# Den Europæiske Unions C 401/2012

| | ISSN 1977-0871
  doi:10.3000/19770871.C_2012.401.dan |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 401 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 55. årgang28. december 2012 |

ISSN 1977-0871

doi:10.3000/19770871.C_2012.401.dan

Den Europæiske Unions

Tidende

C 401

Dansk udgave

Meddelelser og oplysninger

55. årgang28. december 2012

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| Informationsnummer | Indhold | Side |
| --- | --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2012/C 401/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. oktober 2012 til 31. oktober 2012(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004) | 1 |
| 2012/C 401/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2012 til 30. november 2012(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004) | 3 |
| 2012/C 401/03 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november til 30. november 2012(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF) | 9 |

Informationsnummer

Indhold

Side

IV   Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

2012/C 401/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. oktober 2012 til 31. oktober 2012(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

1

2012/C 401/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2012 til 30. november 2012(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

3

2012/C 401/03

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november til 30. november 2012(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

9

| DA | |
| --- | --- |

DA

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IV Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

| 28.12.2012 | DA | Den Europæiske Unions Tidende | C 401/1 |
| --- | --- | --- | --- |

28.12.2012

DA

Den Europæiske Unions Tidende

C 401/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. oktober 2012 til 31. oktober 2012

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (1)
  )

2012/C 401/01

—   Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 29.10.2012 | Clopidogrel Teva Generics B.V. | Teva Generics B.V. |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Leflunomid 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

—   Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 29.10.2012 | Naxcel | Pfizer Ltd |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

---

(1)  EUT L 136 af 30.4.2004, s. 1.

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| 28.12.2012 | DA | Den Europæiske Unions Tidende | C 401/3 |
| --- | --- | --- | --- |

28.12.2012

DA

Den Europæiske Unions Tidende

C 401/3

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2012 til 30. november 2012

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (1)
  )

2012/C 401/02

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 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 |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

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

Filmovertrukket tablet

A10BX09

14.11.2012

15.11.2012

Picato

ingenolmebutat

| 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

capecitabin

| 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

Filmovertrukket tablet

L01BC06

23.11.2012

19.11.2012

Ibandronic acid Accord

Ibandronsyre

| 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

Koncentrat till infusionsvaeske, opløsning

M05BA06

23.11.2012

19.11.2012

Zoledronic acid Hospira

zoledronsyre

| 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

Infussionsvæske, opløsning

Koncentrat till infusionsvaeske, opløsning

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

Injektionsvœske, opløsning

S01LA05

26.11.2012

22.11.2012

Memantine Merz

Memantin

| 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

Filmovertrukket tablet

Oral opløsning

N06DX01

26.11.2012

26.11.2012

Constella

linaclotid

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

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/12/801

Kapsler, hårde

Pending

28.11.2012

—   Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 8.11.2012 | Enyglid | KRKA, d. d., Novo mesto |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Olanzapin 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

—   Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 8.11.2012 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, IRELAND |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de afgørelser, der er truffet vedrørende disse:

| 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)  EUT L 136 af 30.4.2004, s. 1.

---

| 28.12.2012 | DA | Den Europæiske Unions Tidende | C 401/9 |
| --- | --- | --- | --- |

28.12.2012

DA

Den Europæiske Unions Tidende

C 401/9

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november til 30. november 2012

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
   (1)
  eller artikel 38 i direktiv 2001/82/EF
   (2)
  )

2012/C 401/03

—   Udstedelse, videreførsel eller ændring af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 19.11.2012 | Glimepirida Parke-Davis and associated names | Se bilaget I | Se bilaget I | 21.11.2012 |
| 19.11.2012 | Flukicides - Art 35 (amend) | Se bilaget II | Se bilaget II | 23.11.2012 |

Dato for afgørelser

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

19.11.2012

Glimepirida Parke-Davis and associated names

Se bilaget I

Se bilaget I

21.11.2012

19.11.2012

Flukicides - Art 35 (amend)

Se bilaget II

Se bilaget II

23.11.2012

—   Suspension af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 30.11.2012 | Leflunomide actavis Art 31 Suspension | Se bilaget III | Se bilaget III | 4.12.2012 |
| 30.11.2012 | Leflunomide Apotex Art 31 suspension | Se bilaget IV | Se bilaget IV | 4.12.2012 |

Dato for afgørelser

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

30.11.2012

Leflunomide actavis Art 31 Suspension

Se bilaget III

Se bilaget III

4.12.2012

30.11.2012

Leflunomide Apotex Art 31 suspension

Se bilaget IV

Se bilaget IV

4.12.2012

---

(1)  EFT L 311 af 28.11.2001, s. 67.

(2)  EFT L 311 af 28.11.2001, s. 1.

