# Official Journal C 153/28 A

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 153 |
| | |
| English edition | Information and Notices | Volume 6628 April 2023 |

ISSN 1977-091X

Official Journal

of the European Union

C 153

English edition

Information and Notices

Volume 6628 April 2023

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2023/C 153/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2023 to 31 March 2023(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council) | 1 |
| 2023/C 153/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2023 to 31 March 2023(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council) | 12 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2023/C 153/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2023 to 31 March 2023(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

1

2023/C 153/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2023 to 31 March 2023(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

12

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.4.2023 | EN | Official Journal of the European Union | C 153/1 |
| --- | --- | --- | --- |

28.4.2023

EN

Official Journal of the European Union

C 153/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2023 to 31 March 2023

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))

(2023/C 153/01)

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.3.2023 | Pombiliti | cipaglucosidase alfa | Amicus Therapeutics Europe Limited |
| Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

20.3.2023

Pombiliti

cipaglucosidase alfa

Amicus Therapeutics Europe Limited

Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland

EU/1/22/1714

Powder for concentrate for solution for infusion

A16AB23

24.3.2023

24.3.2023

Dapagliflozin Viatris

dapagliflozin

| Viatris Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/23/1721

Film-coated tablet

A10BK01

27.3.2023

24.3.2023

SOTYKTU

deucravacitinib

| Bristol Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland |

Bristol Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/23/1718

Film-coated tablet

L04AA56

27.3.2023

24.3.2023

Tolvaptan Accord

tolvaptan

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/23/1719

Tablet

C03XA01

27.3.2023

31.3.2023

Sitagliptin/Metformin hydrochloride SUN

sitagliptin / metformin hydrochloride

| Sun Pharmaceutical Industries Europe B.V. |
| --- |
| Polarisavenue 87, 2132JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp, Nederland

EU/1/23/1720

Film-coated tablet

A10BD07

3.4.2023

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.3.2023 | Vumerity | Biogen Netherlands B.V. |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.3.2023

Vumerity

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/21/1585

7.3.2023

3.3.2023

Zolgensma

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/20/1443

6.3.2023

6.3.2023

Comirnaty

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

13.3.2023

6.3.2023

Firmagon

| Ferring Pharmaceuticals A/S |
| --- |
| Amager Strandvej 405, 2770 Kastrup, Danmark |

Ferring Pharmaceuticals A/S

Amager Strandvej 405, 2770 Kastrup, Danmark

EU/1/08/504

8.3.2023

6.3.2023

Natpar

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/15/1078

7.3.2023

6.3.2023

Nevirapine Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/598

7.3.2023

6.3.2023

Omidria

| Rayner Surgical (Ireland) Limited |
| --- |
| First Floor, Penrose 1, Penrose Dock, Cork, Ireland |

Rayner Surgical (Ireland) Limited

First Floor, Penrose 1, Penrose Dock, Cork, Ireland

EU/1/15/1018

8.3.2023

6.3.2023

Temomedac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/09/605

10.3.2023

6.3.2023

Temozolomide Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/10/615

7.3.2023

6.3.2023

Trecondi

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/18/1351

8.3.2023

6.3.2023

Trulicity

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

7.3.2023

6.3.2023

Xtandi

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, 2333 BE Leiden, Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/13/846

7.3.2023

9.3.2023

Aybintio

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1454

13.3.2023

9.3.2023

BLINCYTO

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

10.3.2023

9.3.2023

Comirnaty

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

16.3.2023

9.3.2023

Onbevzi

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1499

13.3.2023

9.3.2023

Pandemic influenza vaccine H5N1 AstraZeneca

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

10.3.2023

9.3.2023

Rozlytrek

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/20/1460

10.3.2023

9.3.2023

Vaxzevria

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

10.3.2023

9.3.2023

Zynlonta

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| 112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/22/1695

13.3.2023

10.3.2023

Cibinqo

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/21/1593

13.3.2023

10.3.2023

Jyseleca

| Galapagos NV |
| --- |
| Generaal De Wittelaan L11 A3, 2800 Mechelen Antwerp, België |

Galapagos NV

Generaal De Wittelaan L11 A3, 2800 Mechelen Antwerp, België

EU/1/20/1480

13.3.2023

10.3.2023

Olumiant

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

13.3.2023

10.3.2023

Rinvoq

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

13.3.2023

10.3.2023

Xeljanz

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/17/1178

13.3.2023

15.3.2023

ADVATE

| Takeda Manufacturing Austria AG |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/03/271

16.3.2023

15.3.2023

Azacitidine Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/19/1413

16.3.2023

15.3.2023

Dovato

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/19/1370

16.3.2023

15.3.2023

Dupixent

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

17.3.2023

15.3.2023

Galafold

| Amicus Therapeutics Europe Limited |
| --- |
| Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland |

Amicus Therapeutics Europe Limited

Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland

EU/1/15/1082

24.3.2023

15.3.2023

Hexacima

| Sanofi Pasteur |
| --- |
| 14 Espace Henry Vallée, 69007 Lyon, France |

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/13/828

23.3.2023

15.3.2023

Hexyon

| Sanofi Pasteur |
| --- |
| 14 Espace Henry Vallée, 69007 Lyon, France |

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/13/829

16.3.2023

15.3.2023

Jentadueto

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

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

16.3.2023

15.3.2023

Plenadren

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

EU/1/11/715

16.3.2023

15.3.2023

Ponvory

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/21/1550

16.3.2023

15.3.2023

Tenkasi

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1 avenue de la Gare, 1611 Luxembourg, Luxembourg |

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/15/989

16.3.2023

17.3.2023

Aptivus

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

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/05/315

20.3.2023

17.3.2023

Deferasirox Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/19/1386

20.3.2023

17.3.2023

Entyvio

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbaek Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/14/923

20.3.2023

17.3.2023

Ngenla

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/21/1617

20.3.2023

17.3.2023

VEYVONDI

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/18/1298

21.3.2023

20.3.2023

Dasatinib Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/21/1540

23.3.2023

20.3.2023

Enbrel

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/99/126

22.3.2023

20.3.2023

NUCEIVA

| Evolus Pharma B.V. |
| --- |
| Apollolaan 151, 1077 AR Amsterdam, Nederland |

Evolus Pharma B.V.

