# Official Journal C 401/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.401.eng |
| --- | --- |
| Official Journal
  of the European Union | C 401 |
| | |
| English edition | Information and Notices | Volume 5528 December 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.401.eng

Official Journal

of the European Union

C 401

English edition

Information and Notices

Volume 5528 December 2012

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 401/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2012/C 401/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 3 |
| 2012/C 401/03 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 2012(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 9 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2012/C 401/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012(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

2012/C 401/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 2012(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)

3

2012/C 401/03

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 2012(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)

9

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.12.2012 | EN | Official Journal of the European Union | C 401/1 |
| --- | --- | --- | --- |

28.12.2012

EN

Official Journal of the European Union

C 401/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012

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

2012/C 401/01

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 29.10.2012 | Clopidogrel Teva Generics B.V. | Teva Generics B.V. |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

29.10.2012

Clopidogrel Teva Generics B.V.

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/650/001-015

31.10.2012

29.10.2012

Desloratadine Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/732/001-013

31.10.2012

29.10.2012

Docetaxel Accord

| Accord Healthcare Limited |
| --- |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom |

Accord Healthcare Limited

Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom

EU/1/12/769/001-003

31.10.2012

29.10.2012

Docetaxel Kabi

| Fresenius Kabi Oncology Plc. |
| --- |
| Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom |

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom

EU/1/12/770/001-005

31.10.2012

29.10.2012

Esmya

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21., 1103 Budapest, Magyarország |

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750/001-002

31.10.2012

29.10.2012

Galvus

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

Novartis Europharm Ltd

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

EU/1/07/414/001-010

EU/1/07/414/018

31.10.2012

29.10.2012

Jalra

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

Novartis Europharm Ltd

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

EU/1/08/485/001-011

31.10.2012

29.10.2012

JEVTANA

| Sanofi-aventis groupe |
| --- |
| 54, rue de la Boétie, F-75008 France |

Sanofi-aventis groupe

54, rue de la Boétie, F-75008 France

EU/1/11/676/001

31.10.2012

29.10.2012

Leflunomide medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Fehlandtstrasse 3, D-20354 Hamburg - Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3, D-20354 Hamburg - Deutschland

EU/1/10/637/001-009

31.10.2012

29.10.2012

Tarceva

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

Roche Registration Limited

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

EU/1/05/311/001-003

31.10.2012

29.10.2012

Xgeva

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703/001-003

31.10.2012

29.10.2012

Xiliarx

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

Novartis Europharm Ltd

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

EU/1/08/486/001-011

31.10.2012

29.10.2012

Zoely

| Theramex S.r.l. |
| --- |
| Via Messina 38, 20154 Milano, Italia |

Theramex S.r.l.

Via Messina 38, 20154 Milano, Italia

EU/1/11/690/001-004

9.11.2012

31.10.2012

Clopidogrel Teva Pharma B.V.

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/649/001-016

6.11.2012

31.10.2012

Ibandronic acid Sandoz

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/11/685/001-005

6.11.2012

31.10.2012

Lamivudine/Zidovudine Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/663/001-002

6.11.2012

31.10.2012

Levetiracetam SUN

| Sun Pharmaceutical Industries Europe BV |
| --- |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/741/001

6.11.2012

31.10.2012

Levetiracetam Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/701/001-032

6.11.2012

31.10.2012

PecFent

| Archimedes Development Ltd |
| --- |
| Nottingham, NGT7 2TN, United Kingdom |

Archimedes Development Ltd

Nottingham, NGT7 2TN, United Kingdom

EU/1/10/644/001-006

6.11.2012

31.10.2012

Rivastigmine Actavis

| Actavis Group PTC ehf. |
| --- |
| ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland |

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland

EU/1/11/693/001-016

6.11.2012

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 29.10.2012 | Naxcel | Pfizer Ltd |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

29.10.2012

Naxcel

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/05/053/001-003

31.10.2012

29.10.2012

Zuprevo

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/124/001-004

31.10.2012

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

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| 28.12.2012 | EN | Official Journal of the European Union | C 401/3 |
| --- | --- | --- | --- |

28.12.2012

EN

Official Journal of the European Union

C 401/3

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 2012

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

2012/C 401/02

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.11.2012 | Forxiga | dapagliflozin | Bristol Myers Squibb/AstraZeneca EEIG |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

12.11.2012

Forxiga

dapagliflozin

Bristol Myers Squibb/AstraZeneca EEIG

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

EU/1/12/795

Film-coated tablet

A10BX09

14.11.2012

15.11.2012

Picato

ingenol mebutate

| LEO Pharma A/S |
| --- |
| Industriparken 55, DK-2750 Ballerup, Danmark |

LEO Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/12/796

Gel

D06BX02

19.11.2012

19.11.2012

Capecitabine medac

capecitabine

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Fehlandtstrasse 3, D-20354 Hamburg - Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3, D-20354 Hamburg - Deutschland

EU/1/12/802

Film-coated tablet

L01BC06

23.11.2012

19.11.2012

Ibandronic acid Accord

Ibandronic acid

| Accord Healthcare Limited |
| --- |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom |

Accord Healthcare Limited

Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom

EU/1/12/798

Concentrate for solution for infusion

M05BA06

23.11.2012

19.11.2012

Zoledronic acid Hospira

zoledronic acid

| Hospira UK Ltd. |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Ltd.

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/12/800

Concentrate for solution for infusion

Solution for infusion

M05BA

23.11.2012

22.11.2012

Eylea

aflibercept

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

Bayer Pharma AG

D - 13342 Berlin, Deutschland

EU/1/12/797

Solution for injection

S01LA05

26.11.2012

22.11.2012

Memantine Merz

Memantine

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland |

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland

EU/1/12/799

Film-coated tablet

Oral solution

N06DX01

26.11.2012

26.11.2012

Constella

linaclotide

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, 08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/12/801

Capsule, hard

Pending

28.11.2012

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.11.2012 | Enyglid | KRKA, d. d., Novo mesto |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.11.2012

Enyglid

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/580

12.11.2012

8.11.2012

Rivastigmine 1 A Pharma

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3, Oberhaching 82041, Deutschland |

1 A Pharma GmbH

Keltenring 1 + 3, Oberhaching 82041, Deutschland

EU/1/09/585

12.11.2012

12.11.2012

Ivemend

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/07/437

14.11.2012

12.11.2012

Olanzapine Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/427

14.11.2012

15.11.2012

Naglazyme

| BioMarin Europe Ltd |
| --- |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/05/324

19.11.2012

15.11.2012

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

19.11.2012

15.11.2012

Retacrit

| Hospira UK Limited |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/07/431

19.11.2012

15.11.2012

Sutent

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/06/347

19.11.2012

15.11.2012

Xaluprine

| Nova Laboratories Limited |
| --- |
| Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom |

Nova Laboratories Limited

Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom

EU/1/11/727

19.11.2012

15.11.2012

Xarelto

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

Bayer Pharma AG

13342 Berlin, Deutschland

EU/1/08/472

19.11.2012

19.11.2012

Abilify

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom

EU/1/04/276

22.11.2012

19.11.2012

Actraphane

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, 53100 Siena, Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/02/229

22.11.2012

19.11.2012

Actrapid

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/230

22.11.2012

19.11.2012

Apidra

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/04/285

23.11.2012

19.11.2012

Champix

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/06/360

22.11.2012

19.11.2012

Eliquis

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

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

23.11.2012

19.11.2012

Incivo

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

22.11.2012

19.11.2012

Insulatard

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233

22.11.2012

19.11.2012

Ketek

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, F-92160 Antony, France |

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92160 Antony, France

EU/1/01/191

22.11.2012

19.11.2012

Lumigan

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, Co. Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/02/205

23.11.2012

19.11.2012

Mirapexin

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

Boehringer Ingelheim International GmbH

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

EU/1/97/051

23.11.2012

19.11.2012

Mixtard

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/231

22.11.2012

19.11.2012

Mycophenolate mofetil Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/439

22.11.2012

19.11.2012

Myfenax

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/438

22.11.2012

19.11.2012

Protaphane

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234

22.11.2012

19.11.2012

Revlimid

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

Celgene Europe Limited

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

EU/1/07/391

22.11.2012

19.11.2012

Sifrol

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

Boehringer Ingelheim International GmbH

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

EU/1/97/050

22.11.2012

19.11.2012

Simponi

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, CB Leiden 2333, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, CB Leiden 2333, Nederland

EU/1/09/546

23.11.2012

19.11.2012

Sprycel

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363

22.11.2012

19.11.2012

Tysabri

| Elan Pharma International Ltd. |
| --- |
| Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND |

Elan Pharma International Ltd.

Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND

EU/1/06/346

23.11.2012

22.11.2012

Diacomit

| Biocodex |
| --- |
| 7 avenue Gallieni, 94250 Gentilly, France |

Biocodex

7 avenue Gallieni, 94250 Gentilly, France

EU/1/06/367

26.11.2012

22.11.2012

GILENYA

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

Novartis Europharm Ltd

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

EU/1/11/677

26.11.2012

22.11.2012

Humira

| AbbVie Ltd. |
| --- |
| Maidenhead, SL6 4XE, United Kingdom |

AbbVie Ltd.

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256

26.11.2012

22.11.2012

Olanzapine Apotex

| Apotex Europe B.V. |
| --- |
| Darwinweg 20, 2333 CR Leiden, Nederland |

Apotex Europe B.V.

Darwinweg 20, 2333 CR Leiden, Nederland

EU/1/10/635

26.11.2012

22.11.2012

Prevenar 13

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

Pfizer Limited

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

EU/1/09/590

27.11.2012

22.11.2012

Rasilez

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

Novartis Europharm Ltd

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

EU/1/07/405

26.11.2012

22.11.2012

Rasilez HCT

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

Novartis Europharm Ltd

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

EU/1/08/491

26.11.2012

22.11.2012

Rasitrio

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

Novartis Europharm Limited

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

EU/1/11/730

26.11.2012

22.11.2012

Remicade

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, 2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116

27.11.2012

22.11.2012

Riprazo

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

Novartis Europharm Ltd

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

EU/1/07/409

26.11.2012

22.11.2012

Rivastigmine HEXAL

| HEXAL AG |
| --- |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland |

HEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/09/589

27.11.2012

22.11.2012

RoActemra

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

Roche Registration Limited

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

EU/1/08/492

27.11.2012

22.11.2012

Thyrogen

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, NL-1411 DD Naarden, Nederland |

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/122

27.11.2012

22.11.2012

Tracleer

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

Actelion Registration Ltd

Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220

27.11.2012

22.11.2012

Vimpat

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

UCB Pharma SA.

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

EU/1/08/470

27.11.2012

22.11.2012

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200

27.11.2012

26.11.2012

Temodal

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/98/096

28.11.2012

30.11.2012

Gardasil

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/357

30.11.2012

30.11.2012

Olazax

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/597

4.12.2012

30.11.2012

Silgard

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

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

EU/1/06/358

4.12.2012

30.11.2012

Tygacil

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

Pfizer Limited

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

EU/1/06/336

4.12.2012

30.11.2012

Zevalin

| Spectrum Pharmaceuticals B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Spectrum Pharmaceuticals B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/03/264

4.12.2012

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.11.2012 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, IRELAND |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.11.2012

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, IRELAND

EU/2/11/134

12.11.2012

8.11.2012

Meloxivet

| Eli Lilly and Company Limited |
| --- |
| Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |

Eli Lilly and Company Limited

Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/07/077

12.11.2012

12.11.2012

Rheumocam

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Loughrea, Co. Galway, IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, IRELAND

EU/2/07/078

14.11.2012

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

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

---

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

---

| 28.12.2012 | EN | Official Journal of the European Union | C 401/9 |
| --- | --- | --- | --- |

28.12.2012

EN

Official Journal of the European Union

C 401/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 2012

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

2012/C 401/03

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 19.11.2012 | Glimepirida Parke-Davis and associated names | See Annex I | See Annex I | 21.11.2012 |
| 19.11.2012 | Flukicides - Art 35 (amend) | See Annex II | See Annex II | 23.11.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

19.11.2012

Glimepirida Parke-Davis and associated names

See Annex I

See Annex I

21.11.2012

19.11.2012

Flukicides - Art 35 (amend)

See Annex II

See Annex II

23.11.2012

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 30.11.2012 | Leflunomide actavis Art 31 Suspension | See Annex III | See Annex III | 4.12.2012 |
| 30.11.2012 | Leflunomide Apotex Art 31 suspension | See Annex IV | See Annex IV | 4.12.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

30.11.2012

Leflunomide actavis Art 31 Suspension

See Annex III

See Annex III

4.12.2012

30.11.2012

Leflunomide Apotex Art 31 suspension

See Annex IV

See Annex IV

4.12.2012

---

(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 FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant | Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Cyprus | Parke-Davis Produtos Farmacêuticos Lda |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Member State

EU/EEA

Applicant

Name

Strength

Pharmaceutical form

Route of administration

Cyprus

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride Pfizer

2 mg

Tablet

Oral use

Cyprus

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride Pfizer

3 mg

Tablet

Oral use

Cyprus

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride Pfizer

4 mg

Tablet

Oral use

France

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

GLIMEPIRIDE PFIZER 2 mg, comprimé

2 mg

Tablet

Oral use

France

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

GLIMEPIRIDE PFIZER 3 mg, comprimé

3 mg

Tablet

Oral use

France

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

GLIMEPIRIDE PFIZER 4 mg, comprimé

4 mg

Tablet

Oral use

Germany

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepirid Pfizer 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepirid Pfizer 3 mg Tabletten

3 mg

Tablet

Oral use

Germany

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepirid Pfizer 4 mg Tabletten

4 mg

Tablet

Oral use

Italy

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride Pfizer

2 mg

Tablet

Oral use

Italy

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride Pfizer

3 mg

Tablet

Oral use

Italy

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride Pfizer

4 mg

Tablet

Oral use

Portugal

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepirida Parke-Davis

2 mg

Tablet

Oral use

Portugal

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepirida Parke-Davis

3 mg

Tablet

Oral use

Portugal

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepirida Parke-Davis

4 mg

Tablet

Oral use

Sweden

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepirid Pfizer

2 mg

Tablet

Oral use

Sweden

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepirid Pfizer

3 mg

Tablet

Oral use

Sweden

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepirid Pfizer

4 mg

Tablet

Oral use

United Kingdom

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride tablets, 2 mg

2 mg

Tablet

Oral use

United Kingdom

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride tablets, 3 mg

3 mg

Tablet

Oral use

United Kingdom

| Parke-Davis Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride tablets, 4 mg

4 mg

Tablet

Oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant/Marketing Authorisation Holder | Name | INN | Strength | Pharmaceutical form | Route of administration | Animal species |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Chanelle Animal Health Limited |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Member State

EU/EEA

Applicant/Marketing Authorisation Holder

Name

INN

Strength

Pharmaceutical form

Route of administration

Animal species

Austria

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Tribex 10 % - orale Suspension für Rinder

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Austria

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver 50 mg/ml Ijektionslösung für Rinder

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle

Austria

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver Combi 50 und 75 mg/ml Suspension zum Einggeben für Schafe und Lämmer

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep,

lambs

Austria

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Injektionslösung für Schafe

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

Austria

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Pour on solution for cattle

Closantel

Ivermectin

Information not available

Information not available

Information not available

Information not available

Austria

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Injektionslösung für Rinder

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

Austria

| Novartis Animal Health GmbH |
| --- |
| Biochemiestr. 10 |
| A-6250 Kundl |
| AUSTRIA |

Novartis Animal Health GmbH

Biochemiestr. 10

A-6250 Kundl

AUSTRIA

Endex 19,5 % - wässrige Suspension für Rinder

Triclabendazole

Levamisole

120 mg/ml

75 mg/ml

Oral suspension

oral

Cattle

Austria

| Pfizer Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstrasse 1 |
| A-1210 Wien |
| AUSTRIA |

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstrasse 1

A-1210 Wien

AUSTRIA

Cydectin TriclaMox

Triclabendazole Moxidectin

50mg/ml

1mg/ml

Oral solution

oral

Sheep

Belgium

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Animec Super Solution for Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Belgium

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IDA Business & Technology Park |
| Loughrea, Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRELAND

Triclaben 10 %

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Belgium

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Bimectin Plus 10/100 mg/ml

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Belgium

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver 5 %

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle

Belgium

| Merial Belgium S.A. |
| --- |
| Boulevard Sylvain Dupuis 243 |
| B-1070 Bruxelles |
| BELGIUM |

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIUM

Dovenix

Nitroxinil

250 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

Belgium

| Merial Belgium S.A. |
| --- |
| Boulevard Sylvain Dupuis 243 |
| B-1070 Bruxelles |
| BELGIUM |

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIUM

Ivomec F

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Belgium

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Solution for Injection for Cattle

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

Belgium

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinsenlaan 142 |
| 4818 CP Breda |
| THE NETHERLANDS |

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

THE NETHERLANDS

Endex 19,5

Triclabendazole

Levamisole

12 g/100 ml

7,5 g/100 ml

Oral suspension

oral

Cattle

Belgium

| Virbac de Portugal Laboratórios LDA |
| --- |
| Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2 |
| 2080-104 Almeirim |
| PORTUGAL |

Virbac de Portugal Laboratórios LDA

Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2

2080-104 Almeirim

PORTUGAL

Virbamec F

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Cyprus

| Vetagrica Ltd |
| --- |
| 3 Othelou str. |
| 2540 Dali Industrial Estate |
| P.O. Box 17020 |
| Nicosia |
| CYPRUS |

Vetagrica Ltd

3 Othelou str.

2540 Dali Industrial Estate

P.O. Box 17020

Nicosia

CYPRUS

Ivomec Super injectable solution

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Czech Republic

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IDA Business & Technology Park |
| Loughrea, Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRELAND

Triclaben 100 mg/ml perorální suspenze pro skot

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Czech Republic

| Merial S.A.S. |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCE

Ivomec Super solution for injection

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Czech Republic

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin solution for injection for cattle

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

Czech Republic

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin injekční roztok pro ovce

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

Czech Republic

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin 5 mg/ml + 200 mg/ml Pour on solution for cattle

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on use

Cattle

Denmark

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Bimectin Plus

Clorsulon

Ivermectin

10 mg/ml

1 mg/ml

Solution for injection

subcutaneous

Cattle

Denmark

| Pfizer Oy Animal Health |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINLAND

Cydectin TriclaMox

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

Denmark

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Pour-On

Closantel

Ivermectin

20 mg/ml

0,5 mg/ml

Pour-on

Information not available

Cattle

Denmark

| Pfizer Oy Animal Health |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINLAND

Cydectin TriclaMox

Triclabendazol

Moxidectin

200 mg/ml

5 mg/ml

Oral solution

Information not available

Cattle

Finland

| Pfizer Oy Animal Health |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINLAND

Cydectin Triclamox

Triclabendazole

Moxidectin

5 mg/ml

200 mg/ml

Pour-on

pour-on

Cattle

France

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Fascicur 5 %

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

France

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Fascicur 10 %

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

France

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Cevamec D

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

France

| Janssen-Cilag |
| --- |
| 1 Rue Camille Desmoulins |
| TSA 91003 |
| 92787 Issy Les Moulineaux |
| Cedex 9 |
| FRANCE |

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANCE

Flukiver

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

France

| Janssen-Cilag |
| --- |
| 1 Rue Camille Desmoulins |
| TSA 91003 |
| 92787 Issy Les Moulineaux |
| Cedex 9 |
| FRANCE |

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANCE

Seponver

Closantel

50 mg/ml

Oral suspension

oral

Cattle, Sheep

France

| Janssen-Cilag |
| --- |
| 1 Rue Camille Desmoulins |
| TSA 91003 |
| 92787 Issy Les Moulineaux |
| Cedex 9 |
| FRANCE |

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANCE

Supaverm

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

France

| Janssen-Cilag |
| --- |
| 1 Rue Camille Desmoulins |
| TSA 91003 |
| 92787 Issy Les Moulineaux |
| Cedex 9 |
| FRANCE |

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANCE

Douvigard

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

France

| Merial S.A.S. |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCE

DOVENIX

Nitroxinil

250 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

France

| Merial S.A.S. |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCE

Ivomec D

Clorsulon

Ivermectin

Information not available

Solution for injection

subcutaneous

Information not available

France

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Duotech

Closantel

Oxfendazole

50 mg/ml

25 mg/ml

Oral suspension

oral

Sheep

France

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectine Solution Injectable Pour Cattles

Closantel

Ivermectine

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

France

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectine Solution Injectable Pour Ovines

Closantel

Ivermectine

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

France

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Vermax D

Closantel

Ivermectine

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

France

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Norofas Pour on

Closantel

Ivermectine

200 mg/ml

5 mg/ml

Pour-on

pour-on

Cattle

France

| Novartis Santé Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Fascinex 5 %

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep,

Goat

France

| Novartis Santé Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Fascinex 10 %

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

France

| Novartis Santé Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Fascinex Premelange

Triclabendazole

200 mg/ml

Premix

oral

Cattle

France

| Novartis Santé Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Parsifal Bovins

Triclabendazole

Levamisole

120 mg/ml

63,5 mg/ml

Oral suspension

oral

Cattle

France

| Novartis Santé Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Parsifal Ovins

Triclabendazole

Levamisole

50 mg/ml

32 mg/ml

Oral suspension

oral

Sheep

France

| Novartis Santé Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Triclanil 5 %

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

France

| Novartis Santé Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Triclanil 10 %

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

France

| Novartis Santé Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Fascinex 100

Triclabendazole

100 mg/ml

Oral suspension

oral

Sheep

France

| Novartis Santé Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Fascinex 240

Triclabendazole

240 mg/ml

Oral suspension

oral

Cattle

France

| Pfizer Holding France |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

Pfizer Holding France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

Cydectine Triclamox 1 mg/ml + 50 mg/ml Solution Buvable Pour Ovins

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

France

| Pfizer Holding France |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

Pfizer Holding France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

Cydectine Triclamox 5 mg/ml + 200 mg/ml Solution pour Pour-on pour Bovins

Triclabendazole

Moxidectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Cattle

France

| Virbac de Portugal Laboratorios LDA |
| --- |
| Rua do Centro Empresarial |
| Ed. 13, Quinta da Beloura |
| 2710-693 Sintra |
| PORTUGAL |

Virbac de Portugal Laboratorios LDA

Rua do Centro Empresarial

Ed. 13, Quinta da Beloura

2710-693 Sintra

PORTUGAL

Virbamec D Solution Injectable

Clorsulon

Ivermectine

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Germany

| AniMedica GmbH |
| --- |
| Im Südfeld 9 |
| D-48308 Senden-Bösensell |
| GERMANY |

AniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

GERMANY

Endofluke 100 mg/ml orale Suspension

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle,

sheep

Germany

| AniMedica GmbH |
| --- |
| Im Südfeld 9 |
| D-48308 Senden-Bösensell |
| GERMANY |

AniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

GERMANY

Endofluke

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Germany

| Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd. |
| --- |
| Broomhill Road |
| TALLAGHT |
| DUBLIN 24 |
| IRELAND |

Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd.

