# Euroopa Liidu C 401/2012

| | ISSN 1977-0898
  doi:10.3000/19770898.C_2012.401.est |
| --- | --- |
| Euroopa Liidu
  Teataja | C 401 |
| | |
| Eestikeelne väljaanne | Teave ja teatised | 55. köide28. detsember 2012 |

ISSN 1977-0898

doi:10.3000/19770898.C_2012.401.est

Euroopa Liidu

Teataja

C 401

Eestikeelne väljaanne

Teave ja teatised

55. köide28. detsember 2012

---

| Teatis nr | Sisukord | Lehekülg |
| --- | --- | --- |
| | IV   Teave |
| | TEAVE EUROOPA LIIDU INSTITUTSIOONIDELT, ORGANITELT JA ASUTUSTELT |
| | Euroopa Komisjon |
| 2012/C 401/01 | Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. oktoobrist 2012 kuni 31. oktoobrini 2012(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38) | 1 |
| 2012/C 401/02 | Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. novembrist 2012 kuni 30. novembrini 2012(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38) | 3 |
| 2012/C 401/03 | Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. novembrist 2012 kuni 30. novembrini 2012(Direktiivi 2001/83/EÜ artikli 34 või direktiivi 2001/82/EÜ artikli 38
  kohaselt vastu võetud otsused) | 9 |

Teatis nr

Sisukord

Lehekülg

IV   Teave

TEAVE EUROOPA LIIDU INSTITUTSIOONIDELT, ORGANITELT JA ASUTUSTELT

Euroopa Komisjon

2012/C 401/01

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. oktoobrist 2012 kuni 31. oktoobrini 2012(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38)

(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38)

1

2012/C 401/02

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. novembrist 2012 kuni 30. novembrini 2012(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38)

(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38)

3

2012/C 401/03

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. novembrist 2012 kuni 30. novembrini 2012(Direktiivi 2001/83/EÜ artikli 34 või direktiivi 2001/82/EÜ artikli 38
  kohaselt vastu võetud otsused)

(Direktiivi 2001/83/EÜ artikli 34 või direktiivi 2001/82/EÜ artikli 38

kohaselt vastu võetud otsused)

9

| ET | |
| --- | --- |

ET

---

IV Teave

TEAVE EUROOPA LIIDU INSTITUTSIOONIDELT, ORGANITELT JA ASUTUSTELT

Euroopa Komisjon

| 28.12.2012 | ET | Euroopa Liidu Teataja | C 401/1 |
| --- | --- | --- | --- |

28.12.2012

ET

Euroopa Liidu Teataja

C 401/1

---

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. oktoobrist 2012 kuni 31. oktoobrini 2012

(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38
   (1)
  )

2012/C 401/01

—   Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Heaks kiidetud

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 29.10.2012 | Clopidogrel Teva Generics B.V. | Teva Generics B.V. |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

29.10.2012

Clopidogrel Teva Generics B.V.

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/650/001-015

31.10.2012

29.10.2012

Desloratadine Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/732/001-013

31.10.2012

29.10.2012

Docetaxel Accord

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

Accord Healthcare Limited

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

EU/1/12/769/001-003

31.10.2012

29.10.2012

Docetaxel Kabi

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

Fresenius Kabi Oncology Plc.

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

EU/1/12/770/001-005

31.10.2012

29.10.2012

Esmya

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

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750/001-002

31.10.2012

29.10.2012

Galvus

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

Novartis Europharm Ltd

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

EU/1/07/414/001-010

EU/1/07/414/018

31.10.2012

29.10.2012

Jalra

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

Novartis Europharm Ltd

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

EU/1/08/485/001-011

31.10.2012

29.10.2012

JEVTANA

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

Sanofi-aventis groupe

54, rue de la Boétie, F-75008 France

EU/1/11/676/001

31.10.2012

29.10.2012

Leflunomide medac

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

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3, D-20354 Hamburg - Deutschland

EU/1/10/637/001-009

31.10.2012

29.10.2012

Tarceva

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

Roche Registration Limited

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

EU/1/05/311/001-003

31.10.2012

29.10.2012

Xgeva

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703/001-003

31.10.2012

29.10.2012

Xiliarx

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

Novartis Europharm Ltd

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

EU/1/08/486/001-011

31.10.2012

29.10.2012

Zoely

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

Theramex S.r.l.

Via Messina 38, 20154 Milano, Italia

EU/1/11/690/001-004

9.11.2012

31.10.2012

Clopidogrel Teva Pharma B.V.

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/649/001-016

6.11.2012

31.10.2012

Ibandronic acid Sandoz

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/11/685/001-005

6.11.2012

31.10.2012

Lamivudine/Zidovudine Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/663/001-002

6.11.2012

31.10.2012

Levetiracetam SUN

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

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/741/001

6.11.2012

31.10.2012

Levetiracetam Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/701/001-032

6.11.2012

31.10.2012

PecFent

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

Archimedes Development Ltd

Nottingham, NGT7 2TN, United Kingdom

EU/1/10/644/001-006

6.11.2012

31.10.2012

Rivastigmine Actavis

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

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland

EU/1/11/693/001-016

6.11.2012

—   Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 38): Heaks kiidetud

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 29.10.2012 | Naxcel | Pfizer Ltd |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

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)  ELT L 136, 30.4.2004, lk 1.

---

| 28.12.2012 | ET | Euroopa Liidu Teataja | C 401/3 |
| --- | --- | --- | --- |

28.12.2012

ET

Euroopa Liidu Teataja

C 401/3

---

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. novembrist 2012 kuni 30. novembrini 2012

(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38
   (1)
  )

2012/C 401/02

—   Müügiloa väljaandmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Heaks kiidetud

| Otsuse tegemise kuupäev | Ravimi nimetus | Rahvusvaheline mittekaubanduslik nimetus (INN) | Müügiloa omanik | Kande number ühenduse registris | Ravimivorm | ATC-kood (anatoomilis-terapeutiline keemiline kood) | Teatamise kuupäev |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.11.2012 | Forxiga | dapaglifosiin | Bristol Myers Squibb/AstraZeneca EEIG |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Otsuse tegemise kuupäev

Ravimi nimetus

Rahvusvaheline mittekaubanduslik nimetus (INN)

Müügiloa omanik

Kande number ühenduse registris

Ravimivorm

ATC-kood (anatoomilis-terapeutiline keemiline kood)