Apollolaan 151, 1077 AR Amsterdam, Nederland

EU/1/19/1364

22.3.2023

20.3.2023

Pandemic influenza vaccine H5N1 BAXTER

| Resilience Biomanufacturing Ireland Limited |
| --- |
| 2 Shelbourne Buildings, Crampton Avenue, Dublin 4, D04 W3V6, Ireland |

Resilience Biomanufacturing Ireland Limited

2 Shelbourne Buildings, Crampton Avenue, Dublin 4, D04 W3V6, Ireland

EU/1/09/571

23.3.2023

20.3.2023

Prasugrel Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/18/1273

22.3.2023

20.3.2023

Pregabalin Sandoz GmbH

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1012

27.3.2023

20.3.2023

Trazimera

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/18/1295

22.3.2023

20.3.2023

Voriconazole Hikma

| Hikma Farmacêutica (Portugal), S.A. |
| --- |
| Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal |

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

3.4.2023

23.3.2023

Dasatinib Accordpharma

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/21/1541

27.3.2023

24.3.2023

Abiraterone Mylan

| Mylan Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/21/1571

27.3.2023

24.3.2023

Apealea

| Inceptua AB |
| --- |
| Gustavslundsv. 143, 16751 Bromma, Sverige |

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/18/1292

28.3.2023

24.3.2023

CARVYKTI

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/22/1648

28.3.2023

24.3.2023

COVID-19 Vaccine (inactivated, adjuvanted) Valneva

| Valneva Austria GmbH |
| --- |
| Campus Vienna Biocenter 3, 1030 Wien, Österreich |

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/21/1624

29.3.2023

24.3.2023

Deltyba

| Otsuka Novel Products GmbH |
| --- |
| Erika-Mann-Straße 21, 80636 München, Deutschland |

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

30.3.2023

24.3.2023

Dzuveo

| Laboratoire Aguettant |
| --- |
| 1 Rue Alexander Fleming, 69007 Lyon, France |

Laboratoire Aguettant

1 Rue Alexander Fleming, 69007 Lyon, France

EU/1/18/1284

29.3.2023

24.3.2023

Emadine

| Immedica Pharma AB |
| --- |
| SE-113 63, Stockholm, Sverige |

Immedica Pharma AB

SE-113 63, Stockholm, Sverige

EU/1/98/095

12.4.2023

24.3.2023

Esbriet

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/11/667

27.3.2023

24.3.2023

Esperoct

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/19/1374

27.3.2023

24.3.2023

Ivabradine Zentiva

| Zentiva, k.s. |
| --- |
| U Kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1144

27.3.2023

24.3.2023

Kineret

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| 112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

27.3.2023

24.3.2023

LIBTAYO

| Regeneron Ireland Designated Activity Company (DAC) |
| --- |
| One Warrington Place, Dublin 2, D02 HH27 Ireland |

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

27.3.2023

24.3.2023

Palynziq

| BioMarin International Limited |
| --- |
| Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland |

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/19/1362

27.3.2023

24.3.2023

Retsevmo

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

27.3.2023

24.3.2023

Roclanda

| Santen Oy |
| --- |
| Niittyhaankatu 20, 33720 Tampere, Suomi |

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/20/1502

28.3.2023

24.3.2023

Sibnayal

| ADVICENNE |
| --- |
| 262, rue du Faubourg Saint Honoré 75008 Paris, France |

ADVICENNE

262, rue du Faubourg Saint Honoré 75008 Paris, France

EU/1/20/1517

27.3.2023

24.3.2023

TachoSil

| Corza Medical GmbH |
| --- |
| Speditionstraße 21, 40221 Düsseldorf, Deutschland |

Corza Medical GmbH

Speditionstraße 21, 40221 Düsseldorf, Deutschland

EU/1/04/277

28.3.2023

24.3.2023

Tegsedi

| Akcea Therapeutics Ireland Ltd |
| --- |
| St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland |

Akcea Therapeutics Ireland Ltd

St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland

EU/1/18/1296

4.4.2023

24.3.2023

Zeposia

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/20/1442

27.3.2023

24.3.2023

ZINPLAVA

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1156

28.3.2023

31.3.2023

Bavencio

| Merck Europe B.V. |
| --- |
| Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

4.4.2023

31.3.2023

Byfavo

| PAION Deutschland GmbH |
| --- |
| Heussstraße 25, 52078 Aachen, Deutschland |

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/20/1505

3.4.2023

31.3.2023

Edarbi

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbaek Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/11/734

13.4.2023

31.3.2023

Eliquis

| Bristol-Myers Squibb/Pfizer EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland |

Bristol-Myers Squibb/Pfizer EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/11/691

3.4.2023

31.3.2023

Febuxostat Krka

| KRKA d d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/18/1347

5.4.2023

31.3.2023

Gardasil 9

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1007

4.4.2023

31.3.2023

Hefiya

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

3.4.2023

31.3.2023

Hyrimoz

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

3.4.2023

31.3.2023

Imraldi

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1216

4.4.2023

31.3.2023

MenQuadfi

| Sanofi Pasteur |
| --- |
| 14 Espace Henry Vallée, 69007 Lyon, France |

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/20/1483

3.4.2023

31.3.2023

Myalepta

| Amryt Pharmaceuticals DAC |
| --- |
| 45 Mespil Road, Dublin 4, Ireland |

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/18/1276

4.4.2023

31.3.2023

Ozempic

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

11.4.2023

31.3.2023

Pioglitazone Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/757

4.4.2023

31.3.2023

Ryeqo

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

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/21/1565

3.4.2023

31.3.2023

Sialanar

| Proveca Pharma Limited |
| --- |
| 2 Dublin Landings, North Wall Quay, Dublin 1, Ireland |

