# Uradni list C 401/2012

| | ISSN 1977-1045
  doi:10.3000/19771045.C_2012.401.slv |
| --- | --- |
| Uradni list
  Evropske unije | C 401 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 5528. december 2012 |

ISSN 1977-1045

doi:10.3000/19771045.C_2012.401.slv

Uradni list

Evropske unije

C 401

Slovenska izdaja

Informacije in objave

Zvezek 5528. december 2012

---

| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska Komisija |
| 2012/C 401/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. oktobra 2012 do 31. oktobra 2012(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |
| 2012/C 401/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2012 do 30. novembra 2012(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 3 |
| 2012/C 401/03 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2012 do 30. novembra 2012(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES) | 9 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska Komisija

2012/C 401/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. oktobra 2012 do 31. oktobra 2012(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

1

2012/C 401/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2012 do 30. novembra 2012(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

3

2012/C 401/03

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2012 do 30. novembra 2012(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES)

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES)

9

| SL | |
| --- | --- |

SL

---

IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska Komisija

| 28.12.2012 | SL | Uradni list Evropske unije | C 401/1 |
| --- | --- | --- | --- |

28.12.2012

SL

Uradni list Evropske unije

C 401/1

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. oktobra 2012 do 31. oktobra 2012

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (1)
  )

2012/C 401/01

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 29.10.2012 | Clopidogrel Teva Generics B.V. | Teva Generics B.V. |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

Desloratadin 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

Docetaksel 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

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

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

—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 29.10.2012 | Naxcel | Pfizer Ltd |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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)  UL L 136, 30.4.2004, str. 1.

---

| 28.12.2012 | SL | Uradni list Evropske unije | C 401/3 |
| --- | --- | --- | --- |

28.12.2012

SL

Uradni list Evropske unije

C 401/3

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2012 do 30. novembra 2012

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (1)
  )

2012/C 401/02

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.11.2012 | Forxiga | dapagliflozin | Bristol Myers Squibb/AstraZeneca EEIG |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

12.11.2012

Forxiga

dapagliflozin

Bristol Myers Squibb/AstraZeneca EEIG

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

EU/1/12/795

Filmsko obložene tablete

A10BX09

14.11.2012

15.11.2012

Picato

ingenol mebutata

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

LEO Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/12/796

Gel

D06BX02

19.11.2012

19.11.2012

Ibandronic acid Accord

ibandronska kislina

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

Accord Healthcare Limited

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

EU/1/12/798

Koncentrat za raztopino za infundiranje

M05BA06

23.11.2012

19.11.2012

Kapecitabin medac

kapecitabin

| 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

Filmsko obložene tablete

L01BC06

23.11.2012

19.11.2012

Zoledronic acid Hospira

zoledronske kisline

| 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

Koncentrat za raztopino za infundiranje

Raztopina za infundiranje

M05BA

23.11.2012

22.11.2012

Eylea

aflibercept

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

Bayer Pharma AG

D - 13342 Berlin, Deutschland

EU/1/12/797

Rztopina za injiciranje

S01LA05

26.11.2012

22.11.2012

Memantine Merz

Memantin

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

Merz Pharmaceuticals GmbH

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

EU/1/12/799

Filmsko obložene tablete

Peroralna raztopina

N06DX01

26.11.2012

26.11.2012

Constella

linaklotid

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

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/12/801

Kapsula, trda

Pending

28.11.2012

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 8.11.2012 | Enyglid | KRKA, d. d., Novo mesto |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 8.11.2012 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, IRELAND |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:

| 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)  UL L 136, 30.4.2004, str. 1.

---

| 28.12.2012 | SL | Uradni list Evropske unije | C 401/9 |
| --- | --- | --- | --- |

28.12.2012

SL

Uradni list Evropske unije

C 401/9

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2012 do 30. novembra 2012

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
   (1)
  ali člena 38 Direktive 2001/82/ES
   (2)
  )

2012/C 401/03

—   Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 19.11.2012 | Glimepirida Parke-Davis and associated names | Glej Prilogo I | Glej Prilogo I | 21.11.2012 |
| 19.11.2012 | Flukicides - Art 35 (amend) | Glej Prilogo II | Glej Prilogo II | 23.11.2012 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

19.11.2012

Glimepirida Parke-Davis and associated names

Glej Prilogo I

Glej Prilogo I

21.11.2012

19.11.2012

Flukicides - Art 35 (amend)

Glej Prilogo II

Glej Prilogo II

23.11.2012

—   Umik nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 30.11.2012 | Leflunomide actavis Art 31 Suspension | Glej Prilogo III | Glej Prilogo III | 4.12.2012 |
| 30.11.2012 | Leflunomide Apotex Art 31 suspension | Glej Prilogo IV | Glej Prilogo IV | 4.12.2012 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

30.11.2012

Leflunomide actavis Art 31 Suspension

Glej Prilogo III

Glej Prilogo III

4.12.2012

30.11.2012

Leflunomide Apotex Art 31 suspension

Glej Prilogo IV

Glej Prilogo IV

4.12.2012

---

(1)  UL L 311, 28.11.2001, str. 67.

(2)  UL L 311, 28.11.2001, str. 1.