Broomhill Road

TALLAGHT

DUBLIN 24

IRELAND

Bimectin Fluke

Clorsulon

Ivermectin

10 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Germany

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IDA Business & Technology Park |
| Loughrea, Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRELAND

Triclaben 10 %

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Germany

| Janssen-Cilag GmbH |
| --- |
| Johnson & Johnson Platz 1 |
| D-41470 Neuss |
| GERMANY |

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

GERMANY

Flukiver

Closantel

50 mg/ml

Oral suspension

oral

Cattle,

sheep

Germany

| Janssen-Cilag GmbH |
| --- |
| Johnson & Johnson Platz 1 |
| D-41470 Neuss |
| GERMANY |

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

GERMANY

Flukiver Combi

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral solution

oral

Sheep,

lambs

Germany

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Pour-On

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Cattle

Germany

| Novartis Tiergesundheit GmbH |
| --- |
| Zielstattstr. 40 |
| D-81379 München |
| GERMANY |

Novartis Tiergesundheit GmbH

Zielstattstr. 40

D-81379 München

GERMANY

Fasinex 10 %

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle,

sheep

Germany

| Pfizer GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| GERMANY |

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

GERMANY

Cydectin Triclamox 5 mg/ml

Triclabendazole

Moxidectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Cattle

Germany

| Pfizer GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| GERMANY |

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

GERMANY

Cydectin TriclaMox 1 mg/ml + 50 mg/ml Lösung zum Eingeben für Schafe

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

Greece

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver Combi

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep, Lambs

Greece

| New Vet |
| --- |
| 15 Fleming Street |
| Maroussi 15123 |
| GREECE |

New Vet

15 Fleming Street

Maroussi 15123

GREECE

Zivet

Closantel

Oxfendazole

5 mg/ml

2,5 mg/ml

Oral suspension

oral

Sheep

Greece

| Pfizer Hellas AE |
| --- |
| Mesogeion 243 |
| N.Psichiko 15451 |
| GREECE |

Pfizer Hellas AE

Mesogeion 243

N.Psichiko 15451

GREECE

Cydectin Triclamox

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

Greece

| Provet |
| --- |
| Aspropyrgos |
| 19300, Attik |
| GREECE |

Provet

Aspropyrgos

19300, Attik

GREECE

Rafoxanide/Provet

Rafoxanide

300 mg/tab

Tablets

oral

Sheep

Hungary

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver 5 % injekció A.U.V.

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

Hungary

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver Combi belsőleges szuszpenzió A.U.V.

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

Hungary

| Merial S.A.S. |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCE

Ivomec Super injekció A.U.V.

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Iceland

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver Combi vet

Closantel

50/75 mg/ml

Oral solution

oral

Sheep, Lambs

Ireland

| Biochem Ltd |
| --- |
| Pulleen |
| Kanturk |
| Co. Cork |
| IRELAND |

Biochem Ltd

Pulleen

Kanturk

Co. Cork

IRELAND

Levafluke

Rafoxanide

Levamisole

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| C & H Generics Ltd c/o Michael McEvoy |
| --- |
| Seville House |
| New Dock Street |
| Galway |
| IRELAND |

C & H Generics Ltd c/o Michael McEvoy

Seville House

New Dock Street

Galway

IRELAND

Chanectin Super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Chan Broad Spec

Rafoxanide

Levamisole

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Rafazole Oral Suspension

Rafoxanide

Levamisole

30 mg/ml

30 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Ridafluke 3 %

Rafoxanide

30 mg/ml

Oral suspension

oral

Cattle

Sheep

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Animec Super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Levatum Super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Tribex 10 % for cattle

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Tribex 5 % for Sheep

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Triclaben 5 % for Sheep

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRELAND

Triclaben 10 % for cattle

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Ireland

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Endofluke 10

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Fasifree 10 %

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Bimectin Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Ireland

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Mectaject Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Ireland

| Interchem Ireland Ltd |
| --- |
| Road M |
| Unit 12 Tougher Business Park |
| Newhall |
| Naas |
| Co. Kildare |
| IRELAND |

Interchem Ireland Ltd

Road M

Unit 12 Tougher Business Park

Newhall

Naas

Co. Kildare

IRELAND

Orafluke 10 %

Rafoxanide

Fenbendazole

100 mg/ml

100 mg/ml

Oral suspension

oral

Cattle

Ireland

| Interchem Ireland Ltd |
| --- |
| Road M |
| Unit 12 Tougher Business Park |
| Newhall |
| Naas |
| Co. Kildare |
| IRELAND |

Interchem Ireland Ltd

Road M

Unit 12 Tougher Business Park

Newhall

Naas

Co. Kildare

IRELAND

Orafluke 5 %

Rafoxanide

Fenbendazole

50 mg/ml

50 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Intervet Ireland Ltd |
| --- |
| Magna Drive |
| Magne Business Park |
| Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Ltd

Magna Drive

Magne Business Park

Citywest Road

Dublin 24

Ireland

Panafluke Oral Suspension

Rafoxanide

Fenbendazole

45 mg/ml

30 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| UNITED KINGDOM |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UNITED KINGDOM

Flukiver 5 Injection

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

Ireland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| UNITED KINGDOM |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UNITED KINGDOM

Flukiver Combi Oral Suspension

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

Ireland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| UNITED KINGDOM |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UNITED KINGDOM

Supaverm Oral Suspension

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

Ireland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| UNITED KINGDOM |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UNITED KINGDOM

Flukiver Bovis

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle

Ireland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| UNITED KINGDOM |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UNITED KINGDOM

Flukiver 5 % w/v Oral Suspension

Closantel

50 mg/ml

Oral suspension

oral

Sheep

Ireland

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Sandringham Avenue, Harlow Business Park, Harlow |
| CM19 5TG |
| Essex |
| UNITED KINGDOM |

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

UNITED KINGDOM

Ivomec super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Ireland

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Sandringham Avenue, Harlow Business Park, Harlow |
| CM19 5TG |
| Essex |
| UNITED KINGDOM |

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

UNITED KINGDOM

Trodax 34 %

Nitroxinil

340 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

Ireland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Pour on

Closantel

lvermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Cattle

Ireland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin

Closantel

lvermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

Ireland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closiver for cattle

Closantel

lvermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

Ireland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin for sheep

Closantel

lvermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

Ireland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closiver for sheep

Closantel

lvermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

Ireland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Combifluke Oral Suspension for Sheep

Closantel

Oxfendazole

50 mg/ml

25 mg/ml

Oral suspension

oral

Sheep

Ireland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Parafend Plus Oral Suspension for Sheep

Closantel

Oxfendazole

50 mg/ml

25 mg/ml

Oral suspension

oral

Sheep

Ireland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Duotech Oral Suspension for Sheep

Closantel

Oxfendazole

50 mg/ml

25 mg/ml

Oral suspension

oral

Sheep

Ireland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Endex 19,5 %

Triclabendazole

Levamisole

120 mg/ml

75 mg/ml

Oral suspension

oral

Cattle

Ireland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Endex 8,75 %

Triclabendazole

Levamisole

50 mg/ml

35 mg/ml

Oral suspension

oral

Sheep

Ireland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasinex 10 %

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Ireland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasinex 10 % for Sheep

Triclabendazole

100 mg/ml

Oral suspension

oral

Sheep

Ireland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasinex 5 %

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

Ireland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasinex 24 %

Triclabendazole

240 mg/ml

Oral suspension

oral

Cattle

Ireland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasinex Super 19,5 %

Triclabendazole

Levamisole

120 mg/ml

75 mg/ml

Oral suspension

oral

Cattle

Ireland

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digit Park |
| Citywest Business Campus |
| Dublin 24 |
| IRELAND |

Pfizer Healthcare Ireland

9 Riverwalk

National Digit Park

Citywest Business Campus

Dublin 24

IRELAND

Cydectin Triclamox

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral suolution

oral

Sheep

Ireland

| PharVet Ltd |
| --- |
| Station Road |
| Bagenalstown |
| Co. Carlow |
| IRELAND |

PharVet Ltd

Station Road

Bagenalstown

Co. Carlow

IRELAND

Fenafluke 5 %

Rafoxanide

Fenbendazole

50 mg/ml

50 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| PharVet Ltd |
| --- |
| Station Road |
| Bagenalstown |
| Co. Carlow |
| IRELAND |

PharVet Ltd

Station Road

Bagenalstown

Co. Carlow

IRELAND

Triazole

Rafoxanide

Levamisole

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Quinn’s Chemist |
| --- |
| Bridge Street |
| Crossmolina |
| Co. Mayo |
| IRELAND |

Quinn’s Chemist

Bridge Street

Crossmolina

Co. Mayo

IRELAND

Fluken worm

Rafoxanide

Levamisole

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Univet Limited |
| --- |
| Tullyvin |
| Cootehill |
| Co. Cavan |
| IRELAND |

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRELAND

Curafluke 10 %

Rafoxanide

Fenbendazole

100 mg/ml

100 mg/ml

Oral suspension

oral

Cattle

Ireland

| Univet Limited |
| --- |
| Tullyvin |
| Cootehill |
| Co. Cavan |
| IRELAND |

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRELAND

Curafluke 5 %

Rafoxanide

Fenbendazole

50 mg/ml

50 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Univet Limited |
| --- |
| Tullyvin |
| Cootehill |
| Co. Cavan |
| IRELAND |

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRELAND

Flukex 9 %

Rafoxanide

90 mg/ml

Oral suspension

oral

Cattle

Ireland

| Univet Limited |
| --- |
| Tullyvin |
| Cootehill |
| Co. Cavan |
| IRELAND |

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRELAND

Univet Multidose Fluke and Worm

Rafoxanide

Levamisole

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Cattle, Sheep

Ireland

| Virbac S.A. |
| --- |
| Virbac 1, 1ère Avenue |
| 2065 M - L.I.D., BP 27, 06516 |
| Carros, Cedex |
| FRANCE |

Virbac S.A.