Proveca Pharma Limited

2 Dublin Landings, North Wall Quay, Dublin 1, Ireland

EU/1/16/1135

5.4.2023

31.3.2023

TOBI Podhaler

| Viatris Healthcare Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/10/652

3.4.2023

31.3.2023

Verkazia

| Santen Oy |
| --- |
| Niittyhaankatu 20, 33720 Tampere, Suomi |

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/17/1219

4.4.2023

31.3.2023

Wegovy

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/21/1608

11.4.2023

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.3.2023 | Nevirapine Teva | Teva B.V. |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

6.3.2023

Nevirapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/598

7.3.2023

9.3.2023

Lamivudine / Zidovudine Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/663

14.3.2023

25.3.2023

Dasatinib Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/21/1540

27.3.2023

25.3.2023

Dasatinib Accordpharma

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/21/1541

27.3.2023

31.3.2023

Nitisinone MDK

| MendeliKABS Europe Limited |
| --- |
| Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland |

MendeliKABS Europe Limited

Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland

EU/1/17/1217

4.4.2023

31.3.2023

Pioglitazone Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/757

4.4.2023

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 31.3.2023 | Bovilis Nasalgen-C | Bovine coronavirus vaccine, live attenuated | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

31.3.2023

Bovilis Nasalgen-C

Bovine coronavirus vaccine, live attenuated

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/23/294

Lyophilisate and solvent for suspension for nasal administration

QI02AD10

3.4.2023

31.3.2023

Eurican L4

Canine leptospirosis vaccine (inactivated)

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/23/293

Suspension for injection

QI07AB01

4.4.2023

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.3.2023 | Nobivac Myxo-RHD PLUS | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

1.3.2023

Nobivac Myxo-RHD PLUS

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/19/244

5.3.2023

1.3.2023

Simparica Trio

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/19/243

2.3.2023

9.3.2023

Clevor

| Orion Corporation |
| --- |
| Orionintie 1, 02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/17/222

22.3.2023

9.3.2023

EVANT

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Laboratorios Hipra, S.A.

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

EU/2/18/233

13.3.2023

9.3.2023

Nobivac L4

| 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/2/12/143

15.3.2023

9.3.2023

Purevax RC

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/051

13.3.2023

9.3.2023

Recocam

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland

EU/2/11/133

10.3.2023

17.3.2023

Halocur

| 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/2/99/013

22.3.2023

17.3.2023

Versican Plus DHPPi/L4

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium SA

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

EU/2/14/164

20.3.2023

17.3.2023

Versican Plus DHPPi/L4R

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/163

20.3.2023

17.3.2023

Versican Plus L4

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/171

20.3.2023

24.3.2023

Equip WNV

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/08/086

3.4.2023

24.3.2023

Naxcel

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium SA

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

EU/2/05/053

28.3.2023

24.3.2023

Porcilis PCV M Hyo

| 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/2/14/175

29.3.2023

24.3.2023

Versican Plus Pi/L4R

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/173

27.3.2023

31.3.2023

Aservo EquiHaler

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/19/249

4.4.2023

31.3.2023

Bravecto Plus

| 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/2/18/224

3.4.2023

31.3.2023

BTVPUR

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/10/113

5.4.2023

31.3.2023

Coxevac

| Ceva Santé Animale |
| --- |
| 10 avenue de La Ballastière, 33500 Libourne, France |

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/10/110

4.4.2023

31.3.2023

GALLIPRANT

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/221

3.4.2023

31.3.2023

GUMBOHATCH

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Laboratorios Hipra, S.A.

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

EU/2/19/245

6.4.2023

31.3.2023

Innovax-ND-IBD

| 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/2/17/213

3.4.2023

31.3.2023

Librela

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/20/261

11.4.2023

31.3.2023

Lotilaner Elanco

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/22/288

3.4.2023

31.3.2023

Purevax RCP FeLV

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/048

4.4.2023

31.3.2023

Suprelorin

| VIRBAC S.A. |
| --- |
| 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France |

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France

EU/2/07/072

5.4.2023

31.3.2023

Suvaxyn PRRS MLV

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/17/215

5.4.2023

31.3.2023

Suvaxyn PRRS MLV

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/17/215

5.4.2023

31.3.2023

Zeleris

| Ceva Santé Animale |
| --- |
| 10 avenue de La Ballastière, 33500 Libourne, France |

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/210

4.4.2023

31.3.2023

Zolvix

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/09/101

3.4.2023

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

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

(2)  OJ L 4, 7.1.2019, p. 43.

---

| 28.4.2023 | EN | Official Journal of the European Union | C 153/12 |
| --- | --- | --- | --- |

28.4.2023

EN

Official Journal of the European Union

C 153/12

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2023 to 31 March 2023

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1), Article 38 of Directive 2001/82/EC (2) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3))

(2023/C 153/02)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 28.3.2023 | Veterinary medicinal products containing N-methyl pyrrolidone as an excipient | N-methyl pyrrolidone | See Annex II | See Annex II | 29.3.2023 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

28.3.2023

Veterinary medicinal products containing N-methyl pyrrolidone as an excipient

N-methyl pyrrolidone

See Annex II

See Annex II

29.3.2023

—   Suspension of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 6.3.2023 | Pholcodine containing medicinal products | pholcodine / pholcodine-containing medicinal products | See Annex I | See Annex I | 8.3.2023 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

6.3.2023

Pholcodine containing medicinal products

pholcodine / pholcodine-containing medicinal products

See Annex I

See Annex I

8.3.2023

---

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

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

(3)  OJ L 4, 7.1.2019, p. 43.