---

BILAG I

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat
  EU/EAA | Ansøger | Navn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Cypern | Parke-Davis Produtos Farmacêuticos Lda |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Medlemsstat

EU/EAA

Ansøger

Navn

Styrke

Lægemiddelform

Indgivelsesvej

Cypern

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride Pfizer

2 mg

Tablet

Oral anvendelse

Cypern

| 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 anvendelse

Cypern

| 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 anvendelse

Frankrig

| 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 anvendelse

Frankrig

| 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 anvendelse

Frankrig

| 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 anvendelse

Tyskland

| 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 anvendelse

Tyskland

| 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 anvendelse

Tyskland

| 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 anvendelse

Italien

| 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 anvendelse

Italien

| 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 anvendelse

Italien

| 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 anvendelse

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 anvendelse

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 anvendelse

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 anvendelse

Sverige

| 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 anvendelse

Sverige

| 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 anvendelse

Sverige

| 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 anvendelse

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 anvendelse

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 anvendelse

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 anvendelse

---

BILAG II

LISTE OVER VETERINÆRLÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, DYREARTER, ADMINISTRATIONSVEJE OG ANSØGERE/INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE

| Medlemsstat
  EU/EØS | Ansøger/indehaver af markedsføringstilladelse | Navn | INN | Styrke | Lægemiddelform | Administrationsvej | Dyreart |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Østrig | Chanelle Animal Health Limited |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Medlemsstat

EU/EØS

Ansøger/indehaver af markedsføringstilladelse

Navn

INN

Styrke

Lægemiddelform

Administrationsvej

Dyreart

Østrig

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Tribex 10 % - orale Suspension für Rinder

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Østrig

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver 50 mg/ml Ijektionslösung für Rinder

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Østrig

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

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

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får,

lam

Østrig

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Injektionslösung für Schafe

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Østrig

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Pour on solution for cattle

Closantel

Ivermectin

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Østrig

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Injektionslösung für Rinder

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Østrig

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

Novartis Animal Health GmbH

Biochemiestr. 10

A-6250 Kundl

ØSTRIG

Endex 19,5 % - wässrige Suspension für Rinder

Triclabendazol

Levamisol

120 mg/ml

75 mg/ml

Oral suspension

oral

Kvæg

Østrig

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

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstrasse 1

A-1210 Wien

ØSTRIG

Cydectin TriclaMox

Triclabendazol Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Belgien

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Animec Super Solution for Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Belgien

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRLAND

Triclaben 10 %

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Belgien

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Bimectin Plus 10/100 mg/ml

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Belgien

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver 5 %

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Belgien

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

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIEN

Dovenix

Nitroxinil

250 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Belgien

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

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIEN

Ivomec F

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Belgien

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Solution for Injection for Cattle

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Belgien

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NEDERLANDENE

Endex 19,5

Triclabendazol

Levamisol

12 g/100 ml

7,5 g/100 ml

Oral suspension

oral

Kvæg

Belgien

| 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

Injektionsvæske, opløsning

subkutan

Kvæg

Cypern

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

Vetagrica Ltd

3 Othelou str.

2540 Dali Industrial Estate

P.O. Box 17020

Nicosia

CYPERN

Ivomec Super injectable solution

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Tjekkiet

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRLAND

Triclaben 100 mg/ml perorální suspenze pro skot

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Tjekkiet

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANKRIG

Ivomec Super solution for injection

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Tjekkiet

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin solution for injection for cattle

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Tjekkiet

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin injekční roztok pro ovce

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Tjekkiet

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

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

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on-anvendelse

Kvæg

Danmark

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Bimectin Plus

Clorsulon

Ivermectin

10 mg/ml

1 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Danmark

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINLAND

Cydectin TriclaMox

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Danmark

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Pour-On

Closantel

Ivermectin

20 mg/ml

0,5 mg/ml

Pour-on

Ingen oplysninger foreligger

Kvæg

Danmark

| 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 opløsning

Ingen oplysninger foreligger

Kvæg

Finland

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINLAND

Cydectin Triclamox

Triclabendazol

Moxidectin

5 mg/ml

200 mg/ml

Pour-on

pour-on

Kvæg

Frankrig

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Fascicur 5 %

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Frankrig

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Fascicur 10 %

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Frankrig

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Cevamec D

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Frankrig

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANKRIG

Flukiver

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Frankrig

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANKRIG

Seponver

Closantel

50 mg/ml

Oral suspension

oral

Kvæg, får

Frankrig

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANKRIG

Supaverm

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får

Frankrig

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANKRIG

Douvigard

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Frankrig

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANKRIG

DOVENIX

Nitroxinil

250 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Frankrig

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANKRIG

Ivomec D

Clorsulon

Ivermectin

Ingen oplysninger foreligger

Injektionsvæske, opløsning

subkutan

Ingen oplysninger foreligger

Frankrig

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Duotech

Closantel

Oxfendazol

50 mg/ml

25 mg/ml

Oral suspension

oral

Får

Frankrig

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectine Solution Injectable Pour Cattles

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Frankrig

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectine Solution Injectable Pour Ovines