Teatamise kuupäev

12.11.2012

Forxiga

dapaglifosiin

Bristol Myers Squibb/AstraZeneca EEIG

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

EU/1/12/795

Õhukese polümeerikattega tablett

A10BX09

14.11.2012

15.11.2012

Picato

ingenoolmebutaati

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

LEO Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/12/796

Geel

D06BX02

19.11.2012

19.11.2012

Capecitabine medac

Kapetsitabiin

| 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

Õhukese polümeerikattega tablett

L01BC06

23.11.2012

19.11.2012

Ibandronic acid Accord

Ibandroonhape

| 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

Kontsentraat infusioonilahuse valmistamiseks

M05BA06

23.11.2012

19.11.2012

Zoledronic acid Hospira

zoledroonhapet

| 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

Infusioonilahus

Kontsentraat infusioonilahuse valmistamiseks

M05BA

23.11.2012

22.11.2012

Eylea

Aflibertsept

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

Bayer Pharma AG

D - 13342 Berlin, Deutschland

EU/1/12/797

Süstelahus

S01LA05

26.11.2012

22.11.2012

Memantine Merz

Memantiin

| 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

Õhukese polümeerikattega tablett

Peroraalne lahus

N06DX01

26.11.2012

26.11.2012

Constella

linaklotiid

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

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/12/801

Kõvakapsel

Pending

28.11.2012

—   Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Heaks kiidetud

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 8.11.2012 | Enyglid | KRKA, d. d., Novo mesto |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

8.11.2012

Enyglid

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/580

12.11.2012

8.11.2012

Rivastigmine 1 A Pharma

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

1 A Pharma GmbH

Keltenring 1 + 3, Oberhaching 82041, Deutschland

EU/1/09/585

12.11.2012

12.11.2012

Ivemend

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

Merck Sharp & Dohme Limited

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

EU/1/07/437

14.11.2012

12.11.2012

Olanzapine Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/427

14.11.2012

15.11.2012

Naglazyme

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

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/05/324

19.11.2012

15.11.2012

Prolia

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

19.11.2012

15.11.2012

Retacrit

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

Hospira UK Limited

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

EU/1/07/431

19.11.2012

15.11.2012

Sutent

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

Pfizer Ltd

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

EU/1/06/347

19.11.2012

15.11.2012

Xaluprine

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

Nova Laboratories Limited

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

EU/1/11/727

19.11.2012

15.11.2012

Xarelto

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

Bayer Pharma AG

13342 Berlin, Deutschland

EU/1/08/472

19.11.2012

19.11.2012

Abilify

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

Otsuka Pharmaceutical Europe Ltd

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

EU/1/04/276

22.11.2012

19.11.2012

Actraphane

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

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/02/229

22.11.2012

19.11.2012

Actrapid

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/230

22.11.2012

19.11.2012

Apidra

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/04/285

23.11.2012

19.11.2012

Champix

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

Pfizer Ltd

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

EU/1/06/360

22.11.2012

19.11.2012

Eliquis

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

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

23.11.2012

19.11.2012

Incivo

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

22.11.2012

19.11.2012

Insulatard

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233

22.11.2012

19.11.2012

Ketek

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

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92160 Antony, France

EU/1/01/191

22.11.2012

19.11.2012

Lumigan

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

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/02/205

23.11.2012

19.11.2012

Mirapexin

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

Boehringer Ingelheim International GmbH

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

EU/1/97/051

23.11.2012

19.11.2012

Mixtard

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/231

22.11.2012

19.11.2012

Mycophenolate mofetil Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/439

22.11.2012

19.11.2012

Myfenax

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/438

22.11.2012

19.11.2012

Protaphane

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234

22.11.2012

19.11.2012

Revlimid

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

Celgene Europe Limited

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

EU/1/07/391

22.11.2012

19.11.2012

Sifrol

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

Boehringer Ingelheim International GmbH

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

EU/1/97/050

22.11.2012

19.11.2012

Simponi

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

Janssen Biologics B.V.

Einsteinweg 101, CB Leiden 2333, Nederland

EU/1/09/546

23.11.2012

19.11.2012

Sprycel

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

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363

22.11.2012

19.11.2012

Tysabri

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

Elan Pharma International Ltd.

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

EU/1/06/346

23.11.2012

22.11.2012

Diacomit

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

Biocodex

7 avenue Gallieni, 94250 Gentilly, France

EU/1/06/367

26.11.2012

22.11.2012

GILENYA

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

Novartis Europharm Ltd

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

EU/1/11/677

26.11.2012

22.11.2012

Humira

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

AbbVie Ltd.

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256

26.11.2012

22.11.2012

Olanzapine Apotex

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

Apotex Europe B.V.

Darwinweg 20, 2333 CR Leiden, Nederland

EU/1/10/635

26.11.2012

22.11.2012

Prevenar 13

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

Pfizer Limited

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

EU/1/09/590

27.11.2012

22.11.2012

Rasilez

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

Novartis Europharm Ltd

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

EU/1/07/405

26.11.2012

22.11.2012

Rasilez HCT

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

Novartis Europharm Ltd

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

EU/1/08/491

26.11.2012

22.11.2012

Rasitrio

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

Novartis Europharm Limited

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

EU/1/11/730

26.11.2012

22.11.2012

Remicade

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

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116

27.11.2012

22.11.2012

Riprazo

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

Novartis Europharm Ltd

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

EU/1/07/409

26.11.2012

22.11.2012

Rivastigmine HEXAL

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

HEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/09/589

27.11.2012

22.11.2012

RoActemra

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

Roche Registration Limited

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

EU/1/08/492

27.11.2012

22.11.2012

Thyrogen

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/122

27.11.2012

22.11.2012

Tracleer

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

Actelion Registration Ltd

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

EU/1/02/220

27.11.2012

22.11.2012

Vimpat

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

UCB Pharma SA.

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

EU/1/08/470

27.11.2012

22.11.2012

Viread

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

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200

27.11.2012

26.11.2012

Temodal

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

Merck Sharp & Dohme Limited

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

EU/1/98/096

28.11.2012

30.11.2012

Gardasil

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/357

30.11.2012

30.11.2012

Olazax

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

Glenmark Pharmaceuticals s.r.o.