---

PRILOGA I

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJ V DRŽAVAH ČLANICAH

| Država članica
  EU/EGP | Predlagatelj | Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Ciper | Parke-Davis Produtos Farmacêuticos Lda |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Država članica

EU/EGP

Predlagatelj

Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Ciper

Parke-Davis Produtos Farmacêuticos Lda

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Glimepiride Pfizer

2 mg

tableta

peroralna uporaba

Ciper

| 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

tableta

peroralna uporaba

Ciper

| 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

tableta

peroralna uporaba

Francija

| 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

tableta

peroralna uporaba

Francija

| 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

tableta

peroralna uporaba

Francija

| 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

tableta

peroralna uporaba

Nemčija

| 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 Tabletaten

2 mg

tableta

peroralna uporaba

Nemčija

| 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 Tabletaten

3 mg

tableta

peroralna uporaba

Nemčija

| 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 Tabletaten

4 mg

tableta

peroralna uporaba

Italija

| 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

tableta

peroralna uporaba

Italija

| 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

tableta

peroralna uporaba

Italija

| 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

tableta

peroralna uporaba

Portugalska

| 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

tableta

peroralna uporaba

Portugalska

| 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

tableta

peroralna uporaba

Portugalska

| 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

tableta

peroralna uporaba

Švedska

| 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

tableta

peroralna uporaba

Švedska

| 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

tableta

peroralna uporaba

Švedska

| 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

tableta

peroralna uporaba

Velika Britanija

| 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 tabletas, 2 mg

2 mg

tableta

peroralna uporaba

Velika Britanija

| 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 tabletas, 3 mg

3 mg

tableta

peroralna uporaba

Velika Britanija

| 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 tabletas, 4 mg

4 mg

tableta

peroralna uporaba

---

PRILOGA II

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE ZDRAVILA IN PREDLAGATELJEV/IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica
  EU/EGP | Predlagatelj/Imetnik dovoljenja za promet z zdravilom | Ime | INN | Jakost | Farmacevtska oblika | Pot uporabe | Živalska vrsta |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Chanelle Animal Health Limited |
| 7 Rodney Street |
| Liverpoool |
| L1 9HZ |
| ZDRUŽENO KRALJESTVO |

Država članica

EU/EGP

Predlagatelj/Imetnik dovoljenja za promet z zdravilom

Ime

INN

Jakost

Farmacevtska oblika

Pot uporabe

Živalska vrsta

Avstrija

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Tribex 10 % - orale Suspension für Rinder

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Avstrija

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver 50 mg/ml Ijektionslösung für Rinder

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo

Avstrija

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

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

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce,

jagnjeta

Avstrija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Injektionslösung für Schafe

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Avstrija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Pour on solution for cattle

klozantel

ivermektin

Information not available

podatek ni na voljo

podatek ni na voljo

podatek ni na voljo

Avstrija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Injektionslösung für Rinder

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Avstrija

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

Novartis Animal Health GmbH

Biochemiestr. 10

A-6250 Kundl

AVSTRIJA

Endex 19,5 % - wässrige Suspension für Rinder

triklabendazol

levamizol

120 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

govedo

Avstrija

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

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstrasse 1

A-1210 Wien

AVSTRIJA

Cydectin TriclaMox

triklabendazol moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Belgija

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Animec Super Solution for Injection for Cattle

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Belgija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRSKA

Triclaben 10 %

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Belgija

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Bimectin Plus 10/100 mg/ml

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Belgija

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver 5 %

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo

Belgija

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

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIJA

Dovenix

nitroksinil

250 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Belgija

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

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIJA

Ivomec F

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Belgija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Solution for Injection for Cattle

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Belgija

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NIZOZEMSKA

Endex 19,5

triklabendazol

levamizol

12 g/100 ml

7,5 g/100 ml

peroralna suspenzija

peroralna

govedo

Belgija

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

Virbac de Portugal Laboratórios LDA

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

2080-104 Almeirim

PORTUGALSKA

Virbamec F

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Ciper

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

Vetagrica Ltd

3 Othelou str.

2540 Dali Industrial Estate

P.O. Box 17020

Nicosia

CIPER

Ivomec Super injectable solution

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Češka republika

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRSKA

Triclaben 100 mg/ml perorální suspenze pro skot

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Češka republika

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCIJA

Ivomec Super solution for injection

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Češka republika

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin solution for injection for cattle

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Češka republika

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin injekční roztok pro ovce

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Češka republika

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

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

klozantel

ivermektin

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Danska

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Bimectin Plus

klorsulon

ivermektin

10 mg/ml

1 mg/ml

raztopina za injiciranje

subkutana

govedo

Danska

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINSKA

Cydectin TriclaMox

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Danska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Pour-On

klozantel

ivermektin

20 mg/ml

0,5 mg/ml

kožni poliv

podatek ni na voljo

govedo

Danska

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINSKA

Cydectin TriclaMox

triklabendazol

moksidektin

200 mg/ml

5 mg/ml

peroralna raztopina

podatek ni na voljo

govedo

Finska

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINSKA

Cydectin Triclamox

triklabendazol

moksidektin

5 mg/ml

200 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Francija

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Fascicur 5 %

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Francija

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Fascicur 10 %

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Francija

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Cevamec D

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Francija

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANCIJA

Flukiver

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Francija

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANCIJA

Seponver

klozantel

50 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Francija

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANCIJA

Supaverm

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Francija

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

Janssen-Cilag

1 Rue Camille Desmoulins

TSA 91003

92787 Issy Les Moulineaux

Cedex 9

FRANCIJA

Douvigard

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Francija

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCIJA

DOVENIX

nitroksinil

250 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Francija

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCIJA

Ivomec D

klorsulon

ivermektin

Information not available

raztopina za injiciranje

subkutana

podatek ni na voljo

Francija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Duotech

klozantel

oksfendazol

50 mg/ml

25 mg/ml

peroralna suspenzija

peroralna

ovce

Francija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectine Solution Injectable Pour Cattles

