 Budapest

Hungary

Linco-Spectin 100 por belsőleges oldathoz A.U.V.

Lincomycin hydrochloride and spectinomycin sulphate

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Pigs

Chickens

Turkeys

Oral

Ireland

Pfizer Healthcare Ireland Trading as Pfizer Animal Health,

Ringaskiddy,

Co. Cork

Ireland

Linco-Spectin 100 Soluble Powder

Lincomycin (as Lincomycin Hydrochloride) and Spectinomycin (as spectinomycin sulphate)

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution. Pale yellow to light tan soluble powder

Pigs and poultry (non-layers)

Pigs: Linco-Spectin 100 Soluble Powder is formulated for administration via drinking water. A fresh solution should be prepared each day.

Poultry: For dosing via the drinking water.

Italy

ZOETIS ITALIA S.r.l.

Via Andrea Doria, 41 M

00192 Roma

Italy

LINCOSPECTIN Polvere orale per uso in acqua da bere per polli da carne e suini

LINCOMYCIN (as Hydrochloride) SPECTINOMYCIN (as Sulfate)

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Oral powder for use in drinking water

Pigs

Chickens

Oral

Latvia

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich, Kent

CT13 9NJ

United Kingdom

Linco-Spectin 100

Lincomycin hydrochloride, spectinomycin sulfate

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Soluble powder for oral solution

Pigs

Poultry

Oral

Lithuania

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 100

Lincomycin hydrochloride

Spectinomycin sulphate

33,3 g

66,7 g

Soluble Powder

Pigs

Poultry (non-layers)

Oral

Luxembourg

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

LINCO-SPECTIN 100

Lincomycin and spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Pigs

Poultry

Oral

The Netherlands

Zoetis BV

Rivium Westlaan 74,

2909 LD Capelle a/d Ijssel

The Netherlands

Linco-Spectin 100

Lincomycin and spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Oral powder

Pigs

Poultry, not eggs for human consumption

oral

Poland

Zoetis Polska Sp. z o.o.

ul. Postępu 17B

02-676 Warszawa

Poland

Linco-Spectin 100 (222 g + 444 g)/1000 g, proszek do sporządzania roztworu doustnego dla świń, kur, indyków, kaczek i gołębi

Lincomycin and spectinomycin

222 g lincomycin and 444 g spectinomycin per 1  000 g

Powder for oral solution

Pigs

Chickens

Turkeys

Duck

Pigeon

Oral

Portugal

Zoetis Portugal, Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

LINCO-SPECTIN 100

Lincomycin and Spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Oral Powder

Pigs

Poultry (broilers, pullets and turkeys)

Oral

Romania

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich, Kent

CT13 9NJ

United Kingdom

LINCO-SPECTIN 100

Lincomycin and spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Soluble powder

Pigs

Chickens Turkeys

Oral

Slovakia

Zoetis Česká republika, s.r.o.

Stroupežnického 17

Praha 5 150 00

Czech Republic

Linco-Spectin 100

Lincomycinum (ut Lincomycini hydrochloridum, Spectinomycinum (ut Spectinomycini sulfas tetrahydricus)

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Pigs

Poultry

Oral

Slovenia

Zoetis Belgium SA,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve

Belgium

LincoSpectin 100 prašek za peroralno raztopino za prašiče in perutnino

Lincomycin, Spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for oral solution

Pigs

Poultry

Oral

Spain

Zoetis Spain, S.L.

Avda. de Europa 20B Parque empresarial La Moraleja

28108 Alcobendas, Madrid

Spain

LINCO-SPECTIN 100

Lincomycin and spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Oral powder

Pigs

Poultry

Oral

United Kingdom

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

EC4A 3AE London

United Kingdom

Linco-Spectin 100 Soluble Powder, Powder for Oral Solution

Lincomycin Spectinomycin

33,3 g lincomycin and 66,7 g spectinomycin per 150 g

Powder for Oral Solution

Pigs

Poultry

Pigs: for administration via drinking water.

Poultry: for administration as the sole daily source of drinking water until consumed, followed by non-medicated water for the rest of the day, if necessary

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing authorisation holder | INN | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | domperidone | Motilium 10 mg — Filmtabletten | 10 mg | film-coated tablet | oral use |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | domperidone | Motilium 1 mg/ml — Suspension zum Einnehmen | 1 mg/ml | oral suspension | oral use |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | domperidone | Motilium 10 mg — Zäpfchen | 10 mg | suppository | rectal use |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | domperidone | Motilium 30 mg — Zäpfchen | 30 mg | suppository | rectal use |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | domperidone | Motilium 60 mg — Zäpfchen | 60 mg | suppository | rectal use |
| Belgium | Teva Pharma Belgium N.V.
  Laarstraat 16
  2610 Wilrijk
  Belgium | Domperidone maleate | Domperidon teva | 10 mg | film-coated tablet | oral use |
| Belgium | Eurogenerics N.V.
  Heizel Esplanade b22
  1020 Brussels
  Belgium | Domperidone maleate | Domperidone EG | 10 mg | tablet | oral use |
| Belgium | Eurogenerics N.V.
  Heizel Esplanade b22
  1020 Brussels
  Belgium | Domperidone | Domperidone instant EG | 10 mg | orodispersible tablet | oral use |
| Belgium | Mylan BVBA/SPRL
  Terhulpsesteenweg 6A
  1560 Hoeilaart
  Belgium | Domperidone maleate | Domperidone mylan | 10 mg | film-coated tablet | oral use |
| Belgium | Apotex NV
  Av Etienne Demunter 5/8
  1090 Brussels
  Belgium | Domperidone maleate | Domperitop | 10 mg | film-coated tablet | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone maleate | Motilium | 1 mg/ml | oral suspension | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone maleate | Motilium | 10 mg | film-coated tablet | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 10 mg | suppository | rectal use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 10 mg | effervescent granules | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 1 mg/ml | oral suspension | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 30 mg | suppository | rectal use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 60 mg | suppository | rectal use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium instant | 10 mg | orodispersible tablet | oral use |
| Belgium | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | Oroperidys | 10 mg | orodispersible tablet | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Cinnarizine/
  Domperidone maleate | Touristil | 20 mg/
  19 mg | tablet | oral use |
| Belgium | Kela Pharma nv
  Industriepark 68
  9100 Sint-Niklaas
  Belgium | Domperidone maleate | Zilium | 10 mg | tablet | oral use |
| Bulgaria | Johnson & Johnson D.O.O
  Smartinska cesta 53
  1000 Ljubljana
  Slovenia | domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Bulgaria | Medochemie Ltd.
  1-10 Astronafton Str.+ Limassol
  3505
  Cyprus | domperidone | Costi | 10 mg | tablet | oral use |
| Cyprus | MEDOCHEMIE LTD
  1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos
  Cyprus | domperidone | COSTI TABLETS 10MG | 10 mg | tablet | oral use |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | domperidone | MOTILIUM ORAL SUSPENSION 1MG/ML | 1 mg/ml | oral suspension | oral use |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | domperidone | MOTILIUM SUPPOSITORY 30MG | 30 mg | suppository | rectal use |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | domperidone | MOTILIUM TABLETS 10MG | 10 mg | tablet | oral use |
| Cyprus | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | OROPERIDYS ORODISPERSIBLE TABLETS 10MG | 10 mg | orodispersible tablet | oral use |
| Cyprus | REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos,
  Cyprus | domperidone | PEPTOMET FILM COATED TABLETS 10MG | 10 mg | tablet | oral use |
| Czech Republic | Janssen-Cilag s.r.o.
  Karla Engliše 3201/6
  150 00 Praha 5 — Smíchov
  Czech Republic | domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Czech Republic | Pierre Fabre Medicament
  45 Place Abel Gance
  92654 Boulogne Cedex
  France | domperidone | Oroperidys 10 mg | 10 mg | orodispersible tablet | oral use |
| Denmark | Janssen-Cilag (TIBOTEC)
  Hammerbakken 19
  3460 Birkeroed
  Denmark | domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Denmark | Janssen-Cilag (TIBOTEC)
  Hammerbakken 19
  3460 Birkeroed
  Denmark | domperidone | Motilium | 30 mg | suppository | rectal use |
| Denmark | Alternova A/S
  Lodhusvej 11
  4230 Skaelskoer
  Denmark | domperidone | Domperidon ‘Alternova’ | 10 mg | tablet | oral use |
| Estonia | Actavis Group Hf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | domperidone | Domperidon Actavis | 10 mg | tablet | oral use |
| Estonia | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | Oroperidys 10 mg | 10 mg | orodispersible tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | BIPERIDYS 20 mg, comprimé pelliculé sécable | 20 mg | film-coated tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | BIPERIDYSFLASH 20 mg, comprimé orodispersible | 20 mg | orodispersible tablet | oral use |
| France | ACTAVIS FRANCE
  La Boursidière Centre d'Affaires
  92357 Le Plessis Robinson
  France | domperidone | DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | domperidone | DOMPERIDONE ALMUS 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | ALTER
  3, avenue de la Baltique
  ZI de Courtaboeuf
  91140 Villebon Sur Yvette
  FRANCE | domperidone | DOMPERIDONE ALTER 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon
  France | domperidone | DOMPERIDONE ARROW 1 mg/ml, suspension buvable | 1 mg/ml | oral suspension | oral use |
| France | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon
  France | domperidone | DOMPERIDONE ARROW 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon
  France | domperidone | DOMPERIDONE ARROW 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | AUROBINDO PHARMA FRANCE
  22-26 rue des Gaudines
  78100 Saint-Germain-en-Laye
  France | domperidone | DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | domperidone | DOMPERIDONE BIOGARAN 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | domperidone | DOMPERIDONE BIOGARAN 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | domperidone | DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | CRISTERS
  22 quai Gallieni
  92150 Suresnes
  France | domperidone | DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | EG LABO — LABORATOIRES EUROGENERICS
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | domperidone | DOMPERIDONE EG 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | EG LABO — LABORATOIRES EUROGENERICS
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | domperidone | DOMPERIDONE EG 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | EG LABO — LABORATOIRES EUROGENERICS
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | domperidone | DOMPERIDONE EG 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | SUBSTIPHARM DEVELOPPEMENT
  8, rue Bellini
  75116 Paris
  France | domperidone | DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | SUBSTIPHARM
  8, rue Bellini
  75116 Paris
  France | domperidone | DOMPERIDONE GERDA 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | domperidone | DOMPERIDONE MYLAN 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | domperidone | DOMPERIDONE MYLAN 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | domperidone | DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable | 20 mg | film-coated tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | DOMPERIDONE PIERRE FABRE MEDICAMENT 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | QUALIMED (LYON)
  117, allée des Parcs
  69800 Saint-Priest
  France | domperidone | DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | RATIOPHARM (ALLEMAGNE)
  Graf Arco Strasse 3
  89079 Ulm
  Germany | domperidone | DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | RATIOPHARM (ALLEMAGNE)
  Graf Arco Strasse 3
  89079 Ulm
  Germany | domperidone | DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | Ranbaxy Pharmacie Génériques
  11-15 Quai Dion Bouton
  92800 Puteaux
  France | domperidone | DOMPERIDONE RPG 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | domperidone | DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | domperidone | DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | domperidone | DOMPERIDONE SANDOZ 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | SUBSTIPHARM DEVELOPPEMENT
  8, rue Bellini
  75116 Paris
  France | domperidone | DOMPERIDONE SG-PHARM 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | SUBSTIPHARM DEVELOPPEMENT
  8, rue Bellini
  75116 Paris
  France | domperidone | DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable | 20 mg | film-coated tablet | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | domperidone | DOMPERIDONE TEVA 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | domperidone | DOMPERIDONE TEVA 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | domperidone | DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable | 20 mg | film-coated tablet | oral use |
| France | Sanofi-Aventis France
  1-13, boulevard Romain Rolland
  75014 Paris
  France | domperidone | DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | Sanofi-Aventis France
  1-13, boulevard Romain Rolland
  75014 Paris
  France | domperidone | DOMPERIDONE ZENTIVA 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | Sanofi-Aventis France
  1-13, boulevard Romain Rolland
  75014 Paris
  France | domperidone | DOMPERIDONE ZENTIVA 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | ZYDUS FRANCE
  25, rue des Peupliers
  ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers
  92000 Nanterre
  France | domperidone | DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | Janssen-Cilag
  1, rue Camille Desmoulins
  TSA 91003
  92787 Issy-les-Moulineaux Cedex 9
  France | domperidone | MOTILIUM 1 mg/ml, suspension buvable | 1 mg/ml | oral suspension | oral use |
| France | Janssen-Cilag
  1, rue Camille Desmoulins
  TSA 91003
  92787 Issy-les-Moulineaux Cedex 9
  France | domperidone | MOTILIUM 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | Janssen-Cilag
  1, rue Camille Desmoulins
  TSA 91003
  92787 Issy-les-Moulineaux Cedex 9
  France | domperidone | MOTILIUM 10 mg, granulés effervescents en sachet-dose | 10 mg | effervescent granules | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | OROPERIDYS 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | PERIDYS 1 mg/ml, suspension buvable | 1 mg/ml | oral suspension | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | PERIDYS 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| Germany | 1 A Pharma GmbH
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Domperidonemaleat | Domperidon — 1 A Pharma 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Domperidonemaleat | Domperidon-CT 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Domperidonemaleat | Domperidon AbZ 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Germany | Accord Healthcare Limited
  Sage House, 319, Pinner Road
  HA1 4HF North Harrow, Middlesex
  United Kingdom | Domperidonemaleat | Domperidon Accord 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | ALIUD PHARMA GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Domperidonemaleat | Domperidon AL 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | betapharm Arzneimittel GmbH
  Kobelweg 95
  86156 Augsburg
  Germany | Domperidonemaleat | Domperidon beta 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | HEXAL AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Domperidonemaleat | Domperidom Hexal 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | RATIOPHARM GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | Domperidonemaleat | Domperidon-ratiopharm 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Germany | Stadapharm GmbH
  Stadastr. 2-18
  61118 Bad Vilbel
  Germany | Domperidonemaleat | Domperidon STADA 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | Takeda GmbH
  Byk-Gulden-Str. 2
  78467 Konstanz
  Germany | Domperidone | Motilium Tropfen | 10 mg | oral drops, suspension | oral use |
| Germany | Takeda GmbH
  Byk-Gulden-Str. 2
  78467 Konstanz
  Germany | Domperidone | Motilium | 10 mg | tablet | oral use |
| Germany | TEVA GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Domperidonemaleat | Domperidon-TEVA 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Germany | TEVA GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Domperidonemaleat | Domidon 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Greece | JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
  Epidarvou 4 & Aigialeias
  Maroussi 15125
  Athens,
  Greece | domperidone | CILROTON | 10 mg | film-coated tablet | oral use |
| Greece | JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
  Epidarvou 4 & Aigialeias
  Maroussi 15125
  Athens,
  Greece | domperidone | CILROTON | 5 mg/5 ml | oral solution | oral use |
| Greece | PIERRE FABRE MEDICINES SA
  Messogeion 350, Agia Paraskevi 15341
  Athens,
  Greece | domperidone | OROPERIDYS | 10 mg | orodispersible tablet | oral use |
| Hungary | Extractum Pharma zRT. Megyeri út 64. Budapest H-1044 Hungary | domperidone | Domperidon-EP 10 mg tabletta | 10 mg | tablet | oral use |
| Hungary | Janssen-Cilag Kft.
  Tó park
  H-2045 Törökbálint
  Hungary | domperidone | Motilium 10 mg filmtabletta | 10 mg | film-coated tablet | oral use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium Fastmelts 10 mg Tablets | 10 mg | tablet | oral use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 10 mg Film-Coated Tablets | 10 mg | tablet | oral use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 10 mg Suppositories | 10 mg | suppository | rectal use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 30 mg Suppositories | 30 mg | suppository | rectal use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 60 mg Suppositories | 60 mg | suppository | rectal use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 1 mg/ml Oral Suspension | 1 mg/ml | oral suspension | oral use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium Rx 10 mg Film-coated Tablets. | 10 mg | film-coated tablet | oral use |
| Ireland | Rowex Ltd
  Bantry
  Co Cork
  Ireland | Domperidone | DOMERID 10 mg Tablets. | 10 mg | tablet | oral use |
| Ireland | Rowex Ltd
  Bantry
  Co Cork
  Ireland | Domperidone | Domerid Relief 10 mg Tablets. | 10 mg | tablet | oral use |
| Italy | ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 10 mg | film-coated tablet | oral use |
| Italy | ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 60 mg | suppository | rectal use |
| Italy | ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 30 mg | suppository | rectal use |
| Italy | ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 10 mg | effervescent granules | oral use |
| Italy | ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 1 mg/ml | suspension | oral use |
| Italy | ITALCHIMICI S.P.A.
  Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 20 mg | film-coated tablet | oral use |
| Italy | ITALCHIMICI S.P.A.
  Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 20 mg | effervescent granules | oral use |
| Italy | Janssen-Cilag S.P.A.
  Via Michelangelo buonarroti 23
  20093 Cologno Monzese — Milano
  Italy | Domperidone | MOTILIUM | 1 mg/ml | suspension | oral use |
| Italy | Janssen-Cilag S.P.A.
  Via Michelangelo buonarroti 23
  20093 Cologno Monzese — Milano
  Italy | Domperidone | MOTILIUM | 10 mg | film-coated tablet | oral use |
| Italy | Janssen-Cilag S.P.A.
  Via Michelangelo buonarroti 23
  20093 Cologno Monzese — Milano
  Italy | Domperidone | MOTILIUM | 10 mg | effervescent granules | oral use |
| Italy | DR. REDDY'S S.R.L.
  Via Fernanda Wittgens 3 — 20123 Milano
  Italy | Domperidone | DOMPERIDONE DR. REDDY'S | 10 mg | tablet | oral use |
| Italy | DR. REDDY'S S.R.L.
  Via Fernanda Wittgens 3 — 20123 Milano
  Italy | Domperidone | DOMPERIDONE DR. REDDY'S | 100 mg/100 ml | syrup | oral use |
| Italy | GIULIANI S.P.A
  Via Palagi 2 20129 Milano
  Italy | Domperidone | DIGESTIVO GIULIANI | 5 mg | effervescent granules | oral use |
| Italy | GIULIANI S.P.A
  Via Palagi 2
  20129 Milano
  Italy | Domperidone | DIGESTIVO GIULIANI | 5 mg | chewable tablet | oral use |
| Italy | GIULIANI S.P.A
  Via Palagi 2
  20129 Milano
  Italy | Domperidone | DIGESTIVO GIULIANI | 10 mg | film-coated tablet | oral use |
| Italy | TEVA ITALIA S.R.L.
  Via Messina 38
  20154 Milano
  Italy | Domperidone | DOMPERIDONE TEVA | 10 mg | film-coated tablet | oral use |
| Italy | GERMED PHARMA S.P.A.
  Via Cantù 11
  20092 Cinisello Balsamo — Milano — Italy | Domperidone | DOMPERIDONE GERMED | 10 mg | film-coated tablet | oral use |
| Italy | GERMED PHARMA S.P.A.
  Via Cantù 11
  20092 Cinisello Balsamo — Milano — Italy | Domperidone | DOMPERIDONE GERMED | 10 mg/10 ml | suspension | oral use |
| Italy | ABC FARMACEUTICI S.P.A.,
  Corso Vittorio Emanuele II 72 , 10121 Torino
  Italy | Domperidone | DOMPERIDONE ABC | 10 mg | tablet | oral use |
| Italy | MYLAN S.P.A.
  Via Vittor Pisani 20
  20124 Milano
  Italy | Domperidone | DOMPERIDONE MYLAN GENERICS | 10 mg | tablet | oral use |
| Italy | FG S.R.L.
  Via San Rocco 6 -
  85033 Episcopia — Potenza
  Italy | Domperidone | DOMPERIDONE FG | 10 mg | tablet | oral use |
| Italy | EG S.P.A.
  Via Domenico Scarlatti 31
  20124 Milano
  Italy | Domperidone | DOMPERIDONE EG | 10 mg | tablet | oral use |
| Italy | LABORATORI ALTER S.R.L.
  Via Egadi 7
  20144 Milano
  Italy | Domperidone | DOMPERIDONE ALTER | 10 mg | tablet | oral use |
| Italy | CRINOS S.P.A.
  Via Pavia 6
  20136 Milano
  Italy | Domperidone | RIGES | 10 mg | tablet | oral use |
| Italy | SANDOZ S.P.A.
  Largo Umberto Boccioni 1
  21040 Origgio — Varese
  Italy | Domperidone | PYNINAT | 10 mg | tablet | oral use |
| Italy | DOC GENERICI S.R.L.
  Via Manunzio 7
  20124 Milano
  Italy | Domperidone | DOMPERIDONE DOC GENERICI | 10 mg | tablet | oral use |
| Italy | ALMUS S.R.L.
  Via Cesarea 11/10
  16121 Genova
  Italy | Domperidone | DOMPERIDONE ALMUS | 10 mg | tablet | oral use |
| Italy | FARMAKOPEA S.P.A
  Via Cavriana 14
  20134 Milano
  Italy | Domperidone | DALIA | 10 mg | effervescent tablet | oral use |
| Italy | SANDOZ S.P.A.
  Largo Umberto Boccioni 1
  21040 Origgio — Varese
  Italy | Domperidone | DOMPERIDONE SANDOZ | 10 mg | tablet | oral use |
| Italy | PENSA PHARMA S.P.A.
  Via Ippolito Rossellini 12
  20124 Milano
  Italy | Domperidone | DOMPERIDONE PENSA | 10 mg | effervescent tablet | oral use |
| Italy | FARMAKOPEA S.P.A
  Via Cavriana 14
  20134 Milano
  Italy | Domperidone | GERDI | 5 mg | effervescent tablet | oral use |
| Italy | FARMAKOPEA S.P.A
  Via Cavriana 14
  20134 Milano
  Italy | Domperidone | GERDI | 5 mg | effervescent granules | oral use |
| Italy | CRINOS S.P.A.
  Via Pavia 6
  20136 Milano
  Italy | Domperidone | RAXAR | 10 mg | orodispersible tablet | oral use |
| Italy | PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano
  Italy | Domperidone | NEOPERIDYS | 10 mg | orodispersible tablet | oral use |
| Italy | SOFAR S.p.a. Via Firenze, 40 20060 Trezzano Rosa — Milano
  Italy | Domperidone Maleato | PERMOTIL | 10 mg | tablet | oral use |
| Italy | ANGENERICO S.p.a.
  Via Nocera Umbra 75, 00181 Roma
  Italy | Domperidone Maleato | DOMPERIDONE ANGENERICO | 10 mg | tablet | oral use |
| Latvia | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | Oroperidys 10 mg orodispersible tablets | 10 mg | orodispersible tablet | oral use |
| Latvia | UAB ‘Johnson & Johnson’
  Geležinio Vilko g. 18A
  LT-08104 Vilnius
  Lithuania | domperidone | Motilium 10 mg film-coated tablets | 10 mg | film-coated tablet | oral use |
| Latvia | Actavis Group Hf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | domperidone | Domperidon Actavis 10 mg tablets | 10 mg | tablet | oral use |
| Lithuania | Actavis Group Hf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Domperidone | Domperidon Actavis | 10 mg | tablet | oral use |
| Lithuania | Torrent Pharma GmbH
  Sudwestpark 50
  Nurnberg D-90449
  Germany | Domperidone | Domstal | 10 mg | tablet | oral use |
| Lithuania | UAB ‘Johnson & Johnson’
  Geležinio Vilko g. 18A
  LT-08104 Vilnius
  Lithuania | Domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Lithuania | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | Oroperidys | 10 mg | orodispersible tablet | oral use |
| Luxembourg | eurogenerics SA esplanade heysel b22 1020 bruxelles
  Belgium | domperidone (maleate) | Domperidone EG-10 | 10 mg | tablet | oral use |
| Luxembourg | eurogenerics SA esplanade heysel b22
  1020 bruxelles
  Belgium | domperidone | Domperidone EG-10 | 10 mg | orodispersible tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | domperidone | Motilium Domperidone Base | 10 mg | coated tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | domperidone | Motilium Instant-10 | 10 mg | orodispersible tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | domperidone (maleate) | Motilium-10 | 10 mg | coated tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | domperidone | Motilium pediatrie | 1 mg/ml | oral suspension | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | domperidone | Motilium-1 mg/ml | 1 mg/ml | oral suspension | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | domperidone | Motilium-10 supp. | 10 mg | suppository | rectal use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | domperidone | Motilium-30 supp | 30 mg | suppository | rectal use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | domperidone | Motilium-60 supp | 60 mg | suppository | rectal use |
| Luxembourg | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | domperidone | Oroperidys | 10 mg | orodispersible tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Cinnarizine/Domperidone (maleate) | Touristil | 20 mg/
  15 mg | tablet | oral use |
| Malta | Actavis Group Hf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Domperidone | Domperidon Actavis | 10 mg | tablet | oral use |
| Malta | Medochemie Limited
  PO Box 51409
  Limassol CY-3505
  Cyprus | domperidone | Costi 10 mg Film coated tablets | 10 mg | film-coated tablet | oral use |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | domperidone | motilium 1 mg/ml oral suspension | 1 mg/ml | oral suspension | oral use |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | domperidone | motilium 10 mg film coated tablets | 10 mg | film-coated tablet | oral use |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | domperidone | motilium 30 mg Suppositories | 30 mg | suppository | rectal use |
| Poland | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | Oroperidys | 10 mg | orodispersible tablet | oral use |
| Portugal | Laboratório Medinfar — Produtos Farmacêuticos, S.A.
  Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova
  2700-547 Amadora
  Portugal | domperidone | Cinet | 10 mg | tablet | oral use |
| Portugal | Laboratório Medinfar — Produtos Farmacêuticos, S.A.
  Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova
  2700-547 Amadora
  Portugal | domperidone | Cinet | 10 mg | dispersible tablet | oral use |
| Portugal | Laboratório Medinfar — Produtos Farmacêuticos, S.A.
  Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova
  2700-547 Amadora
  Portugal | domperidone | Cinet | 1 mg/ml | oral suspension | oral use |
| Portugal | Actavis A/S Sucursal
  Rua Virgílio Correia, 11 — A
  1600-219 Lisboa
  Portugal | domperidone | Domperidona Actavis | 10 mg | tablet | oral use |
| Portugal | Baldacci — Portugal, S.A.
  Rua Cândido de Figueiredo, 84-B
  1549-005 Lisboa
  Portugal | domperidone | Domperidona Baldacci | 10 mg | film-coated tablet | oral use |
| Portugal | Ciclum Farma Unipessoal, Lda.
  Quinta da Fonte, Rua Vitor Câmara, 2 — Edifício D. Amélia, Piso 1, Ala B
  2770-229 Paço de Arcos
  Portugal | domperidone | Domperidona Ciclum | 10 mg | tablet | oral use |
| Portugal | GP — Genéricos Portugueses, Lda.
  Rua Henrique Paiva Couceiro, 29 — Venda Nova
  2700-451 Amadora
  Portugal | domperidone | Domperidona GP | 10 mg | tablet | oral use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | domperidone | Domperidona Generis | 10 mg | film-coated tablet | oral use |
| Portugal | Germed Farmacêutica, Lda.
  Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto
  2790-012 Portela de Carnaxide
  Portugal | domperidone | Domperidona Germed | 10 mg | film-coated tablet | oral use |
| Portugal | Labesfal Genéricos, S.A
  Avenida Dr. Afonso Costa, 1370
  3465-051 Campo de Besteiros
  Portugal | domperidone | Domperidona Labesfal | 10 mg | tablet | oral use |
| Portugal | Mylan, Lda.
  Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C — 7.3 e 7.4
  1990-095 Lisboa
  Portugal | domperidone | Domperidona Mylan | 10 mg | film-coated tablet | oral use |
| Portugal | Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.
  Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo
  Portugal | domperidone | Domperidona Ratiopharm | 10 mg | film-coated tablet | oral use |
| Portugal | ToLife — Produtos Farmacêuticos, S.A.
  Avenida do Forte, 3 — Edificio Suécia III, Piso 1
  2794-093 Carnaxide
  Portugal | domperidone | Domperidona ToLife | 10 mg | tablet | oral use |
| Portugal | Wynn Industrial Pharma, S.A.
  Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras
  1070-274 Lisboa
  Portugal | domperidone | Domperidona Wynn | 10 mg | tablet | oral use |
| Portugal | Johnson & Johnson, Lda.
  Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
  2730-055 Barcarena
  Portugal | domperidone | Motilium | 1 mg/ml | oral suspension | oral use |
| Portugal | Johnson & Johnson, Lda.
  Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
  2730-055 Barcarena
  Portugal | domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Portugal | Johnson & Johnson, Lda.
  Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
  2730-055 Barcarena
  Portugal | domperidone | Motilium | 10 mg | effervescent granules | oral use |
| Portugal | Johnson & Johnson, Lda.
  Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
  2730-055 Barcarena
  Portugal | domperidone | Motilium Rapid | 10 mg | orodispersible tablet | oral use |
| Portugal | Laboratórios Azevedos — Indústria Farmacêutica, S.A.
  Edifícios Azevedos — Estrada Nacional 117-2, Alfragide
  2614-504 Amadora
  Portugal | domperidone | Remotil | 10 mg | tablet | oral use |
| Romania | S.C. TERAPIA S.A.
  Str. Fabricii nr. 124, Cluj Napoca,
  Romania | DOMPERIDONE | MOTILIUM 10 mg | 10 mg | film-coated tablet | oral use |
| Romania | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | DOMPERIDONE | OROPERIDYS 10 mg | 10 mg | orodispersible tablet | oral use |
| Slovak Republic | Pierre Fabre Medicament
  45 Place Abel Gance
  92654 Boulogne Cedex
  France | Domperidone | OROPERIDYS 10 mg | 10 mg | tablet | oral use |
| Slovak Republic | Medochemie Ltd.
  1-10 Constantinoupoleos St.
  P.O. Box: 51409
  3505 Limassol Cyprus | Domperidone | COSTI | 10 mg | tablet | oral use |
| Slovenia | KRKA, tovarna zdravil, d.d., Novo mesto
  Šmarješka cesta 6 8501 Novo mesto Slovenia | domperidone | Tametil 10 mg filmsko obložene tablete | 10 mg | film-coated tablet | oral use |
| Spain | LABORATORIOS DR. ESTEVE, S.A.
  Avda. Mare de Déu de Montserrat, 221
  08041 Barcelona
  Spain | Domperidone | Motilium 30 mg supositorios niños | 30 mg | suppository | rectal use |
| Spain | LABORATORIOS DR. ESTEVE, S.A.
  Avda. Mare de Déu de Montserrat, 221
  08041 Barcelona
  Spain | Domperidone | Motilium 10 mg comprimidos recubiertos con película | 10 mg | film-coated tablet | oral use |
| Spain | LABORATORIOS DR. ESTEVE, S.A.
  Avda. Mare de Déu de Montserrat, 221
  08041 Barcelona
  Spain | Domperidone | Motilium 1 mg/ml suspensión oral | 1 mg/ml | oral suspension | oral use |
| Spain | Janssen-Cilag, S.A.
  Po de Las Doce Estrellas, 5-7
  28042 Madrid
  Spain | Domperidone | Nauzelin 1 mg/ml suspensión oral | 1 mg/ml | oral suspension | oral use |
| Spain | Janssen-Cilag, S.A.
  Po de Las Doce Estrellas, 5-7
  28042 Madrid
  Spain | Domperidone | Nauzelin 10 mg comprimidos recubiertos con película | 10 mg | film-coated tablet | oral use |
| Spain | ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain | Domperidone | Domperidona Gamir 10 mg cápsulas duras | 10 mg | capsule, hard | oral use |
| Spain | ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain | Domperidone | Domperidona Gamir 1 mg/ml suspensión oral | 1 mg/ml | oral suspension | oral use |
| Spain | PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3-bajos
  Valencia 46015 Spain | Domperidone maleate | Domperidona Pensa 10 mg comprimidos EFG | 12,72 mg | tablet | oral use |
| Spain | Pierre Fabre Médicament
  45 place Abel Gance
  F-92100 Boulogne
  France | Domperidone | Orosperidys 10 mg comprimidos bucodispersables | 10 mg | orodispersible tablet | oral use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium filmomhulde tabletten 10 mg | 10 mg | film-coated tablet | oral use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium suspensie voor oraal gebruik 1 mg/ml | 1 mg/ml | oral suspension | oral use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium zetpillen voor zuigelingen 10 mg | 10 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium zetpillen voor kinderen 30 mg | 30 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium zetpillen voor volwassenen 60 mg | 60 mg | suppository | rectal use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg | 10 mg | suppository | rectal use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 30 PCH voor kinderen, zetpillen 30 mg | 30 mg | suppository | rectal use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 60 PCH voor volwassenen, zetpillen 60 mg | 60 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Domperidon JJC filmomhulde tabletten 10 mg | 10 mg | film-coated tablet | oral use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Domperidon JJC zetpillen voor volwassenen 60 mg | 60 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Domperidon JJC zetpillen voor kinderen 30 mg | 30 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Domperidon JJC zetpillen voor zuigelingen 10 mg | 10 mg | suppository | rectal use |
| The Netherlands | Samenwerkende Apothekers Nederland B.V.
  Kralingseweg 201
  3062 CE Rotterdam
  The Netherlands | Domperidone | Domperidon 30 mg zetpillen Samenwerkende Apothekers | 30 mg | suppository | rectal use |
| The Netherlands | Samenwerkende Apothekers Nederland B.V.
  Kralingseweg 201
  3062 CE Rotterdam
  The Netherlands | Domperidone | Domperidon 60 mg zetpillen Samenwerkende Apothekers, zetpillen | 60 mg | suppository | rectal use |
| The Netherlands | Mylan B.V.
  Dieselweg 25
  3752 LB Bunschoten
  The Netherlands | Domperidone | Domperidon Mylan 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Pharmacin B.V.
  Molenvliet 103
  3335 LH Zwijndrecht
  The Netherlands | Domperidone | Domperidon Pharmacin 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 10 PCH, filmomhulde tabletten 10 mg | 10 mg | film-coated tablet | oral use |
| The Netherlands | Accord Healthcare Ltd
  Sage House, 319 Pinner Road
  HA1 4 HF North Harrow, Middlesex
  United Kingdom | Domperidone | Domperidon Accord 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Healthypharm B.V.
  Nieuwe Donk 3
  4879 AC Etten-Leur
  The Netherlands | Domperidone | Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Leidapharm B.V.
  Archimedesweg 2
  2333 CN Leiden
  The Netherlands | Domperidone | Domperidon 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Stada Arzneimittel AG
  Stadastrasse 2-18
  61118 Bad Vilbel
  Germany | Domperidone | Domperidon STADA 10 mg tabletten | 10 mg | tablet | oral use |
| The Netherlands | Actavis B.V.
  Baarnsche Dijk 1
  3741 LN Baarn
  The Netherlands | Domperidone | Domperidon Actavis 10 mg, omhulde tabletten | 10 mg | coated tablet | oral use |
| The Netherlands | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC Etten-Leur
  The Netherlands | Domperidone | Domperidon CF 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon PCH 10, filmomhulde tabletten 10 mg | 10 mg | film-coated tablet | oral use |
| The Netherlands | Wise Pharmaceuticals Ltd.
  Hamwells Business Park Unit No7, Hardicker Street
  M19 2RB Manchester
  United Kingdom | Domperidone | Domperidon 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Marel B.V.
  Archimedesweg 2
  2333 CN Leiden
  The Netherlands | Domperidone | Kruidvat Domperidon 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Sandoz B.V.
  Veluwezoom 22
  1327 AH Almere
  The Netherlands | Domperidone | Domperidon Sandoz 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Sofar S.p.A.
  Via Firenze 40
  20060 Trezzano Rosa (MI)
  Italy | Domperidone | Domperidon Sofar 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Bellwood Pharmaceuticals Ltd.
  First Floor 69, St. Patricks Road
  Dalkey, Co. Dublin
  Ireland | Domperidone | Domperidon Bellwood 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Faribérica, Productos Farmacêuticos, SA
  Estrada da Luz, 90-9o CDE
  1600-160 Lissabon
  Portugal | Domperidone | Domperidon Faribérica 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Actavis Nordic A/S
  Ornegardsvej 16
  2820 Gentofte
  Denmark | Domperidone | Domperidon Actavis 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Mediq Farma B.V.
  Hertogswetering 159
  3543 AS Utrecht
  The Netherlands | Domperidone | Domperidon Mdq 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 10 mg PCH, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Samenwerkende Apothekers Nederland B.V.
  Kralingseweg 201
  3062 CE Rotterdam
  The Netherlands | Domperidone | Domperidon 10 mg tabletten Samenwerkende Apothekers | 10 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 10 mg Pharmachemie, tabletten | 10 mg | tablet | oral use |
| The Netherlands | KELA Pharma nv
  Industriepark West 68
  9100 Sint-Niklaas
  Belgium | Domperidone | Domperidon Kela 10 mg, tabletten | 10 mg | tablet | oral use |
| United Kingdom | Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3 7UN
  United Kingdom | domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG,
  United Kingdom | domperidone maleate | Domperidone Tablets 10 mg | 10 mg | coated tablet | oral use |
| United Kingdom | Co-Pharma Limited
  Unit 4, Metro Centre
  Tolpits Lane, Watford
  Hertfordshire
  WD18 9SS
  United Kingdom | domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Manx Healthcare Limited
  Taylor Group House
  Wedgnock Lane
  Warwick
  CV34 5YA
  United Kingdom | domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
  United Kingdom | domperidone maleate | Motilium 10 | 10 mg | tablet | oral use |
| United Kingdom | McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
  United Kingdom | domperidone maleate | Motilium Instants | 10 mg | orodispersible tablet | oral use |
| United Kingdom | Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD,
  United Kingdom | domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS,
  United Kingdom | domperidone | Domperidone 1 mg/ml Oral Suspension | 5 mg | oral suspension | oral use |
| United Kingdom | Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
  United Kingdom | domperidone maleate | Motilium 10 mg Film-coated Tablets | 10 mg | film-coated tablet | oral use |
| United Kingdom | Bristol Laboratories Limited
  Unit 3, Canalside
  Northbridge Road, Berkhamsted
  Hertfordshire
  HP4 1EG
  United Kingdom | domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Focus Pharmaceuticals Limited
  Unit 5, Faraday Court
  First Avenue, Centrum 100
  Burton Upon Trent, Staffordshire
  DE14 2WX
  United Kingdom | domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Medreich plc,
  Warwick House, Plane Tree Crescent, Feltham TW13 7HF
  United Kingdom | domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Wockhardt UK Limited
  Ash Road North
  Wrexham Industrial Estate
  Wrexham LL13 9UF
  United Kingdom | domperidone maleate | Domperidone 10 mg Tablets | 10 mg | film-coated tablet | oral use |
| United Kingdom | Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co. Roscommon,
  Ireland | domperidone maleate | Domperidone 10 mg Tablets | 10 mg | film-coated tablet | oral use |