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Frankrig

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Vermax D

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Frankrig

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Norofas Pour on

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Kvæg

Frankrig

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANKRIG

Fascinex 5 %

Triclabendazol

50 mg/ml

Oral suspension

oral

Får,

Geder

Frankrig

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANKRIG

Fascinex 10 %

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Frankrig

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANKRIG

Fascinex Premelange

Triclabendazol

200 mg/ml

Premix

oral

Kvæg

Frankrig

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANKRIG

Parsifal Bovins

Triclabendazol

Levamisol

120 mg/ml

63,5 mg/ml

Oral suspension

oral

Kvæg

Frankrig

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANKRIG

Parsifal Ovins

Triclabendazol

Levamisol

50 mg/ml

32 mg/ml

Oral suspension

oral

Får

Frankrig

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANKRIG

Triclanil 5 %

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Frankrig

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANKRIG

Triclanil 10 %

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Frankrig

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANKRIG

Fascinex 100

Triclabendazol

100 mg/ml

Oral suspension

oral

Får

Frankrig

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANKRIG

Fascinex 240

Triclabendazol

240 mg/ml

Oral suspension

oral

Kvæg

Frankrig

| Pfizer Holding Frankrig |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANKRIG |

Pfizer Holding Frankrig

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANKRIG

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

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Frankrig

| Pfizer Holding Frankrig |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANKRIG |

Pfizer Holding Frankrig

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANKRIG

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

Triclabendazol

Moxidectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Kvæg

Frankrig

| 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

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Tyskland

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

AniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

TYSKLAND

Endofluke 100 mg/ml orale Suspension

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg,

får

Tyskland

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

AniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

TYSKLAND

Endofluke

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Tyskland

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

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

Broomhill Road

TALLAGHT

DUBLIN 24

IRLAND

Bimectin Fluke

Clorsulon

Ivermectin

10 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Tyskland

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRLAND

Triclaben 10 %

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Tyskland

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

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

TYSKLAND

Flukiver

Closantel

50 mg/ml

Oral suspension

oral

Cattle,

sheep

Tyskland

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

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

TYSKLAND

Flukiver Combi

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral opløsning

oral

Får,

lam

Tyskland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Pour-On

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Kvæg

Tyskland

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

Novartis Tiergesundheit GmbH

Zielstattstr. 40

D-81379 München

TYSKLAND

Fasinex 10 %

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg,

får

Tyskland

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

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

TYSKLAND

Cydectin Triclamox 5 mg/ml

Triclabendazol

Moxidectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Kvæg

Tyskland

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

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

TYSKLAND

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

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Grækenland

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver Combi

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får, lam

Grækenland

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

New Vet

15 Fleming Street

Maroussi 15123

GRÆKENLAND

Zivet

Closantel

Oxfendazol

5 mg/ml

2,5 mg/ml

Oral suspension

oral

Får

Grækenland

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

Pfizer Hellas AE

Mesogeion 243

N.Psichiko 15451

GRÆKENLAND

Cydectin Triclamox

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Grækenland

| Provet |
| --- |
| Aspropyrgos |
| 19300, Attik |
| GRÆKENLAND |

Provet

Aspropyrgos

19300, Attik

GRÆKENLAND

Rafoxanide/Provet

Rafoxanid

300 mg/tab

Tabletter

oral

Får

Ungarn

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver 5 % injekció A.U.V.

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Ungarn

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver Combi belsőleges szuszpenzió A.U.V.

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får

Ungarn

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANKRIG

Ivomec Super injekció A.U.V.

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Island

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver Combi vet

Closantel

50/75 mg/ml

Oral opløsning

oral

Får, lam

Irland

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

Biochem Ltd

Pulleen

Kanturk

Co. Cork

IRLAND

Levafluke

Rafoxanid

Levamisol

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

C & H Generics Ltd c/o Michael McEvoy

Seville House

New Dock Street

Galway

IRLAND

Chanectin Super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Irland

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Chan Broad Spec

Rafoxanid

Levamisol

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Rafazole Oral Suspension

Rafoxanid

Levamisol

30 mg/ml

30 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Ridafluke 3 %

Rafoxanid

30 mg/ml

Oral suspension

oral

Kvæg,

får

Irland

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Animec Super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Irland

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Levatum Super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Irland

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Tribex 10 % for cattle

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Irland

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Tribex 5 % for Sheep

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Irland

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Triclaben 5 % for Sheep

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Irland

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRLAND

Triclaben 10 % for cattle

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Irland

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Endofluke 10

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Fasifree 10 %

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Bimectin Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Irland

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Mectaject Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Irland

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

Interchem Irland Ltd

Road M

Unit 12 Tougher Business Park

Newhall

Naas

Co. Kildare

IRLAND

Orafluke 10 %

Rafoxanid

Fenbendazol

100 mg/ml

100 mg/ml

Oral suspension

oral

Kvæg

Irland

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

Interchem Irland Ltd

Road M

Unit 12 Tougher Business Park

Newhall

Naas

Co. Kildare

IRLAND

Orafluke 5 %

Rafoxanid

Fenbendazol

50 mg/ml

50 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

Intervet Irland Ltd

Magna Drive

Magne Business Park

Citywest Road

Dublin 24

Irland

Panafluke Oral Suspension

Rafoxanid

Fenbendazol

45 mg/ml

30 mg/ml

Oral suspension

oral

Kvæg, får

Irland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| DET FORENEDE KONGERIGE |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