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

EU/1/09/597

4.12.2012

30.11.2012

Silgard

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

Merck Sharp & Dohme Ltd

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

EU/1/06/358

4.12.2012

30.11.2012

Tygacil

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

Pfizer Limited

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

EU/1/06/336

4.12.2012

30.11.2012

Zevalin

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

Spectrum Pharmaceuticals B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/03/264

4.12.2012

—   Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 38): Heaks kiidetud

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 8.11.2012 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, IRELAND |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

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

Kõnealuseid ravimeid käsitleva avaliku hindamisaruandega ja vastavate otsustega tutvuda soovijatel palutakse pöörduda:

| 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)  ELT L 136, 30.4.2004, lk 1.

---

| 28.12.2012 | ET | Euroopa Liidu Teataja | C 401/9 |
| --- | --- | --- | --- |

28.12.2012

ET

Euroopa Liidu Teataja

C 401/9

---

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. novembrist 2012 kuni 30. novembrini 2012

(Direktiivi 2001/83/EÜ artikli 34
   (1)
  või direktiivi 2001/82/EÜ artikli 38
   (2)
  kohaselt vastu võetud otsused
  )

2012/C 401/03

—   Riikliku müügiloa väljaandmine, säilitamine või muutmine

| Otsuse tegemise kuupäev | Ravimi nimetus(ed) | Müügiloa omanik(ud) | Asjaomane liikmesriik | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 19.11.2012 | Glimepirida Parke-Davis and associated names | Vt lisa I | Vt lisa I | 21.11.2012 |
| 19.11.2012 | Flukicides - Art 35 (amend) | Vt lisa II | Vt lisa II | 23.11.2012 |

Otsuse tegemise kuupäev

Ravimi nimetus(ed)

Müügiloa omanik(ud)

Asjaomane liikmesriik

Teatamise kuupäev

19.11.2012

Glimepirida Parke-Davis and associated names

Vt lisa I

Vt lisa I

21.11.2012

19.11.2012

Flukicides - Art 35 (amend)

Vt lisa II

Vt lisa II

23.11.2012

—   Riikliku müügiloa peatamine

| Otsuse tegemise kuupäev | Ravimi nimetus(ed) | Müügiloa omanik(ud) | Asjaomane liikmesriik | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 30.11.2012 | Leflunomide actavis Art 31 Suspension | Vt lisa III | Vt lisa III | 4.12.2012 |
| 30.11.2012 | Leflunomide Apotex Art 31 suspension | Vt lisa IV | Vt lisa IV | 4.12.2012 |

Otsuse tegemise kuupäev

Ravimi nimetus(ed)

Müügiloa omanik(ud)

Asjaomane liikmesriik

Teatamise kuupäev

30.11.2012

Leflunomide actavis Art 31 Suspension

Vt lisa III

Vt lisa III

4.12.2012

30.11.2012

Leflunomide Apotex Art 31 suspension

Vt lisa IV

Vt lisa IV

4.12.2012

---

(1)  EÜT L 311, 28.11.2001, lk 67.

(2)  EÜT L 311, 28.11.2001, lk 1.

---

I LISA

RAVIMITE NIMETUSTE, RAVIMVORMI, TUGEVUSTE, MANUSTAMISVIISI, TAOTLEJA LOETELU LIIKMESRIIKIDES

| EL/EMP
  Liikmesriik | Müügiloa hoidja | Nimi | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- |
| Küpros | Parke-Davis Produtos Farmacêuticos Lda |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

EL/EMP

Liikmesriik

Müügiloa hoidja

Nimi

Tugevus

Ravimvorm

Manustamisviis

Küpros

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride Pfizer

2 mg

Tablett

Suukaudne

Küpros

| 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

Tablett

Suukaudne

Küpros

| 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

Tablett

Suukaudne

Prantsusmaa

| 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

Tablett

Suukaudne

Prantsusmaa

| 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

Tablett

Suukaudne

Prantsusmaa

| 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

Tablett

Suukaudne

Saksamaa

| 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

Tablett

Suukaudne

Saksamaa

| 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

Tablett

Suukaudne

Saksamaa

| 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

Tablett

Suukaudne

Itaalia

| 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

Tablett

Suukaudne

Itaalia

| 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

Tablett

Suukaudne

Itaalia

| 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

Tablett

Suukaudne

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

Tablett

Suukaudne

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

Tablett

Suukaudne

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

Tablett

Suukaudne

Rootsi

| 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

Tablett

Suukaudne

Rootsi

| 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

Tablett

Suukaudne

Rootsi

| 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

Tablett

Suukaudne

Ühendkuningriik

| 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

Tablett

Suukaudne

Ühendkuningriik

| 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

Tablett

Suukaudne

Ühendkuningriik

| 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

Tablett

Suukaudne

---

II LISA

VETERINAARRAVIMI NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, LOOMALIIKIDE, MANUSTAMISVIISIDE, TAOTLEJATE JA MÜÜGILUBADE HOIDJATE LOETELU LIIKMESRIIKIDES

| EL/EMP
  liikmesriik | Taotleja/müügiloa hoidja | Nimetus | INN | Tugevus | Ravimvorm | Manustamisviis | Loomaliigid |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Chanelle Animal Health Limited |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| ÜHENDKUNINGRIIK |

EL/EMP

liikmesriik

Taotleja/müügiloa hoidja

Nimetus

INN

Tugevus

Ravimvorm

Manustamisviis

Loomaliigid

Austria

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Tribex 10 % - orale Suspension für Rinder

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Austria

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver 50 mg/ml Ijektionslösung für Rinder

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised

Austria

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

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

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad,

talled

Austria

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Injektionslösung für Schafe

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Austria

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Pour on solution for cattle

Klosanteel/

ivermektiin

Teave puudub

Teave puudub

Teave puudub

Teave puudub

Austria

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Injektionslösung für Rinder

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Austria

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

Novartis Animal Health GmbH

Biochemiestr. 10

A-6250 Kundl

AUSTRIA

Endex 19,5 % - wässrige Suspension für Rinder

Triklabendasool

levamisool

120 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Austria

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

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstrasse 1

A-1210 Wien

AUSTRIA

Cydectin TriclaMox

Triklabendasool/moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Belgia

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Animec Super Solution for Injection for Cattle

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Belgia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IIRIMAA

Triclaben 10 %

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Belgia

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Bimectin Plus 10/100 mg/ml

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Belgia

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver 5 %

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised

Belgia

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

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIA

Dovenix

Nitroksiniil

250 mg/ml

Süstelahus

subkutaanne

Veised, lambad

Belgia

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

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIA

Ivomec F

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Belgia

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Solution for Injection for Cattle