---

ANNEX I

List of medicinal products and presentations

| Member State
  in EEA | Marketing authorisation holder | Product name | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Vemedia Manufacturing B. V. | Pholco-Méréprine Mono | Pholcodine 1mg/ml | syrup | oral use |
| Croatia | Alkaloid D.O.O. | Pholcodin Alkaloid | Pholcodine Monohydrate 10mg Capsule | capsule, hard | oral use |
| France | Biocodex | Dimetane Sans Sucre | Pholcodine 133mg/100ml | syrup | oral use |
| France | Biogaran | Pholcodine Biogaran | Pholcodine Monohydrate 131mg/100ml | syrup | oral use |
| France | Melisana Pharma | Broncalene Adultes | Chlorphenamine Maleate 0,0133 g/100ml, Pholcodine 0,08 g/100ml | syrup | oral use |
| France | Melisana Pharma | Broncalene Enfants | Chlorphenamine Maleate 0,01 g/100ml, Pholcodine 0,05 g/100ml | syrup | oral use |
| France | Zambon France S.A. | Biocalyptol | Pholcodine 131mg/100ml | syrup | oral use |
| France | Zambon France S.A. | Biocalyptol A La | Pholcodine 131mg/100ml, Guaiacol 19,75 mg/100ml | syrup | oral use |
| France | Zambon France S.A. | Biocalyptol Sans Sucre | Pholcodine 131mg/100ml | syrup | oral use |
| Ireland | Glaxosmithkline Consumer Healthcare (Ireland) Ltd | Day Nurse | Pseudoephedrine Hydrochloride 30mg Capsule, Paracetamol 500mg Capsule, Pholcodine 5mg Capsule | capsule, hard | oral use |
| Ireland | Pinewood Laboratories Limited | Pholcodine Wockhardt Uk | Pholcodine 1mg/ml | oral solution | oral use |
| Lithuania | Laboratoires Bouchara-Recordati | Hexapneumine Adults | Chlorphenamine Maleate 0,6 mg/5ml, Biclotymol 10mg/5ml, Pholcodine 6mg/5ml | syrup | oral use |
| Lithuania | Laboratoires Bouchara-Recordati | Hexapneumine Children | Chlorphenamine Maleate 0,5 mg/5ml, Biclotymol 7,5 mg/5ml, Pholcodine 5mg/5ml | syrup | oral use |
| Luxembourg | Vemedia Manufacturing B. V. | Pholco-Méréprine Mono | Pholcodine 1mg/ml | syrup | oral use |
| Slovenia | Alkaloid-Int D.O.O. | Folkodin Alkaloid-Int | Pholcodine Monohydrate 10mg Capsule | capsule, hard | oral use |
| United Kingdom (Northern Ireland) | Glaxosmithkline Consumer Healthcare (Uk) Trading Limited | Day & Night Nurse | Dextromethorphan Hydrobromide 7,5 mg Capsule, Paracetamol 500mg Capsule, Pholcodine 5mg Capsule | capsule, hard | oral use |
| United Kingdom (Northern Ireland) | Glaxosmithkline Consumer Healthcare (Uk) Trading Limited | Day Nurse | Pseudoephedrine Hydrochloride 30mg Capsule, Paracetamol 500mg Capsule, Pholcodine 5mg Capsule | capsule, hard | oral use |
| United Kingdom (Northern Ireland) | Glaxosmithkline Consumer Healthcare (Uk) Trading Limited | Day Nurse | Pseudoephedrine Hydrochloride 60mg/30ml, Paracetamol 1000mg/30ml, Pholcodine 10mg/30ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | Glaxosmithkline Consumer Healthcare (Uk) Trading Limited | Tixylix Dry Cough | Pholcodine 4mg/5ml | syrup | oral use |
| United Kingdom (Northern Ireland) | Infohealth Ltd | Hill's Balsam Dry Cough Liquid | Pholcodine 10mg/5ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | Linthwaite Contract Manufacturing Ltd (L.C.M. Ltd.) | Pholcodine Linctus L.C.M. | Pholcodine Monohydrate 5mg/5ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | Pinewood Laboratories Limited | Pholcodine Pinewood Laboratories Limited | Pholcodine 5mg/ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | Pinewood Laboratories Limited | Pholcodine Wockhardt Uk Ltd | Pholcodine 2mg/ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | The Boots Company Plc | Almus Cold And Flu Day Liquid | Pseudoephedrine Hydrochloride Bp 0,2  %w/V, Pholcodine Ph. Eur. 0,033  %w/V, Paracetamol Ph. Eur. 3,333  %w/V | oral solution | oral use |
| United Kingdom (Northern Ireland) | The Boots Company Plc | Day Cold & Flu Relief | Pseudoephedrine Hydrochloride Bp 0,2  %w/V, Pholcodine Ph. Eur. 0,033  %w/V, Paracetamol Ph. Eur. 3,333  %w/V | oral solution | oral use |
| United Kingdom (Northern Ireland) | The Boots Company Plc | Night Cough Relief | Diphenhydramine Hydrochloride Ph. Eur. 12,5 mg/5ml, Pholcodine Ph. Eur. 3,75 mg/5ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | The Boots Company Plc | Dry Cough 6 Years + | Pholcodine Ph. Eur. 2mg/5ml | syrup | oral use |
| United Kingdom (Northern Ireland) | Thornton & Ross Ltd | Cofsed Paediatric | Pholcodine Monohydrate 0,4 mg/ml | oral liquid | oral use |
| United Kingdom (Northern Ireland) | Thornton & Ross Ltd | Galenphol Paediatric | Pholcodine Monohydrate 0,4 mg/ml | oral liquid | oral use |
| United Kingdom (Northern Ireland) | Thornton & Ross Ltd | Cofsed | Chlorphenamine Maleate 0,4 mg/ml, Ephedrine Hydrochloride 1,6 mg/ml, Pholcodine Monohydrate 1mg/ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | Thornton & Ross Ltd | Covonia | Pholcodine Monohydrate 1mg/ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | Thornton & Ross Ltd | Galenphol | Pholcodine Monohydrate 1mg/ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | Thornton & Ross Ltd | Galenphol | Pholcodine Monohydrate 2mg/ml | oral solution | oral use |
| United Kingdom (Northern Ireland) | Thornton & Ross Ltd | Galenphol | Pholcodine Monohydrate 5mg/5ml | oral solution | oral use |

Member State

in EEA

Marketing authorisation holder

Product name

INN + Strength

Pharmaceutical form

Route of administration

Belgium

Vemedia Manufacturing B. V.