Virbac 1, 1ère Avenue

2065 M - L.I.D., BP 27, 06516

Carros, Cedex

FRANCE

Virbamec super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Italy

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Maximec Plus

Clorsulon

Ivermectin

Information not available

Solution for injection

Information not available

Cattle

Italy

| FATRO S.p.A. |
| --- |
| Via Emilia 285 |
| 40064 Ozzano Emilia (BO) |
| ITALY |

FATRO S.p.A.

Via Emilia 285

40064 Ozzano Emilia (BO)

ITALY

Tolomec Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Italy

| Pfizer Italia s.r.l. |
| --- |
| Via Isonzo 71 |
| LATINA |
| ITALY |

Pfizer Italia s.r.l.

Via Isonzo 71

LATINA

ITALY

Cydectin Triclamox

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

Italy

| Intervet Production s.r.l. |
| --- |
| via Nettunense |
| km 20,300 |
| Aprilia (LT) |
| ITALY |

Intervet Production s.r.l.

via Nettunense

km 20,300

Aprilia (LT)

ITALY

Ranigel

Rafoxanide

75 mg/ml

Solution for injection

subcutaneous

Cattle

Italy

| Intervet Production s.r.l. |
| --- |
| via Nettunense |
| km 20300 |
| Aprilia (LT) |
| ITALY |

Intervet Production s.r.l.

via Nettunense

km 20300

Aprilia (LT)

ITALY

Ranigel

Rafoxanide

30 mg/ml

Oral suspension

oral

Cattle, Sheep

Italy

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver

Closantel

50 mg/ml

Solution for injection

intramuscular

Cattle

Italy

| Janssen-Cilag S.p.A. |
| --- |
| Via M. Buonarroti 23 |
| 20093 Cologno Monzese (MI) |
| ITALY |

Janssen-Cilag S.p.A.

Via M. Buonarroti 23

20093 Cologno Monzese (MI)

ITALY

Seponver

Closantel

50 mg/ml

Oral suspension

oral

Sheep

Italy

| Janssen-Cilag S.p.A. |
| --- |
| Via M. Buonarroti 23 |
| 20093 Cologno Monzese (MI) |
| ITALY |

Janssen-Cilag S.p.A.

Via M. Buonarroti 23

20093 Cologno Monzese (MI)

ITALY

Seponver Plus

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

Italy

| Merial Italia S.p.A. |
| --- |
| via Vittorio Pisani, 16 |
| 20100 Milano |
| ITALY |

Merial Italia S.p.A.

via Vittorio Pisani, 16

20100 Milano

ITALY

Ivomec Plus

Clorsulon

Ivermectin

100 mg/ml

1 mg/ml

Solution for injection

subcutaneous

Cattle

Italy

| Norbrook Laboratories |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Duotech

Closantel

Oxfendazole

50 mg/ml

25 mg/ml

Oral suspension

oral

Sheep

Italy

| Norbrook Laboratories |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

Italy

| Norbrook Laboratories |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Pour on

Closantel

Ivermectin

Information not available

Information not available

Information not available

Information not available

Italy

| Pfizer Italia s.r.l. |
| --- |
| Via Isonzo 71 |
| LATINA |
| ITALY |

Pfizer Italia s.r.l.

Via Isonzo 71

LATINA

ITALY

Cydectin Triclamox Pour on

Triclabendazole

Moxidectin

Information not available

Pour-on

pour-on

Cattle

Italy

| Virbac de Portugal Laboratorios LDA |
| --- |
| Rua do Centro Empresarial |
| Ed. 13, Quinta da Beloura |
| 2710-693 Sintra |
| PORTUGAL |

Virbac de Portugal Laboratorios LDA

Rua do Centro Empresarial

Ed. 13, Quinta da Beloura

2710-693 Sintra

PORTUGAL

Virbamec F

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Latvia

| Merial S.A.S. |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCE

Ivomec Super solution for injection

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Lithuania

| Merial S.A.S. |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCE

Ivomec Super solution for injection

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Luxembourg

| Merial Belgium S.A. |
| --- |
| Boulevard Sylvain Dupuis 243 |
| B-1070 Bruxelles |
| BELGIUM |

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIUM

Ivomec F

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Luxembourg

| Pfizer Animal Health S.A. |
| --- |
| rue Laid Burniat 1 |
| 1348 Luvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health S.A.

rue Laid Burniat 1

1348 Luvain-la-Neuve

BELGIUM

Cydectin Triclamox

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

Norway

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Duotech vet

Closantel

Oxfendazole

50 mg/ml

25 mg/ml

oral suspension

oral

Sheep

Portugal

| Esteve Farma LDA |
| --- |
| Av. Do Forte, 3 |
| Edifício Suécia III, Piso 1 |
| 2794-044 Carnaxide |
| PORTUGAL |

Esteve Farma LDA

Av. Do Forte, 3

Edifício Suécia III, Piso 1

2794-044 Carnaxide

PORTUGAL

Flukiver 50 mg/ml solução injectável para bovinos e ovinos

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

Portugal

| Esteve Farma LDA |
| --- |
| Av. Do Forte, 3 |
| Edifício Suécia III, Piso 1 |
| 2794-044 Carnaxide |
| PORTUGAL |

Esteve Farma LDA

Av. Do Forte, 3

Edifício Suécia III, Piso 1

2794-044 Carnaxide

PORTUGAL

SEPONVER PLUS (75 mg + 50 mg) suspensão oral para ovinos

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

Portugal

| Esteve Farma LDA |
| --- |
| Av. Do Forte, 3 |
| Edifício Suécia III, Piso 1 |
| 2794-044 Carnaxide |
| PORTUGAL |

Esteve Farma LDA

Av. Do Forte, 3

Edifício Suécia III, Piso 1

2794-044 Carnaxide

PORTUGAL

Flukiver 5 % suspensão oral

Closantel

50 mg/ml

Oral suspension

oral

Cattle, Sheep

Portugal

| Merial Portuguesa Saúde Animal, Lda |
| --- |
| Av. Maria Lamas, Lt.19 - BL A - Piso 2 - Serra das Minas |
| 2635-432 Rio de Mouro |
| PORTUGAL |

Merial Portuguesa Saúde Animal, Lda

Av. Maria Lamas, Lt.19 - BL A - Piso 2 - Serra das Minas

2635-432 Rio de Mouro

PORTUGAL

DOVENIX

Nitroxinil

250 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

Portugal

| Merial Portuguesa Saúde Animal, Lda |
| --- |
| Av. Maria Lamas, Lt.19 - BL A - Piso 2 - Serra das Minas |
| 2635-432 Rio de Mouro |
| PORTUGAL |

Merial Portuguesa Saúde Animal, Lda

Av. Maria Lamas, Lt.19 - BL A - Piso 2 - Serra das Minas

2635-432 Rio de Mouro

PORTUGAL

IVOMEC F

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Portugal

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Duotech Suspensão

Closantel

Oxfendazole

50 mg/ml

25 mg/ml

Oral suspension

oral

Sheep

Portugal

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin FF, solução injectável para bovinos

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

Portugal

| Virbac de Portugal Laboratórios LDA |
| --- |
| Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2 |
| 2080-104 Almeirim |
| PORTUGAL |

Virbac de Portugal Laboratórios LDA

Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2

2080-104 Almeirim

PORTUGAL

Virbamec F

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Romania

| Bomac Laboratories Limited |
| --- |
| Cnr Wiri Station Road & Hobill Ave |
| P.O Box 76-369 |
| Manukau City |
| Auckland |
| NEW ZEALAND |

Bomac Laboratories Limited

Cnr Wiri Station Road & Hobill Ave

P.O Box 76-369

Manukau City

Auckland

NEW ZEALAND

Clos-Atak

Closantel

50 mg/ml

Solution for injection

Intramuscular/subcutaneous

Cattle, Sheep

Romania

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Ranigel

Rafoxanide

30 mg/ml

Oral suspension

oral

Cattle, Sheep

Romania

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Fluxacur

Triclabendazole

Abamectin

Information not available

Oral suspension

oral

Cattle

Sheep

Romania

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver 5 %

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle

Romania

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver Combi

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

Romania

| Kepro B.V. |
| --- |
| Maagdenburgstraat 38 |
| 7421 ZE Deventer |
| THE NETHERLANDS |

Kepro B.V.