Member State

(in EEA)

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

domperidone

Motilium 10 mg — Filmtabletten

10 mg

film-coated tablet

oral use

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

domperidone

Motilium 1 mg/ml — Suspension zum Einnehmen

1 mg/ml

oral suspension

oral use

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

domperidone

Motilium 10 mg — Zäpfchen

10 mg

suppository

rectal use

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

domperidone

Motilium 30 mg — Zäpfchen

30 mg

suppository

rectal use

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

domperidone

Motilium 60 mg — Zäpfchen

60 mg

suppository

rectal use

Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Domperidone maleate

Domperidon teva

10 mg

film-coated tablet

oral use

Belgium

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Domperidone maleate

Domperidone EG

10 mg

tablet

oral use

Belgium

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Domperidone

Domperidone instant EG

10 mg

orodispersible tablet

oral use

Belgium

Mylan BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Domperidone maleate

Domperidone mylan

10 mg

film-coated tablet

oral use

Belgium

Apotex NV

Av Etienne Demunter 5/8

1090 Brussels

Belgium

Domperidone maleate

Domperitop

10 mg

film-coated tablet

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone maleate

Motilium

1 mg/ml

oral suspension

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone maleate

Motilium

10 mg

film-coated tablet

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

10 mg

suppository

rectal use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

10 mg

effervescent granules

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

10 mg

film-coated tablet

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

1 mg/ml

oral suspension

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

30 mg

suppository

rectal use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

60 mg

suppository

rectal use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium instant

10 mg

orodispersible tablet

oral use

Belgium

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

Oroperidys

10 mg

orodispersible tablet

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Cinnarizine/

Domperidone maleate

Touristil

20 mg/

19 mg

tablet

oral use

Belgium

Kela Pharma nv

Industriepark 68

9100 Sint-Niklaas

Belgium

Domperidone maleate

Zilium

10 mg

tablet

oral use

Bulgaria

Johnson & Johnson D.O.O

Smartinska cesta 53

1000 Ljubljana

Slovenia

domperidone

Motilium

10 mg

film-coated tablet

oral use

Bulgaria

Medochemie Ltd.

1-10 Astronafton Str.+ Limassol

3505

Cyprus

domperidone

Costi

10 mg

tablet

oral use

Cyprus

MEDOCHEMIE LTD

1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos

Cyprus

domperidone

COSTI TABLETS 10MG

10 mg

tablet

oral use

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

domperidone

MOTILIUM ORAL SUSPENSION 1MG/ML

1 mg/ml

oral suspension

oral use

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

domperidone

MOTILIUM SUPPOSITORY 30MG

30 mg

suppository

rectal use

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

domperidone

MOTILIUM TABLETS 10MG

10 mg

tablet

oral use

Cyprus

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

OROPERIDYS ORODISPERSIBLE TABLETS 10MG

10 mg

orodispersible tablet

oral use

Cyprus

REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos,

Cyprus

domperidone

PEPTOMET FILM COATED TABLETS 10MG

10 mg

tablet

oral use

Czech Republic

Janssen-Cilag s.r.o.

Karla Engliše 3201/6

150 00 Praha 5 — Smíchov

Czech Republic

domperidone

Motilium

10 mg

film-coated tablet

oral use

Czech Republic

Pierre Fabre Medicament

45 Place Abel Gance

92654 Boulogne Cedex

France

domperidone

Oroperidys 10 mg

10 mg

orodispersible tablet

oral use

Denmark

Janssen-Cilag (TIBOTEC)

Hammerbakken 19

3460 Birkeroed

Denmark

domperidone

Motilium

10 mg

film-coated tablet

oral use

Denmark

Janssen-Cilag (TIBOTEC)

Hammerbakken 19

3460 Birkeroed

Denmark

domperidone

Motilium

30 mg

suppository

rectal use

Denmark

Alternova A/S

Lodhusvej 11

4230 Skaelskoer

Denmark

domperidone

Domperidon ‘Alternova’

10 mg

tablet

oral use

Estonia

Actavis Group Hf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

domperidone

Domperidon Actavis

10 mg

tablet

oral use

Estonia

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

Oroperidys 10 mg

10 mg

orodispersible tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

BIPERIDYS 20 mg, comprimé pelliculé sécable

20 mg

film-coated tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

BIPERIDYSFLASH 20 mg, comprimé orodispersible

20 mg

orodispersible tablet

oral use

France

ACTAVIS FRANCE

La Boursidière Centre d'Affaires

92357 Le Plessis Robinson

France

domperidone

DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

domperidone

DOMPERIDONE ALMUS 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette

FRANCE

domperidone

DOMPERIDONE ALTER 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

domperidone

DOMPERIDONE ARROW 1 mg/ml, suspension buvable

1 mg/ml

oral suspension

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

domperidone

DOMPERIDONE ARROW 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

domperidone

DOMPERIDONE ARROW 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

AUROBINDO PHARMA FRANCE

22-26 rue des Gaudines

78100 Saint-Germain-en-Laye

France

domperidone

DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

domperidone

DOMPERIDONE BIOGARAN 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

domperidone

DOMPERIDONE BIOGARAN 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

domperidone

DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

CRISTERS

22 quai Gallieni

92150 Suresnes

France

domperidone

DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

EG LABO — LABORATOIRES EUROGENERICS

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

domperidone

DOMPERIDONE EG 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

EG LABO — LABORATOIRES EUROGENERICS

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

domperidone

DOMPERIDONE EG 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

EG LABO — LABORATOIRES EUROGENERICS

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

domperidone

DOMPERIDONE EG 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

SUBSTIPHARM DEVELOPPEMENT

8, rue Bellini

75116 Paris

France

domperidone

DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

SUBSTIPHARM

8, rue Bellini

75116 Paris

France

domperidone

DOMPERIDONE GERDA 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

domperidone

DOMPERIDONE MYLAN 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

domperidone

DOMPERIDONE MYLAN 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

domperidone

DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable

20 mg

film-coated tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

DOMPERIDONE PIERRE FABRE MEDICAMENT 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

France

domperidone

DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

Germany

domperidone

DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

Germany

domperidone

DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

Ranbaxy Pharmacie Génériques

11-15 Quai Dion Bouton

92800 Puteaux

France

domperidone

DOMPERIDONE RPG 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

domperidone

DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

domperidone

DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

domperidone

DOMPERIDONE SANDOZ 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

SUBSTIPHARM DEVELOPPEMENT

8, rue Bellini

75116 Paris

France

domperidone

DOMPERIDONE SG-PHARM 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

SUBSTIPHARM DEVELOPPEMENT

8, rue Bellini

75116 Paris

France

domperidone

DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable

20 mg

film-coated tablet

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

domperidone

DOMPERIDONE TEVA 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

domperidone

DOMPERIDONE TEVA 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

domperidone

DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable

20 mg

film-coated tablet

oral use

France

Sanofi-Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

domperidone

DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

Sanofi-Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

domperidone

DOMPERIDONE ZENTIVA 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

Sanofi-Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

domperidone

DOMPERIDONE ZENTIVA 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

ZYDUS FRANCE

25, rue des Peupliers

ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers

92000 Nanterre

France

domperidone

DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

Janssen-Cilag

1, rue Camille Desmoulins

TSA 91003

92787 Issy-les-Moulineaux Cedex 9

France

domperidone

MOTILIUM 1 mg/ml, suspension buvable

1 mg/ml

oral suspension

oral use

France

Janssen-Cilag

1, rue Camille Desmoulins

TSA 91003

92787 Issy-les-Moulineaux Cedex 9

France

domperidone

MOTILIUM 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

Janssen-Cilag

1, rue Camille Desmoulins

TSA 91003

92787 Issy-les-Moulineaux Cedex 9

France

domperidone

MOTILIUM 10 mg, granulés effervescents en sachet-dose

10 mg

effervescent granules

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

OROPERIDYS 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

PERIDYS 1 mg/ml, suspension buvable

1 mg/ml

oral suspension

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

PERIDYS 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

Germany

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Germany

Domperidonemaleat

Domperidon — 1 A Pharma 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Domperidonemaleat

Domperidon-CT 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Domperidonemaleat

Domperidon AbZ 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Germany

Accord Healthcare Limited

Sage House, 319, Pinner Road

HA1 4HF North Harrow, Middlesex

United Kingdom

Domperidonemaleat

Domperidon Accord 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Domperidonemaleat

Domperidon AL 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Domperidonemaleat

Domperidon beta 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

HEXAL AG

Industriestr. 25

83607 Holzkirchen

Germany

Domperidonemaleat

Domperidom Hexal 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

RATIOPHARM GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

Domperidonemaleat

Domperidon-ratiopharm 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Domperidonemaleat

Domperidon STADA 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

Takeda GmbH

Byk-Gulden-Str. 2

78467 Konstanz

Germany

Domperidone

Motilium Tropfen

10 mg

oral drops, suspension

oral use

Germany

Takeda GmbH

Byk-Gulden-Str. 2

78467 Konstanz

Germany

Domperidone

Motilium

10 mg

tablet

oral use

Germany

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Domperidonemaleat

Domperidon-TEVA 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Germany

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Domperidonemaleat

Domidon 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Greece

JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA

Epidarvou 4 & Aigialeias

Maroussi 15125

Athens,

Greece

domperidone

CILROTON

10 mg

film-coated tablet

oral use

Greece

JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA

Epidarvou 4 & Aigialeias

Maroussi 15125

Athens,

Greece

domperidone

CILROTON

5 mg/5 ml

oral solution

oral use

Greece

PIERRE FABRE MEDICINES SA

Messogeion 350, Agia Paraskevi 15341

Athens,

Greece

domperidone

OROPERIDYS

10 mg

orodispersible tablet

oral use

Hungary

Extractum Pharma zRT. Megyeri út 64. Budapest H-1044 Hungary

domperidone

Domperidon-EP 10 mg tabletta

10 mg

tablet

oral use

Hungary

Janssen-Cilag Kft.