DET FORENEDE KONGERIGE

Flukiver 5 Injection

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Irland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| DET FORENEDE KONGERIGE |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

DET FORENEDE KONGERIGE

Flukiver Combi Oral Suspension

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får

Irland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| DET FORENEDE KONGERIGE |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

DET FORENEDE KONGERIGE

Supaverm Oral Suspension

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får

Irland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| DET FORENEDE KONGERIGE |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

DET FORENEDE KONGERIGE

Flukiver Bovis

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Irland

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| DET FORENEDE KONGERIGE |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

DET FORENEDE KONGERIGE

Flukiver 5 % w/v Oral Suspension

Closantel

50 mg/ml

Oral suspension

oral

Får

Irland

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Sandringham Avenue, Harlow Business Park, Harlow |
| CM19 5TG |
| Essex |
| DET FORENEDE KONGERIGE |

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

DET FORENEDE KONGERIGE

Ivomec super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Irland

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Sandringham Avenue, Harlow Business Park, Harlow |
| CM19 5TG |
| Essex |
| DET FORENEDE KONGERIGE |

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

DET FORENEDE KONGERIGE

Trodax 34 %

Nitroxinil

340 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Irland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Pour on

Closantel

lvermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Kvæg

Irland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin

Closantel

lvermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Irland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closiver for cattle

Closantel

lvermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Irland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin for sheep

Closantel

lvermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Irland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closiver for sheep

Closantel

lvermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Irland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Combifluke Oral Suspension for Sheep

Closantel

Oxfendazol

50 mg/ml

25 mg/ml

Oral suspension

oral

Får

Irland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Parafend Plus Oral Suspension for Sheep

Closantel

Oxfendazol

50 mg/ml

25 mg/ml

Oral suspension

oral

Får

Irland

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Duotech Oral Suspension for Sheep

Closantel

Oxfendazol

50 mg/ml

25 mg/ml

Oral suspension

oral

Får

Irland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Endex 19,5 %

Triclabendazol

Levamisol

120 mg/ml

75 mg/ml

Oral suspension

oral

Kvæg

Irland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Endex 8,75 %

Triclabendazol

Levamisol

50 mg/ml

35 mg/ml

Oral suspension

oral

Får

Irland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Fasinex 10 %

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Irland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Fasinex 10 % for Sheep

Triclabendazol

100 mg/ml

Oral suspension

oral

Får

Irland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Fasinex 5 %

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Irland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Fasinex 24 %

Triclabendazol

240 mg/ml

Oral suspension

oral

Kvæg

Irland

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Fasinex Super 19,5 %

Triclabendazol

Levamisol

120 mg/ml

75 mg/ml

Oral suspension

oral

Kvæg

Irland

| Pfizer Healthcare Irland |
| --- |
| 9 Riverwalk |
| National Digit Park |
| Citywest Business Campus |
| Dublin 24 |
| IRLAND |

Pfizer Healthcare Irland

9 Riverwalk

National Digit Park

Citywest Business Campus

Dublin 24

IRLAND

Cydectin Triclamox

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral suolution

oral

Får

Irland

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

PharVet Ltd

Station Road

Bagenalstown

Co. Carlow

IRLAND

Fenafluke 5 %

Rafoxanid

Fenbendazol

50 mg/ml

50 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

PharVet Ltd

Station Road

Bagenalstown

Co. Carlow

IRLAND

Triazole

Rafoxanid

Levamisol

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

Quinn’s Chemist

Bridge Street

Crossmolina

Co. Mayo

IRLAND

Fluken worm

Rafoxanid

Levamisol

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRLAND

Curafluke 10 %

Rafoxanid

Fenbendazol

100 mg/ml

100 mg/ml

Oral suspension

oral

Kvæg

Irland

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRLAND

Curafluke 5 %

Rafoxanid

Fenbendazol

50 mg/ml

50 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRLAND

Flukex 9 %

Rafoxanid

90 mg/ml

Oral suspension

oral

Kvæg

Irland

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRLAND

Univet Multidose Fluke and Worm

Rafoxanid

Levamisol

22,5 mg/ml

15 mg/ml

Oral suspension

oral

Kvæg, får

Irland

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

Virbac S.A.

Virbac 1, 1ère Avenue

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

Carros, Cedex

FRANKRIG

Virbamec super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Italien

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Maximec Plus

Clorsulon

Ivermectin

Ingen oplysninger foreligger

Injektionsvæske, opløsning

Ingen oplysninger foreligger

Kvæg

Italien

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

FATRO S.p.A.

Via Emilia 285

40064 Ozzano Emilia (BO)

ITALIEN

Tolomec Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Italien

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

Pfizer Italia s.r.l.