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Francija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectine Solution Injectable Pour Ovines

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Francija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Vermax D

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Francija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Norofas Pour on

klozantel

ivermektin

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Francija

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCIJA

Fascinex 5 %

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce,

koze

Francija

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCIJA

Fascinex 10 %

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Francija

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCIJA

Fascinex Premelange

triklabendazol

200 mg/ml

zdravilna predmešanica

peroralna

govedo

Francija

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCIJA

Parsifal Bovins

triklabendazol

levamizol

120 mg/ml

63,5 mg/ml

peroralna suspenzija

peroralna

govedo

Francija

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCIJA

Parsifal Ovins

triklabendazol

levamizol

50 mg/ml

32 mg/ml

peroralna suspenzija

peroralna

ovce

Francija

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCIJA

Triclanil 5 %

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Francija

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCIJA

Triclanil 10 %

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Francija

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCIJA

Fascinex 100

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

ovce

Francija

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

Novartis Santé Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCIJA

Fascinex 240

triklabendazol

240 mg/ml

peroralna suspenzija

peroralna

govedo

Francija

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

Pfizer Holding France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCIJA

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

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Francija

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

Pfizer Holding France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCIJA

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

triklabendazol

moksidektin

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Francija

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

Virbac de Portugal Laboratorios LDA

Rua do Centro Empresarial

Ed. 13, Quinta da Beloura

2710-693 Sintra

PORTUGALSKA

Virbamec D Solution Injectable

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Nemčija

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

AniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

NEMČIJA

Endofluke 100 mg/ml orale Suspension

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo,

ovce

Nemčija

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

AniMedica GmbH

Im Südfeld 9

D-48308 Senden-Bösensell

NEMČIJA

Endofluke

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Nemčija

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

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

Broomhill Road

TALLAGHT

DUBLIN 24

IRSKA

Bimectin Fluke

klorsulon

ivermektin

10 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Nemčija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRSKA

Triclaben 10 %

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Nemčija

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

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

NEMČIJA

Flukiver

klozantel

50 mg/ml

peroralna suspenzija

peroralna

govedo,

ovce

Nemčija

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

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

NEMČIJA

Flukiver Combi

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna raztopina

peroralna

ovce,

jagnjeta

Nemčija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Pour-On

klozantel

ivermektin

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Nemčija

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

Novartis Tiergesundheit GmbH

Zielstattstr. 40

D-81379 München

NEMČIJA

Fasinex 10 %

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo,

ovce

Nemčija

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

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

NEMČIJA

Cydectin Triclamox 5 mg/ml

triklabendazol

moksidektin

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Nemčija

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

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

NEMČIJA

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

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Grčija

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver Combi

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce, jagnjeta

Grčija

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

New Vet

15 Fleming Street

Maroussi 15123

GRČIJA

Zivet

klozantel

oksfendazol

5 mg/ml

2,5 mg/ml

peroralna suspenzija

peroralna

ovce

Grčija

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

Pfizer Hellas AE

Mesogeion 243

N.Psichiko 15451

GRČIJA

Cydectin Triclamox

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Grčija

| Provet |
| --- |
| Aspropyrgos |
| 19300, Attik |
| GRČIJA |

Provet

Aspropyrgos

19300, Attik

GRČIJA

Rafoxanide/Provet

rafoksanid

300 mg/tab

tablete

peroralna

ovce

Madžarska

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver 5 % injekció A.U.V.

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Madžarska

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver Combi belsőleges szuszpenzió A.U.V.

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Madžarska

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCIJA

Ivomec Super injekció A.U.V.