Maagdenburgstraat 38

7421 ZE Deventer

THE NETHERLANDS

Kepromec Super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Romania

| Merial S.A.S. |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCE

IVOMEC PLUS

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Romania

| Merial S.A.S. |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCE

DOVENIX

Nitroxinil

25 g/100 ml

Solution for injection

injectable solution

Cattle, Sheep, Goats

Romania

| Pasteur - Filiala Filipesti SRL |
| --- |
| Str. Principala nr. 944 |
| Filipestii de Padure |
| Jud. Prahova |
| ROMANIA |

Pasteur - Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

ROMANIA

Evomec Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Romania

| Pasteur - Filiala Filipesti SRL |
| --- |
| Str. Principala nr. 944 |
| Filipestii de Padure |
| Jud. Prahova |
| ROMANIA |

Pasteur - Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

ROMANIA

Helmizol Plus

Clorsulon

120 mg/bolus

Bolus

oral

Cattle

Romania

| S.C. Romvac Company s.a. |
| --- |
| Șos. Centurii, nr. 7 |
| Voluntari |
| ROMANIA |

S.C. Romvac Company s.a.

Șos. Centurii, nr. 7

Voluntari

ROMANIA

Fasciocid

Triclabendazole

100 mg/ml

Oral solution

oral

Cattle, Sheep

Romania

| S.C. Romvac Company s.a. |
| --- |
| Șos. Centurii, nr. 7 |
| Voluntari |
| ROMANIA |

S.C. Romvac Company s.a.

Șos. Centurii, nr. 7

Voluntari

ROMANIA

Romavermectina B1 1 % Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Romania

| Vanelli S.R.L. |
| --- |
| Iași-Tg. Frumos, km. 10 |
| Iași |
| ROMANIA |

Vanelli S.R.L.

Iași-Tg. Frumos, km. 10

Iași

ROMANIA

Ascacid Forte

Rafoxanide

Albendazole

25 mg/ml

28 mg/ml

Oral suspension

oral

Cattle, Sheep

Romania

| VIM Spectrum S.R.L. |
| --- |
| Sos. Sighisoarei nr. 409 |
| Tg. Mures |
| ROMANIA |

VIM Spectrum S.R.L.

Sos. Sighisoarei nr. 409

Tg. Mures

ROMANIA

Distol

Triclabendazole

Ivermectin

500 mg/tablet

10 mg/tablet

Tablets

oral

Sheep, Goats

Slovak Republic

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IDA Business & Technology Park |
| Loughrea, Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRELAND

Triclaben 100 mg/ml por.sus.ad us.vet.

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Slovak Republic

| Merial S.A.S. |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCE

Ivomec Super inj. ad us.vet.

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Slovak Republic

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin inj. ad us.vet.

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

Slovak Republic

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin injekčný roztok pre ovce

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

Slovak Republic

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin 5 mg/ml + 200 mg/ml Pour on solution for Cattle

Closantelum

Ivermectinum

200 mg/ml

5 mg/ml

Pour on

pour-on

Cattle

Slovenia

| KRKA tovarna zdravil, d.d. |
| --- |
| Šmarješka cesta 6 |
| 8501 Novo Mesto |
| SLOVENIA |

KRKA tovarna zdravil, d.d.

Šmarješka cesta 6

8501 Novo Mesto

SLOVENIA

Fascoverm

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

Slovenia

| KRKA tovarna zdravil, d.d. |
| --- |
| Šmarješka cesta 6 |
| 8501 Novo Mesto |
| SLOVENIA |

KRKA tovarna zdravil, d.d.

Šmarješka cesta 6

8501 Novo Mesto

SLOVENIA

FASCOVERM PLUS

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

Spain

| C & H Generics Limited c/o Michael McEvoy & Co |
| --- |
| Seville House |
| New Dock Street |
| Galway |
| IRELAND |

C & H Generics Limited c/o Michael McEvoy & Co

Seville House

New Dock Street

Galway

IRELAND

Chanectin

Ivermectin

Clorsulon

Information not available

Information not available

Information not available

Cattle

Spain

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Tribex 10 % Suspension Oral Para Bovino

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Spain

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Animec Plus Solución inyectable para bovino

Clorsulon

Ivermectin

Information not available

Information not available

Information not available

Information not available

Spain

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Tribex 5 % Solución Oral Para Ovino

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

Spain

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IDA Business & Technology Park |
| Loughrea, Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRELAND

Alverin Plus solution for injection for cattle

Clorsulon

Ivermectin

Information not available

Information not available

Information not available

Information not available

Spain

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Bimectin Plus

Clorsulon

Ivermectin

Information not available

Information not available

Information not available

Information not available

Spain

| Diana S.A.E. |
| --- |
| Ctra Barcelona-Ripoll, PK 17 |
| 08150 Parets Del Valles, Barcelona |
| SPAIN |

Diana S.A.E.

Ctra Barcelona-Ripoll, PK 17

08150 Parets Del Valles, Barcelona

SPAIN

Vermifor Ecto

Closantel

5 g/100 ml

Solution for injection

Intramuscular/subcutaneous/

Cattle, Sheep

Spain

| FATRO Iberica, S.L. |
| --- |
| C/ Constitución 1, Planta Baja 3 |
| 08960 Sant Just Desvern |
| Barcelona |
| SPAIN |

FATRO Iberica, S.L.

C/ Constitución 1, Planta Baja 3

08960 Sant Just Desvern

Barcelona

SPAIN

Fugosantel

Closantel

5 g/100 ml

Solution for injection

Intramuscular/subcutaneous

Cattle, Sheep

Spain

| Industrial Veterinaria, S.A. |
| --- |
| Esmeralda, 19 |
| E-08950 Esplugues de Llobregat (Barselona) |
| SPAIN |

Industrial Veterinaria, S.A.

Esmeralda, 19

E-08950 Esplugues de Llobregat (Barselona)

SPAIN

Rolenol

Closantel

50 mg/ml

Solution for injection

Intramuscular/subcutaneous

Cattle, Sheep

Spain

| Laboratorios Cenavisa, s.a. |
| --- |
| Cami Pedro Estela, S/N |
| 43205 Reus (Tarragona) |
| SPAIN |

Laboratorios Cenavisa, s.a.

Cami Pedro Estela, S/N

43205 Reus (Tarragona)

SPAIN

Telcen

Closantel

50 mg/ml

Solution for injection

Intramuscular/subcutaneous

Cattle, Sheep

Spain

| Laboratorios Dr. Esteve S.A. |
| --- |
| Avda. Mare de Déu de Montserrat 221 |
| 08041 Barcelona |
| SPAIN |

Laboratorios Dr. Esteve S.A.

Avda. Mare de Déu de Montserrat 221

08041 Barcelona

SPAIN

Flukiver

Closantel

5 g/100 ml

Solution for injection

subcutaneous

Cattle, Sheep

Spain

| Laboratorios Dr. Esteve S.A. |
| --- |
| Avda. Mare de Déu de Montserrat 221 |
| 08041 Barcelona |
| SPAIN |

Laboratorios Dr. Esteve S.A.

Avda. Mare de Déu de Montserrat 221

08041 Barcelona

SPAIN

Seponver Plus

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

Spain

| Laboratorios e Industrias IVEN S.A. |
| --- |
| C/ Luis I 56 |
| Pol. Ind. De Vallecas |
| Madrid |
| SPAIN |

Laboratorios e Industrias IVEN S.A.