Via Isonzo 71

LATINA

ITALIEN

Cydectin Triclamox

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Italien

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

Intervet Production s.r.l.

via Nettunense

km 20,300

Aprilia (LT)

ITALIEN

Ranigel

Rafoxanid

75 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Italien

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

Intervet Production s.r.l.

via Nettunense

km 20300

Aprilia (LT)

ITALIEN

Ranigel

Rafoxanid

30 mg/ml

Oral suspension

oral

Kvæg, får

Italien

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver

Closantel

50 mg/ml

Injektionsvæske, opløsning

intramuskulær

Kvæg

Italien

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

Janssen-Cilag S.p.A.

Via M. Buonarroti 23

20093 Cologno Monzese (MI)

ITALIEN

Seponver

Closantel

50 mg/ml

Oral suspension

oral

Får

Italien

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

Janssen-Cilag S.p.A.

Via M. Buonarroti 23

20093 Cologno Monzese (MI)

ITALIEN

Seponver Plus

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får

Italien

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

Merial Italia S.p.A.

via Vittorio Pisani, 16

20100 Milano

ITALIEN

Ivomec Plus

Clorsulon

Ivermectin

100 mg/ml

1 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Italien

| Norbrook Laboratories |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Duotech

Closantel

Oxfendazol

50 mg/ml

25 mg/ml

Oral suspension

oral

Får

Italien

| Norbrook Laboratories |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Italien

| Norbrook Laboratories |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Pour on

Closantel

Ivermectin

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Italien

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

Pfizer Italia s.r.l.

Via Isonzo 71

LATINA

ITALIEN

Cydectin Triclamox Pour on

Triclabendazol

Moxidectin

Ingen oplysninger foreligger

Pour-on

pour-on

Kvæg

Italien

| 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

Injektionsvæske, opløsning

subkutan

Kvæg

Letland

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANKRIG

Ivomec Super solution for injection

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Litauen

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANKRIG

Ivomec Super solution for injection

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Luxembourg

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

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIEN

Ivomec F

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Luxembourg

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

Pfizer Animal Health S.A.

rue Laid Burniat 1

1348 Luvain-la-Neuve

BELGIEN

Cydectin Triclamox

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Norge

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Duotech vet

Closantel

Oxfendazol

50 mg/ml

25 mg/ml

Oral suspension

oral

Får

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

Injektionsvæske, opløsning

subkutan

Kvæg, får

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

Får

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

Kvæg, får

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

Injektionsvæske, opløsning

subkutan

Kvæg, får

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

Injektionsvæske, opløsning

subkutan

Kvæg

Portugal

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Duotech Suspensão

Closantel

Oxfendazol

50 mg/ml

25 mg/ml

Oral suspension

oral

Får

Portugal

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin FF, solução injectável para bovinos

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

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

Injektionsvæske, opløsning

subkutan

Kvæg

Rumænien

| 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

Injektionsvæske, opløsning

intramuskulær/subkutan

Kvæg, får

Rumænien

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Ranigel

Rafoxanid

30 mg/ml

Oral suspension

oral

Kvæg, får

Rumænien

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Fluxacur

Triclabendazol

Abamectin

Ingen oplysninger foreligger

Oral suspension

oral

Kvæg,

får

Rumænien

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver 5 %

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Rumænien

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver Combi

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får

Rumænien

| Kepro B.V. |
| --- |
| Maagdenburgstraat 38 |
| 7421 ZE Deventer |
| NEDERLANDENE |

Kepro B.V.

Maagdenburgstraat 38

7421 ZE Deventer

NEDERLANDENE

Kepromec Super

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Rumænien

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANKRIG

IVOMEC PLUS

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Rumænien

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANKRIG

DOVENIX

Nitroxinil

25 g/100 ml

Injektionsvæske, opløsning

injectable solution

Kvæg, får, geder

Rumænien

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

Pasteur - Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

RUMÆNIEN

Evomec Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Rumænien

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

Pasteur - Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

RUMÆNIEN

Helmizol Plus

Clorsulon

120 mg/bolus

Bolus

oral

Kvæg

Rumænien

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

S.C. Romvac Company s.a.

Șos. Centurii, nr. 7

Voluntari

RUMÆNIEN

Fasciocid

Triclabendazol

100 mg/ml

Oral opløsning

oral

Kvæg, får

Rumænien

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

S.C. Romvac Company s.a.

Șos. Centurii, nr. 7

Voluntari

RUMÆNIEN

Romavermectina B1 1 % Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Rumænien

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

Vanelli S.R.L.

Iași-Tg. Frumos, km. 10

Iași

RUMÆNIEN

Ascacid Forte

Rafoxanid

Albendazol

25 mg/ml

28mg/ml

Oral suspension

oral

Kvæg, får

Rumænien

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

VIM Spectrum S.R.L.

Sos. Sighisoarei nr. 409

Tg. Mures

RUMÆNIEN

Distol

Triclabendazol

Ivermectin

500 mg/tablet

10 mg/tablet

Tabletter

oral

Får, geder

Slovakiet

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRLAND

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

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Slovakiet

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANKRIG

Ivomec Super inj. ad us.vet.

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Slovakiet

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin inj. ad us.vet.