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Islandija

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver Combi vet

klozantel

50/75 mg/ml

peroralna raztopina

peroralna

ovce, jagnjeta

Irska

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

Biochem Ltd

Pulleen

Kanturk

Co. Cork

IRSKA

Levafluke

rafoksanid

levamizol

22,5 mg/ml

15 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

C & H Generics Ltd c/o Michael McEvoy

Seville House

New Dock Street

Galway

IRSKA

Chanectin Super

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Irska

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Chan Broad Spec

rafoksanid

levamizol

22,5 mg/ml

15 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Rafazole Oral Suspension

rafoksanid

levamizol

30 mg/ml

30 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Ridafluke 3 %

rafoksanid

30 mg/ml

peroralna suspenzija

peroralna

govedo

ovce

Irska

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Animec Super

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Irska

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Levatum Super

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Irska

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Tribex 10 % for cattle

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Irska

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Tribex 5 % for Sheep

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Triclaben 5 % for Sheep

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road

Loughrea

Co. Galway

IRSKA

Triclaben 10 % for cattle

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Irska

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Endofluke 10

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Fasifree 10 %

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Bimectin Plus

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Irska

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Mectaject Plus

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Irska

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

Interchem Ireland Ltd

Road M

Unit 12 Tougher Business Park

Newhall

Naas

Co. Kildare

IRSKA

Orafluke 10 %

rafoksanid

fenbendazol

100 mg/ml

100 mg/ml

peroralna suspenzija

peroralna

govedo

Irska

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

Interchem Ireland Ltd

Road M

Unit 12 Tougher Business Park

Newhall

Naas

Co. Kildare

IRSKA

Orafluke 5 %

rafoksanid

fenbendazol

50 mg/ml

50 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Intervet Ireland Ltd

Magna Drive

Magne Business Park

Citywest Road

Dublin 24

Irska

Panafluke Oral Suspension

rafoksanid

fenbendazol

45 mg/ml

30 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ZDRUŽENO KRALJESTVO

Flukiver 5 Injection

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Irska

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ZDRUŽENO KRALJESTVO

Flukiver Combi Oral Suspension

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ZDRUŽENO KRALJESTVO

Supaverm Oral Suspension

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ZDRUŽENO KRALJESTVO

Flukiver Bovis

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo

Irska

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ZDRUŽENO KRALJESTVO

Flukiver 5 % w/v Oral Suspension

klozantel

50 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

ZDRUŽENO KRALJESTVO

Ivomec super

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Irska

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

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

ZDRUŽENO KRALJESTVO

Trodax 34 %

nitroksinil

340 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Irska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Pour on

klozantel

ivermektin

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Irska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Irska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closiver for cattle

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Irska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin for sheep

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Irska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closiver for sheep

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Irska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Combifluke Oral Suspension for Sheep

klozantel

oksfendazol

50 mg/ml

25 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Parafend Plus Oral Suspension for Sheep

klozantel

oksfendazol

50 mg/ml

25 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Duotech Oral Suspension for Sheep

klozantel

oksfendazol

50 mg/ml

25 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Endex 19,5 %

triklabendazol

levamizol

120 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

govedo

Irska

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Endex 8,75 %

triklabendazol

levamizol

50 mg/ml

35 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Fasinex 10 %

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Irska

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Fasinex 10 % for Sheep

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Fasinex 5 %

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Irska

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Fasinex 24 %

triklabendazol

240 mg/ml

peroralna suspenzija

peroralna

govedo

Irska

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Fasinex Super 19,5 %

triklabendazol

levamizol

120 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

govedo

Irska

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

Pfizer Healthcare Ireland

9 Riverwalk

National Digit Park

Citywest Business Campus

Dublin 24

IRSKA

Cydectin Triclamox

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Irska

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

PharVet Ltd

Station Road

Bagenalstown

Co. Carlow

IRSKA

Fenafluke 5 %

rafoksanid

fenbendazol

50 mg/ml

50 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

PharVet Ltd

Station Road

Bagenalstown

Co. Carlow

IRSKA

Triazole

rafoksanid

levamizol

22,5 mg/ml

15 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Quinn’s Chemist

Bridge Street

Crossmolina

Co. Mayo

IRSKA

Fluken worm

rafoksanid

levamizol

22,5 mg/ml

15 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRSKA

Curafluke 10 %

rafoksanid

fenbendazol

100 mg/ml

100 mg/ml

peroralna suspenzija

peroralna

govedo

Irska

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRSKA

Curafluke 5 %

rafoksanid

fenbendazol

50 mg/ml

50 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRSKA

Flukex 9 %

rafoksanid

90 mg/ml

peroralna suspenzija

peroralna

govedo

Irska

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

Univet Limited

Tullyvin

Cootehill

Co. Cavan

IRSKA

Univet Multidose Fluke and Worm

rafoksanid

levamizol

22,5 mg/ml

15 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Irska

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

Virbac S.A.

Virbac 1, 1ère Avenue

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

Carros, Cedex

FRANCIJA

Virbamec super

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Italija

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Maximec Plus

klorsulon

ivermektin

Information not available

raztopina za injiciranje

podatki niso razpoložljivi

govedo

Italija

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

FATRO S.p.A.

Via Emilia 285

40064 Ozzano Emilia (BO)

ITALIJA

Tolomec Plus

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Italija

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

Pfizer Italia s.r.l.

Via Isonzo 71

LATINA

ITALIJA

Cydectin Triclamox

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Italija

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

Intervet Production s.r.l.

via Nettunense

km 20,300

Aprilia (LT)

ITALIJA

Ranigel

rafoksanid

75 mg/ml

raztopina za injiciranje

subkutana

govedo

Italija

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

Intervet Production s.r.l.

via Nettunense

km 20300

Aprilia (LT)

ITALIJA

Ranigel

rafoksanid

30 mg/ml

peroralna raztopina

peroralna

govedo, ovce

Italija

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver

klozantel

50 mg/ml

raztopina za injiciranje

intramuskularna

govedo

Italija

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

Janssen-Cilag S.p.A.

Via M. Buonarroti 23

20093 Cologno Monzese (MI)

ITALIJA

Seponver

klozantel

50 mg/ml

peroralna suspenzija

peroralna

ovce

Italija

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

Janssen-Cilag S.p.A.