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Belgia

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

MADALMAAD

Endex 19,5

Triklabendasool/

levamisool

12 g/100 ml

7,5 g/100 ml

Suukaudne suspensioon

suukaudne

Veised

Belgia

| 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

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Küpros

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

Vetagrica Ltd

3 Othelou str.

2540 Dali Industrial Estate

P.O. Box 17020

Nicosia

KÜPROS

Ivomec Super injectable solution

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Tšehhi Vabariik

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IIRIMAA

Triclaben 100 mg/ml perorální suspenze pro skot

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Tšehhi Vabariik

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

PRANTSUSMAA

Ivomec Super solution for injection

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Tšehhi Vabariik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin solution for injection for cattle

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Tšehhi Vabariik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin injekční roztok pro ovce

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Tšehhi Vabariik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

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

Klosanteel/

ivermektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Taani

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Bimectin Plus

Klorsuloon/

ivermektiin

10 mg/ml

1 mg/ml

Süstelahus

subkutaanne

Veised

Taani

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

SOOME

Cydectin TriclaMox

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Taani

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Pour-On

Klosanteel/

ivermektiin

20 mg/ml

0,5 mg/ml

Kriipsulahus

Teave puudub

Veised

Taani

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

SOOME

Cydectin TriclaMox

Triklabendasool/

moksidektiin

200 mg/ml

5 mg/ml

Suukaudne lahus

Teave puudub

Veised

Soome

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

SOOME

Cydectin TriclaMox

Triklabendasool

moksidektiin

5 mg/ml

200 mg/ml

Kriipsulahus

kriipsmanustamine

Veised

Prantsusmaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Fascicur 5 %

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Prantsusmaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Fascicur 10 %

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Prantsusmaa

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Cevamec D

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Prantsusmaa

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

PRANTSUSMAA

Flukiver

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised, lambad

Prantsusmaa

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

PRANTSUSMAA

Seponver

Klosanteel

50 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Prantsusmaa

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

PRANTSUSMAA

Supaverm

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Prantsusmaa

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

PRANTSUSMAA

Douvigard

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised, lambad

Prantsusmaa

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

PRANTSUSMAA

DOVENIX

Nitroksiniil

250 mg/ml

Süstelahus

subkutaanne

Veised, lambad

Prantsusmaa

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

PRANTSUSMAA

Ivomec D

Klorsuloon/

ivermektiin

Teave puudub

Süstelahus

subkutaanne

Teave puudub

Prantsusmaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Duotech

Klosanteel/

oksfendasool

50 mg/ml

25 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Prantsusmaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectine Solution Injectable Pour Cattles

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Prantsusmaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectine Solution Injectable Pour Ovines

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Prantsusmaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Vermax D

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Prantsusmaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Norofas Pour on

Klosanteel/

ivermektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Prantsusmaa

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

PRANTSUSMAA

Fascinex 5 %

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad,

kitsed

Prantsusmaa

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

PRANTSUSMAA

Fascinex 10 %

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Prantsusmaa

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

PRANTSUSMAA

Fascinex Premelange

Triklabendasool

200 mg/ml

Eelsegu

suukaudne

Veised

Prantsusmaa

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

PRANTSUSMAA

Parsifal Bovins

Triklabendasool/

levamisool

120 mg/ml

63,5 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Prantsusmaa

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

PRANTSUSMAA

Parsifal Ovins

Triklabendasool/

levamisool

50 mg/ml

32 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Prantsusmaa

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

PRANTSUSMAA

Triclanil 5 %

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Prantsusmaa

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

PRANTSUSMAA

Triclanil 10 %

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Prantsusmaa

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

PRANTSUSMAA

Fascinex 100

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Prantsusmaa

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

PRANTSUSMAA

Fascinex 240

Triklabendasool

240 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Prantsusmaa

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

Pfizer Holding France

23/25 Avenue du Docteur Lannelongue

75014 Paris

PRANTSUSMAA

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

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Prantsusmaa

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

Pfizer Holding France

23/25 Avenue du Docteur Lannelongue

75014 Paris

PRANTSUSMAA

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

Triklabendasool/

moksidektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Prantsusmaa

| 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

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Saksamaa

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

AniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

SAKSAMAA

Endofluke 100 mg/ml orale Suspension

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised,

lambad

Saksamaa

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

AniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

SAKSAMAA

Endofluke

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Saksamaa

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

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

Broomhill Road

TALLAGHT

DUBLIN 24

IIRIMAA

Bimectin Fluke

Klorsuloon/

ivermektiin

10 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Saksamaa

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IIRIMAA

Triclaben 10 %

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Saksamaa

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

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

SAKSAMAA

Flukiver

Klosanteel

50 mg/ml

Suukaudne suspensioon

suukaudne

Veised,

lambad

Saksamaa

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

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

SAKSAMAA

Flukiver Combi

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne lahus

suukaudne

Lambad,

talled

Saksamaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Pour-On

Klosanteel/

ivermektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Saksamaa

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

Novartis Tiergesundheit GmbH

Zielstattstr. 40

D-81379 München

SAKSAMAA

Fasinex 10 %

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised,

lambad

Saksamaa

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

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

SAKSAMAA

Cydectin Triclamox 5 mg/ml

Triklabendasool/

moksidektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Saksamaa

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

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

SAKSAMAA

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

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Kreeka

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver Combi

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad, talled

Kreeka

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

New Vet

15 Fleming Street

Maroussi 15123

KREEKA

Zivet

Klosanteel/

oksfendasool

5 mg/ml

2,5 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Kreeka

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

Pfizer Hellas AE

Mesogeion 243

N.Psichiko 15451

KREEKA

Cydectin TriclaMox

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Kreeka

| Provet |
| --- |
| Aspropyrgos |
| 19300, Attik |
| KREEKA |

Provet

Aspropyrgos

19300, Attik

KREEKA

Rafoxanide/Provet

Rafoksaniid

300 mg/tab

Tabletid

suukaudne

Lambad

Ungari

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver 5 % injekció A.U.V.

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised, lambad

Ungari

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver Combi belsőleges szuszpenzió A.U.V.

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Ungari

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

PRANTSUSMAA

Ivomec Super injekció A.U.V.