Pholco-Méréprine Mono

Pholcodine 1mg/ml

syrup

oral use

Croatia

Alkaloid D.O.O.

Pholcodin Alkaloid

Pholcodine Monohydrate 10mg Capsule

capsule, hard

oral use

France

Biocodex

Dimetane Sans Sucre

Pholcodine 133mg/100ml

syrup

oral use

France

Biogaran

Pholcodine Biogaran

Pholcodine Monohydrate 131mg/100ml

syrup

oral use

France

Melisana Pharma

Broncalene Adultes

Chlorphenamine Maleate 0,0133 g/100ml, Pholcodine 0,08 g/100ml

syrup

oral use

France

Melisana Pharma

Broncalene Enfants

Chlorphenamine Maleate 0,01 g/100ml, Pholcodine 0,05 g/100ml

syrup

oral use

France

Zambon France S.A.

Biocalyptol

Pholcodine 131mg/100ml

syrup

oral use

France

Zambon France S.A.

Biocalyptol A La

Pholcodine 131mg/100ml, Guaiacol 19,75 mg/100ml

syrup

oral use

France

Zambon France S.A.

Biocalyptol Sans Sucre

Pholcodine 131mg/100ml

syrup

oral use

Ireland

Glaxosmithkline Consumer Healthcare (Ireland) Ltd

Day Nurse

Pseudoephedrine Hydrochloride 30mg Capsule, Paracetamol 500mg Capsule, Pholcodine 5mg Capsule

capsule, hard

oral use

Ireland

Pinewood Laboratories Limited

Pholcodine Wockhardt Uk

Pholcodine 1mg/ml

oral solution

oral use

Lithuania

Laboratoires Bouchara-Recordati

Hexapneumine Adults

Chlorphenamine Maleate 0,6 mg/5ml, Biclotymol 10mg/5ml, Pholcodine 6mg/5ml

syrup

oral use

Lithuania

Laboratoires Bouchara-Recordati

Hexapneumine Children

Chlorphenamine Maleate 0,5 mg/5ml, Biclotymol 7,5 mg/5ml, Pholcodine 5mg/5ml

syrup

oral use

Luxembourg

Vemedia Manufacturing B. V.

Pholco-Méréprine Mono

Pholcodine 1mg/ml

syrup

oral use

Slovenia

Alkaloid-Int D.O.O.

Folkodin Alkaloid-Int

Pholcodine Monohydrate 10mg Capsule

capsule, hard

oral use

United Kingdom (Northern Ireland)

Glaxosmithkline Consumer Healthcare (Uk) Trading Limited

Day & Night Nurse

Dextromethorphan Hydrobromide 7,5 mg Capsule, Paracetamol 500mg Capsule, Pholcodine 5mg Capsule

capsule, hard

oral use

United Kingdom (Northern Ireland)

Glaxosmithkline Consumer Healthcare (Uk) Trading Limited

Day Nurse

Pseudoephedrine Hydrochloride 30mg Capsule, Paracetamol 500mg Capsule, Pholcodine 5mg Capsule

capsule, hard

oral use

United Kingdom (Northern Ireland)

Glaxosmithkline Consumer Healthcare (Uk) Trading Limited

Day Nurse

Pseudoephedrine Hydrochloride 60mg/30ml, Paracetamol 1000mg/30ml, Pholcodine 10mg/30ml

oral solution

oral use

United Kingdom (Northern Ireland)

Glaxosmithkline Consumer Healthcare (Uk) Trading Limited

Tixylix Dry Cough

Pholcodine 4mg/5ml

syrup

oral use

United Kingdom (Northern Ireland)

Infohealth Ltd

Hill's Balsam Dry Cough Liquid

Pholcodine 10mg/5ml

oral solution

oral use

United Kingdom (Northern Ireland)

Linthwaite Contract Manufacturing Ltd (L.C.M. Ltd.)

Pholcodine Linctus L.C.M.

Pholcodine Monohydrate 5mg/5ml

oral solution

oral use

United Kingdom (Northern Ireland)

Pinewood Laboratories Limited

Pholcodine Pinewood Laboratories Limited

Pholcodine 5mg/ml

oral solution

oral use

United Kingdom (Northern Ireland)

Pinewood Laboratories Limited

Pholcodine Wockhardt Uk Ltd

Pholcodine 2mg/ml

oral solution

oral use

United Kingdom (Northern Ireland)

The Boots Company Plc

Almus Cold And Flu Day Liquid

Pseudoephedrine Hydrochloride Bp 0,2  %w/V, Pholcodine Ph. Eur. 0,033  %w/V, Paracetamol Ph. Eur. 3,333  %w/V

oral solution

oral use

United Kingdom (Northern Ireland)

The Boots Company Plc

Day Cold & Flu Relief

Pseudoephedrine Hydrochloride Bp 0,2  %w/V, Pholcodine Ph. Eur. 0,033  %w/V, Paracetamol Ph. Eur. 3,333  %w/V

oral solution

oral use

United Kingdom (Northern Ireland)

The Boots Company Plc

Night Cough Relief

Diphenhydramine Hydrochloride Ph. Eur. 12,5 mg/5ml, Pholcodine Ph. Eur. 3,75 mg/5ml

oral solution

oral use

United Kingdom (Northern Ireland)