C/ Luis I 56

Pol. Ind. De Vallecas

Madrid

SPAIN

Endoectiven

Closantel

50 mg/ml

Solution for injection

Intramuscular/subcutaneous

Cattle, Sheep

Spain

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135 |
| 17170 Amer (Gerona) |
| SPAIN |

Laboratorios Hipra S.A.

Avda. La Selva 135

17170 Amer (Gerona)

SPAIN

Leclosan

Closantel

50 mg/ml

Solution for injection

Intramuscular/subcutaneous

Cattle, Sheep

Spain

| Laboratorios Ovejero, S.A. |
| --- |
| Ctra León - Vilecha, 30 |
| 24192 León |
| SPAIN |

Laboratorios Ovejero, S.A.

Ctra León - Vilecha, 30

24192 León

SPAIN

Distomicide

Nitroxinil

25 g/100 ml

Solution for injection

subcutaneous

Cattle, Sheep

Spain

| Merial Laboratorios S.A. |
| --- |
| C/ Tarragona n.161 |
| Locales D/E |
| 08014 Barcelona |
| SPAIN |

Merial Laboratorios S.A.

C/ Tarragona n.161

Locales D/E

08014 Barcelona

SPAIN

Dovenix

Nitroxinil

25 g/100 ml

Solution for injection

subcutaneous

Cattle, Sheep

Spain

| Merial Laboratorios S.A. |
| --- |
| C/ Tarragona n.161 |
| Locales D/E |
| 08014 Barcelona |
| SPAIN |

Merial Laboratorios S.A.

C/ Tarragona n.161

Locales D/E

08014 Barcelona

SPAIN

Ivomec F

Clorsulon

100 mg/ml

Solution for injection

subcutaneous

Cattle

Spain

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin pour-on

Closantel

Invermectine

Information not available

Information not available

pour-on

Cattle

Spain

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Duotech suspensión oral

Closantel

Oxfendazol

50 mg/ml

25 mg/ml

Oral suspension

oral

Sheep

Spain

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Solucion Inyectable para Bovino

Closantel

Invermectine

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

Spain

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Solucion Inyectable para Ovino

Closantel

Invermectine

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

Spain

| Novartis Sanidad Animal S.L. |
| --- |
| C/ De La Marina 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPAIN

Endex 19,5 %

Triclabendazole

12 g/100 ml

Oral suspension

oral

Cattle

Spain

| Novartis Sanidad Animal S.L. |
| --- |
| C/ De La Marina 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPAIN

Fasinex 10 % Bovino

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

Spain

| Novartis Sanidad Animal S.L. |
| --- |
| C/ De La Marina 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPAIN

Fasinex 5 % Ovino

Triclabendazole

5 g/100 ml

Oral suspension

oral

Sheep

Spain

| Novartis Sanidad Animal S.L. |
| --- |
| C/ De La Marina 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPAIN

Endex 8,57 %

Triclabendazole

Levamisole

5 g/100 ml

3,75 g/100 ml

Oral suspension

oral

Sheep

Spain

| Novartis Sanidad Animal S.L. |
| --- |
| C/ De La Marina 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPAIN

Fasinex 10 % Ovino

Triclabendazole

100 mg/ml

Oral suspension

oral

Sheep

Spain

| Pfizer S.L. |
| --- |
| Avenida de Europa 20 B |
| Parque Empresarial La Moraleja Alcobendas |
| Madrid |
| SPAIN |

Pfizer S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja Alcobendas

Madrid

SPAIN

Cydectin Triclamox 5 mg/ml + 200 mg/ml Pour On Solution For Cattle

Triclabendazole

Moxidectin

Information not available

Information not available

Information not available

Information not available

Spain

| Pfizer S.L. |
| --- |
| Avenida de Europa 20 B |
| Parque Empresarial La Moraleja Alcobendas |
| Madrid |
| SPAIN |

Pfizer S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja Alcobendas

Madrid

SPAIN

Cydectin Triclamox 1 mg/ml + 50 mg/ml Solución Oral Para Ovino

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

Spain

| S.P. Veterinaria S.A. |
| --- |
| Ctra Reus a Vinyols Km.4,1 |
| 43330 Riudoms (Tarragona) |
| SPAIN |

S.P. Veterinaria S.A.

Ctra Reus a Vinyols Km.4,1

43330 Riudoms (Tarragona)

SPAIN

Endoex Inyectable

Closantel

5 g/100 ml

Solution for injection

Intramuscular/subcutaneous

Cattle, Sheep

Spain

| S.P. Veterinaria S.A. |
| --- |
| Ctra Reus a Vinyols Km.4,1 |
| 43330 Riudoms (Tarragona) |
| SPAIN |

S.P. Veterinaria S.A.

Ctra Reus a Vinyols Km.4,1

43330 Riudoms (Tarragona)

SPAIN

Endoex Oral

Closantel

5 g/100 ml

Oral solution

oral

Cattle, Sheep

Spain

| Virbac de Portugal Laboratórios LDA |
| --- |
| Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2 |
| 2080-104 Almeirim |
| PORTUGAL |

Virbac de Portugal Laboratórios LDA

Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2

2080-104 Almeirim

PORTUGAL

Virbamec F

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

Sweden

| Pfizer Oy Animal Health |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINLAND

Moxidektin/

Triklabendazol Fort Dodge

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

The Netherlands

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Tribex 5 % orale suspensie voor schapen

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

The Netherlands

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Tribex 10 % orale suspensie voor rundvee

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

The Netherlands

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver 50 mg/ml, oplossing voor injectie

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle

The Netherlands

| Janssen Pharmaceutica N.V. |
| --- |
| 30 Turnhoutseweg |
| B-2340 Beerse |
| BELGIUM |

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIUM

Flukiver combi orale suspensie voor schapen en lammeren

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep, Lambs

The Netherlands

| Merial B.V. |
| --- |
| Kleermakersstraat 10 |
| 1191 JL Velserbroek |
| THE NETHERLANDS |

Merial B.V.

Kleermakersstraat 10

1191 JL Velserbroek

THE NETHERLANDS

Ivomec Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

oral

Cattle

The Netherlands

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinsenlaan 142 |
| 4818 CP Breda |
| THE NETHERLANDS |

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

THE NETHERLANDS

Endex 19,5 %

Triclabendazole

Levamisole

120 mg/ml

75 mg/ml

Oral suspension

oral

Cattle

The Netherlands

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinsenlaan 142 |
| 4818 CP Breda |
| THE NETHERLANDS |

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

THE NETHERLANDS

Endex 8,75 %

Triclabendazole

Levamisole

50 mg/ml

37,5 mg/ml

Oral suspension

oral

Sheep

The Netherlands

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinsenlaan 142 |
| 4818 CP Breda |
| THE NETHERLANDS |

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

THE NETHERLANDS

Fasinex 10 %

Triclabendazole

10 g/100 ml

Oral suspension

oral

Cattle

The Netherlands

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinsenlaan 142 |
| 4818 CP Breda |
| THE NETHERLANDS |

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

THE NETHERLANDS

Fasinex 5 %

Triclabendazole

5 g/100 ml

Oral suspension

oral

Sheep

The Netherlands

| Pfizer Animal Health B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

THE NETHERLANDS

Cydectin Triclamox 1 mg/ml + 50 mg/ml orale oplossing voor schapen

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

The Netherlands

| Schippers Europe B.V. |
| --- |
| Rond Deel 12 |
| 5531 AH Bladel |
| THE NETHERLANDS |

Schippers Europe B.V.