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Slovakiet

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin injekčný roztok pre ovce

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Slovakiet

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

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

Closantelum

Ivermectinum

200 mg/ml

5 mg/ml

Pour-on

pour-on

Kvæg

Slovenien

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

KRKA tovarna zdravil, d.d.

Šmarješka cesta 6

8501 Novo Mesto

SLOVENIEN

Fascoverm

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Slovenien

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

KRKA tovarna zdravil, d.d.

Šmarješka cesta 6

8501 Novo Mesto

SLOVENIEN

FASCOVERM PLUS

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får

Spanien

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

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

Seville House

New Dock Street

Galway

IRLAND

Chanectin

Ivermectin

Clorsulon

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Kvæg

Spanien

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Tribex 10 % Suspension Oral Para Bovino

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Spanien

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Animec Plus Solución inyectable para bovino

Clorsulon

Ivermectin

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Spanien

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Tribex 5 % Solución Oral Para Ovino

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Spanien

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRLAND

Alverin Plus solution for injection for cattle

Clorsulon

Ivermectin

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Spanien

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Bimectin Plus

Clorsulon

Ivermectin

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Spanien

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

Diana S.A.E.

Ctra Barcelona-Ripoll, PK 17

08150 Parets Del Valles, Barcelona

SPANIEN

Vermifor Ecto

Closantel

5 g/100 ml

Injektionsvæske, opløsning

intramuskulær/subkutan

Kvæg, får

Spanien

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

FATRO Iberica, S.L.

C/ Constitución 1, Planta Baja 3

08960 Sant Just Desvern

Barcelona

SPANIEN

Fugosantel

Closantel

5 g/100 ml

Injektionsvæske, opløsning

intramuskulær/subkutan

Kvæg, får

Spanien

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

Industrial Veterinaria, S.A.

Esmeralda, 19

E-08950 Esplugues de Llobregat (Barselona)

SPANIEN

Rolenol

Closantel

50 mg/ml

Injektionsvæske, opløsning

intramuskulær/subkutan

Kvæg, får

Spanien

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

Laboratorios Cenavisa, s.a.

Cami Pedro Estela, S/N

43205 Reus (Tarragona)

SPANIEN

Telcen

Closantel

50 mg/ml

Injektionsvæske, opløsning

intramuskulær/subkutan

Kvæg, får

Spanien

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

Laboratorios Dr. Esteve S.A.

Avda. Mare de Déu de Montserrat 221

08041 Barcelona

SPANIEN

Flukiver

Closantel

5 g/100 ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Spanien

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

Laboratorios Dr. Esteve S.A.

Avda. Mare de Déu de Montserrat 221

08041 Barcelona

SPANIEN

Seponver Plus

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får

Spanien

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

Laboratorios e Industrias IVEN S.A.

C/ Luis I 56

Pol. Ind. De Vallecas

Madrid

SPANIEN

Endoectiven

Closantel

50 mg/ml

Injektionsvæske, opløsning

intramuskulær/subkutan

Kvæg, får

Spanien

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

Laboratorios Hipra S.A.

Avda. La Selva 135

17170 Amer (Gerona)

SPANIEN

Leclosan

Closantel

50 mg/ml

Injektionsvæske, opløsning

intramuskulær/subkutan

Kvæg, får

Spanien

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

Laboratorios Ovejero, S.A.

Ctra León - Vilecha, 30

24192 León

SPANIEN

Distomicide

Nitroxinil

25 g/100 ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Spanien

| 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

Injektionsvæske, opløsning

subkutan

Kvæg, får

Spanien

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

Merial Laboratorios S.A.

C/ Tarragona n.161

Locales D/E

08014 Barcelona

SPANIEN

Ivomec F

Clorsulon

100 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Spanien

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin pour-on

Closantel

Invermectin

Ingen oplysninger foreligger

Ingen oplysninger foreligger

pour-on

Kvæg

Spanien

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Duotech suspensión oral

Closantel

Oxfendazol

50 mg/ml

25 mg/ml

Oral suspension

oral

Får

Spanien

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Solucion Inyectable para Bovino

Closantel

Invermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Spanien

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Solucion Inyectable para Ovino

Closantel

Invermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Spanien

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPANIEN

Endex 19,5 %

Triclabendazol

12 g/100 ml

Oral suspension

oral

Kvæg

Spanien

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPANIEN

Fasinex 10 % Bovino

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Spanien

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPANIEN

Fasinex 5 % Ovino

Triclabendazol

5 g/100 ml

Oral suspension

oral

Får

Spanien

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPANIEN

Endex 8,57 %

Triclabendazol

Levamisol

5 g/100 ml

3,75 g/100 ml

Oral suspension

oral

Får

Spanien

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

SPANIEN

Fasinex 10 % Ovino

Triclabendazol

100 mg/ml

Oral suspension

oral

Får

Spanien

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

Pfizer S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja Alcobendas

Madrid

SPANIEN

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

Triclabendazol

Moxidectin

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Ingen oplysninger foreligger

Spanien

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

Pfizer S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja Alcobendas

Madrid

SPANIEN

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

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Spanien

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

S.P. Veterinaria S.A.