Via M. Buonarroti 23

20093 Cologno Monzese (MI)

ITALIJA

Seponver Plus

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Italija

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

Merial Italia S.p.A.

via Vittorio Pisani, 16

20100 Milano

ITALIJA

Ivomec Plus

klorsulon

ivermektin

100 mg/ml

1 mg/ml

raztopina za injiciranje

subkutana

govedo

Italija

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

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Duotech

klozantel

oksfendazol

50 mg/ml

25 mg/ml

peroralna suspenzija

peroralna

ovce

Italija

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

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Italija

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

Norbrook Laboratories

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Pour on

klozantel

ivermektin

Information not available

podatek ni na voljo

podatek ni na voljo

podatek ni na voljo

Italija

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

Pfizer Italia s.r.l.

Via Isonzo 71

LATINA

ITALIJA

Cydectin Triclamox Pour on

triklabendazol

moksidektin

Information not available

kožni poliv

dajanje kožnega poliva

govedo

Italija

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

Virbac de Portugal Laboratorios LDA

Rua do Centro Empresarial

Ed. 13, Quinta da Beloura

2710-693 Sintra

PORTUGALSKA

Virbamec F

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Latvija

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCIJA

Ivomec Super solution for injection

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Litva

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCIJA

Ivomec Super solution for injection

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Luksemburg

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

Merial Belgium S.A.

Boulevard Sylvain Dupuis 243

B-1070 Bruxelles

BELGIJA

Ivomec F

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Luksemburg

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

Pfizer Animal Health S.A.

rue Laid Burniat 1

1348 Luvain-la-Neuve

BELGIJA

Cydectin Triclamox

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Norveška

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Duotech vet

klozantel

oksfendazol

50 mg/ml

25 mg/ml

peroralna suspenzija

peroralna

ovce

Portugalska

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

Esteve Farma LDA

Av. Do Forte, 3

Edifício Suécia III, Piso 1

2794-044 Carnaxide

PORTUGALSKA

Flukiver 50 mg/ml solução injectável para bovinos e ovinos

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Portugalska

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

Esteve Farma LDA

Av. Do Forte, 3

Edifício Suécia III, Piso 1

2794-044 Carnaxide

PORTUGALSKA

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

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Portugalska

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

Esteve Farma LDA

Av. Do Forte, 3

Edifício Suécia III, Piso 1

2794-044 Carnaxide

PORTUGALSKA

Flukiver 5 % suspensão oral

klozantel

50 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Portugalska

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

Merial Portuguesa Saúde Animal, Lda

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

2635-432 Rio de Mouro

PORTUGALSKA

DOVENIX

nitroksinil

250 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Portugalska

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

Merial Portuguesa Saúde Animal, Lda

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

2635-432 Rio de Mouro

PORTUGALSKA

IVOMEC F

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Portugalska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Duotech Suspensão

klozantel

oksfendazol

50 mg/ml

25 mg/ml

peroralna suspenzija

peroralna

ovce

Portugalska

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin FF, solução injectável para bovinos

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Portugalska

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

Virbac de Portugal Laboratórios LDA

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

2080-104 Almeirim

PORTUGALSKA

Virbamec F

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Romunija

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

Bomac Laboratories Limited

Cnr Wiri Station Road & Hobill Ave

P.O Box 76-369

Manukau City

Auckland

NOVA ZELANDIJA

Clos-Atak

klozantel

50 mg/ml

raztopina za injiciranje

intramuskularna/subkutana

govedo, ovce

Romunija

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NIZOZEMSKA

Ranigel

rafoksanid

30 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Romunija

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NIZOZEMSKA

Fluxacur

triklabendazol

abamektin

Information not available

peroralna suspenzija

peroralna

govedo

ovce

Romunija

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver 5 %

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo

Romunija

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver Combi

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Romunija

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

Kepro B.V.

Maagdenburgstraat 38

7421 ZE Deventer

NIZOZEMSKA

Kepromec Super

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Romunija

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCIJA

IVOMEC PLUS

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Romunija

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCIJA

DOVENIX

nitroksinil

25 g/100 ml

raztopina za injiciranje

raztopina za injiciranje

govedo, ovce, koze

Romunija

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

Pasteur - Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

ROMUNIJA

Evomec Plus

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Romunija

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

Pasteur - Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

ROMUNIJA

Helmizol Plus

klorsulon

120 mg/bolus

bolus

peroralna

govedo

Romunija

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

S.C. Romvac Company s.a.

Șos. Centurii, nr. 7

Voluntari

ROMUNIJA

Fasciocid

triklabendazol

100 mg/ml

peroralna raztopina

peroralna

govedo, ovce

Romunija

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

S.C. Romvac Company s.a.

Șos. Centurii, nr. 7

Voluntari

ROMUNIJA

Romavermectina B1 1 % Plus

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Romunija

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

Vanelli S.R.L.

Iași-Tg. Frumos, km. 10

Iași

ROMUNIJA

Ascacid Forte

rafoksanid

albendazol

25 mg/ml

28 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Romunija

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

VIM Spectrum S.R.L.

Sos. Sighisoarei nr. 409

Tg. Mures

ROMUNIJA

Distol

triklabendazol

ivermektin

500 mg/tablet

10 mg/tablet

tablete

peroralna

govedo, ovce

Slovaška republika

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRSKA

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

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Slovaška republika

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

Merial S.A.S.