Tó park

H-2045 Törökbálint

Hungary

domperidone

Motilium 10 mg filmtabletta

10 mg

film-coated tablet

oral use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium Fastmelts 10 mg Tablets

10 mg

tablet

oral use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 10 mg Film-Coated Tablets

10 mg

tablet

oral use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 10 mg Suppositories

10 mg

suppository

rectal use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 30 mg Suppositories

30 mg

suppository

rectal use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 60 mg Suppositories

60 mg

suppository

rectal use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 1 mg/ml Oral Suspension

1 mg/ml

oral suspension

oral use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium Rx 10 mg Film-coated Tablets.

10 mg

film-coated tablet

oral use

Ireland

Rowex Ltd

Bantry

Co Cork

Ireland

Domperidone

DOMERID 10 mg Tablets.

10 mg

tablet

oral use

Ireland

Rowex Ltd

Bantry

Co Cork

Ireland

Domperidone

Domerid Relief 10 mg Tablets.

10 mg

tablet

oral use

Italy

ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

10 mg

film-coated tablet

oral use

Italy

ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

60 mg

suppository

rectal use

Italy

ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

30 mg

suppository

rectal use

Italy

ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

10 mg

effervescent granules

oral use

Italy

ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

1 mg/ml

suspension

oral use

Italy

ITALCHIMICI S.P.A.

Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

20 mg

film-coated tablet

oral use

Italy

ITALCHIMICI S.P.A.

Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

20 mg

effervescent granules

oral use

Italy

Janssen-Cilag S.P.A.

Via Michelangelo buonarroti 23

20093 Cologno Monzese — Milano

Italy

Domperidone

MOTILIUM

1 mg/ml

suspension

oral use

Italy

Janssen-Cilag S.P.A.

Via Michelangelo buonarroti 23

20093 Cologno Monzese — Milano

Italy

Domperidone

MOTILIUM

10 mg

film-coated tablet

oral use

Italy

Janssen-Cilag S.P.A.

Via Michelangelo buonarroti 23

20093 Cologno Monzese — Milano

Italy

Domperidone

MOTILIUM

10 mg

effervescent granules

oral use

Italy

DR. REDDY'S S.R.L.

Via Fernanda Wittgens 3 — 20123 Milano

Italy

Domperidone

DOMPERIDONE DR. REDDY'S

10 mg

tablet

oral use

Italy

DR. REDDY'S S.R.L.

Via Fernanda Wittgens 3 — 20123 Milano

Italy

Domperidone

DOMPERIDONE DR. REDDY'S

100 mg/100 ml

syrup

oral use

Italy

GIULIANI S.P.A

Via Palagi 2 20129 Milano

Italy

Domperidone

DIGESTIVO GIULIANI

5 mg

effervescent granules

oral use

Italy

GIULIANI S.P.A

Via Palagi 2

20129 Milano

Italy

Domperidone

DIGESTIVO GIULIANI

5 mg

chewable tablet

oral use

Italy

GIULIANI S.P.A

Via Palagi 2

20129 Milano

Italy

Domperidone

DIGESTIVO GIULIANI

10 mg

film-coated tablet

oral use

Italy

TEVA ITALIA S.R.L.

Via Messina 38

20154 Milano

Italy

Domperidone

DOMPERIDONE TEVA

10 mg

film-coated tablet

oral use

Italy

GERMED PHARMA S.P.A.

Via Cantù 11

20092 Cinisello Balsamo — Milano — Italy

Domperidone

DOMPERIDONE GERMED

10 mg

film-coated tablet

oral use

Italy

GERMED PHARMA S.P.A.

Via Cantù 11

20092 Cinisello Balsamo — Milano — Italy

Domperidone

DOMPERIDONE GERMED

10 mg/10 ml

suspension

oral use

Italy

ABC FARMACEUTICI S.P.A.,

Corso Vittorio Emanuele II 72 , 10121 Torino

Italy

Domperidone

DOMPERIDONE ABC

10 mg

tablet

oral use

Italy

MYLAN S.P.A.

Via Vittor Pisani 20

20124 Milano

Italy

Domperidone

DOMPERIDONE MYLAN GENERICS

10 mg

tablet

oral use

Italy

FG S.R.L.

Via San Rocco 6 -

85033 Episcopia — Potenza

Italy

Domperidone

DOMPERIDONE FG

10 mg

tablet

oral use

Italy

EG S.P.A.

Via Domenico Scarlatti 31

20124 Milano

Italy

Domperidone

DOMPERIDONE EG

10 mg

tablet

oral use

Italy

LABORATORI ALTER S.R.L.

Via Egadi 7

20144 Milano

Italy

Domperidone

DOMPERIDONE ALTER

10 mg

tablet

oral use

Italy

CRINOS S.P.A.

Via Pavia 6

20136 Milano

Italy

Domperidone

RIGES

10 mg

tablet

oral use

Italy

SANDOZ S.P.A.

Largo Umberto Boccioni 1

21040 Origgio — Varese

Italy

Domperidone

PYNINAT

10 mg

tablet

oral use

Italy

DOC GENERICI S.R.L.

Via Manunzio 7

20124 Milano

Italy

Domperidone

DOMPERIDONE DOC GENERICI

10 mg

tablet

oral use

Italy

ALMUS S.R.L.

Via Cesarea 11/10

16121 Genova

Italy

Domperidone

DOMPERIDONE ALMUS

10 mg

tablet

oral use

Italy

FARMAKOPEA S.P.A

Via Cavriana 14

20134 Milano

Italy

Domperidone

DALIA

10 mg

effervescent tablet

oral use

Italy

SANDOZ S.P.A.

Largo Umberto Boccioni 1

21040 Origgio — Varese

Italy

Domperidone

DOMPERIDONE SANDOZ

10 mg

tablet

oral use

Italy

PENSA PHARMA S.P.A.

Via Ippolito Rossellini 12

20124 Milano

Italy

Domperidone

DOMPERIDONE PENSA

10 mg

effervescent tablet

oral use

Italy

FARMAKOPEA S.P.A

Via Cavriana 14

20134 Milano

Italy

Domperidone

GERDI

5 mg

effervescent tablet

oral use

Italy

FARMAKOPEA S.P.A

Via Cavriana 14

20134 Milano

Italy

Domperidone

GERDI

5 mg

effervescent granules

oral use

Italy

CRINOS S.P.A.

Via Pavia 6

20136 Milano

Italy

Domperidone

RAXAR

10 mg

orodispersible tablet

oral use

Italy

PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano

Italy

Domperidone

NEOPERIDYS

10 mg

orodispersible tablet

oral use

Italy

SOFAR S.p.a. Via Firenze, 40 20060 Trezzano Rosa — Milano

Italy

Domperidone Maleato

PERMOTIL

10 mg

tablet

oral use

Italy

ANGENERICO S.p.a.

Via Nocera Umbra 75, 00181 Roma

Italy

Domperidone Maleato

DOMPERIDONE ANGENERICO

10 mg

tablet

oral use

Latvia

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

Oroperidys 10 mg orodispersible tablets

10 mg

orodispersible tablet

oral use

Latvia

UAB ‘Johnson & Johnson’

Geležinio Vilko g. 18A

LT-08104 Vilnius

Lithuania

domperidone

Motilium 10 mg film-coated tablets

10 mg

film-coated tablet

oral use

Latvia

Actavis Group Hf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

domperidone

Domperidon Actavis 10 mg tablets

10 mg

tablet

oral use

Lithuania

Actavis Group Hf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Domperidone

Domperidon Actavis

10 mg

tablet

oral use

Lithuania

Torrent Pharma GmbH

Sudwestpark 50

Nurnberg D-90449

Germany

Domperidone

Domstal

10 mg

tablet

oral use

Lithuania

UAB ‘Johnson & Johnson’

Geležinio Vilko g. 18A

LT-08104 Vilnius

Lithuania

Domperidone

Motilium

10 mg

film-coated tablet

oral use

Lithuania

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

Oroperidys

10 mg

orodispersible tablet

oral use

Luxembourg

eurogenerics SA esplanade heysel b22 1020 bruxelles

Belgium

domperidone (maleate)

Domperidone EG-10

10 mg

tablet

oral use

Luxembourg

eurogenerics SA esplanade heysel b22

1020 bruxelles

Belgium

domperidone

Domperidone EG-10

10 mg

orodispersible tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

domperidone

Motilium Domperidone Base

10 mg

coated tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

domperidone

Motilium Instant-10

10 mg

orodispersible tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

domperidone (maleate)

Motilium-10

10 mg

coated tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

domperidone

Motilium pediatrie

1 mg/ml

oral suspension

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

domperidone

Motilium-1 mg/ml

1 mg/ml

oral suspension

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

domperidone

Motilium-10 supp.

10 mg

suppository

rectal use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

domperidone

Motilium-30 supp

30 mg

suppository

rectal use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

domperidone

Motilium-60 supp

60 mg

suppository

rectal use

Luxembourg

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

domperidone

Oroperidys

10 mg

orodispersible tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Cinnarizine/Domperidone (maleate)

Touristil

20 mg/

15 mg

tablet

oral use

Malta

Actavis Group Hf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Domperidone

Domperidon Actavis

10 mg

tablet

oral use

Malta

Medochemie Limited

PO Box 51409

Limassol CY-3505

Cyprus

domperidone

Costi 10 mg Film coated tablets

10 mg

film-coated tablet

oral use

Malta

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

domperidone

motilium 1 mg/ml oral suspension

1 mg/ml

oral suspension

oral use

Malta

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

domperidone

motilium 10 mg film coated tablets

10 mg

film-coated tablet

oral use

Malta

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

domperidone

motilium 30 mg Suppositories

30 mg

suppository

rectal use

Poland

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

Oroperidys

10 mg

orodispersible tablet

oral use

Portugal

Laboratório Medinfar — Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova

2700-547 Amadora

Portugal

domperidone

Cinet

10 mg

tablet

oral use

Portugal

Laboratório Medinfar — Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova

2700-547 Amadora

Portugal

domperidone

Cinet

10 mg

dispersible tablet

oral use

Portugal

Laboratório Medinfar — Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova

2700-547 Amadora

Portugal

domperidone

Cinet

1 mg/ml

oral suspension

oral use

Portugal

Actavis A/S Sucursal

Rua Virgílio Correia, 11 — A

1600-219 Lisboa

Portugal

domperidone

Domperidona Actavis

10 mg

tablet

oral use

Portugal

Baldacci — Portugal, S.A.

Rua Cândido de Figueiredo, 84-B

1549-005 Lisboa

Portugal

domperidone

Domperidona Baldacci

10 mg

film-coated tablet

oral use

Portugal

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, 2 — Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

domperidone

Domperidona Ciclum

10 mg

tablet

oral use

Portugal

GP — Genéricos Portugueses, Lda.

Rua Henrique Paiva Couceiro, 29 — Venda Nova

2700-451 Amadora

Portugal

domperidone

Domperidona GP

10 mg

tablet

oral use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

domperidone

Domperidona Generis

10 mg

film-coated tablet

oral use

Portugal

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto

2790-012 Portela de Carnaxide

Portugal

domperidone

Domperidona Germed

10 mg

film-coated tablet

oral use

Portugal

Labesfal Genéricos, S.A

Avenida Dr. Afonso Costa, 1370

3465-051 Campo de Besteiros

Portugal

domperidone

Domperidona Labesfal

10 mg

tablet

oral use

Portugal

Mylan, Lda.

Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C — 7.3 e 7.4

1990-095 Lisboa

Portugal

domperidone

Domperidona Mylan

10 mg

film-coated tablet

oral use

Portugal

Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.

Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo

Portugal

domperidone

Domperidona Ratiopharm

10 mg

film-coated tablet

oral use

Portugal

ToLife — Produtos Farmacêuticos, S.A.

Avenida do Forte, 3 — Edificio Suécia III, Piso 1

2794-093 Carnaxide

Portugal

domperidone

Domperidona ToLife

10 mg

tablet

oral use

Portugal

Wynn Industrial Pharma, S.A.

Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras

1070-274 Lisboa

Portugal

domperidone

Domperidona Wynn

10 mg

tablet

oral use

Portugal

Johnson & Johnson, Lda.

Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo

2730-055 Barcarena

Portugal

domperidone

Motilium

1 mg/ml

oral suspension

oral use

Portugal

Johnson & Johnson, Lda.

Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo

2730-055 Barcarena

Portugal

domperidone

Motilium

10 mg

film-coated tablet

oral use

Portugal

Johnson & Johnson, Lda.

Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo

2730-055 Barcarena

Portugal

domperidone

Motilium

10 mg

effervescent granules

oral use

Portugal

Johnson & Johnson, Lda.

Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo

2730-055 Barcarena

Portugal

domperidone

Motilium Rapid

10 mg

orodispersible tablet

oral use

Portugal

Laboratórios Azevedos — Indústria Farmacêutica, S.A.

Edifícios Azevedos — Estrada Nacional 117-2, Alfragide

2614-504 Amadora

Portugal

domperidone

Remotil

10 mg

tablet

oral use

Romania

S.C. TERAPIA S.A.

Str. Fabricii nr. 124, Cluj Napoca,

Romania

DOMPERIDONE

MOTILIUM 10 mg

10 mg

film-coated tablet

oral use

Romania

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

DOMPERIDONE

OROPERIDYS 10 mg

10 mg

orodispersible tablet

oral use

Slovak Republic

Pierre Fabre Medicament

45 Place Abel Gance

92654 Boulogne Cedex

France

Domperidone

OROPERIDYS 10 mg

10 mg

tablet

oral use

Slovak Republic

Medochemie Ltd.

1-10 Constantinoupoleos St.

P.O. Box: 51409

3505 Limassol Cyprus

Domperidone

COSTI

10 mg

tablet

oral use

Slovenia

KRKA, tovarna zdravil, d.d., Novo mesto

Šmarješka cesta 6 8501 Novo mesto Slovenia

domperidone

Tametil 10 mg filmsko obložene tablete

10 mg

film-coated tablet

oral use

Spain

LABORATORIOS DR. ESTEVE, S.A.

Avda. Mare de Déu de Montserrat, 221

08041 Barcelona

Spain

Domperidone

Motilium 30 mg supositorios niños

30 mg

suppository

rectal use

Spain

LABORATORIOS DR. ESTEVE, S.A.

Avda. Mare de Déu de Montserrat, 221

08041 Barcelona

Spain

Domperidone

Motilium 10 mg comprimidos recubiertos con película

10 mg

film-coated tablet

oral use

Spain

LABORATORIOS DR. ESTEVE, S.A.

Avda. Mare de Déu de Montserrat, 221

08041 Barcelona

Spain

Domperidone

Motilium 1 mg/ml suspensión oral

1 mg/ml

oral suspension

oral use

Spain

Janssen-Cilag, S.A.

Po de Las Doce Estrellas, 5-7

28042 Madrid

Spain

Domperidone

Nauzelin 1 mg/ml suspensión oral

1 mg/ml

oral suspension

oral use

Spain

Janssen-Cilag, S.A.

Po de Las Doce Estrellas, 5-7

28042 Madrid

Spain

Domperidone

Nauzelin 10 mg comprimidos recubiertos con película

10 mg

film-coated tablet

oral use

Spain

ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain

Domperidone

Domperidona Gamir 10 mg cápsulas duras

10 mg

capsule, hard

oral use

Spain

ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain

Domperidone

Domperidona Gamir 1 mg/ml suspensión oral

1 mg/ml

oral suspension

oral use

Spain

PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3-bajos

Valencia 46015 Spain

Domperidone maleate

Domperidona Pensa 10 mg comprimidos EFG

12,72 mg

tablet

oral use

Spain

Pierre Fabre Médicament

45 place Abel Gance

F-92100 Boulogne

France

Domperidone

Orosperidys 10 mg comprimidos bucodispersables

10 mg

orodispersible tablet

oral use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium filmomhulde tabletten 10 mg

10 mg

film-coated tablet

oral use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium suspensie voor oraal gebruik 1 mg/ml

1 mg/ml

oral suspension

oral use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium zetpillen voor zuigelingen 10 mg

10 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium zetpillen voor kinderen 30 mg

30 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium zetpillen voor volwassenen 60 mg

60 mg

suppository

rectal use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg

10 mg

suppository

rectal use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 30 PCH voor kinderen, zetpillen 30 mg

30 mg

suppository

rectal use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 60 PCH voor volwassenen, zetpillen 60 mg

60 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Domperidon JJC filmomhulde tabletten 10 mg

10 mg

film-coated tablet

oral use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Domperidon JJC zetpillen voor volwassenen 60 mg

60 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Domperidon JJC zetpillen voor kinderen 30 mg

30 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Domperidon JJC zetpillen voor zuigelingen 10 mg

10 mg

suppository

rectal use

The Netherlands

Samenwerkende Apothekers Nederland B.V.

Kralingseweg 201

3062 CE Rotterdam

The Netherlands

Domperidone

Domperidon 30 mg zetpillen Samenwerkende Apothekers

30 mg

suppository

rectal use

The Netherlands

Samenwerkende Apothekers Nederland B.V.

Kralingseweg 201

3062 CE Rotterdam

The Netherlands

Domperidone

Domperidon 60 mg zetpillen Samenwerkende Apothekers, zetpillen

60 mg

suppository

rectal use

The Netherlands

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Domperidone

Domperidon Mylan 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Domperidone

Domperidon Pharmacin 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 10 PCH, filmomhulde tabletten 10 mg

10 mg

film-coated tablet

oral use

The Netherlands

Accord Healthcare Ltd

Sage House, 319 Pinner Road

HA1 4 HF North Harrow, Middlesex

United Kingdom

Domperidone

Domperidon Accord 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Healthypharm B.V.

Nieuwe Donk 3

4879 AC Etten-Leur

The Netherlands

Domperidone

Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Leidapharm B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

Domperidone

Domperidon 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Domperidone

Domperidon STADA 10 mg tabletten

10 mg

tablet

oral use

The Netherlands

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Domperidone

Domperidon Actavis 10 mg, omhulde tabletten

10 mg

coated tablet

oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten-Leur

The Netherlands

Domperidone

Domperidon CF 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon PCH 10, filmomhulde tabletten 10 mg

10 mg

film-coated tablet

oral use

The Netherlands

Wise Pharmaceuticals Ltd.

Hamwells Business Park Unit No7, Hardicker Street

M19 2RB Manchester

United Kingdom

Domperidone

Domperidon 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

Domperidone

Kruidvat Domperidon 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Domperidone

Domperidon Sandoz 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Sofar S.p.A.

Via Firenze 40

20060 Trezzano Rosa (MI)

Italy

Domperidone

Domperidon Sofar 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Bellwood Pharmaceuticals Ltd.

First Floor 69, St. Patricks Road

Dalkey, Co. Dublin

Ireland

Domperidone

Domperidon Bellwood 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Faribérica, Productos Farmacêuticos, SA

Estrada da Luz, 90-9o CDE

1600-160 Lissabon

Portugal

Domperidone

Domperidon Faribérica 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Actavis Nordic A/S

Ornegardsvej 16

2820 Gentofte

Denmark

Domperidone

Domperidon Actavis 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Mediq Farma B.V.

Hertogswetering 159

3543 AS Utrecht

The Netherlands

Domperidone

Domperidon Mdq 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 10 mg PCH, tabletten

10 mg

tablet

oral use

The Netherlands

Samenwerkende Apothekers Nederland B.V.

Kralingseweg 201

3062 CE Rotterdam

The Netherlands

Domperidone

Domperidon 10 mg tabletten Samenwerkende Apothekers

10 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 10 mg Pharmachemie, tabletten

10 mg

tablet

oral use

The Netherlands

KELA Pharma nv

Industriepark West 68

9100 Sint-Niklaas

Belgium

Domperidone

Domperidon Kela 10 mg, tabletten

10 mg

tablet

oral use

United Kingdom

Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3 7UN

United Kingdom

domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG,

United Kingdom

domperidone maleate

Domperidone Tablets 10 mg

10 mg

coated tablet

oral use

United Kingdom

Co-Pharma Limited

Unit 4, Metro Centre

Tolpits Lane, Watford

Hertfordshire

WD18 9SS

United Kingdom

domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Manx Healthcare Limited

Taylor Group House

Wedgnock Lane

Warwick

CV34 5YA

United Kingdom

domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,

United Kingdom

domperidone maleate

Motilium 10

10 mg

tablet

oral use

United Kingdom

McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,

United Kingdom

domperidone maleate

Motilium Instants

10 mg

orodispersible tablet

oral use

United Kingdom

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD,

United Kingdom

domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS,

United Kingdom

domperidone

Domperidone 1 mg/ml Oral Suspension

5 mg

oral suspension

oral use

United Kingdom

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS

United Kingdom

domperidone maleate

Motilium 10 mg Film-coated Tablets

10 mg

film-coated tablet

oral use

United Kingdom

Bristol Laboratories Limited

Unit 3, Canalside

Northbridge Road, Berkhamsted

Hertfordshire

HP4 1EG

United Kingdom

domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Focus Pharmaceuticals Limited