Ctra Reus a Vinyols Km.4,1

43330 Riudoms (Tarragona)

SPANIEN

Endoex Inyectable

Closantel

5 g/100 ml

Injektionsvæske, opløsning

intramuscular/subcutaneous

Kvæg, får

Spanien

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

S.P. Veterinaria S.A.

Ctra Reus a Vinyols Km.4,1

43330 Riudoms (Tarragona)

SPANIEN

Endoex Oral

Closantel

5 g/100 ml

Oral opløsning

oral

Kvæg, får

Spanien

| 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

Injektionsvæske, opløsning

subkutan

Kvæg

Sverige

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINLAND

Moxidektin/

Triklabendazol Fort Dodge

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Nederlandene

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Tribex 5 % orale suspensie voor schapen

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Nederlandene

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Tribex 10 % orale suspensie voor rundvee

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Nederlandene

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver 50 mg/ml, oplossing voor injectie

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Nederlandene

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIEN

Flukiver combi orale suspensie voor schapen en lammeren

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får, lam

Nederlandene

| Merial B.V. |
| --- |
| Kleermakersstraat 10 |
| 1191 JL Velserbroek |
| NEDERLANDENE |

Merial B.V.

Kleermakersstraat 10

1191 JL Velserbroek

NEDERLANDENE

Ivomec Plus

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

oral

Kvæg

Nederlandene

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NEDERLANDENE

Endex 19,5 %

Triclabendazol

Levamisol

120 mg/ml

75 mg/ml

Oral suspension

oral

Kvæg

Nederlandene

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NEDERLANDENE

Endex 8,75 %

Triclabendazol

Levamisol

50 mg/ml

37,5 mg/ml

Oral suspension

oral

Får

Nederlandene

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NEDERLANDENE

Fasinex 10 %

Triclabendazol

10 g/100 ml

Oral suspension

oral

Kvæg

Nederlandene

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NEDERLANDENE

Fasinex 5 %

Triclabendazol

5 g/100 ml

Oral suspension

oral

Får

Nederlandene

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

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

NEDERLANDENE

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

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Nederlandene

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

Schippers Europe B.V.

Rond Deel 12

5531 AH Bladel

NEDERLANDENE

Endex

Triclabendazol

Levamisol

50 mg/ml

37,5 mg/ml

Oral suspension

oral

Får

Nederlandene

| 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

Injektionsvæske, opløsning

subkutan

Kvæg

Nederlandene

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

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

NEDERLANDENE

Endex Suspensie

Triclabendazol

Levamisol

50 mg/ml

37,5 mg/ml

Oral suspension

oral

Får

Nederlandene

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

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

NEDERLANDENE

Fasinex 5 %

Triclabendazol

5 g/100 ml

Oral suspension

oral

Får

Nederlandene

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

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

NEDERLANDENE

Fasinex 10 %

Triclabendazol

10 g/100 ml

Oral suspension

oral

Kvæg

Det Forenede Kongerige

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Alverin Plus Solution for Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Animec Super Solution for Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Tribex 5 % Oral Suspension for Sheep

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Det Forenede Kongerige

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Tribex 10 % Oral Suspension for Cattle

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Det Forenede Kongerige

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Triclacert 5 % Oral Suspension for Sheep

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Det Forenede Kongerige

| Chanelle Animal Health Limited |
| --- |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| DET FORENEDE KONGERIGE |

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

DET FORENEDE KONGERIGE

Triclacert 10 % Oral Suspension for Cattle

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Det Forenede Kongerige

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Bimectin Plus Solution for Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRLAND

Endofluke 100 mg/ml Oral Suspension

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg, får

Det Forenede Kongerige

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| DET FORENEDE KONGERIGE |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

DET FORENEDE KONGERIGE

Flukiver 5 % w/v Oral Suspension

Closantel

50 mg/ml

Oral suspension

oral

Får

Det Forenede Kongerige

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| DET FORENEDE KONGERIGE |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

DET FORENEDE KONGERIGE

Flukiver Bovis 50 mg/ml Solution for Injection

Closantel

50 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| DET FORENEDE KONGERIGE |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

DET FORENEDE KONGERIGE

Mebadown Super Oral Suspension

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får, lam

Det Forenede Kongerige

| Janssen-Cilag Ltd |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire |
| HP12 4EG |
| DET FORENEDE KONGERIGE |

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

DET FORENEDE KONGERIGE

Supaverm Oral Suspension

Closantel

Mebendazol

50 mg/ml

75 mg/ml

Oral suspension

oral

Får

Det Forenede Kongerige

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Sandringham Avenue, Harlow Business Park, Harlow |
| CM19 5TG |
| Essex |
| DET FORENEDE KONGERIGE |

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

DET FORENEDE KONGERIGE

Ivomec Super Injection for Cattle

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Sandringham Avenue, Harlow Business Park, Harlow |
| CM19 5TG |
| Essex |
| DET FORENEDE KONGERIGE |

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

DET FORENEDE KONGERIGE

Trodax 34 % w/v Solution for Injection

Nitroxinil

340 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg, får

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Pour-on Solution for Cattle

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Kvæg

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Solution for Injection

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closamectin Solution for Injection for Sheep