29 Avenue Tony Garnier

69007 Lyon

FRANCIJA

Ivomec Super inj. ad us.vet.

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Slovaška republika

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin inj. ad us.vet.

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Slovaška republika

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin injekčný roztok pre ovce

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Slovaška republika

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

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

closantelum

ivermectinum

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Slovenija

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

KRKA tovarna zdravil, d.d.

Šmarješka cesta 6

8501 Novo Mesto

SLOVENIJA

Fascoverm

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Slovenija

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

KRKA tovarna zdravil, d.d.

Šmarješka cesta 6

8501 Novo Mesto

SLOVENIJA

FASCOVERM PLUS

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Španija

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

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

Seville House

New Dock Street

Galway

IRSKA

Chanectin

ivermektin

klorsulon

Information not available

podatek ni na voljo

podatek ni na voljo

govedo

Španija

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Tribex 10 % Suspension Oral Para Bovino

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Španija

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Animec Plus Solución inyectable para bovino

klorsulon

ivermektin

Information not available

podatek ni na voljo

podatek ni na voljo

podatek ni na voljo

Španija

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Tribex 5 % Solución Oral Para Ovino

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Španija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IDA Business & Technology Park

Loughrea, Co. Galway

IRSKA

Alverin Plus solution for injection for cattle

klorsulon

ivermektin

Information not available

podatek ni na voljo

podatek ni na voljo

podatek ni na voljo

Španija

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Bimectin Plus

klorsulon

ivermektin

Information not available

podatek ni na voljo

podatek ni na voljo

podatek ni na voljo

Španija

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

Diana S.A.E.

Ctra Barcelona-Ripoll, PK 17

08150 Parets Del Valles, Barcelona

ŠPANIJA

Vermifor Ecto

klozantel

5 g/100 ml

raztopina za injiciranje

intramuskularna/subkutana/

govedo, ovce

Španija

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

FATRO Iberica, S.L.

C/ Constitución 1, Planta Baja 3

08960 Sant Just Desvern

Barcelona

ŠPANIJA

Fugosantel

klozantel

5 g/100 ml

raztopina za injiciranje

intramuskularna/subkutana

govedo, ovce

Španija

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

Industrial Veterinaria, S.A.

Esmeralda, 19

E-08950 Esplugues de Llobregat (Barselona)

ŠPANIJA

Rolenol

klozantel

50 mg/ml

raztopina za injiciranje

intramuskularna/subkutana

govedo, ovce

Španija

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

Laboratorios Cenavisa, s.a.

Cami Pedro Estela, S/N

43205 Reus (Tarragona)

ŠPANIJA

Telcen

klozantel

50 mg/ml

raztopina za injiciranje

intramuskularna/subkutana

govedo, ovce

Španija

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

Laboratorios Dr. Esteve S.A.

Avda. Mare de Déu de Montserrat 221

08041 Barcelona

ŠPANIJA

Flukiver

klozantel

5 g/100 ml

raztopina za injiciranje

subkutana

govedo, ovce

Španija

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

Laboratorios Dr. Esteve S.A.

Avda. Mare de Déu de Montserrat 221

08041 Barcelona

ŠPANIJA

Seponver Plus

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Španija

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

Laboratorios e Industrias IVEN S.A.

C/ Luis I 56

Pol. Ind. De Vallecas

Madrid

ŠPANIJA

Endoectiven

klozantel

50 mg/ml

raztopina za injiciranje

intramuskularna/subkutana

govedo, ovce

Španija

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

Laboratorios Hipra S.A.

Avda. La Selva 135

17170 Amer (Gerona)

ŠPANIJA

Leclosan

klozantel

50 mg/ml

raztopina za injiciranje

intramuskularna/subkutana

govedo, ovce

Španija

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

Laboratorios Ovejero, S.A.

Ctra León - Vilecha, 30

24192 León

ŠPANIJA

Distomicide

nitroksinil

25 g/100 ml

raztopina za injiciranje

subkutana

govedo, ovce

Španija

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

Merial Laboratorios S.A.

C/ Tarragona n.161

Locales D/E

08014 Barcelona

ŠPANIJA

Dovenix

nitroksinil

25 g/100 ml

raztopina za injiciranje

subkutana

govedo, ovce

Španija

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

Merial Laboratorios S.A.

C/ Tarragona n.161

Locales D/E

08014 Barcelona

ŠPANIJA

Ivomec F

klorsulon

100 mg/ml

raztopina za injiciranje

subkutana

govedo

Španija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin pour-on

klozantel

ivermektin

Information not available

podatek ni na voljo

dajanje kožnega poliva

govedo

Španija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Duotech suspensión oral

klozantel

oksfendazol

50 mg/ml

25 mg/ml

peroralna suspenzija

peroralna

ovce

Španija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Solucion Inyectable para Bovino

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Španija

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Solucion Inyectable para Ovino

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Španija

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

ŠPANIJA

Endex 19,5 %

triklabendazol

12 g/100 ml

peroralna suspenzija

peroralna

govedo

Španija

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

ŠPANIJA

Fasinex 10 % Bovino

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Španija

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

ŠPANIJA

Fasinex 5 % Ovino

triklabendazol

5 g/100 ml

peroralna suspenzija

peroralna

ovce

Španija

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

ŠPANIJA

Endex 8,57 %

triklabendazol

levamizol

5 g/100 ml

3,75 g/100 ml

peroralna suspenzija

peroralna

ovce

Španija

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

Novartis Sanidad Animal S.L.