Unit 5, Faraday Court

First Avenue, Centrum 100

Burton Upon Trent, Staffordshire

DE14 2WX

United Kingdom

domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Medreich plc,

Warwick House, Plane Tree Crescent, Feltham TW13 7HF

United Kingdom

domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Wockhardt UK Limited

Ash Road North

Wrexham Industrial Estate

Wrexham LL13 9UF

United Kingdom

domperidone maleate

Domperidone 10 mg Tablets

10 mg

film-coated tablet

oral use

United Kingdom

Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co. Roscommon,

Ireland

domperidone maleate

Domperidone 10 mg Tablets

10 mg

film-coated tablet

oral use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Applicant/Marketing authorisation holder | Product name | INN | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Chevita Tierarzneimittel GmbH
  Kaplanstrasse 10
  4600 Wels
  Austria | Chevi-Tyl 200 mg/g Arzneimittel-Vormischung zu Herstellung von Fütterungsarzneimitteln für Schweine, Hühner und Puten | Tylosin tartarate | 20 g/100 g powder | Premix for medicated feeding stuff | Pigs, chicken, turkey |
| Austria | Chevita Tierarzneimittel GmbH
  Kaplanstrasse 10
  4600 Wels
  Austria | Chevi-Tyl 200 mg/g Pulver zum Eingeben für Schweine, Hühner und Puten | Tylosin tartarate | 20 g/100 g powder | Powder for oral solution | Pigs, chicken, turkey |
| Austria | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 1 g/g Granulat zum Eingeben über das Trinkwasser für Schweine, Hühner, Puten und Kälber | Tylosin | 1 g tylosin (= 1,1 g tylosin tartate) per 1,1 g of granules | Granules for oral solution | Calves, pigs, chicken, turkey |
| Austria | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 mg/g Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Masthühner und Junghennen | Tylosin | 100 mg tylosin as tylosin phosphate per g (= 1 00  000 IU) | Premix for medicated feeding stuff | Pigs, broilers, pullets |
| Austria | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Masthühner und Junghennen | Tylosin | 250 mg tylosin as tylosin phosphate per g (= 2 50  000 IU) | Premix for medicated feeding stuff | Pigs, broilers, pullets |
| Austria | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g Granulat zum Eingeben für Schweine | Tylosin | 20 mg tylosin as tylosin phosphate per g (= 20  000 IU) | Granules for oral solution | Pigs |
| Austria | Richter Pharma AG
  Feldgasse 19
  4600 Wels
  Austria | Tylan 20 mg/g — Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine | Tylosin phosphate | 20 g/kg | Premix for medicated feeding stuff | Pigs |
| Austria | Richter Pharma AG
  Feldgasse 19
  4600 Wels
  Austria | Tylan soluble — 1 g/g Pulver zur Herstellung einer Lösung zum Eingeben für Schweine, Hühner und Truthühner | Tylosin | 110 g tylosin tartate per 110 g powder (= 100 g tylosin-activity) | Powder for oral solution | Pigs, chicken, turkeys |
| Austria | AniMed Service AG
  Liebochstrasse 9
  8143 Dobl
  Austria | Tylosin-Phosphat ‘AniMed Service’ 100 mg/g — Pulver zum Eingeben für Schweine | Tylosin | 100 g tylosin (as tylosin phophate) per 1  000 g powder | Powder for oral solution | Pigs |
| Austria | Vana GmbH
  Wolfgang Schmälzlgasse 6
  1020 Vienna
  Austria | Vanatyl-Pulver für Tiere | Tylosin | 110 g tylosin tartate per 110 g powder (= 100 g tylosin-base) | Powder for oral solution | Pigs, chicken (broiler), turkeys |
| Austria | AniMed Service AG
  Liebochstrasse 9
  8143 Dobl
  Austria | Tylosintartrat PUR ‘AniMed Service’ 1 g/g — Pulver zum Eingeben für Tiere | Tylosin | 1 g tylosin (as tylosin tartate) per 1 g of powder | Powder for oral solution | Cattle (calve)
  Chickens
  Pigs
  Turkeys |
| Belgium | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g OG | Tylosin phosphate | 20 mg/g
  (20  000 IU) | Granules for oral solution | Pigs |
| Belgium | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g OG | Tylosin phosphate | 250 mg/g
  (2 50  000 IU) | Granules for oral solution | Pigs |
| Belgium | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 % w/w | Tylosin tartarate | 1 g in 1,1 g granules
  (1,1 g) | Granules for oral solution | Calves
  Pigs
  Chicken
  Turkey |
| Belgium | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 mg/g Premix | Tylosin phosphate | 100 mg/g
  (1 00  000 IU) | Premix for medicated feeding stuff | Pigs
  Broilers
  Pullets |
| Belgium | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g Premix | Tylosin phosphate | 250 mg/g
  (2 50  000 IU) | Premix for medicated feeding stuff | Pigs
  Broilers
  Pullets |
| Belgium | Eli Lilly Benelux N.V.
  Elanco Animal Health
  Markiesstraat 1
  1000 Brussel
  Belgium | Tylan 20 Granules | Tylosin phosphate | 20 mg/g
  (20  000 IU) | Granules for oral solution | Pigs
  Broilers
  Pullets |
| Belgium | Eli Lilly Benelux N.V.
  Elanco Animal Health
  Markiesstraat 1
  1000 Brussel
  Belgium | Tylan 100 Granules | Tylosin phosphate | 100 mg/g
  (1 00  000 IU) | Granules for oral solution | Pigs
  Broilers
  Pullets |
| Belgium | Eli Lilly Benelux N.V.
  Elanco Animal Health
  Markiesstraat 1
  1000 Brussel
  Belgium | Tylan 20 Vet Premix | Tylosin phosphate | 20 mg/g
  (20  000 IU) | Premix for medicated feeding stuff | Pigs
  Broilers
  Pullets |
| Belgium | Eli Lilly Benelux N.V.
  Elanco Animal Health
  Markiesstraat 1
  1000 Brussel
  Belgium | Tylan 100 Vet Premix | Tylosin phosphate | 100 mg/g
  (1 00  000 IU) | Premix for medicated feeding stuff | Pigs
  Broilers
  Pullets |
| Belgium | Eli Lilly Benelux N.V.
  Elanco Animal Health
  Markiesstraat 1
  1000 Brussel
  Belgium | Tylan 250 Vet Premix | Tylosin phosphate | 250 mg/g
  (2 50  000 IU) | Premix for medicated feeding stuff | Pigs
  Broilers
  Pullets |
| Belgium | Eli Lilly Benelux N.V.
  Elanco Animal Health
  Markiesstraat 1
  1000 Brussel
  Belgium | Tylan Soluble | Tylosin tartarate | 108 (100 g)/lagena
  109 (1  000 g)/saccus
  (1  000 mg/g) | Powder for oral solution | Calves
  Pigs
  Chicken
  Turkey |
| Belgium | Kela NV (Kela Laboratoria NV)
  Sint Lenaartseweg 48
  2320 Hoogstraten
  Belgium | Tylosine 75 % Kela | Tylosin tartarate | 750 mg/g
  (7 50  000 IU/g) | Powder for oral solution | Pigs
  Chicken |
| Bulgaria | Gabrofam OOD
  7002 Russe
  16 Aleia Vazrajdane str., ap.42
  Bulgaria | ТИЛОЗИН 60 % — БГ Водоразтворим прах | Tylosin | Tylosin tartarate 60 mg/g | Powder for oral solution | Hens and pigs |
| Bulgaria | Biovet JSC
  39 Petar Rakov Str
  4550 Peshtera
  Bulgaria | TИЛОВЕТ 10 % гранули за перорално приложение за свине, прасета, пилета, пуйки, телета за угояване | Tylosin | Tylosin phosphate 100 mg/g | Granules for oral solution | Swine, pigs, chickens, turkeys, calves for fattening |
| Bulgaria | Biovet JSC
  39 Petar Rakov Str
  4550 Peshtera
  Bulgaria | TИЛОВЕТ 25 % премикс за медикаментозен фураж за свине, прасета, пилета, пуйки, телета за угояване | Tylosin | Tylosin phosphate 250 mg/g | Premix for medicated feeding stuff | Swine, pigs, chickens, turkeys, calves for fattening |
| Bulgaria | Biovet JSC
  39 Petar Rakov Str
  4550 Peshtera
  Bulgaria | TИЛОВЕТ 10 % премикс за медикаментозен фураж за свине, прасета, пилета, пуйки, телета за угояване | Tylosin | Tylosin phosphate 100 mg/g | Premix for medicated feeding stuff | Swine, pigs, chickens, turkeys, calves for fattening |
| Bulgaria | Biovet JSC
  39 Petar Rakov Str
  4550 Peshtera
  Bulgaria | ТИЛОВЕТ пулвис водоразтворим прах за пилета, пуйки, прасета и телета | Tylosin | Tylosin tartarate 500 mg/g | Powder for oral solution | Chickens, turkeys, pigs and calves |
| Bulgaria | Biovet JSC
  39 Petar Rakov Str
  4550 Peshtera
  Bulgaria | Тиловет Форте водоразтворими гранули за свине | Tylosin | 200 mg/g | Granules for oral solution | Swine |
| Bulgaria | Pharma SIS
  4 San Stefano Str.
  Dobrich
  Bulgaria | Оратил 100 | Tylosin | 108,18 g/110 g | Powder for oral solution | Chicken, turkeys and pigs |
| Bulgaria | Pharma SIS
  4 San Stefano Str.
  Dobrich
  Bulgaria | Тилозин 100 премикс | Tylosin | 10 g/100 g | Premix for medicated feeding stuff | Swine |
| Bulgaria | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g Орални гранули за свине | Tylosin | 20 mg/g | Granules for oral solution | Swine |
| Bulgaria | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки | Tylosin | 100 mg/g | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Bulgaria | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки | Tylosin | 250 mg/g | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Bulgaria | Pharma Vet
  40 Otec Paisii Str.
  Shumen
  Bulgaria | Tилофарм водоразтворим прах | Tylosin | 4 0 0 00  000 IU (50 g) | Powder for oral solution | Hens and pigs |
| Bulgaria | Zavet JSC
  5 Kiril i Metodii Str.
  Zavet
  Bulgaria | Тилозин 50 % водоразтворим прах | Tylosin | 5 00  000 IU/g | Powder for oral solution | Pigs, swine, broilers, turkeys, chicken and turkey breeders |
| Croatia | Medical Intertrade d.o.o.
  Dr. Franje Tuđmana 3
  10431, Sveta Nedelja
  Croatia | Tylan Soluble | Tylosin | bottle: 100 g
  bag: 1  000 g | Powder for oral solution | Chickens, turkeys, pigs |
| Croatia | GENERA d.d.
  Svetonedeljska 2
  Kalinovica, 10436 Rakov Potok
  Croatia | Tilozin tartarat | Tylosin | Powder,
  1 bottle: 70 g | Powder for oral solution | Chickens, turkeys, pigs |
| Cyprus | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 100 % Κοκκία για χορήγηση με το πόσιμο νερό για μόσχους, χοίρους, ορνίθια και ινδόρνιθες | TYLOSIN | 1,1 g of granules contains 1 g of tylosin (corresponding to 1,1 g of tylosin tartrate) | Granules for oral solution | Calves, pigs, chickens, turkeys |
| Cyprus | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | TYLAN G 100 PREMIX
  100 g/kg
  Προμίγμα για φαρμακούχες ζωοτροφές για χοίρους. | Tylosin phosphate | 100,0 g/kg | Premix for medicated feeding stuff | Pigs |
| Cyprus | DOX-AL ITALIA S.p.a.
  Via Mascagni 6
  20884 Sulbiate (MB)
  Italy | TYLOSINA BMP Powder
  Τylosin (from tylosin tartrate) 200 g/Kg
  Φαρμακούχο πρόμιγμα σε κόκκους για χοίρους και κοτόπουλα κρεωπαραγωγής | Tylosin | 200,0 g/kg | Premix for medicated feeding stuff | Swine, broilers |
| Czech Republic | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 % w/w granules for oral administration in drinking water for oral solution for pigs, chicken, turkey and calves | Tylosin | 1 g Tylosinum (odpovídající 1,1 g Tylosini tartaras)/1,1 g | Granules for oral solution | Calves, pigs, chicken, turkey |
| Czech Republic | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g oral granules for pigs | Tylosin | Tylosinum (ut Tylosini phosphas) 20 mg v 1 g (odpovídá 20  000 IU) | Granules for oral solution | Pigs |
| Czech Republic | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 250 mg/g oral granules for pigs | Tylosin | Tylosinum (ut Tylosini phosphas): 250 mg/g (odpovídá 2 50  000 IU.) | Granules for oral solution | Pigs |
| Czech Republic | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | Tylan powder for oral solution | Tylosin | Tylosinum (ut tylosini tartras) 800 I.U./mg | Powder for oral solution | Chicken broilers, breeding pullets and laying hens, production pullets, turkey, pigs, calves |
| Czech Republic | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | TYLAN 100 mg/g granules for pigs | Tylosin | Tylosinum (ut phosphas) 100 mg aktivity (odpovídá 1 00  000 IU)/g | Granules for oral solution | Pigs |
| Czech Republic | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | TYLAN 100 mg/g medicated pre-mix for pigs | Tylosin | Tylosinum (ut phosphas) 100 mg aktivity (odpovídá 1 00  000 IU)/g | Premix for medicated feeding stuff | Pigs |
| Denmark | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan Vet. | Tylosin | 100 g/kg | Premix for medicated feeding stuff | Pig |
| Denmark | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan Vet. | Tylosin | 2 % | Premix for medicated feeding stuff | Pig |
| Denmark | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan Vet. | Tylosin | No information available | Powder for oral solution | Pig, poultry |
| Denmark | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan Vet. | Tylosin | 2 % | Powder for oral solution | Pig |
| Denmark | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan Vet. | Tylosin | 10 % | Powder for oral solution | Pig |
| Denmark | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Tylmasin | Tylosin | 20 mg/g | Granules for oral solution | Pig |
| Denmark | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Tylmasin | Tylosin | 250 mg/g | Granules for oral solution | Pig |
| Denmark | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Tylmasin | Tylosin | 1 g/g | Granules for oral solution | Calf, pig, poultry |
| Denmark | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Tylmasin | Tylosin | 100 mg/g | Premix for medicated feeding stuff | Poultry, pig |
| Denmark | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Tylmasin | Tylosin | 250 mg/g | Premix for medicated feeding stuff | Poultry, pig |
| Denmark | Ceva Animal Health A/S
  Ladegårdsvej 2
  DK-7100 Vejle
  Denmark | Tylosin ‘Ceva’ Vet | Tylosin | No information available | Powder for oral solution | Poultry, pig |
| Denmark | ScanVet Animal Health A/S
  Kongevejen 66
  DK-3480 Fredensborg
  Denmark | Tylocure | Tylosin | 1 g/g | Granules for oral solution | Pig |
| Estonia | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 500WSP | Tylosin | 500 mg/g | Powder for oral solution | Cattle, pigs, chicken, turkey |
| Estonia | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 1  000 mg/g granules for use in drinking water for pigs, chickens, turkeys and calves | Tylosin | 1  000 mg/g | Granules for oral solution | Cattle, pigs, chicken, turkey |
| Finland | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan Premix vet
  20 mg/g esisekoite lääkerehua varten | Tylosin phosphate | 20 mg/g | Premix for medicated feeding stuff | Pig |
| Finland | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan vet jauhe oraaliliuosta varten | Tylosin tartarate | 1 g oral powder contains 1 g tylosin tartrate resp 800 mg tylosin | Powder for oral solution | Pig, poultry |
| France | SOGEVAL
  200 AVENUE DE MAYENNE
  ZONE INDUSTRIELLE DES TOUCHES
  53000 LAVAL
  France | CONCENTRAT V007 TYLAN 100 | Tylosin phosphate | 20  000 IU/g | Premix for medicated feeding stuff | Pig
  Poultry |
| France | VIRBAC
  1ere avenue 2065 m L. I. D.
  06516 Carros
  France | AXENTYL | Tylosin tartarate | 80 mg/g | Powder for oral solution | Pig |
| France | Lilly France S.A.S.
  24 bld Vital Bouhot
  CS 50004
  92521 Neuilly sur Seine cedex
  France | TYLAN 20 PREMIX | Tylosin phosphate | 20  000 IU/g | Premix for medicated feeding stuff | Pig
  Poultry |
| France | QALIAN
  34 RUE JEAN MONNET
  ZI D'ETRICHE
  49500 SEGRE
  France | COMPOMIX V T | Tylosin tartarate | 92  000 IU/g | Powder for oral solution | Pig |
| France | QALIAN
  34 RUE JEAN MONNET
  ZI D'ETRICHE
  49500 SEGRE
  France | SANTAMIX TYLO 20 | Tylosin phosphate | 20  000 IU/g | Premix for medicated feeding stuff | Pig
  Poultry |
| France | QALIAN
  34 RUE JEAN MONNET
  ZI D'ETRICHE
  49500 SEGRE
  France | TYLORAL | Tylosin tartarate | 10 0 0 00  000 IU/sachet or jar | Powder for oral solution | Turkey
  Pig
  Cow
  Poultry |
| France | QALIAN
  34 RUE JEAN MONNET
  ZI D'ETRICHE
  49500 SEGRE | TYLOSINE BUVABLE NOE | Tylosin tartarate | 10 0 0 00  000 IU/sachet | Powder for oral solution | Turkey
  Pig
  Cow
  Poultry |
| France | LABORATOIRES BIOVE
  3 RUE DE LORRAINE
  62510 ARQUES
  France | TYLOLIDE | Tylosin tartarate | 10 0 0 00  000 IU/jar | Powder for oral solution | Turkey
  Pig
  Cow
  Poultry |
| France | Lilly France S.A.S.
  24 bld Vital Bouhot
  CS 50004
  92521 Neuilly sur Seine cedex
  France | TYLAN SOLUBLE 100 % | Tylosin tartarate | 10 0 0 00  000 IU/jar | Powder for oral solution | Pig
  Cow
  Poultry |
| France | SOGEVAL
  200 AVENUE DE MAYENNE
  ZONE INDUSTRIELLE DES TOUCHES
  53000 LAVAL
  France | SOGETYL 100 MUI POUDRE POUR SO LUTION BUVABLE POUR VEAUX PORCINS ET VOLAILLE | Tylosin tartarate | 10 0 0 00  000 IU/jar | Powder for oral solution | Pig
  Cow
  Poultry |
| France | QALIAN
  34 RUE JEAN MONNET
  ZI D'ETRICHE
  49500 SEGRE
  France | TYLO 20 PM PORC VOLAILLE | Tylosin phosphate | 20  000 IU/g | Premix for medicated feeding stuff | Pig
  Poultry |
| France | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 20 G/KG PREMELANGE M EDICAMENTEUX VOLAILLE PORCS | Tylosin phosphate | 20  000 IU/g | Premix for medicated feeding stuff | Pig
  Poultry |
| France | QALIAN
  34 RUE JEAN MONNET
  ZI D'ETRICHE
  49500 SEGRE
  France | TYLOSOL 9,2 | Tylosin tartarate | 92  000 IU/g | Powder for oral solution | Pig |
| France | DELTAVIT
  ZONE D'ACTIVITES DU BOIS DE TEILLAY
  35150 JANZE
  France | PM 21 TYLOSINE 20 PORC-VOLAILL E | Tylosin phosphate | 20  000 IU/g | Premix for medicated feeding stuff | Pig
  Poultry |
| France | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | TYLMASIN | Tylosin tartarate | 10 0 0 00  000 IU/jar | Granules for oral solution | Pig
  Cow
  Poultry |
| France | LABORATORIOS MAYMO
  VIA AUGUSTA 302
  08017 BARCELONA
  Spain | MAYLOSINE | Tylosin tartarate | No information available | Powder for oral solution | Poultry
  Pig
  Cattle |
| Germany | aniMedica GmbH
  Im Südfeld 9
  D-48308 Senden-Bösensell
  Germany | Tylosin G 5 % AMV | Tylosin phosphate | 50 g/1 kg | Premix for medicated feeding stuff | Pig |
| Germany | aniMedica GmbH
  Im Südfeld 9
  D-48308 Senden-Bösensell
  Germany | Tylenterol | Tylosin phosphate | 20 mg/g | Premix for medicated feeding stuff | Pig |
| Germany | aniMedica GmbH
  Im Südfeld 9
  D-48308 Senden-Bösensell
  Germany | TP 10 % AMV | Tylosin phosphate | 100,000 IU/g | Premix for medicated feeding stuff | Pig
  chicken |
| Germany | aniMedica GmbH
  Im Südfeld 9
  D-48308 Senden-Bösensell
  Germany | Klato lan | Tylosin tartarate | 1  000 mg/g | Powder for oral solution | Pig
  chicken |
| Germany | bela-pharm GmbH & Co. KG
  Lohner Str. 19
  D-49377 Vechta
  Germany | Tylosintartrat 100 % Kompaktat | Tylosin tartarate | 1  000 mg/g | Granules for oral solution | Pig
  chicken |
| Germany | bela-pharm GmbH & Co. KG
  Lohner Str. 19
  D-49377 Vechta
  Germany | Tylo-Suscit 100 % Kompaktat | Tylosin tartarate | 1  000 mg/g | Granules for oral solution | Pig
  chicken
  turkey |
| Germany | bela-pharm GmbH & Co. KG
  Lohner Str. 19
  D-49377 Vechta
  Germany | Tylo-Suscit 25 | Tylosin tartarate | 250 mg/g | Powder for oral solution | Pig
  chicken |
| Germany | bioptivet Tierarzneimittel GmbH & Co.
  Im Landwehrwinkel 22
  D-59073 Hamm
  Germany | Tylogran WSP, 1000 mg/g | Tylosin tartarate | 1  000 mg/g | Granules for oral solution | Pig
  chicken |
| Germany | Dopharma Research B.V.
  Zalmweg 24
  NL-4941 VX Raamsdonksveer
  The Netherlands | TP 25 % Pulver | Tylosin phosphate | 250 mg/g | Powder for oral solution | Pig |
| Germany | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 % w/w Granulat zum Eingeben über das Trinkwasser für Schweine, Hühner, Puten und Kälber | Tylosin tartarate | 1,0 g/1,1 g | Granules for oral solution | Cattle (calf)
  pig
  chicken
  turkey |
| Germany | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g Granulat zum Eingeben für Schweine | Tylosin | 250 mg/g | Granules for oral solution | Pig |
| Germany | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g Granulat zum Eingeben für Schweine | Tylosin | 20 mg/g | Granules for oral solution | Pig |
| Germany | KLAT-Chemie GmbH
  Visbeker Str. 12
  D-26197 Ahlhorn
  Germany | Klato lan feed | Tylosin phosphate | 1  000 mg/g | Powder for oral solution | Pig
  chicken |
| Germany | Kon-Pharma GmbH
  Senator-Bauer-Str. 34
  D-30625 Hannover
  Germany | Tylosintartrat 100 % | Tylosin tartarate | 1 g/g | Powder for oral solution | Pig
  chicken |
| Germany | Lilly Deutschland GmbH
  Abt. Elanco Animal Health
  Werner-Reimers-Straße 2-4
  D-61352 Bad Homburg
  Germany | Tylan Mix 2 % | Tylosin phosphate | 20 g/kg | Premix for medicated feeding stuff | Pig |
| Germany | Lilly Deutschland GmbH
  Abt. Elanco Animal Health
  Werner-Reimers-Straße 2-4
  D-61352 Bad Homburg
  Germany | Tylan soluble | Tylosin tartarate | 100 g/110 g | Powder for oral solution | Cattle(calf)
  pig
  chicken
  turkey |
| Germany | Lilly Deutschland GmbH
  Abt. Elanco Animal Health
  Werner-Reimers-Straße 2-4
  D-61352 Bad Homburg
  Germany | Tylan G 25 % | Tylosin phosphate | 250 mg/g | Powder for oral solution | Pig |
| Germany | bela-pharm GmbH & Co. KG
  Lohner Str. 19
  D-49377 Vechta
  Germany | Tylo-Suscit 100 % Kompaktat | Tylosin tartarate | 1 g/g | Granules for oral solution | Pig
  chicken
  turkey |
| Greece | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 2 % | Tylosin | 20 mg/g | Granules for oral solution | Pigs |
| Greece | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 100 % | Tylosin | 1 g | Granules for oral solution | Calves, pigs, chickens, turkeys |
| Greece | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 10 % premix | Tylosin | 100 mg/g | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Greece | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMACIN 25 % premix | Tylosin | 250 mg/g | Premix for medicated feeding stuff | Pigs, broilers and pullets. |
| Hungary | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 100 mg/g gyógypremix sertések, broilercsirkék és jércék számára A.U.V. | Tylosin phosphate | 100 mg/g | Premix for medicated feeding stuff | Pigs and chickens |
| Hungary | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 % granulátum ivóvízbe keveréshez
  sertés, házityúk, pulyka és borjú számára A.U.V. | Tylosin tartarate | 100 % | Granules for oral solution | Pigs, chickens, turkeys and calves |
| Hungary | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g granulátum sertések számára A.U.V. | Tylosin phosphate | 20 mg/g | Granules for oral solution | Pigs |
| Hungary | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 250 mg/g gyógypremix sertések, broilercsirkék és jércék számára A.U.V. | Tylosin phosphate | 250 mg/g | Premix for medicated feeding stuff | Pigs and chickens |
| Hungary | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | Tylan G 100 gyógypremix A.U.V. | Tylosin phosphate | 100 g/kg | Premix for medicated feeding stuff | Pigs and chickens |
| Hungary | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | Tylan vízoldékony por A.U.V. | Tylosin tartarate | 100 % | Powder for oral solution | Pigs, chickens, turkeys and calves |
| Hungary | Kela NV (Kela Laboratoria NV)
  Sint Lenaartseweg 48
  2320 Hoogstraten
  Belgium | TYLOSIN 75 % Kela oral por A.U.V. | Tylosin tartarate | 750 mg/g | Powder for oral solution | Pigs and chickens |
| Ireland | Eli Lilly & Company Ltd
  Elanco Animal Health
  Lilly House
  Priestley Road
  Basingstoke, RG24 9NL
  United Kingdom | Tylan G20 Premix for medicated feedingstuff | Tylosin | 20 g/kg | Premix for medicated feeding stuff | Pigs |
| Ireland | Eli Lilly & Company Ltd
  Elanco Animal Health
  Lilly House
  Priestley Road
  Basingstoke, RG24 9NL
  United Kingdom | Tylan G100 Premix | Tylosin | 100 g/kg | Premix for medicated feeding stuff | Pigs |
| Ireland | Eli Lilly & Company Ltd
  Elanco Animal Health
  Lilly House
  Priestley Road
  Basingstoke, RG24 9NL
  United Kingdom | Tylan G250 Premix for medicated feedingstuff | Tylosin | 250 g/kg | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Ireland | Eli Lilly & Company Ltd
  Elanco Animal Health
  Lilly House
  Priestley Road
  Basingstoke, RG24 9NL
  United Kingdom | Tylan G50 Premix for medicated feedingstuff | Tylosin phosphate | 50 g/kg | Premix for medicated feeding stuff | Pigs |
| Ireland | Eli Lilly & Company Ltd
  Elanco Animal Health
  Lilly House
  Priestley Road
  Basingstoke, RG24 9NL
  United Kingdom | Tylan Soluble Powder for Oral Solution | Tylosin tartarate | 100 g | Powder for oral solution | Calves, pigs and poultry |
| Ireland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g Oral Granules for pigs | Tylosin | 20 mg/g | Granules for oral solution | Pigs |
| Ireland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 mg/g Premix for medicated feeding stuff for pigs, broilers and pullets | Tylosin | 100 mg/g | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Ireland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g Premix for medicated feeding stuff for pigs, broilers and pullets | Tylosin | 250 mg/g | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Ireland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 % W/W Granules for use in Drinking Water for pigs, chickens, turkeys and calves | Tylosin tartarate | 100 % w/w | Granules for oral solution | Calves, pigs, chickens, turkeys |
| Italy | Vetoquinol Italia
  Via Piana, 265
  47032 Bertinoro (FC)
  Italy | ASCOTYL 200 MP | Tylosin | 200 mg/g | Premix for medicated feeding stuff | Pigs, chickens |
| Italy | LABORATORIO VACCINOGENO PAGNINI SNC
  Via A. Diaz 147/149
  Portici (NA)
  Italy | BRONCOTYL 100 | Tylosin | 100 g/kg | Premix for medicated feeding stuff | Cattle, pigs, chickens |
| Italy | Eli Lilly Italia S.p.A.
  Via A. Gramsci, 731-733
  50019 Sesto Fiorentino (IT)
  Italy | NEO TYLAN G250 PREMIX | Tylosin phosphate | 250 mg/g | Premix for medicated feeding stuff | Chickens,
  Pigs |
| Italy | Sintofarm
  Via P. Togliatti, 5
  Guastalla (RE)
  Italy | PHARMASIN 100 | Tylosin | 100 g/g | Granules for oral solution | Pigs, Chickens, Turkeys and Calves |