The Boots Company Plc

Dry Cough 6 Years +

Pholcodine Ph. Eur. 2mg/5ml

syrup

oral use

United Kingdom (Northern Ireland)

Thornton & Ross Ltd

Cofsed Paediatric

Pholcodine Monohydrate 0,4 mg/ml

oral liquid

oral use

United Kingdom (Northern Ireland)

Thornton & Ross Ltd

Galenphol Paediatric

Pholcodine Monohydrate 0,4 mg/ml

oral liquid

oral use

United Kingdom (Northern Ireland)

Thornton & Ross Ltd

Cofsed

Chlorphenamine Maleate 0,4 mg/ml, Ephedrine Hydrochloride 1,6 mg/ml, Pholcodine Monohydrate 1mg/ml

oral solution

oral use

United Kingdom (Northern Ireland)

Thornton & Ross Ltd

Covonia

Pholcodine Monohydrate 1mg/ml

oral solution

oral use

United Kingdom (Northern Ireland)

Thornton & Ross Ltd

Galenphol

Pholcodine Monohydrate 1mg/ml

oral solution

oral use

United Kingdom (Northern Ireland)

Thornton & Ross Ltd

Galenphol

Pholcodine Monohydrate 2mg/ml

oral solution

oral use

United Kingdom (Northern Ireland)

Thornton & Ross Ltd

Galenphol

Pholcodine Monohydrate 5mg/5ml

oral solution

oral use

---

ANNEX II

List of nationally authorised veterinary medicinal products

ANNEX IIA

List of nationally authorised veterinary medicinal products recommended for maintenance of the marketing authorisations

| Member State EU/EEA | Applicant/Marketing authorisation holder | Name | INN/Active substance | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Bayer Animal Health GmbH |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Member State EU/EEA

Applicant/Marketing authorisation holder

Name

INN/Active substance

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde bis 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Austria

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde über 4 kg bis 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Belgium

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 40/200

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 100/500

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Bulgaria

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Bulgaria

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on solution for dogs over 4 up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Croatia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on, otopina za nakapavanje, za pse do 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on, otopina za nakapavanje, za pse od 4 do 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Cyprus

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on διάλυμα για σκύλους έως 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Cyprus

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on διάλυμα για σκύλους από 4kg έως 10kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix roztok pro nakapání na kůži — spot-on pro psy do 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Czech Republic

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix roztok pro nakapání na kůži — spot-on pro psy od 4 do 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Denmark

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic Vet. til hunde 4-10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Denmark

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic Vet. til hunde op til 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Estonia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Estonia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Finland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet enintään 4 kg painaville koirille

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Finland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet koirille 4–10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

France

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix petit chien

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

France

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix très petit chien

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Germany

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde bis 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Germany

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde über 4 kg bis 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Greece

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Greece

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Hungary

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot on 4 kg alatti kutyáknak A.U.V.

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Hungary

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot on 4-10 kg közötti kutyáknak A.U.V.

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Ireland

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Ireland

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Advantix Spot-on per cani fino a 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Advantix Spot-on per cani oltre 4 kg fino a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petcuten soluzione spot-on per cani fino a 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petcuten Spot-on per cani oltre 4 kg fino a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petsidill spot-on per cani fino ta 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on Solution

Dog (up to 4 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petsidill spot-on per cani oltre a 4 kg fino a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on Solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Poli-Ecto soluzione spot-on per cani fino a 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Poli-Ecto soluzione spot-on per cani oltre 4 kg fino a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Lithuania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix, užlašinamasis tirpalas <= 4 kg svorio šunims

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix, užlašinamasis tirpalas > 4-10 kg svorio šunims

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 40/200

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 100/500

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot-on oplossing voor honden vanaf 4 kg tot 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot-on oplossing voor honden tot 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Petcuten spot-on oplossing voor honden tot en met 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Petcuten spot-on oplossing voor honden van meer dan 4 kg tot en met 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Netherlands

| Veterinaire Groothandel Wijchen B.V. |
| --- |
| Graafschap Hornelaan 137A |
| 6001 AC Weert |
| The Netherlands |

Veterinaire Groothandel Wijchen B.V.

Graafschap Hornelaan 137A

6001 AC Weert

The Netherlands

Advantix 40/200 spot-on oplossing voor honden

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Netherlands

| Veterinaire Groothandel Wijchen B.V. |
| --- |
| Graafschap Hornelaan 137A |
| 6001 AC Weert |
| The Netherlands |

Veterinaire Groothandel Wijchen B.V.

Graafschap Hornelaan 137A

6001 AC Weert

The Netherlands

Advantix 100/500 spot-on oplossing voor honden

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Netherlands

| Polymeds B.V. |
| --- |
| Osloweg 99A |
| 9723BK Groningen |
| The Netherlands |

Polymeds B.V.

Osloweg 99A

9723BK Groningen

The Netherlands

Advantix spot-on oplossing voor honden vanaf 4 kg tot 10 Kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Norway

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Norway

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Poland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-On (100 mg + 500 mg)/1 ml; roztwór do nakrapiania

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Poland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-On (40 mg + 200 mg)/0,4 ml; roztwór do nakrapiania

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Portugal

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solução para unção punctiforme para cães até 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Portugal

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solução para unção punctiforme para cães com mais de 4 kg até 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Romania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix soluţie spot-on pentru câini cu greutatea de la 4 kg până la 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Romania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix soluţie spot-on pentru câini cu greutatea până la 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Slovak Republic

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot-on roztok pre psy

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Slovenia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix kožni nanos, raztopina za pse do 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix kožni nanos, raztopina za pse od 4 do 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solucion spot-on para perros hasta 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solucion spot-on para perros de mas de 4 hasta 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Poli-ecto solucion spot-on para perros hasta 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Poli-ecto solucion spot-on para perros de mas de 4 hasta 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

UK/Northern Ireland (1)

| Elanco Europe Ltd. |
| --- |
| Form 2 Bartley Way |
| Hook RG27 9XA |
| United Kingdom |

Elanco Europe Ltd.