C/ De La Marina 206

08013 Barcelona

ŠPANIJA

Fasinex 10 % Ovino

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

ovce

Španija

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

Pfizer S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja Alcobendas

Madrid

ŠPANIJA

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

triklabendazol

moksidektin

Information not available

podatek ni na voljo

podatek ni na voljo

podatek ni na voljo

Španija

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

Pfizer S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja Alcobendas

Madrid

ŠPANIJA

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

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Španija

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

S.P. Veterinaria S.A.

Ctra Reus a Vinyols Km.4,1

43330 Riudoms (Tarragona)

ŠPANIJA

Endoex Inyectable

klozantel

5 g/100 ml

raztopina za injiciranje

intramuskularna/subkutana

govedo, ovce

Španija

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

S.P. Veterinaria S.A.

Ctra Reus a Vinyols Km.4,1

43330 Riudoms (Tarragona)

ŠPANIJA

Endoex Oral

klozantel

5 g/100 ml

peroralna raztopina

peroralna

govedo, ovce

Španija

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

Virbac de Portugal Laboratórios LDA

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

2080-104 Almeirim

PORTUGALSKA

Virbamec F

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Švedska

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

Pfizer Oy Animal Health

Tietokuja 4

00330 Helsinki

FINSKA

Moxidektin/

Triklabendazol Fort Dodge

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Nizozemska

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Tribex 5 % orale suspensie voor schapen

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Nizozemska

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Tribex 10 % orale suspensie voor rundvee

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Nizozemska

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver 50 mg/ml, oplossing voor injectie

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo

Nizozemska

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

Janssen Pharmaceutica N.V.

30 Turnhoutseweg

B-2340 Beerse

BELGIJA

Flukiver combi orale suspensie voor schapen en lammeren

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce, jagnjeta

Nizozemska

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

Merial B.V.

Kleermakersstraat 10

1191 JL Velserbroek

NIZOZEMSKA

Ivomec Plus

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

peroralna

govedo

Nizozemska

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NIZOZEMSKA

Endex 19,5 %

triklabendazol

levamizol

120 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

govedo

Nizozemska

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NIZOZEMSKA

Endex 8,75 %

triklabendazol

levamizol

50 mg/ml

37,5 mg/ml

peroralna suspenzija

peroralna

ovce

Nizozemska

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NIZOZEMSKA

Fasinex 10 %

triklabendazol

10 g/100 ml

peroralna suspenzija

peroralna

govedo

Nizozemska

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

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

NIZOZEMSKA

Fasinex 5 %

triklabendazol

5 g/100 ml

peroralna suspenzija

peroralna

ovce

Nizozemska

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

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

NIZOZEMSKA

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

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Nizozemska

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

Schippers Europe B.V.

Rond Deel 12

5531 AH Bladel

NIZOZEMSKA

Endex

triklabendazol

levamizol

50 mg/ml

37,5 mg/ml

peroralna suspenzija

peroralna

ovce

Nizozemska

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

Virbac de Portugal Laboratorios LDA

Rua do Centro Empresarial

Ed. 13, Quinta da Beloura

2710-693 Sintra

PORTUGALSKA

Virbamec F. oplossing voor injectie

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Nizozemska

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

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

NIZOZEMSKA

Endex Suspensie

triklabendazol

levamizol

50 mg/ml

37,5 mg/ml

peroralna suspenzija

peroralna

ovce

Nizozemska

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

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

NIZOZEMSKA

Fasinex 5 %

triklabendazol

5 g/100 ml

peroralna suspenzija

peroralna

ovce

Nizozemska

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

Wirtz Farma B.V.

Leijsendwarsstraat 26

4901 PG, Oosterhout

NIZOZEMSKA

Fasinex 10 %

triklabendazol

10 g/100 ml

peroralna suspenzija

peroralna

govedo

Združeno kraljestvo

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Alverin Plus Solution for Injection for Cattle

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Animec Super Solution for Injection for Cattle

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Tribex 5 % Oral Suspension for Sheep

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Združeno kraljestvo

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Tribex 10 % Oral Suspension for Cattle

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Združeno kraljestvo

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Triclacert 5 % Oral Suspension for Sheep

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Združeno kraljestvo

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

Chanelle Animal Health Limited

7 Rodney Street

Liverpoool

L1 9HZ

ZDRUŽENO KRALJESTVO

Triclacert 10 % Oral Suspension for Cattle

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Združeno kraljestvo

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Bimectin Plus Solution for Injection for Cattle

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Cross Vet Pharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

IRSKA

Endofluke 100 mg/ml Oral Suspension

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Združeno kraljestvo

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ZDRUŽENO KRALJESTVO

Flukiver 5 % w/v Oral Suspension

klozantel

50 mg/ml

peroralna suspenzija

peroralna

ovce

Združeno kraljestvo

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ZDRUŽENO KRALJESTVO

Flukiver Bovis 50 mg/ml Solution for Injection

klozantel

50 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ZDRUŽENO KRALJESTVO

Mebadown Super Oral Suspension

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce, jagnjeta

Združeno kraljestvo

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

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

ZDRUŽENO KRALJESTVO

Supaverm Oral Suspension

klozantel

mebendazol

50 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

ovce

Združeno kraljestvo

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

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

ZDRUŽENO KRALJESTVO

Ivomec Super Injection for Cattle

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Merial Animal Health Limited