| Italy | DOX-AL ITALIA S.p.a.
  Via Mascagni 6
  20884 Sulbiate (MB)
  Italy | PURTYL | Tylosin | 1 g/g | Powder for oral solution | Cattle, chickens, turkeys and pigs |
| Italy | Medilabor
  Via Cuneo, 17
  Cuneo
  Italy | Tilosina 10 % | Tylosin tartarate | 100 g/kg | Powder for oral solution | Calves, pigs, chickens |
| Italy | Filozoo Srl
  V. del Commercio 28/30
  41012 Carpi (MO)
  Italy | Tilosina 20 % Filozoo | Tylosin tartarate | 200 g/kg | Powder for oral solution | Calves, chickens, pigs |
| Italy | Chemifarma S.p.A.
  Via Don Eugenio Servadei 16
  47122 Forlì, Forlì-Cesena
  Italy | Tilosina 20 % Chemifarma | Tylosin tartarate | 200 mg/g | Oral solution | Calves, chickens, pigs |
| Italy | Neofarma
  Via Emilia Km.18
  1854 — 47020 Longiano (FC)
  Italy | Tilosina 20 % liquida Neofarma | Tylosin tartarate | 200 mg/g | Oral solution | Calves, chickens, pigs |
| Italy | TREI
  Via Affarosa, 4
  42010 Rio Saliceto (RE)
  Italy | Tilosina 20 % liquida TreI | Tylosin tartarate | 200 mg/g | Oral solution | Calves, chickens, pigs |
| Italy | Chemifarma S.p.A.
  Via Don Eugenio Servadei 16
  47122 Forlì, Forlì-Cesena
  Italy | Tilosina 20 % liquida Chemifarma | Tylosin tartarate | 200 mg/g | Oral solution | Calves, chickens, pigs |
| Italy | LABORATORIO VACCINOGENO PAGNINI SNC
  Via A. Diaz 147/149
  Portici (NA)
  Italy | Tilosina 20 % Pagnini | Tylosin tartarate | 200 mg/g | Powder for oral solution | Calves, Pigs, Chickens-Broilers (not producing eggs for human consumption) |
| Italy | TREI
  Via Affarosa, 4
  42010 Rio Saliceto (RE)
  Italy | Tilosina 20 % TreI | Tylosin tartarate | 200 g/kg | Powder for oral solution | Calves, Pigs, Chickens-Broilers (not producing eggs for human consumption) |
| Italy | Vetoquinol Italia
  Via Piana, 265
  47032 Bertinoro (FC)
  Italy | Tilosina 20 % Vetoquinol | Tylosin tartarate | 200 mg/g | Powder for oral solution | Pigs, chickens |
| Italy | Filozoo Srl
  V. del Commercio 28/30
  41012 Carpi (MO)
  Italy | Tilosina 200 premix | Tylosin | 200 g/kg | Premix for medicated feeding stuff | Pigs, chickens |
| Italy | Ceva Salute Animale S.p.A.
  Viale Colleoni, 15
  20864 Agrate Brianza (MB)
  Italy | Tilsol 200 liquido | Tylosin | 200 g/kg | Powder for oral solution | Calves, Pigs, Chickens-Broilers, Turkeys (not producing eggs for human consumption) |
| Italy | Ceva Salute Animale S.p.A.
  Viale Colleoni, 15
  20864 Agrate Brianza (MB)
  Italy | Tilsol 200 solubile | Tylosin | 200 g/kg | Powder for oral solution | Calves, Pigs, Chickens-Broilers (not producing eggs for human consumption) |
| Italy | Eli Lilly Italia S.p.A.
  Via A. Gramsci, 731-733
  50019 Sesto Fiorentino (IT)
  Italy | Tylan solubile | Tylosin tartarate | 100 g/g | Powder for oral solution | Calves, Pigs, Herns-Broilers, Turkeys |
| Italy | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Tylmasin | Tylosin phosphate | 250 mg/g | Premix for medicated feeding stuff | Pigs and chickens (not producing eggs for human consumption) |
| Italy | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Tylmasin 20 mg/g granulato per uso orale per suini | Tylosin phosphate | 20 mg/g | Granules for oral solution | Pigs |
| Italy | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Tylmasin 250 mg/g granulato per uso orale per suini | Tylosin phosphate | 250 mg/g | Granules for oral solution | Pigs |
| Italy | Medilabor
  Via Cuneo, 17
  12030 Cavallermaggiore (CN)
  Italy | Tylomed 100 | Tylosin phosphate | 100 g/kg | Premix for medicated feeding stuff | Pigs and chickens (not producing eggs for human consumption) |
| Italy | DOX-AL ITALIA S.p.a.
  Via Mascagni 6
  20884 Sulbiate (MB)
  Italy | Tyloplus 200 | Tylosin | 200 g/kg | Premix for medicated feeding stuff | Pigs and chickens (not producing eggs for human consumption) |
| Italy | Chemifarma S.p.A.
  Via Don Eugenio Servadei 16
  47122 Forlì, Forlì-Cesena
  Italy | Tylosin 200 premix | Tylosin | 200 g/kg | Premix for medicated feeding stuff | Pigs and chickens (not producing eggs for human consumption) |
| Italy | TREI
  Via Affarosa, 4
  42010 Rio Saliceto (RE)
  Italy | Tylox 100 premix | Tylosin phosphate | 100 g/kg | Premix for medicated feeding stuff | Pigs and chickens (not producing eggs for human consumption) |
| Latvia | Magnum Veterinārija SIA
  Ulbrokas iela 23
  Rīga, LV-1021
  Latvia | Tylokel 75 MV 750 mg/g šķīdināmais pulveris iekšķīgi lietojama šķīduma pagatavošanai cūkām un mājputniem | Tylosin tartarate | 750 mg/g | Powder for oral solution | Pigs and poultry |
| Latvia | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 500 WSP 500 mg/g ūdenī šķīstošs pulveris iekšķīgai lietošanai cūkām, liellopiem, vistām un tītariem | Tylosin tartarate | 500 mg/g | Powder for oral solution | Cattle, pigs, chickens, turkey |
| Latvia | Vet Line SIA
  M. Rāmavas 2
  Valdlauči, Ķekavas pag.,LV-1076
  Latvia | Macrolan WS pulveris iekšķīgai lietošanai teļiem, kazām, aitām, cūkām un mājputniem | Tylosin tartarate | 1  000 mg/g | Powder for oral solution | Cattle, goats, sheep, pigs, poultry |
| Lithuania | bela-pharm GmbH & Co. KG
  Lohner Str. 19
  D-49377 Vechta
  Germany | TYLO-SUSCIT 100 % Kompaktat, geriamieji milteliai | Tylosin tartarate | 1  000 mg/g | Powder for oral solution | Pigs and chicken |
| Lithuania | Chemifarma S.p.A.
  Via Don Eugenio Servadei 16
  47122 Forlì, Forlì-Cesena
  Italy | TILOSINA 20 % CHEMIFARMA, geriamieji milteliai | Tylosin tartarate | 200 mg/g | Powder for oral solution | Non ruminating calves, pigs, poultry |
| Lithuania | Dopharma Research B.V.
  Zalmweg 24, 4941 VX Raamsdonksveer,
  the Netherlands | Tylogran WSP, granulės geriamajam tirpalui | Tylosin tartarate | 1  000 mg/g | Granules for oral solution | Calves, swine, chicken, turkeys |
| Lithuania | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 500 mg/g vandenyje tirpūs milteliai kiaulėms, veršeliams, vištoms ir kalakutams | Tylosin tartarate | 500 mg/g | Powder for oral solution | Swine, calf, chicken and turkey |
| Lithuania | DOX-AL ITALIA S.p.a.
  Via Mascagni 6
  20884 Sulbiate (MB)
  Italy | TILOSINA 20 % LIQUIDA, geriamasis tirpalas | Tylosin | 200 g/kg | Oral solution | Calves, swine and broilers. |
| Lithuania | Franvet,
  Zone Industrielle d'Etriché,
  49500 Segré,
  France | TYLORAL, geriamieji milteliai | Tylosin tartarate | 10 0 0 00  000 IU/sachet | Powder for oral solution | Poultry, swine, calves |
| Lithuania | DOX-AL ITALIA S.p.a.
  Via Mascagni 6
  20884 Sulbiate (MB)
  Italy | PURTYL, geriamieji milteliai | Tylosin tartarate | 1  000 mg/g | Powder for oral solution | Chicken, turkeys, swine and calves |
| Lithuania | Kela NV (Kela Laboratoria NV)
  Sint Lenaartseweg 48
  2320 Hoogstraten
  Belgium | TYLOSIN 75 %, geriamieji milteliai | Tylosin tartarate | 750 mg/g | Powder for oral solution | Swine, chicken |
| Malta | Industrial Veterinaria, S.A — INVESA
  Esmeralda 19
  E-08950 Esplugues de Llobregat, Barcelona
  Spain | TILOSINA 100 GANADEXIL | Tylosin | 100 mg/g | Powder for oral solution | Poultry, turkey, swine |
| The Netherlands | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 20 mg/g Orale Granules voor varkens | Tylosin phosphate | 20 mg/g | Granules for oral solution | Pig |
| The Netherlands | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 100 mg/g premix voor gemedicineerd voer voor varkens, slachtkuikens en opfokleghennen | Tylosin phosphate | 100 mg/g | Premix for medicated feeding stuff | Pig, chicken (broilers, future layers/breeders) |
| The Netherlands | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 % W/W Water Oplosbare Granules | Tylosin tartarate | 1 g/1,1 g | Granules for oral solution | Cattle (calves), pig, chicken, turkey |
| The Netherlands | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g Orale Granules voor varkens | Tylosin phosphate | 250 mg/g | Granules for oral solution | Pig |
| The Netherlands | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 250 mg/g premix voor gemedicineerd voer voor varkens, slachtkuikens en opfokleghennen | Tylosin phosphate | 250 mg/g | Premix for medicated feeding stuff | Pig, chicken (broilers, future layers/breeders) |
| The Netherlands | Eli Lilly Nederland B.V.
  Elanco Animal Health
  Grootslag 1-5
  3991 RA Houten
  The Netherlands | TYLAN G250 PREMIX 25 % | Tylosin phosphate | 250 g/kg | Premix for medicated feeding stuff | Pig, chicken (broilers, future layers/breeders) |
| The Netherlands | Eli Lilly Nederland B.V.
  Elanco Animal Health
  Grootslag 1-5
  3991 RA Houten
  The Netherlands | TYLAN W.O., poeder voor oraal gebruik bij kippen, kalkoenen, varkens en kalveren | Tylosin tartarate | Unadulterated | Powder for oral solution | Cattle (calves), pig, chicken, turkey |
| The Netherlands | Eli Lilly Nederland B.V.
  Elanco Animal Health
  Grootslag 1-5
  3991 RA Houten
  The Netherlands | TYLAN 100 PREMIX 10 % | Tylosin phosphate | 100 g/kg | Premix for medicated feeding stuff | Pig, chicken (broilers, future layers/breeders) |
| The Netherlands | Eli Lilly Nederland B.V.
  Elanco Animal Health
  Grootslag 1-5
  3991 RA Houten
  The Netherlands | TYLAN 2 % TOPDRESSING | Tylosin phosphate | 20 g/kg | Powder for oral solution | Pig |
| The Netherlands | Eli Lilly Nederland B.V.
  Elanco Animal Health
  Grootslag 1-5
  3991 RA Houten
  The Netherlands | TYLAN 20 PREMIX 2 % | Tylosin phosphate | 20 g/kg | Premix for medicated feeding stuff | Pig, chicken (broilers, future layers/breeders) |
| The Netherlands | Dopharma Reasearch B.V.
  Zalmweg 24
  4941 VX Raamsdonkveer
  The Netherlands | TYLOGRAN WSP | Tylosin tartarate | Unadulterated | Powder for oral solution | Cattle (calves), pig, chicken, turkey |
| The Netherlands | Eli Lilly Nederland B.V.
  Elanco Animal Health
  Grootslag 1-5
  3991 RA Houten
  The Netherlands | Tylosinetartraat 100 % | Tylosin tartarate | Unadulterated | Powder for oral solution | Cattle (calves), pig, chicken (broilers, future layers/breeders), turkey |
| Poland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 mg/g Premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych | Tylosin phosphate | 100 mg/g | Premix for medicated feeding stuff | Pigs, Broilers and Pullets |
| Poland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g granulat doustny dla świń | Tylosin phosphate | 20 mg/g | Granules for oral solution | Pigs |
| Poland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych | Tylosin phosphate | 250 mg/g | Premix for medicated feeding stuff | Pigs, Broilers and Pullets |
| Poland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g granulat doustny dla świń | Tylosin phosphate | 250 mg/g | Granules for oral solution | Pigs |
| Poland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 1 g/g granulat do podania w wodzie do picia dla świń, cieląt, kur i indyków | Tylosin tartarate | 1 g/g | Granules for oral solution | Calves, pigs, chickens, turkeys |
| Poland | Ceva Salute Animale S.p.A.
  Viale Colleoni, 15
  20864 Agrate Brianza (MB)
  Italy | Tilsol 200, 200 g/1000 g | Tylosin | 200 g/1  000 g | Powder for oral solution | Chicken, pig |
| Poland | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | Tylan Soluble Powder | Tylosin | 1  000 g/kg | Powder for oral solution | Chicken, turkey, pig, cattle |
| Poland | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | Tylan G 100 Premix | Tylosin | 100 mg/kg | Premix for medicated feeding stuff | Pigs |
| Poland | P.F.H.U. ‘Veta’ Mariusz Hołownia
  Kownaty 74
  18-421 Kownaty
  Poland | Tylo-Kel 75 proszek do sporządzania roztworu doustnego dla kur i świń | Tylosin tartarate | 750 mg/g | Powder for oral solution | Chicken, pig |
| Poland | Przedsiębiorstwo Farmaceutyczne Okoniewscy ‘VETOS FARMA’ Sp. z o.o.
  ul. Dzierżoniowska 21
  58-260 Bielawa
  Poland | FARMATYL, tylozyny winian 1000 g/kg proszek do sporządzania roztworu doustnego dla kur, indyków i świń | Tylosin tartarate | 1  000 g/kg | Powder for oral solution | Turkey, hen, pig |
| Poland | Vetoquinol Biowet Sp. z o.o.
  ul. Kosynierów Gdyńskich 13-14
  66-400 Gorzów Wielkopolski
  Poland | Tylbian, 110 mg/g | Tylosin tartarate | 110 mg/g | Granules for oral solution | Hen
  turkey
  pig
  cattle |
| Portugal | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 g/g Grânulos para administração na água de bebida para suínos, galinhas e frangos, perús e vitelos. | Tylosin | 1,1 g of granules contains 1 g of tylosin | Granules for oral solution | Calves, pigs, chickens, turkeys |
| Portugal | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g Pré-mistura para alimento medicamentoso para suínos, galinhas e frangos de engorda | Tylosin | 250 mg per g. (equivalent to 2 50  000 IU) | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Portugal | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 mg/g Pré-mistura medicamentosa para alimento medicamentoso para suínos, frangos de engorda e galinhas | Tylosin | 100 mg per g. (equivalent to 1 00  000 IU) | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Portugal | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 20 mg/g Grânulos Orais para suínos | Tylosin | 20 mg per g (equivalent to 20  000 IU) | Granules for oral solution | Pigs |
| Portugal | REPRESENTAGRO — REPRESENTAÇOES LDA
  Estrada da Lapa 1
  2665-507 Venda do Pinheiro
  Portugal | ORATIL 100 P, pó para solução oral para suínos, frangos e perus | Tylosin | 1  000 mg | Powder for oral solution | Pigs, broilers, turkeys |
| Portugal | PRODIVET, Comércio de Produtos Químicos, Farmacêuticos e Cosméticos, SA
  Av. Infante D. Henrique no 333-H 3o piso Esc. 41
  1800-282 Lisboa
  Portugal | PRODITYL, Pó para solução oral para administração na água de bebida para suínos, frangos e perus | Tylosin | 1,1 g | Powder for oral solution | Pigs, broilers, turkeys |
| Portugal | Ceva Saúde Animal Produtos Farmacêuticos e Imunológicos, Lda.
  Rua Doutor António Loureiro Borges, 9/9A — 9oA
  Miraflores, 1495-131 Algés
  Portugal | TILPLUS 100 PÓ para solução oral para suínos, frangos e perus | Tylosin | 100 g | Powder for oral solution | Pigs, broilers, turkeys |
| Portugal | Lilly Portugal — Produtos Farmaceuticos, Lda.
  Torre Occidente
  Rua Galileu Galilei, n.o 2
  Piso 7 fração A/D,
  1500-392 Lisboa
  Portugal | Tylan 100 g/Kg Pré mistura medicamentosa para alimento medicamentoso para suínos e frangos de carne, reprodutoras e poedeiras | Tylosin | 100 g/kg | Premix for medicated feeding stuff | Pigs, broilers, chickens |
| Portugal | Lilly Portugal — Produtos Farmaceuticos, Lda.
  Torre Occidente
  Rua Galileu Galilei, n.o 2
  Piso 7 fração A/D,
  1500-392 Lisboa
  Portugal | Tylan 20 g/Kg Pré mistura medicamentosa para alimento medicamentoso para suínos e frangos de carne, reprodutoras e poedeiras | TYLOSIN | 20 g/kg | Premix for medicated feeding stuff | Pigs, broilers, chickens |
| Portugal | Lilly Portugal — Produtos Farmaceuticos, Lda.
  Torre Occidente
  Rua Galileu Galilei, n.o 2
  Piso 7 fração A/D,
  1500-392 Lisboa
  Portugal | Tylan 250 g/Kg Pré mistura medicamentosa para alimento medicamentoso para Suínos e frangos de carne | TYLOSIN | 250 g/kg | Premix for medicated feeding stuff | Pigs, broilers, chickens |
| Portugal | Lilly Portugal — Produtos Farmaceuticos, Lda.
  Torre Occidente
  Rua Galileu Galilei, n.o 2
  Piso 7 fração A/D,
  1500-392 Lisboa
  Portugal | TYLAN PÓ SOLÚVEL | TYLOSIN | 100 g per bottle | Powder for oral solution | Pigs, broilers, turkeys |
| Portugal | ZOOPAN Produtos Pecuários S.A.
  Rua da Liberdade, no 77
  2050-023 Aveiras de Baixo
  Portugal | TYLOSIN 750 mg/g Pó oral para administração na água de bebida para suínos e frangos | TYLOSIN | 750 mg/g | Powder for oral solution | Pigs, broilers |
| Romania | S.C. PASTEUR -FILIALA FILIPESTI
  Str. Principala, nr. 944
  Filipestii de Padure, Jud. Prahova
  Romania | Tilozina 100 | Tylosin phosphate | 10 g/100 g | Premix for medicated feeding stuff | Poultry, pigs |
| Romania | S.C. PASTEUR -FILIALA FILIPESTI
  Str. Principala, nr. 944
  Filipestii de Padure, Jud. Prahova
  Romania | Tilozina | Tylosin tartarate | 0,58 g/g | Powder for oral solution | Cattle, pigs, poultry |
| Romania | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g | Tylosin phosphate | 250 mg/g | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Romania | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 mg/g | Tylosin phosphate | 100 mg/g | Premix for medicated feeding stuff | Pigs, broilers and pullets |
| Romania | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g | Tylosin phosphate | 20 mg/g | Granules for oral solution | Pigs |
| Romania | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 % | Tylosin tartarate | 1 g/g | Granules for oral solution | Calves, pigs, poultry |
| Romania | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | Tylan G 100 g/kg | Tylosin phosphate | 100 g/kg | Premix for medicated feeding stuff | Pigs |
| Romania | Crida Pharm SRL
  str. Intrarea Vagonetului nr.2, bl.101, ap.47, parter, sector 6
  Bucharest
  Romania | Tylosin 60 % | Tylosin tartarate | 60 g/100 g | Powder for oral solution | Pigs, broilers |
| Romania | SC Delos Impex 96 SRLStr
  Horia, Closca si Crisan, Otopeni
  judetul Ilfov
  Romania | Tilodem 50 | Tylosin tartarate | 500 mg/g | Powder for oral solution | Pigs, poultry (broilers, breeding broilers, laying hens, replacement pullets) |
| Romania | SC Delos Impex 96 SRLStr
  Horia, Closca si Crisan, Otopeni
  judetul Ilfov
  Romania | Tilosin 10 % | Tylosin tartarate | 100 mg/g | Powder for oral solution | Pigs, poultry |
| Romania | Chemifarma S.p.A.
  Via Don Eugenio Servadei 16
  47122 Forlì, Forlì-Cesena
  Italy | Tilosina 20 % Chemifarma | Tylosin tartarate | 20 g/100 g | Powder for oral solution | Cattle, pigs, poultry (broilers, turkeys) |
| Romania | Anupco LTd.
  Crockatt Road
  Lady Lane Industrial Estate, Hadleigh
  Ipswich, Suffolk, IP7 6RD
  United Kingdom | Tylosin 75 | Tylosin tartarate | 825 mg/g | Powder for oral solution | Pigs, poultry (chicken, turkey) |
| Romania | Kela NV (Kela Laboratoria NV)
  Sint Lenaartseweg 48
  2320 Hoogstraten
  Belgium | Tylosin 75 % Kela | Tylosin tartarate | 750 mg/g | Powder for oral solution | Pigs, poultry |
| Slovakia | Pharmagal spol. s.r.o.
  Murgašova 5
  949 01 Nitra
  Slovakia | RESETYL prášok na perorálny roztok | Tylosin tartarate | 1  000 g/1  100 g | Powder for oral solution | Chickens (broilers, pullets, laying hens), turkeys, pigs, calves |
| Slovakia | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | TYLAN vodorozpustný prášok | Tylosin tartarate | 1  000 g/1  100 g | Powder for oral solution | Chickens (broilers, pullets, laying hens), turkeys, pigs, calves |
| Slovakia | Eli Lilly Regional Operations GmbH
  Elanco Animal Health
  Kölblgasse 8-10
  1030 Vienna
  Austria | TYLAN 100 mg/g premix | Tylosin phosphate | 100 mg/g | Premix for medicated feeding stuff | Pigs |
| Slovenia | IRIS Mednarodna trgovina d.o.o.,
  Cesta v Gorice 8
  1000 Ljubljana
  Slovenia | TYLAN SOLUBLE prašek za peroralno raztopino za prašiče, kokoši in purane | Tylosin | 100 g | Powder for oral solution | Pigs, chicken, turkey |
| Spain | Elanco Valquímica, S.A.
  Avda. de la Industria, no 30
  Polígono Industrial de Alcobendas
  28108 Alcobendas (Madrid)
  Spain | TRELACON G 250 PREMEZCLA | Tylosin | 250 mg/g | Premix for medicated feeding stuff | Pigs, poultry |
| Spain | Elanco Valquímica, S.A.
  Avda. de la Industria, no 30
  Polígono Industrial de Alcobendas
  28108 Alcobendas (Madrid)
  Spain | TRELACON G 50 PREMEZCLA | Tylosin | 50 mg/g | Premix for medicated feeding stuff | Pigs, poultry |
| Spain | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 100 MG/G PREMEZCLA MEDICAMENTOSA PARA PORCINO POLLOS DE ENGORDE | Tylosin | 100 mg/g | Premix for medicated feeding stuff | Pigs, broilers, pullets |
| Spain | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 250 MG/G PREMEZCLA MEDICAMENTOSA PARA PORCINO POLLOS DE ENGORDE | Tylosin phosphate | 250 mg/g | Premix for medicated feeding stuff | Pigs, broilers, pullets |
| Spain | S.P. VETERINARIA, S.A.
  CTRA. REUS-VINYOLS, KM.4,1.
  RIUDOMS (Tarragona)
  Spain | HIDROTIL POLVO ORAL | Tylosin tartarate | 100 g/100 g | Powder for oral solution | Broilers, layer hens and future layer pullets turkeys, pigs and cattle (claves) |
| Spain | Elanco Valquímica, S.A.
  Avda. de la Industria, no 30
  Polígono Industrial de Alcobendas
  28108 Alcobendas (Madrid)
  Spain | TRELACON G 20 G/KG PREMEZCLA MEDICAMENTOSA | Tylosin phosphate | 20 mg/g | Premix for medicated feeding stuff | Pigs, broilers and replacement pullets |
| Spain | Elanco Valquímica, S.A.
  Avda. de la Industria, no 30
  Polígono Industrial de Alcobendas
  28108 Alcobendas (Madrid)
  Spain | TRELACON G 100 G/KG PREMEZCLA MEDICAMENTOSA | Tylosin phosphate | 100 mg/g | Premix for medicated feeding stuff | Pigs, broilers and replacement pullets |
| Spain | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 1G/G GRANULADO PARA ADMINISTRACIÓN EN AGUA DE BEBIDA | Tylosin tartarate | 1 g/g | Granules for oral solution | Pigs, calves, chickens, turkeys |
| Spain | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | PHARMASIN 20 MG/G GRANULADO ORAL PARA PORCINO | Tylosin phosphate | 20 mg/g | Granules for oral solution | Pigs |
| Spain | Elanco Valquímica, S.A.
  Avda. de la Industria, no 30
  Polígono Industrial de Alcobendas
  28108 Alcobendas (Madrid)
  Spain | TAILAN | Tylosin | 1 g/g | Powder for oral solution | Pigs, poultry (broilers, pullets, layers and turkeys), bovine (pre-ruminants calves). |
| Spain | S.P. VETERINARIA, S.A.
  Ctra. Reus-Vinyols, km.4,1.
  Riudoms (Tarragona)
  Spain | ORATIL — 100 | Tylosin tartarate | 1 g/g | Powder for oral solution | Pigs, chickens, turkeys, calves |
| Spain | INDUSTRIAL VETERINARIA, S.A.
  Esmeralda 19.
  08950 Esplugues de Llobregat (Barcelona)
  Spain | TILOSINA 100 GANADEXIL | Tylosin tartarate | 1 g/g | Powder for oral solution | Pigs, chickens, turkeys |
| Spain | MEVET, S. A.U.
  Polígono Industrial El Segre
  parcela 409-410.
  25191 Lérida
  Spain | TILOVALL PREMEZCLA | Tylosin phosphate | 20 mg/g | Premix for medicated feeding stuff | Pigs, poultry and cattle |
| Spain | LABORATORIOS CALIER, S.A.
  BARCELONÉS, 26.
  08520 Les Franqueses del Valles (Barcelona)
  Spain | GANAMIX TILOSINA 10 % PREMEZCLA | Tylosin phosphate | 10 mg/g | Premix for medicated feeding stuff | Pigs, poultry and cattle |
| Spain | LABORATORIOS HIPRA, S.A.
  Avda. La Selva, 135.
  17170 Amer (Girona)
  Spain | HIPRAMIX-TIL | Tylosin phosphate | 20 mg/g | Premix for medicated feeding stuff | Pigs, poultry and cattle |
| Spain | ANDRES PINTALUBA, S.A.
  Pol. Industrial Agro-Reus
  c/Prudenci Bertrana 5.
  43206 Reus (Tarragona)
  Spain | APSAMIX TILOSINA 10 % | Tylosin phosphate | 10 mg/g | Premix for medicated feeding stuff | Pigs, poultry and cattle |
| Spain | MEVET, S. A.U.
  Polígono Industrial El Segre
  parcela 409-410.
  25191 Lérida
  Spain | TILOVALL POLVO | Tylosin tartarate | 1 g/g | Powder for oral solution | Porcine, chickens, calves |
| Spain | SUPER’S DIANA, S.L.
  Ctra. C-17, km 17.
  08150 Parets del Valles (Barcelona)
  Spain | TILOSAN | Tylosin phosphate | 20 mg/g | Premix for medicated feeding stuff | Pigs |
| Sweden | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan vet. | Tylosin | 0,83 | Powder for oral solution | Pigs and domestic birds |
| Sweden | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan vet. | Tylosin | 0,02 | Premix for medicated feeding stuff | Pigs |
| Sweden | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskaer 3E, 2 tv.
  2730 HERLEV
  Denmark | Tylan vet. | Tylosin | 0,1 | Premix for medicated feeding stuff | Pigs |
| United Kingdom | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets | Tylosin | 100 mg/g | Premix for medicated feeding stuff | Pigs
  Poultry |
| United Kingdom | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 100 % w/w Granules for Use in Drinking Water for Pigs, Chickens, Turkeys and Calves | Tylosin | 100 % w/w | Granules for oral solution | Cattle
  Chickens
  Pigs
  Turkey |
| United Kingdom | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 20 mg/g Oral Granules for Pigs | Tylosin | 20 mg/mg | Premix for medicated feeding stuff | Pigs |
| United Kingdom | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Pharmasin 250 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets | Tylosin | 250 mg/g | Premix for medicated feeding stuff | Pigs
  Poultry |
| United Kingdom | Eli Lilly & Company Ltd
  Elanco Animal Health
  Lilly House
  Priestley Road
  Basingstoke, RG24 9NL
  United Kingdom | Tylan G20 Premix for Medicated Feedingstuff | Tylosin | 2,00 % w/w | Premix for medicated feeding stuff | Pigs |
| United Kingdom | Eli Lilly & Company Ltd
  Lilly House
  Priestley Road
  Basingstoke, RG24 9NL
  United Kingdom | Tylan G250 Premix for Medicated Feedingstuff | Tylosin | 25 % w/w | Premix for medicated feeding stuff | Chickens
  Pigs |
| United Kingdom | Eli Lilly & Company Ltd
  Lilly House
  Priestley Road
  Basingstoke, RG24 9NL
  United Kingdom | Tylan G50 Premix for Medicated Feedingstuff | Tylosin | 5,00 % w/w | Premix for medicated feeding stuff | Pigs |
| United Kingdom | Eli Lilly & Company Ltd
  Lilly House
  Priestley Road
  Basingstoke, RG24 9NL
  United Kingdom | Tylan Soluble Powder for Oral Solution | Tylosin | 10 % w/w | Powder for oral solution | Cattle
  Chickens
  Pigs
  Turkeys |