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Island

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver Combi vet

Klosanteel

50/75 mg/ml

Suukaudne lahus

suukaudne

Lambad, talled

Iirimaa

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

Biochem Ltd

Pulleen

Kanturk

Co. Cork

IIRIMAA

Levafluke

Rafoksaniid/

levamisool

22,5 mg/ml

15 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

C & H Generics Ltd c/o Michael McEvoy

Seville House

New Dock Street

Galway

IIRIMAA

Chanectin Super

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Iirimaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Chan Broad Spec

Rafoksaniid/

levamisool

22,5 mg/ml

15 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Rafazole Oral Suspension

Rafoksaniid/

levamisool

30 mg/ml

30 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Ridafluke 3 %

Rafoksaniid

30 mg/ml

Suukaudne suspensioon

suukaudne

Veised,

lambad

Iirimaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Animec Super

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Iirimaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Levatum Super

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Iirimaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Tribex 10 % for cattle

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Iirimaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Tribex 5 % for Sheep

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Triclaben 5 % for Sheep

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IIRIMAA

Triclaben 10 % for cattle

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Iirimaa

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Endofluke 10

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Fasifree 10 %

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Bimectin Plus

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Iirimaa

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Mectaject Plus

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Iirimaa

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

Interchem Ireland Ltd

Road M

Unit 12 Tougher Business Park

Newhall

Naas

Co. Kildare

IIRIMAA

Orafluke 10 %

Rafoksaniid/

fenbendasool

100 mg/ml

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Iirimaa

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

Interchem Ireland Ltd

Road M

Unit 12 Tougher Business Park

Newhall

Naas

Co. Kildare

IIRIMAA

Orafluke 5 %

Rafoksaniid/

fenbendasool

50 mg/ml

50 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Intervet Ireland Ltd

Magna Drive

Magne Business Park

Citywest Road

Dublin 24

Iirimaa

Panafluke Oral Suspension

Rafoksaniid/

fenbendasool

45 mg/ml

30 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ÜHENDKUNINGRIIK

Flukiver 5 Injection

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised, lambad

Iirimaa

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ÜHENDKUNINGRIIK

Flukiver Combi Oral Suspension

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ÜHENDKUNINGRIIK

Supaverm Oral Suspension

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ÜHENDKUNINGRIIK

Flukiver Bovis

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised

Iirimaa

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ÜHENDKUNINGRIIK

Flukiver 5 % w/v Oral Suspension

Klosanteel

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

ÜHENDKUNINGRIIK

Ivomec super

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Iirimaa

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

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

ÜHENDKUNINGRIIK

Trodax 34 %

Nitroksiniil

340 mg/ml

Süstelahus

subkutaanne

Veised, lambad

Iirimaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Pour on

Klosanteel/

ivermektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Iirimaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Iirimaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closiver for cattle

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Iirimaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin for sheep

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Iirimaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closiver for sheep

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Iirimaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Combifluke Oral Suspension for Sheep

Klosanteel/

oksfendasool

50 mg/ml

25 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Parafend Plus Oral Suspension for Sheep

Klosanteel/

oksfendasool

50 mg/ml

25 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Duotech Oral Suspension for Sheep

Klosanteel/

oksfendasool

50 mg/ml

25 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Endex 19,5 %

Triklabendasool/

levamisool

120 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Iirimaa

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Endex 8,75 %

Triklabendasool/

levamisool

50 mg/ml

35 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Fasinex 10 %

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Iirimaa

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Fasinex 10 % for Sheep

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Fasinex 5 %

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Iirimaa

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Fasinex 24 %

Triklabendasool

240 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Iirimaa

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Fasinex Super 19,5 %

Triklabendasool/

levamisool

120 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Iirimaa

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

Pfizer Healthcare Ireland

9 Riverwalk

National Digit Park

Citywest Business Campus

Dublin 24

IIRIMAA

Cydectin TriclaMox

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Iirimaa

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

PharVet Ltd

Station Road

Bagenalstown

Co. Carlow

IIRIMAA

Fenafluke 5 %

Rafoksaniid/

fenbendasool

50 mg/ml

50 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

PharVet Ltd

Station Road

Bagenalstown

Co. Carlow

IIRIMAA

Triazole

Rafoksaniid/

levamisool

22,5 mg/ml

15 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Quinn’s Chemist

Bridge Street

Crossmolina

Co. Mayo

IIRIMAA

Fluken worm

Rafoksaniid/

levamisool

22,5 mg/ml

15 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IIRIMAA

Curafluke 10 %

Rafoksaniid/

fenbendasool

100 mg/ml

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Iirimaa

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IIRIMAA

Curafluke 5 %

Rafoksaniid/

fenbendasool

50 mg/ml

50 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IIRIMAA

Flukex 9 %

Rafoksaniid

90 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Iirimaa

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IIRIMAA

Univet Multidose Fluke and Worm

Rafoksaniid/

levamisool

22,5 mg/ml

15 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Iirimaa

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

Virbac S.A.

Virbac 1, 1ère Avenue

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

Carros, Cedex

PRANTSUSMAA

Virbamec super

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Itaalia

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Maximec Plus

Klorsuloon/

ivermektiin

Teave puudub

Süstelahus

Teave puudub

Veised

Itaalia

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

FATRO S.p.A.

Via Emilia 285

40064 Ozzano Emilia (BO)

ITAALIA

Tolomec Plus

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Itaalia

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

Pfizer Italia s.r.l.

Via Isonzo 71

LATINA

ITAALIA

Cydectin TriclaMox

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Itaalia

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

Intervet Production s.r.l.

via Nettunense

km 20,300

Aprilia (LT)

ITAALIA

Ranigel

Rafoksaniid

75 mg/ml

Süstelahus

subkutaanne

Veised

Itaalia

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

Intervet Production s.r.l.

via Nettunense

km 20300

Aprilia (LT)

ITAALIA

Ranigel

Rafoksaniid

30 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Itaalia

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver

Klosanteel

50 mg/ml

Süstelahus

intra-muskulaarne

Veised

Itaalia

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

Janssen-Cilag S.p.A.

Via M. Buonarroti 23

20093 Cologno Monzese (MI)

ITAALIA

Seponver

Klosanteel

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Itaalia

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

Janssen-Cilag S.p.A.