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closiver Pour-on Solution for Cattle

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Kvæg

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closiver Solution for Injection for Cattle

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closiver Solution for Injection for Sheep

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Får

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Closivet Solution for Injection for Cattle

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Norofas Pour-On

Closantel

Ivermectin

200 mg/ml

5 mg/ml

Pour-on

pour-on

Kvæg

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Norofas Solution for Injection

Closantel

Ivermectin

125 mg/ml

5 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

| Norbrook Laboratories Ltd |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Northern Ireland |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

DET FORENEDE KONGERIGE

Triclafas Drench 5 % w/v Oral Suspension

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Det Forenede Kongerige

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Combinex Cattle Oral Suspension

Triclabendazol

Levamisol

120 mg/ml

75 mg/ml

Oral suspension

oral

Kvæg

Det Forenede Kongerige

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Combinex Oral Suspension

Triclabendazol

Levamisol

50 mg/ml

37,5 mg/ml

Oral suspension

oral

Får

Det Forenede Kongerige

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

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

Triclabendazole

Ivermectin

50 mg/ml

1 mg/ml

Oral suspension

oral

Får

Det Forenede Kongerige

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Fasinex 5 % w/v Oral Suspension

Triclabendazol

50 mg/ml

Oral suspension

oral

Får

Det Forenede Kongerige

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

Fasinex 10 % Oral Suspension for Cattle

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg

Det Forenede Kongerige

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

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

Triclabendazol

100 mg/ml

Oral suspension

oral

Kvæg, får

Det Forenede Kongerige

| Novartis Animal Health United Kingdom Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| DET FORENEDE KONGERIGE |

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

DET FORENEDE KONGERIGE

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

Triclabendazol

240 mg/ml

Oral suspension

oral

Kvæg

Det Forenede Kongerige

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| DET FORENEDE KONGERIGE |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

DET FORENEDE KONGERIGE

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

Triclabendazol

Moxidectin

50 mg/ml

1 mg/ml

Oral opløsning

oral

Får

Det Forenede Kongerige

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| DET FORENEDE KONGERIGE |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

DET FORENEDE KONGERIGE

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

Triclabendazol

Moxidectin

200 mg/ml

5 mg/ml

Pour-on

Ingen oplysninger foreligger

Kvæg

Det Forenede Kongerige

| 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

Injektionsvæske, opløsning

subkutan

Kvæg

Det Forenede Kongerige

| Virbac Ltd |
| --- |
| Woolpit Business Park |
| Windmill Avenue |
| Woolpit |
| Bury St Edmunds |
| Suffolk IP30 9UP |
| DET FORENEDE KONGERIGE |

Virbac Ltd

Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk IP30 9UP

DET FORENEDE KONGERIGE

Virbamec Super Solution for Injection

Clorsulon

Ivermectin

100 mg/ml

10 mg/ml

Injektionsvæske, opløsning

subkutan

Kvæg

---

BILAG III

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE

| Medlemsstat
  EU/EAA | Indehaver af markedsføringstilladelsen | Navn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Actavis Group PTC ehf. |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Island |

Medlemsstat

EU/EAA

Indehaver af markedsføringstilladelsen

Navn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Island

Leflunomid Actavis 10 mg Filmtabletten

10 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Island

Leflunomid Actavis 100 mg Filmtabletten

100 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Island

Leflunomid Actavis 20 mg Filmtabletten

20 mg

Filmovertrukken tablet

Oral anvendelse

Den Tjekkiske republik

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Island

LEFLUNOMID ACTAVIS 10 MG

10 mg

Filmovertrukken tablet

Oral anvendelse

Den Tjekkiske republik

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Island

LEFLUNOMID ACTAVIS 100 MG

100 mg

Filmovertrukken tablet

Oral anvendelse

Den Tjekkiske republik

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Island

LEFLUNOMID ACTAVIS 20 MG

20 mg

Filmovertrukken tablet

Oral anvendelse

Holland

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Island

Leflunomide Actavis 10 mg, filmomhulde tabletten

10 mg

Filmovertrukken tablet

Oral anvendelse

Holland

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Island

Leflunomide Actavis 100 mg, filmomhulde tabletten

100 mg

Filmovertrukken tablet

Oral anvendelse

Holland

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Island

Leflunomide Actavis 20 mg, filmomhulde tabletten

20 mg

Filmovertrukken tablet

Oral anvendelse

---

BILAG IV

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat
  EU/EAA | Indehaver af markedsføringstilladelse | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Belgien | Apotex Europe BV |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Medlemsstat

EU/EAA

Indehaver af markedsføringstilladelse

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Belgien

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

Leflunomide Apotex

10 mg

Tablet

Oral anvendelse

Belgien

| 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 anvendelse

Tjekkiet

| 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 anvendelse

Tjekkiet

| 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 anvendelse

Nederlandene

| 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 anvendelse

Nederlandene

| 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 anvendelse

Spanien

| 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 anvendelse

Spanien

| 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 anvendelse

---