Member State EU/EEA

Applicant/Marketing authorisation holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Austria

Chevita Tierarzneimittel GmbH

Kaplanstrasse 10

4600 Wels

Austria

Chevi-Tyl 200 mg/g Arzneimittel-Vormischung zu Herstellung von Fütterungsarzneimitteln für Schweine, Hühner und Puten

Tylosin tartarate

20 g/100 g powder

Premix for medicated feeding stuff

Pigs, chicken, turkey

Austria

Chevita Tierarzneimittel GmbH

Kaplanstrasse 10

4600 Wels

Austria

Chevi-Tyl 200 mg/g Pulver zum Eingeben für Schweine, Hühner und Puten

Tylosin tartarate

20 g/100 g powder

Powder for oral solution

Pigs, chicken, turkey

Austria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 1 g/g Granulat zum Eingeben über das Trinkwasser für Schweine, Hühner, Puten und Kälber

Tylosin

1 g tylosin (= 1,1 g tylosin tartate) per 1,1 g of granules

Granules for oral solution

Calves, pigs, chicken, turkey

Austria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 mg/g Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Masthühner und Junghennen

Tylosin

100 mg tylosin as tylosin phosphate per g (= 1 00  000 IU)

Premix for medicated feeding stuff

Pigs, broilers, pullets

Austria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Masthühner und Junghennen

Tylosin

250 mg tylosin as tylosin phosphate per g (= 2 50  000 IU)

Premix for medicated feeding stuff

Pigs, broilers, pullets

Austria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g Granulat zum Eingeben für Schweine

Tylosin

20 mg tylosin as tylosin phosphate per g (= 20  000 IU)

Granules for oral solution

Pigs

Austria

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Tylan 20 mg/g — Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine

Tylosin phosphate

20 g/kg

Premix for medicated feeding stuff

Pigs

Austria

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Tylan soluble — 1 g/g Pulver zur Herstellung einer Lösung zum Eingeben für Schweine, Hühner und Truthühner

Tylosin

110 g tylosin tartate per 110 g powder (= 100 g tylosin-activity)

Powder for oral solution

Pigs, chicken, turkeys

Austria

AniMed Service AG

Liebochstrasse 9

8143 Dobl

Austria

Tylosin-Phosphat ‘AniMed Service’ 100 mg/g — Pulver zum Eingeben für Schweine

Tylosin

100 g tylosin (as tylosin phophate) per 1  000 g powder

Powder for oral solution

Pigs

Austria

Vana GmbH

Wolfgang Schmälzlgasse 6

1020 Vienna

Austria

Vanatyl-Pulver für Tiere

Tylosin

110 g tylosin tartate per 110 g powder (= 100 g tylosin-base)

Powder for oral solution

Pigs, chicken (broiler), turkeys

Austria

AniMed Service AG

Liebochstrasse 9

8143 Dobl

Austria

Tylosintartrat PUR ‘AniMed Service’ 1 g/g — Pulver zum Eingeben für Tiere

Tylosin

1 g tylosin (as tylosin tartate) per 1 g of powder

Powder for oral solution

Cattle (calve)

Chickens

Pigs

Turkeys

Belgium

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g OG

Tylosin phosphate

20 mg/g

(20  000 IU)

Granules for oral solution

Pigs

Belgium

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g OG

Tylosin phosphate

250 mg/g

(2 50  000 IU)

Granules for oral solution

Pigs

Belgium

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 % w/w

Tylosin tartarate

1 g in 1,1 g granules

(1,1 g)

Granules for oral solution

Calves

Pigs

Chicken

Turkey

Belgium

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 mg/g Premix

Tylosin phosphate

100 mg/g

(1 00  000 IU)

Premix for medicated feeding stuff

Pigs

Broilers

Pullets

Belgium

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g Premix

Tylosin phosphate

250 mg/g

(2 50  000 IU)

Premix for medicated feeding stuff

Pigs

Broilers

Pullets

Belgium

Eli Lilly Benelux N.V.

Elanco Animal Health

Markiesstraat 1

1000 Brussel

Belgium

Tylan 20 Granules

Tylosin phosphate

20 mg/g

(20  000 IU)

Granules for oral solution

Pigs

Broilers

Pullets

Belgium

Eli Lilly Benelux N.V.

Elanco Animal Health

Markiesstraat 1

1000 Brussel

Belgium

Tylan 100 Granules

Tylosin phosphate

100 mg/g

(1 00  000 IU)

Granules for oral solution

Pigs

Broilers

Pullets

Belgium

Eli Lilly Benelux N.V.

Elanco Animal Health

Markiesstraat 1

1000 Brussel

Belgium

Tylan 20 Vet Premix

Tylosin phosphate

20 mg/g

(20  000 IU)

Premix for medicated feeding stuff

Pigs

Broilers

Pullets

Belgium

Eli Lilly Benelux N.V.

Elanco Animal Health

Markiesstraat 1

1000 Brussel

Belgium

Tylan 100 Vet Premix

Tylosin phosphate

100 mg/g

(1 00  000 IU)

Premix for medicated feeding stuff

Pigs

Broilers

Pullets

Belgium

Eli Lilly Benelux N.V.

Elanco Animal Health

Markiesstraat 1

1000 Brussel

Belgium

Tylan 250 Vet Premix

Tylosin phosphate

250 mg/g

(2 50  000 IU)

Premix for medicated feeding stuff

Pigs

Broilers

Pullets

Belgium

Eli Lilly Benelux N.V.

Elanco Animal Health

Markiesstraat 1

1000 Brussel

Belgium

Tylan Soluble

Tylosin tartarate

108 (100 g)/lagena

109 (1  000 g)/saccus

(1  000 mg/g)

Powder for oral solution

Calves

Pigs

Chicken

Turkey

Belgium

Kela NV (Kela Laboratoria NV)

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Tylosine 75 % Kela

Tylosin tartarate

750 mg/g

(7 50  000 IU/g)

Powder for oral solution

Pigs

Chicken

Bulgaria

Gabrofam OOD

7002 Russe

16 Aleia Vazrajdane str., ap.42

Bulgaria

ТИЛОЗИН 60 % — БГ Водоразтворим прах

Tylosin

Tylosin tartarate 60 mg/g

Powder for oral solution

Hens and pigs

Bulgaria

Biovet JSC

39 Petar Rakov Str

4550 Peshtera

Bulgaria

TИЛОВЕТ 10 % гранули за перорално приложение за свине, прасета, пилета, пуйки, телета за угояване

Tylosin

Tylosin phosphate 100 mg/g

Granules for oral solution

Swine, pigs, chickens, turkeys, calves for fattening

Bulgaria

Biovet JSC

39 Petar Rakov Str

4550 Peshtera

Bulgaria

TИЛОВЕТ 25 % премикс за медикаментозен фураж за свине, прасета, пилета, пуйки, телета за угояване

Tylosin

Tylosin phosphate 250 mg/g

Premix for medicated feeding stuff

Swine, pigs, chickens, turkeys, calves for fattening

Bulgaria

Biovet JSC

39 Petar Rakov Str

4550 Peshtera

Bulgaria

TИЛОВЕТ 10 % премикс за медикаментозен фураж за свине, прасета, пилета, пуйки, телета за угояване

Tylosin

Tylosin phosphate 100 mg/g

Premix for medicated feeding stuff

Swine, pigs, chickens, turkeys, calves for fattening

Bulgaria

Biovet JSC

39 Petar Rakov Str

4550 Peshtera

Bulgaria

ТИЛОВЕТ пулвис водоразтворим прах за пилета, пуйки, прасета и телета

Tylosin

Tylosin tartarate 500 mg/g

Powder for oral solution

Chickens, turkeys, pigs and calves

Bulgaria

Biovet JSC

39 Petar Rakov Str

4550 Peshtera

Bulgaria

Тиловет Форте водоразтворими гранули за свине

Tylosin

200 mg/g

Granules for oral solution

Swine

Bulgaria

Pharma SIS

4 San Stefano Str.

Dobrich

Bulgaria

Оратил 100

Tylosin

108,18 g/110 g

Powder for oral solution

Chicken, turkeys and pigs

Bulgaria

Pharma SIS

4 San Stefano Str.

Dobrich

Bulgaria

Тилозин 100 премикс

Tylosin

10 g/100 g

Premix for medicated feeding stuff

Swine

Bulgaria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g Орални гранули за свине

Tylosin

20 mg/g

Granules for oral solution

Swine

Bulgaria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки

Tylosin

100 mg/g

Premix for medicated feeding stuff

Pigs, broilers and pullets

Bulgaria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки

Tylosin

250 mg/g

Premix for medicated feeding stuff

Pigs, broilers and pullets

Bulgaria

Pharma Vet

40 Otec Paisii Str.

Shumen

Bulgaria

Tилофарм водоразтворим прах

Tylosin

4 0 0 00  000 IU (50 g)

Powder for oral solution

Hens and pigs

Bulgaria

Zavet JSC

5 Kiril i Metodii Str.

Zavet

Bulgaria

Тилозин 50 % водоразтворим прах

Tylosin

5 00  000 IU/g

Powder for oral solution

Pigs, swine, broilers, turkeys, chicken and turkey breeders

Croatia

Medical Intertrade d.o.o.

Dr. Franje Tuđmana 3

10431, Sveta Nedelja

Croatia

Tylan Soluble

Tylosin

bottle: 100 g

bag: 1  000 g

Powder for oral solution

Chickens, turkeys, pigs

Croatia

GENERA d.d.

Svetonedeljska 2

Kalinovica, 10436 Rakov Potok

Croatia

Tilozin tartarat

Tylosin

Powder,

1 bottle: 70 g

Powder for oral solution

Chickens, turkeys, pigs

Cyprus

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 100 % Κοκκία για χορήγηση με το πόσιμο νερό για μόσχους, χοίρους, ορνίθια και ινδόρνιθες

TYLOSIN

1,1 g of granules contains 1 g of tylosin (corresponding to 1,1 g of tylosin tartrate)

Granules for oral solution

Calves, pigs, chickens, turkeys

Cyprus

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

TYLAN G 100 PREMIX

100 g/kg

Προμίγμα για φαρμακούχες ζωοτροφές για χοίρους.

Tylosin phosphate

100,0 g/kg

Premix for medicated feeding stuff

Pigs

Cyprus

DOX-AL ITALIA S.p.a.

Via Mascagni 6

20884 Sulbiate (MB)

Italy

TYLOSINA BMP Powder

Τylosin (from tylosin tartrate) 200 g/Kg

Φαρμακούχο πρόμιγμα σε κόκκους για χοίρους και κοτόπουλα κρεωπαραγωγής

Tylosin

200,0 g/kg

Premix for medicated feeding stuff

Swine, broilers

Czech Republic

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 % w/w granules for oral administration in drinking water for oral solution for pigs, chicken, turkey and calves

Tylosin

1 g Tylosinum (odpovídající 1,1 g Tylosini tartaras)/1,1 g

Granules for oral solution

Calves, pigs, chicken, turkey

Czech Republic

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g oral granules for pigs

Tylosin

Tylosinum (ut Tylosini phosphas) 20 mg v 1 g (odpovídá 20  000 IU)

Granules for oral solution

Pigs

Czech Republic

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 250 mg/g oral granules for pigs

Tylosin

Tylosinum (ut Tylosini phosphas): 250 mg/g (odpovídá 2 50  000 IU.)

Granules for oral solution

Pigs

Czech Republic

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Tylan powder for oral solution

Tylosin

Tylosinum (ut tylosini tartras) 800 I.U./mg

Powder for oral solution

Chicken broilers, breeding pullets and laying hens, production pullets, turkey, pigs, calves

Czech Republic

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

TYLAN 100 mg/g granules for pigs

Tylosin

Tylosinum (ut phosphas) 100 mg aktivity (odpovídá 1 00  000 IU)/g

Granules for oral solution

Pigs

Czech Republic

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

TYLAN 100 mg/g medicated pre-mix for pigs

Tylosin

Tylosinum (ut phosphas) 100 mg aktivity (odpovídá 1 00  000 IU)/g

Premix for medicated feeding stuff

Pigs

Denmark

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan Vet.

Tylosin

100 g/kg

Premix for medicated feeding stuff

Pig

Denmark

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan Vet.

Tylosin

2 %

Premix for medicated feeding stuff

Pig

Denmark

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan Vet.

Tylosin

No information available

Powder for oral solution

Pig, poultry

Denmark

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan Vet.

Tylosin

2 %

Powder for oral solution

Pig

Denmark

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan Vet.

Tylosin

10 %

Powder for oral solution

Pig

Denmark

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Tylmasin

Tylosin

20 mg/g

Granules for oral solution

Pig

Denmark

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Tylmasin

Tylosin

250 mg/g

Granules for oral solution

Pig

Denmark

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Tylmasin

Tylosin

1 g/g

Granules for oral solution

Calf, pig, poultry

Denmark

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Tylmasin

Tylosin

100 mg/g

Premix for medicated feeding stuff

Poultry, pig

Denmark

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Tylmasin

Tylosin

250 mg/g

Premix for medicated feeding stuff

Poultry, pig

Denmark

Ceva Animal Health A/S

Ladegårdsvej 2

DK-7100 Vejle

Denmark

Tylosin ‘Ceva’ Vet

Tylosin

No information available

Powder for oral solution

Poultry, pig

Denmark

ScanVet Animal Health A/S

Kongevejen 66

DK-3480 Fredensborg

Denmark

Tylocure

Tylosin

1 g/g

Granules for oral solution

Pig

Estonia

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 500WSP

Tylosin

500 mg/g

Powder for oral solution

Cattle, pigs, chicken, turkey

Estonia

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 1  000 mg/g granules for use in drinking water for pigs, chickens, turkeys and calves

Tylosin

1  000 mg/g

Granules for oral solution

Cattle, pigs, chicken, turkey

Finland

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan Premix vet

20 mg/g esisekoite lääkerehua varten

Tylosin phosphate

20 mg/g

Premix for medicated feeding stuff

Pig

Finland

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan vet jauhe oraaliliuosta varten

Tylosin tartarate

1 g oral powder contains 1 g tylosin tartrate resp 800 mg tylosin

Powder for oral solution

Pig, poultry

France

SOGEVAL

200 AVENUE DE MAYENNE

ZONE INDUSTRIELLE DES TOUCHES

53000 LAVAL

France

CONCENTRAT V007 TYLAN 100

Tylosin phosphate

20  000 IU/g

Premix for medicated feeding stuff

Pig

Poultry

France

VIRBAC

1ere avenue 2065 m L. I. D.

06516 Carros

France

AXENTYL

Tylosin tartarate

80 mg/g

Powder for oral solution

Pig

France

Lilly France S.A.S.

24 bld Vital Bouhot

CS 50004

92521 Neuilly sur Seine cedex

France

TYLAN 20 PREMIX

Tylosin phosphate

20  000 IU/g

Premix for medicated feeding stuff

Pig

Poultry

France

QALIAN

34 RUE JEAN MONNET

ZI D'ETRICHE

49500 SEGRE

France

COMPOMIX V T

Tylosin tartarate

92  000 IU/g

Powder for oral solution

Pig

France

QALIAN

34 RUE JEAN MONNET

ZI D'ETRICHE

49500 SEGRE

France

SANTAMIX TYLO 20

Tylosin phosphate

20  000 IU/g

Premix for medicated feeding stuff

Pig

Poultry

France

QALIAN

34 RUE JEAN MONNET

ZI D'ETRICHE

49500 SEGRE

France

TYLORAL

Tylosin tartarate

10 0 0 00  000 IU/sachet or jar

Powder for oral solution

Turkey

Pig

Cow

Poultry

France

QALIAN

34 RUE JEAN MONNET

ZI D'ETRICHE

49500 SEGRE

TYLOSINE BUVABLE NOE

Tylosin tartarate

10 0 0 00  000 IU/sachet

Powder for oral solution

Turkey

Pig

Cow

Poultry

France

LABORATOIRES BIOVE

3 RUE DE LORRAINE

62510 ARQUES

France

TYLOLIDE

Tylosin tartarate

10 0 0 00  000 IU/jar

Powder for oral solution

Turkey

Pig

Cow

Poultry

France

Lilly France S.A.S.