Via M. Buonarroti 23

20093 Cologno Monzese (MI)

ITAALIA

Seponver Plus

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Itaalia

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

Merial Italia S.p.A.

via Vittorio Pisani, 16

20100 Milano

ITAALIA

Ivomec Plus

Klorsuloon/

ivermektiin

100 mg/ml

1 mg/ml

Süstelahus

subkutaanne

Veised

Itaalia

| Norbrook Laboratories |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Põhja-Iirimaa |
| ÜHENDKUNINGRIIK |

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Põhja-Iirimaa

ÜHENDKUNINGRIIK

Duotech

Klosanteel/

oksfendasool

50 mg/ml

25 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Itaalia

| Norbrook Laboratories |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Põhja-Iirimaa |
| ÜHENDKUNINGRIIK |

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Põhja-Iirimaa

ÜHENDKUNINGRIIK

Closamectin

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Itaalia

| Norbrook Laboratories |
| --- |
| Station Works |
| Camlough Road |
| Newry, County Down |
| BT35 6JP |
| Põhja-Iirimaa |
| ÜHENDKUNINGRIIK |

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Põhja-Iirimaa

ÜHENDKUNINGRIIK

Closamectin Pour on

Klosanteel/

ivermektiin

Teave puudub

Teave puudub

Teave puudub

Teave puudub

Itaalia

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

Pfizer Italia s.r.l.

Via Isonzo 71

LATINA

ITAALIA

Cydectin Triclamox Pour on

Triklabendasool/

moksidektiin

Teave puudub

Kriipsulahus

kriips-manustamine

Veised

Itaalia

| 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

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Läti

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

PRANTSUSMAA

Ivomec Super solution for injection

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Leedu

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

PRANTSUSMAA

Ivomec Super solution for injection

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Luksemburg

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

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIA

Ivomec F

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Luksemburg

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

Pfizer Animal Health S.A.

rue Laid Burniat 1

1348 Luvain-la-Neuve

BELGIA

Cydectin TriclaMox

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Norra

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Duotech vet

Klosanteel/

oksfendasool

50 mg/ml

25 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

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

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised, lambad

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

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

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

Klosanteel

50 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

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

Nitroksiniil

250 mg/ml

Süstelahus

subkutaanne

Veised, lambad

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

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Portugal

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Duotech Suspensão

Klosanteel/

oksfendasool

50 mg/ml

25 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Portugal

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin FF, solução injectável para bovinos

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

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

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Rumeenia

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

Bomac Laboratories Limited

Cnr Wiri Station Road & Hobill Ave

P.O Box 76-369

Manukau City

Auckland

UUS-MEREMAA

Clos-Atak

Klosanteel

50 mg/ml

Süstelahus

Intra-muskulaarne/subkutaanne

Veised, lambad

Rumeenia

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

MADALMAAD

Ranigel

Rafoksaniid

30 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Rumeenia

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

MADALMAAD

Fluxacur

Triklabendasool/

abamektiiin

Teave puudub

Suukaudne suspensioon

suukaudne

Veised,

lambad

Rumeenia

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver 5 %

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised

Rumeenia

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver Combi

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Rumeenia

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

Kepro B.V.

Maagdenburgstraat 38

7421 ZE Deventer

MADALMAAD

Kepromec Super

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Rumeenia

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

PRANTSUSMAA

IVOMEC PLUS

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Rumeenia

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

PRANTSUSMAA

DOVENIX

Nitroksiniil

25 g/100 ml

Süstelahus

süstelahus

Veised, lambad, kitsed

Rumeenia

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

Pasteur - Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

RUMEENIA

Evomec Plus

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Rumeenia

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

Pasteur - Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

RUMEENIA

Helmizol Plus

Klorsuloon

120 mg/bolus

Boolus

suukaudne

Veised

Rumeenia

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

S.C. Romvac Company s.a.

Șos. Centurii, nr. 7

Voluntari

RUMEENIA

Fasciocid

Triklabendasool

100 mg/ml

Suukaudne lahus

suukaudne

Veised, lambad

Rumeenia

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

S.C. Romvac Company s.a.

Șos. Centurii, nr. 7

Voluntari

RUMEENIA

Romavermectina B1 1 % Plus

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Rumeenia

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

Vanelli S.R.L.

Iași-Tg. Frumos, km. 10

Iași

RUMEENIA

Ascacid Forte

Rafoksaniid/

albendasool

25 mg/ml

28 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Rumeenia

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

VIM Spectrum S.R.L.

Sos. Sighisoarei nr. 409

Tg. Mures

RUMEENIA

Distol

Triklabendasool

ivermektiin

500 mg/tablet

10 mg/tablet

Tabletid

suukaudne

Lambad, kitsed

Slovakkia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IIRIMAA

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

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Slovakkia

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

PRANTSUSMAA

Ivomec Super inj. ad us.vet.

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Slovakkia

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin inj. ad us.vet.

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Slovakkia

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin injekčný roztok pre ovce

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Slovakkia

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

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

Klosanteel/

ivermektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Sloveenia

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

KRKA tovarna zdravil, d.d.

Šmarješka cesta 6

8501 Novo Mesto

SLOVEENIA

Fascoverm

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised, lambad

Sloveenia

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

KRKA tovarna zdravil, d.d.

Šmarješka cesta 6

8501 Novo Mesto

SLOVEENIA

FASCOVERM PLUS

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Hispaania

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

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

Seville House

New Dock Street

Galway

IIRIMAA

Chanectin

Ivermektiin/

klorsuloon

Teave puudub

Teave puudub

Teave puudub

Veised

Hispaania

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Tribex 10 % Suspension Oral Para Bovino

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Hispaania

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Animec Plus Solución inyectable para bovino

Klorsuloon/

ivermektiin

Teave puudub

Teave puudub

Teave puudub

Teave puudub

Hispaania

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Tribex 5 % Solución Oral Para Ovino

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Hispaania

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IIRIMAA

Alverin Plus solution for injection for cattle

Klorsuloon/

ivermektiin

Teave puudub

Teave puudub

Teave puudub

Teave puudub

Hispaania

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Bimectin Plus

Klorsuloon/

ivermektiin

Teave puudub

Teave puudub

Teave puudub

Teave puudub

Hispaania

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

Diana S.A.E.

Ctra Barcelona-Ripoll, PK 17

08150 Parets Del Valles, Barcelona

HISPAANIA

Vermifor Ecto

Klosanteel

5 g/100 ml

Süstelahus

Intra-muskulaarne/subkutaanne

Veised, lambad

Hispaania

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

FATRO Iberica, S.L.

C/ Constitución 1, Planta Baja 3

08960 Sant Just Desvern

Barcelona

HISPAANIA

Fugosantel

Klosanteel

5 g/100 ml

Süstelahus

Intra-muskulaarne/subkutaanne

Veised, lambad

Hispaania

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

Industrial Veterinaria, S.A.