Form 2 Bartley Way

Hook RG27 9XA

United Kingdom

Advantix Spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

UK/Northern Ireland1

| Elanco Europe Ltd. |
| --- |
| Form 2 Bartley Way |
| Hook RG27 9XA |
| United Kingdom |

Elanco Europe Ltd.

Form 2 Bartley Way

Hook RG27 9XA

United Kingdom

Advantix Spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog (up to 4 kg)

Spot-on use

---

(1)  For the United Kingdom, as from 1 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

ANNEX IIB

List of nationally authorised veterinary medicinal products recommended for variation of the marketing authorisations (quantitative NMP concentration and target animal safety warnings)

| Member State EU/EEA | Applicant/Marketing authorisation holder | Name | INN/Active substance | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Krka d.d. Novo Mesto |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Member State EU/EEA

Applicant/Marketing authorisation holder

Name

INN/Active substance

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg lösung zum auftropfen für hunde von 10 kg bis 25 kg

Imidacloprid

Permethrin

250 mg/2,5  ml

1250 mg/2,5  ml

Spot-on solution

Dog

Spot-on use

Austria

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg lösung zum auftropfen für hunde bis 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Austria

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg lösung zum auftropfen für hunde von 4 kg bis 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Austria

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 0,4 ml spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Austria

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 1 ml spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Austria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act Lösung zum Auftropfen für Hunde 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5  ml

Spot-on solution

Dog

Spot-on use

Austria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act Lösung zum Auftropfen für Hunde 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Belgium

| Dechra Veterinary Products |
| --- |
| Achterstenhoek 48 |
| 2275 Lille |
| Belgium |

Dechra Veterinary Products

Achterstenhoek 48

2275 Lille

Belgium

Myorelax

Guaifenesin

100 mg/ml

Solution for infusion

Horse

Intravenous use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Belgium

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Belgium

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Belgium

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Bulgaria

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Bulgaria

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Bulgaria

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Bulgaria

| DSM Denitrans Ltd. |
| --- |
| Razgrad, 11 Neofit Rilski str. |
| Bulgaria |

DSM Denitrans Ltd.

Razgrad, 11 Neofit Rilski str.

Bulgaria

Neofenicol inj

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Bulgaria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Bulgaria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Croatia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa, 200 mg/40 mg, otopina za nakapavanje, za pse do 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Croatia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa, 500 mg/100 mg, otopina za nakapavanje, za pse od 4 kg do 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Croatia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa, 1250 mg/250 mg, otopina za nakapavanje, za pse od 10 kg do 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, otopina za nakapavanje, za pse 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, otopina za nakapavanje, za pse 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Cyprus

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on διάλυμα επίχυσης για σκύλους 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Cyprus

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on διάλυμα επίχυσης για σκύλους 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg roztok pro nakapání na kůži — spot-on pro psy do 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Czech Republic

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg roztok pro nakapání na kůži — spot-on pro psy od 4 kg do 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg roztok pro nakapání na kůži — spot-on pro psy od 10 kg do 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act roztok pro nakapání na kůži — spot-on pro psy 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act roztok pro nakapání na kůži — spot-on pro psy 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Denmark

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect (til hunde 5-10 kg)

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Cutaneous use

Denmark

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect (til hunde 2-5 kg)

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Cutaneous use

Estonia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Estonia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Estonia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa

Imidacloprid

Permethrin

250 mg/2,5  ml

1250 mg/2,5  ml

Spot-on solution

Dog

Spot-on use

Estonia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Estonia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Estonia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Estonia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Finland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa vet koirille, jotka painavat enintään 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Finland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa vet koirille, jotka painavat yli 4 kg-10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Finland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa vet koirille, jotka painavat yli 10 kg-25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Finland

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 2–5 kg:n painoiselle koiralle

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Cutaneous use

Finland

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 5–10 kg:n painoiselle koiralle

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Cutaneous use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act solution pour spot-on pour chiens 2 — 5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act solution pour spot-on pour chiens 5 — 10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontect solution pour spot-on pour chiens 2 — 5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Cutaneous use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontect solution pour spot-on pour chiens 5 — 10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Cutaneous use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg solution pour spot-on pour chiens de 10 kg a 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg solution pour spot-on pour chiens jusqu’a 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg solution pour spot-on pour chiens de 4 kg a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

France

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Myorelax 100 mg/ml solution pour perfusion pour chevaux

Guaifenesin

100 mg/ml

Solution for infusion

Horse

Intravenous use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Permetrix biocanina 1250 mg/250 mg solution pour spot-on pour chiens de 10 kg a 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Permetrix biocanina 200 mg/40 mg solution pour spot-on pour chiens jusqu'a 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Permetrix biocanina 500 mg/100 mg solution pour spot-on pour chiens de 4 kg a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

France

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 20 mg solution pour spot-on pour petits chats et chatons

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

France

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 20 mg solution pour spot-on pour chats et chatons

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Germany

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg lösung zum auftropfen für hunde von 10 kg bis 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Germany

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg lösung zum auftropfen für hunde bis 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Germany

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg lösung zum auftropfen für hunde von 4 kg bis 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Germany

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 1250 mg/250 mg lösung zum auftropfen für hunde über 10 kg bis 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Germany

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 200 mg/40 mg lösung zum auftropfen für hunde bis 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Germany

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 500 mg/100 mg lösung zum auftropfen für hunde über 4 kg bis 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Germany

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55216 Ingelheim |
| Germany |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55216 Ingelheim

Germany

Frontline Tri-Act Lösung zum Auftropfen für Hunde 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Germany

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55216 Ingelheim |
| Germany |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55216 Ingelheim