24 bld Vital Bouhot

CS 50004

92521 Neuilly sur Seine cedex

France

TYLAN SOLUBLE 100 %

Tylosin tartarate

10 0 0 00  000 IU/jar

Powder for oral solution

Pig

Cow

Poultry

France

SOGEVAL

200 AVENUE DE MAYENNE

ZONE INDUSTRIELLE DES TOUCHES

53000 LAVAL

France

SOGETYL 100 MUI POUDRE POUR SO LUTION BUVABLE POUR VEAUX PORCINS ET VOLAILLE

Tylosin tartarate

10 0 0 00  000 IU/jar

Powder for oral solution

Pig

Cow

Poultry

France

QALIAN

34 RUE JEAN MONNET

ZI D'ETRICHE

49500 SEGRE

France

TYLO 20 PM PORC VOLAILLE

Tylosin phosphate

20  000 IU/g

Premix for medicated feeding stuff

Pig

Poultry

France

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 20 G/KG PREMELANGE M EDICAMENTEUX VOLAILLE PORCS

Tylosin phosphate

20  000 IU/g

Premix for medicated feeding stuff

Pig

Poultry

France

QALIAN

34 RUE JEAN MONNET

ZI D'ETRICHE

49500 SEGRE

France

TYLOSOL 9,2

Tylosin tartarate

92  000 IU/g

Powder for oral solution

Pig

France

DELTAVIT

ZONE D'ACTIVITES DU BOIS DE TEILLAY

35150 JANZE

France

PM 21 TYLOSINE 20 PORC-VOLAILL E

Tylosin phosphate

20  000 IU/g

Premix for medicated feeding stuff

Pig

Poultry

France

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

TYLMASIN

Tylosin tartarate

10 0 0 00  000 IU/jar

Granules for oral solution

Pig

Cow

Poultry

France

LABORATORIOS MAYMO

VIA AUGUSTA 302

08017 BARCELONA

Spain

MAYLOSINE

Tylosin tartarate

No information available

Powder for oral solution

Poultry

Pig

Cattle

Germany

aniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

Germany

Tylosin G 5 % AMV

Tylosin phosphate

50 g/1 kg

Premix for medicated feeding stuff

Pig

Germany

aniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

Germany

Tylenterol

Tylosin phosphate

20 mg/g

Premix for medicated feeding stuff

Pig

Germany

aniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

Germany

TP 10 % AMV

Tylosin phosphate

100,000 IU/g

Premix for medicated feeding stuff

Pig

chicken

Germany

aniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

Germany

Klato lan

Tylosin tartarate

1  000 mg/g

Powder for oral solution

Pig

chicken

Germany

bela-pharm GmbH & Co. KG

Lohner Str. 19

D-49377 Vechta

Germany

Tylosintartrat 100 % Kompaktat

Tylosin tartarate

1  000 mg/g

Granules for oral solution

Pig

chicken

Germany

bela-pharm GmbH & Co. KG

Lohner Str. 19

D-49377 Vechta

Germany

Tylo-Suscit 100 % Kompaktat

Tylosin tartarate

1  000 mg/g

Granules for oral solution

Pig

chicken

turkey

Germany

bela-pharm GmbH & Co. KG

Lohner Str. 19

D-49377 Vechta

Germany

Tylo-Suscit 25

Tylosin tartarate

250 mg/g

Powder for oral solution

Pig

chicken

Germany

bioptivet Tierarzneimittel GmbH & Co.

Im Landwehrwinkel 22

D-59073 Hamm

Germany

Tylogran WSP, 1000 mg/g

Tylosin tartarate

1  000 mg/g

Granules for oral solution

Pig

chicken

Germany

Dopharma Research B.V.

Zalmweg 24

NL-4941 VX Raamsdonksveer

The Netherlands

TP 25 % Pulver

Tylosin phosphate

250 mg/g

Powder for oral solution

Pig

Germany

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 % w/w Granulat zum Eingeben über das Trinkwasser für Schweine, Hühner, Puten und Kälber

Tylosin tartarate

1,0 g/1,1 g

Granules for oral solution

Cattle (calf)

pig

chicken

turkey

Germany

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g Granulat zum Eingeben für Schweine

Tylosin

250 mg/g

Granules for oral solution

Pig

Germany

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g Granulat zum Eingeben für Schweine

Tylosin

20 mg/g

Granules for oral solution

Pig

Germany

KLAT-Chemie GmbH

Visbeker Str. 12

D-26197 Ahlhorn

Germany

Klato lan feed

Tylosin phosphate

1  000 mg/g

Powder for oral solution

Pig

chicken

Germany

Kon-Pharma GmbH

Senator-Bauer-Str. 34

D-30625 Hannover

Germany

Tylosintartrat 100 %

Tylosin tartarate

1 g/g

Powder for oral solution

Pig

chicken

Germany

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Straße 2-4

D-61352 Bad Homburg

Germany

Tylan Mix 2 %

Tylosin phosphate

20 g/kg

Premix for medicated feeding stuff

Pig

Germany

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Straße 2-4

D-61352 Bad Homburg

Germany

Tylan soluble

Tylosin tartarate

100 g/110 g

Powder for oral solution

Cattle(calf)

pig

chicken

turkey

Germany

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Straße 2-4

D-61352 Bad Homburg

Germany

Tylan G 25 %

Tylosin phosphate

250 mg/g

Powder for oral solution

Pig

Germany

bela-pharm GmbH & Co. KG

Lohner Str. 19

D-49377 Vechta

Germany

Tylo-Suscit 100 % Kompaktat

Tylosin tartarate

1 g/g

Granules for oral solution

Pig

chicken

turkey

Greece

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 2 %

Tylosin

20 mg/g

Granules for oral solution

Pigs

Greece

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 100 %

Tylosin

1 g

Granules for oral solution

Calves, pigs, chickens, turkeys

Greece

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 10 % premix

Tylosin

100 mg/g

Premix for medicated feeding stuff

Pigs, broilers and pullets

Greece

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMACIN 25 % premix

Tylosin

250 mg/g

Premix for medicated feeding stuff

Pigs, broilers and pullets.

Hungary

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 100 mg/g gyógypremix sertések, broilercsirkék és jércék számára A.U.V.

Tylosin phosphate

100 mg/g

Premix for medicated feeding stuff

Pigs and chickens

Hungary

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 % granulátum ivóvízbe keveréshez

sertés, házityúk, pulyka és borjú számára A.U.V.

Tylosin tartarate

100 %

Granules for oral solution

Pigs, chickens, turkeys and calves

Hungary

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g granulátum sertések számára A.U.V.

Tylosin phosphate

20 mg/g

Granules for oral solution

Pigs

Hungary

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 250 mg/g gyógypremix sertések, broilercsirkék és jércék számára A.U.V.

Tylosin phosphate

250 mg/g

Premix for medicated feeding stuff

Pigs and chickens

Hungary

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Tylan G 100 gyógypremix A.U.V.

Tylosin phosphate

100 g/kg

Premix for medicated feeding stuff

Pigs and chickens

Hungary

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Tylan vízoldékony por A.U.V.

Tylosin tartarate

100 %

Powder for oral solution

Pigs, chickens, turkeys and calves

Hungary

Kela NV (Kela Laboratoria NV)

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

TYLOSIN 75 % Kela oral por A.U.V.

Tylosin tartarate

750 mg/g

Powder for oral solution

Pigs and chickens

Ireland

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke, RG24 9NL

United Kingdom

Tylan G20 Premix for medicated feedingstuff

Tylosin

20 g/kg

Premix for medicated feeding stuff

Pigs

Ireland

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke, RG24 9NL

United Kingdom

Tylan G100 Premix

Tylosin

100 g/kg

Premix for medicated feeding stuff

Pigs

Ireland

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke, RG24 9NL

United Kingdom

Tylan G250 Premix for medicated feedingstuff

Tylosin

250 g/kg

Premix for medicated feeding stuff

Pigs, broilers and pullets

Ireland

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke, RG24 9NL

United Kingdom

Tylan G50 Premix for medicated feedingstuff

Tylosin phosphate

50 g/kg

Premix for medicated feeding stuff

Pigs

Ireland

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke, RG24 9NL

United Kingdom

Tylan Soluble Powder for Oral Solution

Tylosin tartarate

100 g

Powder for oral solution

Calves, pigs and poultry

Ireland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g Oral Granules for pigs

Tylosin

20 mg/g

Granules for oral solution

Pigs

Ireland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 mg/g Premix for medicated feeding stuff for pigs, broilers and pullets

Tylosin

100 mg/g

Premix for medicated feeding stuff

Pigs, broilers and pullets

Ireland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g Premix for medicated feeding stuff for pigs, broilers and pullets

Tylosin

250 mg/g

Premix for medicated feeding stuff

Pigs, broilers and pullets

Ireland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 % W/W Granules for use in Drinking Water for pigs, chickens, turkeys and calves

Tylosin tartarate

100 % w/w

Granules for oral solution

Calves, pigs, chickens, turkeys

Italy

Vetoquinol Italia

Via Piana, 265

47032 Bertinoro (FC)

Italy

ASCOTYL 200 MP

Tylosin

200 mg/g

Premix for medicated feeding stuff

Pigs, chickens

Italy

LABORATORIO VACCINOGENO PAGNINI SNC

Via A. Diaz 147/149

Portici (NA)

Italy

BRONCOTYL 100

Tylosin

100 g/kg

Premix for medicated feeding stuff

Cattle, pigs, chickens

Italy

Eli Lilly Italia S.p.A.

Via A. Gramsci, 731-733

50019 Sesto Fiorentino (IT)

Italy

NEO TYLAN G250 PREMIX

Tylosin phosphate

250 mg/g

Premix for medicated feeding stuff

Chickens,

Pigs

Italy

Sintofarm

Via P. Togliatti, 5

Guastalla (RE)

Italy

PHARMASIN 100

Tylosin

100 g/g

Granules for oral solution

Pigs, Chickens, Turkeys and Calves

Italy

DOX-AL ITALIA S.p.a.

Via Mascagni 6

20884 Sulbiate (MB)

Italy

PURTYL

Tylosin

1 g/g

Powder for oral solution

Cattle, chickens, turkeys and pigs

Italy

Medilabor

Via Cuneo, 17

Cuneo

Italy

Tilosina 10 %

Tylosin tartarate

100 g/kg

Powder for oral solution

Calves, pigs, chickens

Italy

Filozoo Srl

V. del Commercio 28/30

41012 Carpi (MO)

Italy

Tilosina 20 % Filozoo

Tylosin tartarate

200 g/kg

Powder for oral solution

Calves, chickens, pigs

Italy

Chemifarma S.p.A.

Via Don Eugenio Servadei 16

47122 Forlì, Forlì-Cesena

Italy

Tilosina 20 % Chemifarma

Tylosin tartarate

200 mg/g

Oral solution

Calves, chickens, pigs

Italy

Neofarma

Via Emilia Km.18

1854 — 47020 Longiano (FC)

Italy

Tilosina 20 % liquida Neofarma

Tylosin tartarate

200 mg/g

Oral solution

Calves, chickens, pigs

Italy

TREI

Via Affarosa, 4

42010 Rio Saliceto (RE)

Italy

Tilosina 20 % liquida TreI

Tylosin tartarate

200 mg/g

Oral solution

Calves, chickens, pigs

Italy

Chemifarma S.p.A.

Via Don Eugenio Servadei 16

47122 Forlì, Forlì-Cesena

Italy

Tilosina 20 % liquida Chemifarma

Tylosin tartarate

200 mg/g

Oral solution

Calves, chickens, pigs

Italy

LABORATORIO VACCINOGENO PAGNINI SNC

Via A. Diaz 147/149

Portici (NA)

Italy

Tilosina 20 % Pagnini

Tylosin tartarate

200 mg/g

Powder for oral solution

Calves, Pigs, Chickens-Broilers (not producing eggs for human consumption)

Italy

TREI

Via Affarosa, 4

42010 Rio Saliceto (RE)

Italy

Tilosina 20 % TreI

Tylosin tartarate

200 g/kg

Powder for oral solution

Calves, Pigs, Chickens-Broilers (not producing eggs for human consumption)

Italy

Vetoquinol Italia

Via Piana, 265

47032 Bertinoro (FC)

Italy

Tilosina 20 % Vetoquinol

Tylosin tartarate

200 mg/g

Powder for oral solution

Pigs, chickens

Italy

Filozoo Srl

V. del Commercio 28/30

41012 Carpi (MO)

Italy

Tilosina 200 premix

Tylosin

200 g/kg

Premix for medicated feeding stuff

Pigs, chickens

Italy

Ceva Salute Animale S.p.A.

Viale Colleoni, 15

20864 Agrate Brianza (MB)

Italy

Tilsol 200 liquido

Tylosin

200 g/kg

Powder for oral solution

Calves, Pigs, Chickens-Broilers, Turkeys (not producing eggs for human consumption)

Italy

Ceva Salute Animale S.p.A.

Viale Colleoni, 15

20864 Agrate Brianza (MB)

Italy

Tilsol 200 solubile

Tylosin

200 g/kg

Powder for oral solution

Calves, Pigs, Chickens-Broilers (not producing eggs for human consumption)

Italy

Eli Lilly Italia S.p.A.

Via A. Gramsci, 731-733

50019 Sesto Fiorentino (IT)

Italy

Tylan solubile

Tylosin tartarate

100 g/g

Powder for oral solution

Calves, Pigs, Herns-Broilers, Turkeys

Italy

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Tylmasin

Tylosin phosphate

250 mg/g

Premix for medicated feeding stuff

Pigs and chickens (not producing eggs for human consumption)

Italy

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Tylmasin 20 mg/g granulato per uso orale per suini

Tylosin phosphate

20 mg/g

Granules for oral solution

Pigs

Italy

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Tylmasin 250 mg/g granulato per uso orale per suini

Tylosin phosphate

250 mg/g

Granules for oral solution

Pigs

Italy

Medilabor

Via Cuneo, 17

12030 Cavallermaggiore (CN)

Italy

Tylomed 100

Tylosin phosphate

100 g/kg

Premix for medicated feeding stuff

Pigs and chickens (not producing eggs for human consumption)

Italy

DOX-AL ITALIA S.p.a.

Via Mascagni 6

20884 Sulbiate (MB)

Italy

Tyloplus 200

Tylosin

200 g/kg

Premix for medicated feeding stuff

Pigs and chickens (not producing eggs for human consumption)

Italy

Chemifarma S.p.A.

Via Don Eugenio Servadei 16

47122 Forlì, Forlì-Cesena

Italy

Tylosin 200 premix

Tylosin

200 g/kg

Premix for medicated feeding stuff

Pigs and chickens (not producing eggs for human consumption)

Italy

TREI

Via Affarosa, 4

42010 Rio Saliceto (RE)

Italy

Tylox 100 premix

Tylosin phosphate

100 g/kg

Premix for medicated feeding stuff

Pigs and chickens (not producing eggs for human consumption)

Latvia

Magnum Veterinārija SIA

Ulbrokas iela 23

Rīga, LV-1021

Latvia

Tylokel 75 MV 750 mg/g šķīdināmais pulveris iekšķīgi lietojama šķīduma pagatavošanai cūkām un mājputniem

Tylosin tartarate

750 mg/g

Powder for oral solution

Pigs and poultry

Latvia

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 500 WSP 500 mg/g ūdenī šķīstošs pulveris iekšķīgai lietošanai cūkām, liellopiem, vistām un tītariem

Tylosin tartarate

500 mg/g

Powder for oral solution

Cattle, pigs, chickens, turkey

Latvia

Vet Line SIA

M. Rāmavas 2

Valdlauči, Ķekavas pag.,LV-1076

Latvia

Macrolan WS pulveris iekšķīgai lietošanai teļiem, kazām, aitām, cūkām un mājputniem

Tylosin tartarate

1  000 mg/g

Powder for oral solution

Cattle, goats, sheep, pigs, poultry

Lithuania

bela-pharm GmbH & Co. KG

Lohner Str. 19

D-49377 Vechta

Germany

TYLO-SUSCIT 100 % Kompaktat, geriamieji milteliai

Tylosin tartarate

1  000 mg/g

Powder for oral solution

Pigs and chicken

Lithuania

Chemifarma S.p.A.

Via Don Eugenio Servadei 16

47122 Forlì, Forlì-Cesena

Italy

TILOSINA 20 % CHEMIFARMA, geriamieji milteliai

Tylosin tartarate

200 mg/g

Powder for oral solution

Non ruminating calves, pigs, poultry

Lithuania

Dopharma Research B.V.

Zalmweg 24, 4941 VX Raamsdonksveer,

the Netherlands

Tylogran WSP, granulės geriamajam tirpalui

Tylosin tartarate

1  000 mg/g

Granules for oral solution

Calves, swine, chicken, turkeys

Lithuania

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 500 mg/g vandenyje tirpūs milteliai kiaulėms, veršeliams, vištoms ir kalakutams

Tylosin tartarate

500 mg/g

Powder for oral solution

Swine, calf, chicken and turkey

Lithuania

DOX-AL ITALIA S.p.a.

Via Mascagni 6

20884 Sulbiate (MB)

Italy

TILOSINA 20 % LIQUIDA, geriamasis tirpalas

Tylosin

200 g/kg

Oral solution

Calves, swine and broilers.

Lithuania

Franvet,

Zone Industrielle d'Etriché,

49500 Segré,

France

TYLORAL, geriamieji milteliai

Tylosin tartarate

10 0 0 00  000 IU/sachet

Powder for oral solution

Poultry, swine, calves

Lithuania

DOX-AL ITALIA S.p.a.

Via Mascagni 6

20884 Sulbiate (MB)

Italy

PURTYL, geriamieji milteliai

Tylosin tartarate

1  000 mg/g

Powder for oral solution

Chicken, turkeys, swine and calves

Lithuania

Kela NV (Kela Laboratoria NV)

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

TYLOSIN 75 %, geriamieji milteliai

Tylosin tartarate

750 mg/g

Powder for oral solution

Swine, chicken

Malta

Industrial Veterinaria, S.A — INVESA

Esmeralda 19

E-08950 Esplugues de Llobregat, Barcelona

Spain

TILOSINA 100 GANADEXIL

Tylosin

100 mg/g

Powder for oral solution

Poultry, turkey, swine

The Netherlands

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 20 mg/g Orale Granules voor varkens

Tylosin phosphate

20 mg/g

Granules for oral solution

Pig

The Netherlands

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 100 mg/g premix voor gemedicineerd voer voor varkens, slachtkuikens en opfokleghennen

Tylosin phosphate

100 mg/g

Premix for medicated feeding stuff

Pig, chicken (broilers, future layers/breeders)

The Netherlands

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 % W/W Water Oplosbare Granules

Tylosin tartarate

1 g/1,1 g

Granules for oral solution

Cattle (calves), pig, chicken, turkey

The Netherlands

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g Orale Granules voor varkens

Tylosin phosphate

250 mg/g

Granules for oral solution

Pig

The Netherlands

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 250 mg/g premix voor gemedicineerd voer voor varkens, slachtkuikens en opfokleghennen

Tylosin phosphate

250 mg/g

Premix for medicated feeding stuff

Pig, chicken (broilers, future layers/breeders)

The Netherlands

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

TYLAN G250 PREMIX 25 %

Tylosin phosphate

250 g/kg

Premix for medicated feeding stuff

Pig, chicken (broilers, future layers/breeders)

The Netherlands

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

TYLAN W.O., poeder voor oraal gebruik bij kippen, kalkoenen, varkens en kalveren

Tylosin tartarate

Unadulterated

Powder for oral solution

Cattle (calves), pig, chicken, turkey

The Netherlands

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

TYLAN 100 PREMIX 10 %

Tylosin phosphate

100 g/kg

Premix for medicated feeding stuff

Pig, chicken (broilers, future layers/breeders)

The Netherlands

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

TYLAN 2 % TOPDRESSING

Tylosin phosphate

20 g/kg

Powder for oral solution

Pig

The Netherlands

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

TYLAN 20 PREMIX 2 %

Tylosin phosphate

20 g/kg

Premix for medicated feeding stuff

Pig, chicken (broilers, future layers/breeders)

The Netherlands

Dopharma Reasearch B.V.

Zalmweg 24

4941 VX Raamsdonkveer

The Netherlands

TYLOGRAN WSP

Tylosin tartarate

Unadulterated

Powder for oral solution

Cattle (calves), pig, chicken, turkey

The Netherlands

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

Tylosinetartraat 100 %

Tylosin tartarate

Unadulterated

Powder for oral solution

Cattle (calves), pig, chicken (broilers, future layers/breeders), turkey

Poland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 mg/g Premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych

Tylosin phosphate

100 mg/g

Premix for medicated feeding stuff

Pigs, Broilers and Pullets

Poland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g granulat doustny dla świń

Tylosin phosphate

20 mg/g

Granules for oral solution

Pigs

Poland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych

Tylosin phosphate

250 mg/g

Premix for medicated feeding stuff

Pigs, Broilers and Pullets

Poland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g granulat doustny dla świń

Tylosin phosphate

250 mg/g

Granules for oral solution

Pigs

Poland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 1 g/g granulat do podania w wodzie do picia dla świń, cieląt, kur i indyków

Tylosin tartarate

1 g/g

Granules for oral solution

Calves, pigs, chickens, turkeys

Poland

Ceva Salute Animale S.p.A.

Viale Colleoni, 15

20864 Agrate Brianza (MB)

Italy

Tilsol 200, 200 g/1000 g

Tylosin

200 g/1  000 g

Powder for oral solution

Chicken, pig

Poland

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Tylan Soluble Powder

Tylosin

1  000 g/kg

Powder for oral solution

Chicken, turkey, pig, cattle

Poland

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Tylan G 100 Premix

Tylosin

100 mg/kg

Premix for medicated feeding stuff

Pigs

Poland

P.F.H.U. ‘Veta’ Mariusz Hołownia

Kownaty 74

18-421 Kownaty

Poland

Tylo-Kel 75 proszek do sporządzania roztworu doustnego dla kur i świń

Tylosin tartarate

750 mg/g

Powder for oral solution

Chicken, pig

Poland

Przedsiębiorstwo Farmaceutyczne Okoniewscy ‘VETOS FARMA’ Sp. z o.o.

ul. Dzierżoniowska 21

58-260 Bielawa

Poland

FARMATYL, tylozyny winian 1000 g/kg proszek do sporządzania roztworu doustnego dla kur, indyków i świń

Tylosin tartarate

1  000 g/kg

Powder for oral solution

Turkey, hen, pig

Poland

Vetoquinol Biowet Sp. z o.o.

ul. Kosynierów Gdyńskich 13-14

66-400 Gorzów Wielkopolski

Poland

Tylbian, 110 mg/g

Tylosin tartarate

110 mg/g

Granules for oral solution

Hen

turkey

pig

cattle

Portugal

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 g/g Grânulos para administração na água de bebida para suínos, galinhas e frangos, perús e vitelos.

Tylosin

1,1 g of granules contains 1 g of tylosin

Granules for oral solution

Calves, pigs, chickens, turkeys

Portugal

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g Pré-mistura para alimento medicamentoso para suínos, galinhas e frangos de engorda

Tylosin

250 mg per g. (equivalent to 2 50  000 IU)

Premix for medicated feeding stuff

Pigs, broilers and pullets

Portugal

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 mg/g Pré-mistura medicamentosa para alimento medicamentoso para suínos, frangos de engorda e galinhas

Tylosin

100 mg per g. (equivalent to 1 00  000 IU)

Premix for medicated feeding stuff

Pigs, broilers and pullets

Portugal

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 20 mg/g Grânulos Orais para suínos

Tylosin

20 mg per g (equivalent to 20  000 IU)

Granules for oral solution

Pigs

Portugal

REPRESENTAGRO — REPRESENTAÇOES LDA

Estrada da Lapa 1

2665-507 Venda do Pinheiro

Portugal

ORATIL 100 P, pó para solução oral para suínos, frangos e perus

Tylosin

1  000 mg

Powder for oral solution

Pigs, broilers, turkeys

Portugal

PRODIVET, Comércio de Produtos Químicos, Farmacêuticos e Cosméticos, SA

Av. Infante D. Henrique no 333-H 3o piso Esc. 41

1800-282 Lisboa

Portugal

PRODITYL, Pó para solução oral para administração na água de bebida para suínos, frangos e perus

Tylosin

1,1 g

Powder for oral solution

Pigs, broilers, turkeys

Portugal

Ceva Saúde Animal Produtos Farmacêuticos e Imunológicos, Lda.

Rua Doutor António Loureiro Borges, 9/9A — 9oA

Miraflores, 1495-131 Algés

Portugal

TILPLUS 100 PÓ para solução oral para suínos, frangos e perus

Tylosin

100 g

Powder for oral solution

Pigs, broilers, turkeys

Portugal

Lilly Portugal — Produtos Farmaceuticos, Lda.