Esmeralda, 19

E-08950 Esplugues de Llobregat (Barselona)

HISPAANIA

Rolenol

Klosanteel

50 mg/ml

Süstelahus

Intra-muskulaarne/subkutaanne

Veised, lambad

Hispaania

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

Laboratorios Cenavisa, s.a.

Cami Pedro Estela, S/N

43205 Reus (Tarragona)

HISPAANIA

Telcen

Klosanteel

50 mg/ml

Süstelahus

Intra-muskulaarne/subkutaanne

Veised, lambad

Hispaania

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

Laboratorios Dr. Esteve S.A.

Avda. Mare de Déu de Montserrat 221

08041 Barcelona

HISPAANIA

Flukiver

Klosanteel

5 g/100 ml

Süstelahus

subkutaanne

Veised, lambad

Hispaania

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

Laboratorios Dr. Esteve S.A.

Avda. Mare de Déu de Montserrat 221

08041 Barcelona

HISPAANIA

Seponver Plus

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Hispaania

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

Laboratorios e Industrias IVEN S.A.

C/ Luis I 56

Pol. Ind. De Vallecas

Madrid

HISPAANIA

Endoectiven

Klosanteel

50 mg/ml

Süstelahus

Intra-muskulaarne/subkutaanne

Veised, lambad

Hispaania

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

Laboratorios Hipra S.A.

Avda. La Selva 135

17170 Amer (Gerona)

HISPAANIA

Leclosan

Klosanteel

50 mg/ml

Süstelahus

Intra-muskulaarne/subkutaanne

Veised, lambad

Hispaania

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

Laboratorios Ovejero, S.A.

Ctra León - Vilecha, 30

24192 León

HISPAANIA

Distomicide

Nitroksiniil

25 g/100 ml

Süstelahus

subkutaanne

Veised, lambad

Hispaania

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

Merial Laboratorios S.A.

C/ Tarragona n.161

Locales D/E

08014 Barcelona

HISPAANIA

Dovenix

Nitroksiniil

25 g/100 ml

Süstelahus

subkutaanne

Veised, lambad

Hispaania

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

Merial Laboratorios S.A.

C/ Tarragona n.161

Locales D/E

08014 Barcelona

HISPAANIA

Ivomec F

Klorsuloon

100 mg/ml

Süstelahus

subkutaanne

Veised

Hispaania

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin pour-on

Klosanteel/

ivermektiin

Teave puudub

Teave puudub

kriips-manustamine

Veised

Hispaania

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Duotech suspensión oral

Klosanteel/

oksfendasool

50 mg/ml

25 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Hispaania

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Solucion Inyectable para Bovino

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Hispaania

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Solucion Inyectable para Ovino

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Hispaania

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

HISPAANIA

Endex 19,5 %

Triklabendasool

12 g/100 ml

Suukaudne suspensioon

suukaudne

Veised

Hispaania

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

HISPAANIA

Fasinex 10 % Bovino

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Hispaania

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

HISPAANIA

Fasinex 5 % Ovino

Triklabendasool

5 g/100 ml

Suukaudne suspensioon

suukaudne

Lambad

Hispaania

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

HISPAANIA

Endex 8,57 %

Triklabendasool/

levamisool

5 g/100 ml

3,75 g/100 ml

Suukaudne suspensioon

suukaudne

Lambad

Hispaania

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

HISPAANIA

Fasinex 10 % Ovino

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Hispaania

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

Pfizer S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja Alcobendas

Madrid

HISPAANIA

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

Triklabendasool/

moksidektiin

Teave puudub

Teave puudub

Teave puudub

Teave puudub

Hispaania

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

Pfizer S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja Alcobendas

Madrid

HISPAANIA

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

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Hispaania

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

S.P. Veterinaria S.A.

Ctra Reus a Vinyols Km.4,1

43330 Riudoms (Tarragona)

HISPAANIA

Endoex Inyectable

Klosanteel

5 g/100 ml

Süstelahus

Intra-muskulaarne/subkutaanne

Veised, lambad

Hispaania

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

S.P. Veterinaria S.A.

Ctra Reus a Vinyols Km.4,1

43330 Riudoms (Tarragona)

HISPAANIA

Endoex Oral

Klosanteel

5 g/100 ml

Suukaudne lahus

suukaudne

Veised, lambad

Hispaania

| 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

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Rootsi

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

SOOME

Moxidektin/

Triklabendazol Fort Dodge

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Madalmaad

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Tribex 5 % orale suspensie voor schapen

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Madalmaad

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Tribex 10 % orale suspensie voor rundvee

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Madalmaad

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver 50 mg/ml, oplossing voor injectie

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised

Madalmaad

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIA

Flukiver combi orale suspensie voor schapen en lammeren

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad, talled

Madalmaad

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

Merial B.V.

Kleermakersstraat 10

1191 JL Velserbroek

MADALMAAD

Ivomec Plus

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

suukaudne

Veised

Madalmaad

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

MADALMAAD

Endex 19,5 %

Triklabendasool/

levamisool

120 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Madalmaad

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

MADALMAAD

Endex 8,75 %

Triklabendasool/

levamisool

50 mg/ml

37,5 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Madalmaad

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

MADALMAAD

Fasinex 10 %

Triklabendasool

10 g/100 ml

Suukaudne suspensioon

suukaudne

Veised

Madalmaad

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

MADALMAAD

Fasinex 5 %

Triklabendasool

5 g/100 ml

Suukaudne suspensioon

suukaudne

Lambad

Madalmaad

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

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

MADALMAAD

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

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Madalmaad

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

Schippers Europe B.V.