Rond Deel 12

5531 AH Bladel

THE NETHERLANDS

Endex

Triclabendazole

Levamisole

50 mg/ml

37,5 mg/ml

Oral suspension

oral

Sheep

The Netherlands

| Virbac de Portugal Laboratorios LDA |
| --- |
| Rua do Centro Empresarial |
| Ed. 13, Quinta da Beloura |
| 2710-693 Sintra |
| PORTUGAL |

Virbac de Portugal Laboratorios LDA

Rua do Centro Empresarial

Ed. 13, Quinta da Beloura

2710-693 Sintra

PORTUGAL

Virbamec F. oplossing voor injectie

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

The Netherlands

| Wirtz Farma B.V. |
| --- |
| Leijsendwarsstraat 26 |
| 4901 PG, Oosterhout |
| THE NETHERLANDS |

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

THE NETHERLANDS

Endex Suspensie

Triclabendazole

Levamisole

50 mg/ml

37,5 mg/ml

Oral suspension

oral

Sheep

The Netherlands

| Wirtz Farma B.V. |
| --- |
| Leijsendwarsstraat 26 |
| 4901 PG, Oosterhout |
| THE NETHERLANDS |

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

THE NETHERLANDS

Fasinex 5 %

Triclabendazole

5 g/100 ml

Oral suspension

oral

Sheep

The Netherlands

| Wirtz Farma B.V. |
| --- |
| Leijsendwarsstraat 26 |
| 4901 PG, Oosterhout |
| THE NETHERLANDS |

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

THE NETHERLANDS

Fasinex 10 %

Triclabendazole

10 g/100 ml

Oral suspension

oral

Cattle

United Kingdom

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Alverin Plus Solution for Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Animec Super Solution for Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Tribex 5 % Oral Suspension for Sheep

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

United Kingdom

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Tribex 10 % Oral Suspension for Cattle

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

United Kingdom

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Triclacert 5 % Oral Suspension for Sheep

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

United Kingdom

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| UNITED KINGDOM |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

UNITED KINGDOM

Triclacert 10 % Oral Suspension for Cattle

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

United Kingdom

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Bimectin Plus Solution for Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Cross Vet Pharm Group Ltd |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| IRELAND |

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRELAND

Endofluke 100 mg/ml Oral Suspension

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle, Sheep

United Kingdom

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| UNITED KINGDOM |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UNITED KINGDOM

Flukiver 5 % w/v Oral Suspension

Closantel

50 mg/ml

Oral suspension

oral

Sheep

United Kingdom

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| UNITED KINGDOM |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UNITED KINGDOM

Flukiver Bovis 50 mg/ml Solution for Injection

Closantel

50 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| UNITED KINGDOM |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UNITED KINGDOM

Mebadown Super Oral Suspension

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep, Lambs

United Kingdom

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| UNITED KINGDOM |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UNITED KINGDOM

Supaverm Oral Suspension

Closantel

Mebendazole

50 mg/ml

75 mg/ml

Oral suspension

oral

Sheep

United Kingdom

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Sandringham Avenue, Harlow Business Park, Harlow |
| CM19 5TG |
| Essex |
| UNITED KINGDOM |

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

UNITED KINGDOM

Ivomec Super Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Sandringham Avenue, Harlow Business Park, Harlow |
| CM19 5TG |
| Essex |
| UNITED KINGDOM |

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

UNITED KINGDOM

Trodax 34 % w/v Solution for Injection

Nitroxinil

340 mg/ml

Solution for injection

subcutaneous

Cattle, Sheep

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Pour-on Solution for Cattle

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Cattle

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Solution for Injection

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closamectin Solution for Injection for Sheep

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closiver Pour-on Solution for Cattle

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Cattle

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closiver Solution for Injection for Cattle

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closiver Solution for Injection for Sheep

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Sheep

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Closivet Solution for Injection for Cattle

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Norofas Pour-On

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Cattle

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Norofas Solution for Injection

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| UNITED KINGDOM |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

UNITED KINGDOM

Triclafas Drench 5 % w/v Oral Suspension

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

United Kingdom

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Combinex Cattle Oral Suspension

Triclabendazole

Levamisole

120 mg/ml

75 mg/ml

Oral suspension

oral

Cattle

United Kingdom

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Combinex Oral Suspension

Triclabendazole

Levamisole

50 mg/ml

37,5 mg/ml

Oral suspension

oral

Sheep

United Kingdom

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasimec Duo S 0,1 %/5 % Oral Suspension for Sheep

Triclabendazole

Ivermectin

50 mg/ml

1 mg/ml

Oral suspension

oral

Sheep

United Kingdom

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasinex 5 % w/v Oral Suspension

Triclabendazole

50 mg/ml

Oral suspension

oral

Sheep

United Kingdom

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasinex 10 % Oral Suspension for Cattle

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle

United Kingdom

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasinex 100 10 %(w/v) Oral Suspension for Cattle and Sheep

Triclabendazole

100 mg/ml

Oral suspension

oral

Cattle, Sheep

United Kingdom

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UNITED KINGDOM

Fasinex 240, 24 % w/v Oral Suspension for Cattle

Triclabendazole

240 mg/ml

Oral suspension

oral

Cattle

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

Cydectin TriclaMox 1 mg/ml + 50 mg/ml Oral Solution for Sheep

Triclabendazole

Moxidectin

50 mg/ml

1 mg/ml

Oral solution

oral

Sheep

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

Triclabendazole

Moxidectin

200 mg/ml

5 mg/ml

Pour-on

Information not available

Cattle

United Kingdom

| Virbac de Portugal Laboratórios LDA |
| --- |
| Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2 |
| 2080-104 Almeirim |
| PORTUGAL |

Virbac de Portugal Laboratórios LDA

Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2

2080-104 Almeirim

PORTUGAL

Supremadex Solution for Injection

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

United Kingdom

| Virbac Ltd |
| --- |
| Woolpit Business Park |
| Windmill Avenue |
| Woolpit |
| Bury St Edmunds |
| Suffolk IP30 9UP |
| UNITED KINGDOM |

Virbac Ltd

Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk IP30 9UP

UNITED KINGDOM

Virbamec Super Solution for Injection

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Solution for injection

subcutaneous

Cattle

---

ANNEX III

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

| Member State
  EU/EEA | Marketing Authorisation holder | (Invented) name | Strengths | Phramaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Actavis Group PTC ehf. |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Member State

EU/EEA

Marketing Authorisation holder

(Invented) name

Strengths

Phramaceutical form

Route of administration

Austria

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomid Actavis 10 mg Filmtabletten

10 mg

Film-coated tablet

Oral use

Austria

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomid Actavis 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomid Actavis 20 mg Filmtabletten

20 mg

Film-coated tablet

Oral use

Czech Republic

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

LEFLUNOMID ACTAVIS 10 MG

10 mg

Film-coated tablet

Oral use

Czech Republic

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

LEFLUNOMID ACTAVIS 100 MG

100 mg

Film-coated tablet

Oral use

Czech Republic

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

LEFLUNOMID ACTAVIS 20 MG

20 mg

Film-coated tablet

Oral use

The Netherlands

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomide Actavis 10 mg, filmomhulde tabletten

10 mg

Film-coated tablet

Oral use

The Netherlands

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomide Actavis 100 mg, filmomhulde tabletten

100 mg

Film-coated tablet

Oral use

The Netherlands

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomide Actavis 20 mg, filmomhulde tabletten

20 mg

Film-coated tablet

Oral use

---

ANNEX IV

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

| Member State
  EU/EEA | Marketing authorisation holder | (Invented) name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Apotex Europe BV |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Member State

EU/EEA

Marketing authorisation holder

(Invented) name

Strength

Pharmaceutical form

Route of administration

Belgium

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

Leflunomide Apotex

10 mg

Tablet

Oral use

Belgium

| Apotex Europe BV |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

Leflunomide Apotex

20 mg

Tablet

Oral use

Czech Republic

| Apotex Europe BV |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

LEFLUNOMID APOTEX 10 MG

10 mg

Tablet

Oral use

Czech Republic

| Apotex Europe BV |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

LEFLUNOMID APOTEX 20 MG

20 mg

Tablet

Oral use

The Netherlands

| Apotex Europe BV |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| the Netherlands |

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

the Netherlands

Leflunomide Apotex 10 mg, tabletten

10 mg

Tablet

Oral use

The Netherlands

| Apotex Europe BV |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| the Netherlands |

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

the Netherlands

Leflunomide Apotex 20 mg, tabletten

20 mg

Tablet

Oral use

Spain

| Apotex Europe BV |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

LEFLUNOMIDA APOTEX 10 mg comprimidos EFG

10 mg

Tablet

Oral use

Spain

| Apotex Europe BV |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

LEFLUNOMIDA APOTEX 20 mg comprimidos EFG

20 mg

Tablet

Oral use

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