Torre Occidente

Rua Galileu Galilei, n.o 2

Piso 7 fração A/D,

1500-392 Lisboa

Portugal

Tylan 100 g/Kg Pré mistura medicamentosa para alimento medicamentoso para suínos e frangos de carne, reprodutoras e poedeiras

Tylosin

100 g/kg

Premix for medicated feeding stuff

Pigs, broilers, chickens

Portugal

Lilly Portugal — Produtos Farmaceuticos, Lda.

Torre Occidente

Rua Galileu Galilei, n.o 2

Piso 7 fração A/D,

1500-392 Lisboa

Portugal

Tylan 20 g/Kg Pré mistura medicamentosa para alimento medicamentoso para suínos e frangos de carne, reprodutoras e poedeiras

TYLOSIN

20 g/kg

Premix for medicated feeding stuff

Pigs, broilers, chickens

Portugal

Lilly Portugal — Produtos Farmaceuticos, Lda.

Torre Occidente

Rua Galileu Galilei, n.o 2

Piso 7 fração A/D,

1500-392 Lisboa

Portugal

Tylan 250 g/Kg Pré mistura medicamentosa para alimento medicamentoso para Suínos e frangos de carne

TYLOSIN

250 g/kg

Premix for medicated feeding stuff

Pigs, broilers, chickens

Portugal

Lilly Portugal — Produtos Farmaceuticos, Lda.

Torre Occidente

Rua Galileu Galilei, n.o 2

Piso 7 fração A/D,

1500-392 Lisboa

Portugal

TYLAN PÓ SOLÚVEL

TYLOSIN

100 g per bottle

Powder for oral solution

Pigs, broilers, turkeys

Portugal

ZOOPAN Produtos Pecuários S.A.

Rua da Liberdade, no 77

2050-023 Aveiras de Baixo

Portugal

TYLOSIN 750 mg/g Pó oral para administração na água de bebida para suínos e frangos

TYLOSIN

750 mg/g

Powder for oral solution

Pigs, broilers

Romania

S.C. PASTEUR -FILIALA FILIPESTI

Str. Principala, nr. 944

Filipestii de Padure, Jud. Prahova

Romania

Tilozina 100

Tylosin phosphate

10 g/100 g

Premix for medicated feeding stuff

Poultry, pigs

Romania

S.C. PASTEUR -FILIALA FILIPESTI

Str. Principala, nr. 944

Filipestii de Padure, Jud. Prahova

Romania

Tilozina

Tylosin tartarate

0,58 g/g

Powder for oral solution

Cattle, pigs, poultry

Romania

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g

Tylosin phosphate

250 mg/g

Premix for medicated feeding stuff

Pigs, broilers and pullets

Romania

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 mg/g

Tylosin phosphate

100 mg/g

Premix for medicated feeding stuff

Pigs, broilers and pullets

Romania

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g

Tylosin phosphate

20 mg/g

Granules for oral solution

Pigs

Romania

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 %

Tylosin tartarate

1 g/g

Granules for oral solution

Calves, pigs, poultry

Romania

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Tylan G 100 g/kg

Tylosin phosphate

100 g/kg

Premix for medicated feeding stuff

Pigs

Romania

Crida Pharm SRL

str. Intrarea Vagonetului nr.2, bl.101, ap.47, parter, sector 6

Bucharest

Romania

Tylosin 60 %

Tylosin tartarate

60 g/100 g

Powder for oral solution

Pigs, broilers

Romania

SC Delos Impex 96 SRLStr

Horia, Closca si Crisan, Otopeni

judetul Ilfov

Romania

Tilodem 50

Tylosin tartarate

500 mg/g

Powder for oral solution

Pigs, poultry (broilers, breeding broilers, laying hens, replacement pullets)

Romania

SC Delos Impex 96 SRLStr

Horia, Closca si Crisan, Otopeni

judetul Ilfov

Romania

Tilosin 10 %

Tylosin tartarate

100 mg/g

Powder for oral solution

Pigs, poultry

Romania

Chemifarma S.p.A.

Via Don Eugenio Servadei 16

47122 Forlì, Forlì-Cesena

Italy

Tilosina 20 % Chemifarma

Tylosin tartarate

20 g/100 g

Powder for oral solution

Cattle, pigs, poultry (broilers, turkeys)

Romania

Anupco LTd.

Crockatt Road

Lady Lane Industrial Estate, Hadleigh

Ipswich, Suffolk, IP7 6RD

United Kingdom

Tylosin 75

Tylosin tartarate

825 mg/g

Powder for oral solution

Pigs, poultry (chicken, turkey)

Romania

Kela NV (Kela Laboratoria NV)

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Tylosin 75 % Kela

Tylosin tartarate

750 mg/g

Powder for oral solution

Pigs, poultry

Slovakia

Pharmagal spol. s.r.o.

Murgašova 5

949 01 Nitra

Slovakia

RESETYL prášok na perorálny roztok

Tylosin tartarate

1  000 g/1  100 g

Powder for oral solution

Chickens (broilers, pullets, laying hens), turkeys, pigs, calves

Slovakia

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

TYLAN vodorozpustný prášok

Tylosin tartarate

1  000 g/1  100 g

Powder for oral solution

Chickens (broilers, pullets, laying hens), turkeys, pigs, calves

Slovakia

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

TYLAN 100 mg/g premix

Tylosin phosphate

100 mg/g

Premix for medicated feeding stuff

Pigs

Slovenia

IRIS Mednarodna trgovina d.o.o.,

Cesta v Gorice 8

1000 Ljubljana

Slovenia

TYLAN SOLUBLE prašek za peroralno raztopino za prašiče, kokoši in purane

Tylosin

100 g

Powder for oral solution

Pigs, chicken, turkey

Spain

Elanco Valquímica, S.A.

Avda. de la Industria, no 30

Polígono Industrial de Alcobendas

28108 Alcobendas (Madrid)

Spain

TRELACON G 250 PREMEZCLA

Tylosin

250 mg/g

Premix for medicated feeding stuff

Pigs, poultry

Spain

Elanco Valquímica, S.A.

Avda. de la Industria, no 30

Polígono Industrial de Alcobendas

28108 Alcobendas (Madrid)

Spain

TRELACON G 50 PREMEZCLA

Tylosin

50 mg/g

Premix for medicated feeding stuff

Pigs, poultry

Spain

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 100 MG/G PREMEZCLA MEDICAMENTOSA PARA PORCINO POLLOS DE ENGORDE

Tylosin

100 mg/g

Premix for medicated feeding stuff

Pigs, broilers, pullets

Spain

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 250 MG/G PREMEZCLA MEDICAMENTOSA PARA PORCINO POLLOS DE ENGORDE

Tylosin phosphate

250 mg/g

Premix for medicated feeding stuff

Pigs, broilers, pullets

Spain

S.P. VETERINARIA, S.A.

CTRA. REUS-VINYOLS, KM.4,1.

RIUDOMS (Tarragona)

Spain

HIDROTIL POLVO ORAL

Tylosin tartarate

100 g/100 g

Powder for oral solution

Broilers, layer hens and future layer pullets turkeys, pigs and cattle (claves)

Spain

Elanco Valquímica, S.A.

Avda. de la Industria, no 30

Polígono Industrial de Alcobendas

28108 Alcobendas (Madrid)

Spain

TRELACON G 20 G/KG PREMEZCLA MEDICAMENTOSA

Tylosin phosphate

20 mg/g

Premix for medicated feeding stuff

Pigs, broilers and replacement pullets

Spain

Elanco Valquímica, S.A.

Avda. de la Industria, no 30

Polígono Industrial de Alcobendas

28108 Alcobendas (Madrid)

Spain

TRELACON G 100 G/KG PREMEZCLA MEDICAMENTOSA

Tylosin phosphate

100 mg/g

Premix for medicated feeding stuff

Pigs, broilers and replacement pullets

Spain

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 1G/G GRANULADO PARA ADMINISTRACIÓN EN AGUA DE BEBIDA

Tylosin tartarate

1 g/g

Granules for oral solution

Pigs, calves, chickens, turkeys

Spain

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

PHARMASIN 20 MG/G GRANULADO ORAL PARA PORCINO

Tylosin phosphate

20 mg/g

Granules for oral solution

Pigs

Spain

Elanco Valquímica, S.A.

Avda. de la Industria, no 30

Polígono Industrial de Alcobendas

28108 Alcobendas (Madrid)

Spain

TAILAN

Tylosin

1 g/g

Powder for oral solution

Pigs, poultry (broilers, pullets, layers and turkeys), bovine (pre-ruminants calves).

Spain

S.P. VETERINARIA, S.A.

Ctra. Reus-Vinyols, km.4,1.

Riudoms (Tarragona)

Spain

ORATIL — 100

Tylosin tartarate

1 g/g

Powder for oral solution

Pigs, chickens, turkeys, calves

Spain

INDUSTRIAL VETERINARIA, S.A.

Esmeralda 19.

08950 Esplugues de Llobregat (Barcelona)

Spain

TILOSINA 100 GANADEXIL

Tylosin tartarate

1 g/g

Powder for oral solution

Pigs, chickens, turkeys

Spain

MEVET, S. A.U.

Polígono Industrial El Segre

parcela 409-410.

25191 Lérida

Spain

TILOVALL PREMEZCLA

Tylosin phosphate

20 mg/g

Premix for medicated feeding stuff

Pigs, poultry and cattle

Spain

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26.

08520 Les Franqueses del Valles (Barcelona)

Spain

GANAMIX TILOSINA 10 % PREMEZCLA

Tylosin phosphate

10 mg/g

Premix for medicated feeding stuff

Pigs, poultry and cattle

Spain

LABORATORIOS HIPRA, S.A.

Avda. La Selva, 135.

17170 Amer (Girona)

Spain

HIPRAMIX-TIL

Tylosin phosphate

20 mg/g

Premix for medicated feeding stuff

Pigs, poultry and cattle

Spain

ANDRES PINTALUBA, S.A.

Pol. Industrial Agro-Reus

c/Prudenci Bertrana 5.

43206 Reus (Tarragona)

Spain

APSAMIX TILOSINA 10 %

Tylosin phosphate

10 mg/g

Premix for medicated feeding stuff

Pigs, poultry and cattle

Spain

MEVET, S. A.U.

Polígono Industrial El Segre

parcela 409-410.

25191 Lérida

Spain

TILOVALL POLVO

Tylosin tartarate

1 g/g

Powder for oral solution

Porcine, chickens, calves

Spain

SUPER’S DIANA, S.L.

Ctra. C-17, km 17.

08150 Parets del Valles (Barcelona)

Spain

TILOSAN

Tylosin phosphate

20 mg/g

Premix for medicated feeding stuff

Pigs

Sweden

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan vet.

Tylosin

0,83

Powder for oral solution

Pigs and domestic birds

Sweden

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan vet.

Tylosin

0,02

Premix for medicated feeding stuff

Pigs

Sweden

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskaer 3E, 2 tv.

2730 HERLEV

Denmark

Tylan vet.

Tylosin

0,1

Premix for medicated feeding stuff

Pigs

United Kingdom

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets

Tylosin

100 mg/g

Premix for medicated feeding stuff

Pigs

Poultry

United Kingdom

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 100 % w/w Granules for Use in Drinking Water for Pigs, Chickens, Turkeys and Calves

Tylosin

100 % w/w

Granules for oral solution

Cattle

Chickens

Pigs

Turkey

United Kingdom

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 20 mg/g Oral Granules for Pigs

Tylosin

20 mg/mg

Premix for medicated feeding stuff

Pigs

United Kingdom

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

Pharmasin 250 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets

Tylosin

250 mg/g

Premix for medicated feeding stuff

Pigs

Poultry

United Kingdom

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke, RG24 9NL

United Kingdom

Tylan G20 Premix for Medicated Feedingstuff

Tylosin

2,00 % w/w

Premix for medicated feeding stuff

Pigs

United Kingdom

Eli Lilly & Company Ltd

Lilly House

Priestley Road

Basingstoke, RG24 9NL

United Kingdom

Tylan G250 Premix for Medicated Feedingstuff

Tylosin

25 % w/w

Premix for medicated feeding stuff

Chickens

Pigs

United Kingdom

Eli Lilly & Company Ltd

Lilly House

Priestley Road

Basingstoke, RG24 9NL

United Kingdom

Tylan G50 Premix for Medicated Feedingstuff

Tylosin

5,00 % w/w

Premix for medicated feeding stuff

Pigs

United Kingdom

Eli Lilly & Company Ltd

Lilly House

Priestley Road

Basingstoke, RG24 9NL

United Kingdom

Tylan Soluble Powder for Oral Solution

Tylosin

10 % w/w

Powder for oral solution

Cattle

Chickens

Pigs

Turkeys

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing Authorisation
  Holder | INN | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Estonia | Septodont
  58, rue du Pont de Creteil
  94100 Saint-Maur-
  Des-Fosses
  France | Ephedrine hydrochloride
  arsenous anhydride
  lidocaine | CAUSTINERF ARSENICAL | 1 g, 30 g, 30 g | Dental paste | Topical use |
| France | Septodont
  58, rue du Pont de Creteil
  94100 Saint-Maur-
  Des-Fosses
  France | Ephedrine hydrochloride
  arsenous anhydride
  lidocaine | CAUSTINERF ARSENICAL, pâte pour usage dentaire | 1 g, 30 g, 30 g | Dental paste | Topical use |
| France | ATO ZIZINE
  69, rue de Wattignies
  BP 50018
  75560 Paris Cedex 12
  France | Ephedrine hydrochloride
  arsenous anhydride
  lidocaine | YRANICID ARSENICAL, pâte pour usage dentaire | 1 g, 30 g, 30 g | Dental paste | Topical use |
| Italy | Giovanni Ogna E Figli S.p.A.
  Viale Zara 23
  20159 Milano
  Italy | Ephedrine hydrochloride
  arsenous anhydride
  lidocaine | PASTA ARSENICALE NORMALE | 1 g, 30 g, 30 g | Dental paste | Topical use |
| Latvia | Septodont
  58, rue du Pont de Creteil
  94100 Saint-Maur-
  Des-Fosses
  France | Ephedrine hydrochloride
  arsenous anhydride
  lidocaine | Caustinerf arsenical pasta lietošanai zobārstniecībā | 1 g, 30 g, 30 g | Dental paste | Topical use |
| Lithuania | Septodont
  58, rue du Pont de Creteil
  94100 Saint-Maur-
  Des-Fosses
  France | Ephedrine hydrochloride
  arsenous anhydride
  lidocaine | Caustinerf Arsenical | 1 g, 30 g, 30 g | Dental paste | Topical use |

Member State

(in EEA)

Marketing Authorisation

Holder

INN

Invented name

Strength

Pharmaceutical Form

Route of administration

Estonia

Septodont

58, rue du Pont de Creteil

94100 Saint-Maur-

Des-Fosses

France

Ephedrine hydrochloride

arsenous anhydride

lidocaine

CAUSTINERF ARSENICAL

1 g, 30 g, 30 g

Dental paste

Topical use

France

Septodont

58, rue du Pont de Creteil

94100 Saint-Maur-

Des-Fosses

France

Ephedrine hydrochloride

arsenous anhydride

lidocaine

CAUSTINERF ARSENICAL, pâte pour usage dentaire

1 g, 30 g, 30 g

Dental paste

Topical use

France

ATO ZIZINE

69, rue de Wattignies

BP 50018

75560 Paris Cedex 12

France

Ephedrine hydrochloride

arsenous anhydride

lidocaine

YRANICID ARSENICAL, pâte pour usage dentaire

1 g, 30 g, 30 g

Dental paste

Topical use

Italy

Giovanni Ogna E Figli S.p.A.

Viale Zara 23

20159 Milano

Italy

Ephedrine hydrochloride

arsenous anhydride

lidocaine

PASTA ARSENICALE NORMALE

1 g, 30 g, 30 g

Dental paste

Topical use

Latvia

Septodont

58, rue du Pont de Creteil

94100 Saint-Maur-

Des-Fosses

France

Ephedrine hydrochloride

arsenous anhydride

lidocaine

Caustinerf arsenical pasta lietošanai zobārstniecībā

1 g, 30 g, 30 g

Dental paste

Topical use

Lithuania

Septodont

58, rue du Pont de Creteil

94100 Saint-Maur-

Des-Fosses

France

Ephedrine hydrochloride

arsenous anhydride

lidocaine

Caustinerf Arsenical

1 g, 30 g, 30 g

Dental paste

Topical use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State EU/EEA | Applicant/Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Route of administration | Animal species |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg Lösung zum Auftropfen für Katzen | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| Austria (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg Lösung zum Auftropfen für Hunde | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| Austria (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg Lösung zum Auftropfen für Hunde | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| Austria (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg Lösung zum Auftropfen für Hunde | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| Austria (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412,5 mg Lösung zum Auftropfen für Hunde | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| Belgium | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg spot-on oplossing voor katten | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| Belgium | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg spot-on oplossing voor honden | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| Belgium | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg spot-on oplossing voor honden | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| Belgium | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg spot-on oplossing voor honden | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| Belgium | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412,5 mg spot-on oplossing voor honden | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| Czech Republic (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg roztok pro nakapání na kůži spot-on pro kočky | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| Czech Republic (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg roztok pro nakapání na kůži spot-on pro psy | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| Czech Republi (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg roztok pro nakapání na kůži spot-on pro psy | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| Czech Republic (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg roztok pro nakapání na kůži spot-on pro psy | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| Czech Republic (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412,5 mg roztok pro nakapání na kůži spot-on pro psy | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| Denmark | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg spot-on løsning for katte | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| Denmark | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg spot-on løsning for hunde | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| Denmark | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg spot-on løsning for hunde | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| Denmark | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg spot-on løsning for hunde | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| Denmark | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412,5 mg spot-on løsning for hunde | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| Greece | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg Διάλυμα για επίχυση σε σημείο (spot-on) για γάτες | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| Greece | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| Greece | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| Greece | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| Greece | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412,50 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| Ireland | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg spot-on solution for cats | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| Ireland | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg spot-on solution for dogs | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| Ireland | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg spot-on solution for dogs | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| Ireland | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg spot-on solution for dogs | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| Ireland | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412,5 mg spot-on solution for dogs | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| Italy | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg soluzione spot-on per gatti | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| Italy | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg soluzione spot-on per cani | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| Italy | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg soluzione spot-on per cani | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| Italy | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg soluzione spot-on per cani | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| Italy | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412,5 mg soluzione spot-on per cani | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| The Netherlands (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg spot-on oplossing voor katten | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| The Netherlands (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg spot-on oplossing voor honden | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| The Netherlands (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg spot-on oplossing voor honden | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| The Netherlands (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg spot-on oplossing voor honden | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| The Netherlands (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412,5 mg spot-on oplossing voor honden | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| Spain (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex GATOS 52,5 mg solución spot-on para gatos | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| Spain (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex75 mg solución spot-on para perros pequeños | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| Spain (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex 150 mg solución spot-on para perros medianos | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| Spain (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex 300 mg solución spot-on para perros grandes | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| Spain (1) | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex 412,5 mg solución spot-on para perros muy grandes | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| Slovak Republic | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg na vonkajšiu aplikáciu na kožu mačiek | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| Slovak Republic | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg na vonkajšiu aplikáciu na kožu pre psov | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| Slovak Republic | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg na vonkajšiu aplikáciu na kožu pre psov | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| Slovak Republic | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg na vonkajšiu aplikáciu na kožu pre psov | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| Slovak Republic | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412,5 mg na vonkajšiu aplikáciu na kožu pre psov | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |
| United Kingdom | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex CAT 52,5 mg spot-on solution for cats | Fipronil | 52,5 mg | Spot-on solution | Spot-on use | Cats |
| United Kingdom | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex S 75 mg spot-on solution for dogs | Fipronil | 75 mg | Spot-on solution | Spot-on use | Dogs |
| United Kingdom | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex M 150 mg spot-on solution for dogs | Fipronil | 150 mg | Spot-on solution | Spot-on use | Dogs |
| United Kingdom | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex L 300 mg spot-on solution for dogs | Fipronil | 300 mg | Spot-on solution | Spot-on use | Dogs |
| United Kingdom | VET-AGRO TRADING Sp. z o.o.
  Mełgiewska str. 18,
  20-234 Lublin,
  Poland | Fiprex XL 412.5 mg spot-on solution for dogs | Fipronil | 412,5 mg | Spot-on solution | Spot-on use | Dogs |

Member State EU/EEA

Applicant/Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Route of administration

Animal species

Austria (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg Lösung zum Auftropfen für Katzen

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

Austria (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg Lösung zum Auftropfen für Hunde

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

Austria (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg Lösung zum Auftropfen für Hunde

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

Austria (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg Lösung zum Auftropfen für Hunde

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

Austria (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412,5 mg Lösung zum Auftropfen für Hunde

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

Belgium

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg spot-on oplossing voor katten

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

Belgium

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg spot-on oplossing voor honden

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

Belgium

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg spot-on oplossing voor honden

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

Belgium

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg spot-on oplossing voor honden

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

Belgium

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412,5 mg spot-on oplossing voor honden

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

Czech Republic (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg roztok pro nakapání na kůži spot-on pro kočky

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

Czech Republic (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg roztok pro nakapání na kůži spot-on pro psy

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

Czech Republi (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg roztok pro nakapání na kůži spot-on pro psy

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

Czech Republic (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg roztok pro nakapání na kůži spot-on pro psy

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

Czech Republic (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412,5 mg roztok pro nakapání na kůži spot-on pro psy

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

Denmark

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg spot-on løsning for katte

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

Denmark

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg spot-on løsning for hunde

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

Denmark

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg spot-on løsning for hunde

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

Denmark

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg spot-on løsning for hunde

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

Denmark

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412,5 mg spot-on løsning for hunde

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

Greece

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg Διάλυμα για επίχυση σε σημείο (spot-on) για γάτες

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

Greece

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

Greece

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

Greece

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

Greece

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412,50 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

Ireland

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg spot-on solution for cats

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

Ireland

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg spot-on solution for dogs

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

Ireland

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg spot-on solution for dogs

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

Ireland

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg spot-on solution for dogs

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

Ireland

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412,5 mg spot-on solution for dogs

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

Italy

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg soluzione spot-on per gatti

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

Italy

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg soluzione spot-on per cani

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

Italy

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg soluzione spot-on per cani

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

Italy

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg soluzione spot-on per cani

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

Italy

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412,5 mg soluzione spot-on per cani

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

The Netherlands (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg spot-on oplossing voor katten

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

The Netherlands (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg spot-on oplossing voor honden

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

The Netherlands (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg spot-on oplossing voor honden

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

The Netherlands (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg spot-on oplossing voor honden

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

The Netherlands (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412,5 mg spot-on oplossing voor honden

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

Spain (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex GATOS 52,5 mg solución spot-on para gatos

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

Spain (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex75 mg solución spot-on para perros pequeños

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

Spain (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex 150 mg solución spot-on para perros medianos

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

Spain (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex 300 mg solución spot-on para perros grandes

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

Spain (1)

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex 412,5 mg solución spot-on para perros muy grandes

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

Slovak Republic

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg na vonkajšiu aplikáciu na kožu mačiek

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

Slovak Republic

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg na vonkajšiu aplikáciu na kožu pre psov

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

Slovak Republic

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg na vonkajšiu aplikáciu na kožu pre psov

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

Slovak Republic

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg na vonkajšiu aplikáciu na kožu pre psov

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

Slovak Republic

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412,5 mg na vonkajšiu aplikáciu na kožu pre psov

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

United Kingdom

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex CAT 52,5 mg spot-on solution for cats

Fipronil

52,5 mg

Spot-on solution

Spot-on use

Cats

United Kingdom

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex S 75 mg spot-on solution for dogs

Fipronil

75 mg

Spot-on solution

Spot-on use

Dogs

United Kingdom

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex M 150 mg spot-on solution for dogs

Fipronil

150 mg

Spot-on solution

Spot-on use

Dogs

United Kingdom

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex L 300 mg spot-on solution for dogs

Fipronil

300 mg

Spot-on solution

Spot-on use

Dogs

United Kingdom

VET-AGRO TRADING Sp. z o.o.

Mełgiewska str. 18,

20-234 Lublin,

Poland

Fiprex XL 412.5 mg spot-on solution for dogs

Fipronil

412,5 mg

Spot-on solution

Spot-on use

Dogs

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(1)  Marketing authorisation granted

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