Sandringham House

Sandringham Avenue, Harlow Business Park, Harlow

CM19 5TG

Essex

ZDRUŽENO KRALJESTVO

Trodax 34 % w/v Solution for Injection

nitroksinil

340 mg/ml

raztopina za injiciranje

subkutana

govedo, ovce

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Pour-on Solution for Cattle

klozantel

ivermektin

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Solution for Injection

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closamectin Solution for Injection for Sheep

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closiver Pour-on Solution for Cattle

klozantel

ivermektin

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closiver Solution for Injection for Cattle

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closiver Solution for Injection for Sheep

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

ovce

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Closivet Solution for Injection for Cattle

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Norofas Pour-On

klozantel

ivermektin

200 mg/ml

5 mg/ml

kožni poliv

dajanje kožnega poliva

govedo

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Norofas Solution for Injection

klozantel

ivermektin

125 mg/ml

5 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Norbrook Laboratories Ltd

Station Works

Camlough Road

Newry, County Down

BT35 6JP

Northern Ireland

ZDRUŽENO KRALJESTVO

Triclafas Drench 5 % w/v Oral Suspension

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Združeno kraljestvo

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Combinex Cattle Oral Suspension

triklabendazol

levamizol

120 mg/ml

75 mg/ml

peroralna suspenzija

peroralna

govedo

Združeno kraljestvo

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Combinex Oral Suspension

triklabendazol

levamizol

50 mg/ml

37,5 mg/ml

peroralna suspenzija

peroralna

ovce

Združeno kraljestvo

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

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

triklabendazol

ivermektin

50 mg/ml

1 mg/ml

peroralna suspenzija

peroralna

ovce

Združeno kraljestvo

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Fasinex 5 % w/v Oral Suspension

triklabendazol

50 mg/ml

peroralna suspenzija

peroralna

ovce

Združeno kraljestvo

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

Fasinex 10 % Oral Suspension for Cattle

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo

Združeno kraljestvo

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

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

triklabendazol

100 mg/ml

peroralna suspenzija

peroralna

govedo, ovce

Združeno kraljestvo

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

Novartis Animal Health United Kingdom Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

ZDRUŽENO KRALJESTVO

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

triklabendazol

240 mg/ml

peroralna suspenzija

peroralna

govedo

Združeno kraljestvo

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

ZDRUŽENO KRALJESTVO

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

triklabendazol

moksidektin

50 mg/ml

1 mg/ml

peroralna raztopina

peroralna

ovce

Združeno kraljestvo

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

ZDRUŽENO KRALJESTVO

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

triklabendazol

moksidektin

200 mg/ml

5 mg/ml

kožni poliv

podatek ni na voljo

govedo

Združeno kraljestvo

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

Virbac de Portugal Laboratórios LDA

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

2080-104 Almeirim

PORTUGALSKA

Supremadex Solution for Injection

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

Združeno kraljestvo

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

Virbac Ltd

Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk IP30 9UP

ZDRUŽENO KRALJESTVO

Virbamec Super Solution for Injection

klorsulon

ivermektin

100 mg/ml

10 mg/ml

raztopina za injiciranje

subkutana

govedo

---

PRILOGA III

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica
  EU/EGP | Imetnik dovoljenja za promet z zdravilom | Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Actavis Group PTC ehf. |
| Reykjavikurvegur 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Država članica

EU/EGP

Imetnik dovoljenja za promet z zdravilom

Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Leflunomid Actavis 10 mg Filmtabletten

10 mg

Filmsko obložena tableta

Peroralna uporaba

Avstrija

| 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

Filmsko obložena tableta

Peroralna uporaba

Avstrija

| 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

Filmsko obložena tableta

Peroralna uporaba

Češka republika

| 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

Filmsko obložena tableta

Peroralna uporaba

Češka republika

| 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

Filmsko obložena tableta

Peroralna uporaba

Češka republika

| 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

Filmsko obložena tableta

Peroralna uporaba

Nizozemska

| 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

Filmsko obložena tableta

Peroralna uporaba

Nizozemska

| 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

Filmsko obložena tableta

Peroralna uporaba

Nizozemska

| 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

Filmsko obložena tableta

Peroralna uporaba

---

PRILOGA IV

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica
  EU/EGP | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Belgija | Apotex Europe BV |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Država članica

EU/EGP

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Belgija

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

Leflunomide Apotex

10 mg

Tableta

Peroralna uporaba

Belgija

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

Apotex Europe BV

Darwinweg 20

2333 CR Leiden

The Netherlands

Leflunomide Apotex

20 mg

Tableta

Peroralna uporaba

Češka republika

| 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

Tableta

Peroralna uporaba

Češka republika

| 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

Tableta

Peroralna uporaba

Nizozemska

| 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

Tableta

Peroralna uporaba

Nizozemska

| 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

Tableta

Peroralna uporaba

Španija

| 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

Tableta

Peroralna uporaba

Španija

| 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

Tableta

Peroralna uporaba

---