Rond Deel 12

5531 AH Bladel

MADALMAAD

Endex

Triklabendasool/

levamisool

50 mg/ml

37,5 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Madalmaad

| 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

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Madalmaad

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

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

MADALMAAD

Endex Suspensie

Triklabendasool/

levamisool

50 mg/ml

37,5 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Madalmaad

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

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

MADALMAAD

Fasinex 5 %

Triklabendasool

5 g/100 ml

Suukaudne suspensioon

suukaudne

Lambad

Madalmaad

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

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

MADALMAAD

Fasinex 10 %

Triklabendasool

10 g/100 ml

Suukaudne suspensioon

suukaudne

Veised

Ühendkuningriik

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Alverin Plus Solution for Injection for Cattle

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Animec Super Solution for Injection for Cattle

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Tribex 5 % Oral Suspension for Sheep

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Ühendkuningriik

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Tribex 10 % Oral Suspension for Cattle

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Ühendkuningriik

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Triclacert 5 % Oral Suspension for Sheep

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Ühendkuningriik

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ÜHENDKUNINGRIIK

Triclacert 10 % Oral Suspension for Cattle

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Ühendkuningriik

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Bimectin Plus Solution for Injection for Cattle

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IIRIMAA

Endofluke 100 mg/ml Oral Suspension

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Ühendkuningriik

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ÜHENDKUNINGRIIK

Flukiver 5 % w/v Oral Suspension

Klosanteel

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Ühendkuningriik

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ÜHENDKUNINGRIIK

Flukiver Bovis 50 mg/ml Solution for Injection

Klosanteel

50 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ÜHENDKUNINGRIIK

Mebadown Super Oral Suspension

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad, talled

Ühendkuningriik

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ÜHENDKUNINGRIIK

Supaverm Oral Suspension

Klosanteel/

mebendasool

50 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Ühendkuningriik

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

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

ÜHENDKUNINGRIIK

Ivomec Super Injection for Cattle

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

ÜHENDKUNINGRIIK

Trodax 34 % w/v Solution for Injection

Nitroksiniil

340 mg/ml

Süstelahus

subkutaanne

Veised, lambad

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Pour-on Solution for Cattle

Klosanteel/

ivermektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Solution for Injection

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closamectin Solution for Injection for Sheep

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closiver Pour-on Solution for Cattle

Klosanteel/

ivermektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closiver Solution for Injection for Cattle

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closiver Solution for Injection for Sheep

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Lambad

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Closivet Solution for Injection for Cattle

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Norofas Pour-On

Klosanteel/

ivermektiin

200 mg/ml

5 mg/ml

Kriipsulahus

kriips-manustamine

Veised

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Norofas Solution for Injection

Klosanteel/

ivermektiin

125 mg/ml

5 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ÜHENDKUNINGRIIK

Triclafas Drench 5 % w/v Oral Suspension

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Ühendkuningriik

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Combinex Cattle Oral Suspension

Triklabendasool/

levamisool

120 mg/ml

75 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Ühendkuningriik

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Combinex Oral Suspension

Triklabendasool/

levamisool

50 mg/ml

37,5 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Ühendkuningriik

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

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

Triklabendasool/

ivermektiin

50 mg/ml

1 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Ühendkuningriik

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Fasinex 5 % w/v Oral Suspension

Triklabendasool

50 mg/ml

Suukaudne suspensioon

suukaudne

Lambad

Ühendkuningriik

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

Fasinex 10 % Oral Suspension for Cattle

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Ühendkuningriik

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

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

Triklabendasool

100 mg/ml

Suukaudne suspensioon

suukaudne

Veised, lambad

Ühendkuningriik

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ÜHENDKUNINGRIIK

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

Triklabendasool

240 mg/ml

Suukaudne suspensioon

suukaudne

Veised

Ühendkuningriik

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| ÜHENDKUNINGRIIK |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

ÜHENDKUNINGRIIK

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

Triklabendasool/

moksidektiin

50 mg/ml

1 mg/ml

Suukaudne lahus

suukaudne

Lambad

Ühendkuningriik

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| ÜHENDKUNINGRIIK |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

ÜHENDKUNINGRIIK

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

Triklabendasool/

moksidektiin

200 mg/ml

5 mg/ml

Kriipsulahus

Teave puudub

Veised

Ühendkuningriik

| 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

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

Ühendkuningriik

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

Virbac Ltd

Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk IP30 9UP

ÜHENDKUNINGRIIK

Virbamec Super Solution for Injection

Klorsuloon/

ivermektiin

100 mg/ml

10 mg/ml

Süstelahus

subkutaanne

Veised

---

III LISA

RAVIMI NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE, MÜÜGILOA HOIDJATE LOETELU LIIKMESRIIKIDES

| EL/EMP
  Liikmesriik | Müügiloa hoidja | Nimi | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- |
| Austria | Actavis Group PTC ehf. |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

EL/EMP

Liikmesriik

Müügiloa hoidja

Nimi

Tugevus

Ravimvorm

Manustamisviis

Austria

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomid Actavis 10 mg Filmtabletten

10 mg

Õhukese polümeerikattega tablett

Suukaudne

Austria

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomid Actavis 100 mg Filmtabletten

100 mg

Õhukese polümeerikattega tablett

Suukaudne

Austria

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomid Actavis 20 mg Filmtabletten

20 mg

Õhukese polümeerikattega tablett

Suukaudne

Tšehhi Vabariik

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

LEFLUNOMID ACTAVIS 10 MG

10 mg

Õhukese polümeerikattega tablett

Suukaudne

Tšehhi Vabariik

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

LEFLUNOMID ACTAVIS 100 MG

100 mg

Õhukese polümeerikattega tablett

Suukaudne

Tšehhi Vabariik

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

LEFLUNOMID ACTAVIS 20 MG

20 mg

Õhukese polümeerikattega tablett

Suukaudne

Holland

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomide Actavis 10 mg, filmomhulde tabletten

10 mg

Õhukese polümeerikattega tablett

Suukaudne

Holland

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomide Actavis 100 mg, filmomhulde tabletten

100 mg

Õhukese polümeerikattega tablett

Suukaudne

Holland

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomide Actavis 20 mg, filmomhulde tabletten

20 mg

Õhukese polümeerikattega tablett

Suukaudne

---

IV LISA

RAVIMI(TE) NIMETUSTE, RAVIMVORMI(DE), TUGEVUS(T)E, MANUSTAMISVIISI(DE), MÜÜGILOA HOIDJA(TE) LOETELU LIIKMESRIIKIDES

| EL/EMP
  Liikmesriik | Müügiloa hoidja | Ravimi väljamõeldud nimetus | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- |
| Belgia | Apotex Europe BV |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

EL/EMP

Liikmesriik

Müügiloa hoidja

Ravimi väljamõeldud nimetus

Tugevus

Ravimvorm

Manustamisviis

Belgia

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

Leflunomide Apotex

10 mg

Tablett

Suukaudne

Belgia

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

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

Leflunomide Apotex

20 mg

Tablett

Suukaudne

Tśehhi Vabariik

| 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

Tablett

Suukaudne

Tśehhi Vabariik

| 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

Tablett

Suukaudne

Madalmaad

| 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

Tablett

Suukaudne

Madalmaad

| 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

Tablett

Suukaudne

Hispaania

| 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

Tablett

Suukaudne

Hispaania

| 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

Tablett

Suukaudne

---