Germany

Frontline Tri-Act Lösung zum Auftropfen für Hunde 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Germany

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| 31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

31303 Burgdorf

Germany

My-50mg/ml

Guaifenesin

50 mg/ml

Solution for infusion

Horse

Intravenous use

Germany

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| 31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

31303 Burgdorf

Germany

Myolaxin 15 %

Guaifenesin

15 mg/ml

Solution for infusion

Horse

Intravenous use

Germany

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Myorelax 100 mg/ml Infusionslösung für Pferde

Guaifenesin

100 mg/ml

Solution for infusion

Horse

Intravenous use

Germany

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 20 mg lösung zum auftropfen für katzen und katzenwelpen

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Germany

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 20 mg lösung zum auftropfen für katzen und katzenwelpen

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Germany

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 0,4 ml spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Germany

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 1 ml spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Germany

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 100 mg/500 mg spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Germany

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 40 mg/200 mg spot-on solution for dogs up to 4kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Germany

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 0,4 ml spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Germany

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 1 ml spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Greece

| Hellafarm AE |
| --- |
| 1st km Paiania-Markopoulou Avenue |
| 19002, Paiania, Attiki, Athens |
| Greece |

Hellafarm AE

1st km Paiania-Markopoulou Avenue

19002, Paiania, Attiki, Athens

Greece

Norodin 24

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous use

Greece

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act spot-on.so (33,8 + 252,4 )mg/0,5 ml

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5  ml

Spot-on solution

Dog

Spot-on use

Greece

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act spot-on.so (67,6 + 504,8 )mg/1ml

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Greece

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix spot-on.so

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Greece

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix spot-on.so

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Greece

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Greece

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Greece

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Greece

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Greece

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Greece

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Oxytetracycline L.A/Dopharma

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, calf, pig

Intramuscular use

Hungary

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg rácsepegtető oldat 10-25 kg-os kutyáknak A.U.V.

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Hungary

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg rácsepegtető oldat 4kg alatti kutyáknak A.U.V.

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Hungary

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg rácsepegtető oldat 4-10 kg-os kutyáknak A.U.V.

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Hungary

| Merial |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Merial

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act rácsepegtető oldat 2–5 kg-os kutyáknak

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Hungary

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act rácsepegtető oldat 5–10 kg-os kutyáknak

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 20 mg spot-on solution for small cats

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 20 mg spot-on solution for small cats and kittens

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 200 mg/40 mg spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Ireland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 0,4 millilitre(s) spot-on solution

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Ireland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 1,0 millilitre(s) spot-on solution

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Ireland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 0,4 ml spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Ireland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 1 ml spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Daclotrix 200 mg/40 mg spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Daclotrix 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Daclotrix 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Italy

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg soluzione spot-on per cani fino a 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Italy

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg soluzione spot-on per cani da 4 kg a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Italy

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg soluzione spot-on per cani da 10 kg a 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Italy

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 20 mg soluzione spot-on per gatti di taglia piccola.

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Italy

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 200 mg/40 mg soluzione spot-on per cani fino a 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Italy

| Boehringer Ingelheim Animal Health Italia S.p.A. |
| --- |
| Via Lorenzini 8 |
| 20139 Milano |
| Italy |

Boehringer Ingelheim Animal Health Italia S.p.A.

Via Lorenzini 8

20139 Milano

Italy

Frontline Tri-Act soluzione spot-on per cani 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog (2-5 kg)

Spot-on use

Italy

| Boehringer Ingelheim Animal Health Italia S.p.A. |
| --- |
| Via Lorenzini 8 |
| 20139 Milano |
| Italy |

Boehringer Ingelheim Animal Health Italia S.p.A.

Via Lorenzini 8

20139 Milano

Italy

Frontline Tri-Act soluzione spot-on per cani 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog (5-10 kg)

Spot-on use

Italy

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 20 mg soluzione spot-on per gatti di taglia piccola e gattini

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Italy

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Preventix soluzione spot-on per cani fino a 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Italy

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Preventix soluzione spot-on per cani oltre 4 kg fino a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Italy

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix soluzione spot-on per cani fino a 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Italy

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix soluzione spot-on per cani oltre 4 kg fino a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Italy

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Italy

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Italy

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Italy

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Latvia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act šķīdums pilināšanai uz ādas suņiem 2 — 5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5  ml

Spot-on solution

Dog (2-5 kg)

Spot-on use

Latvia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act šķīdums pilināšanai uz ādas suņiem 5 — 10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog (5-10 kg)

Spot-on use

Latvia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg šķīdums pilināšanai uz ādas suņiem no 4 kg līdz 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog (over 4 kg up to 10 kg)

Spot-on use

Latvia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg šķīdums pilināšanai uz ādas suņiem no 10 kg līdz 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Latvia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 40 mg/200 mg šķīdums pilināšanai uz ādas suņiem līdz 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Latvia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 100 mg/500 mg šķīdums pilināšanai uz ādas suņiem no 4 kg līdz 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Lithuania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, užlašinamasis tirpalas 2–5 kg šunims

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, užlašinamasis tirpalas 5-10 kg šunims

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg užlašinamasis tirpalas šunims, sveriantiems daugiau kaip 4 kg ir iki 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg užlašinamasis tirpalas šunims, sveriantiems iki 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Lithuania

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg užlašinamasis tirpalas šunims, sveriantiems daugiau kaip 10 kg ir iki 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 40/200 spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Lithuania

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 100/500 spot-on solution for dogs over 4 up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Luxembourg

| Dechra Veterinary Products |
| --- |
| Achterstenhoek 48 |
| 2275 Lille |
| Belgium |

Dechra Veterinary Products

Achterstenhoek 48

2275 Lille

Belgium

Myorelax

Guaifenesin

100 mg/ml

Solution for infusion

Horse

Intravenous use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Luxembourg

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Malta

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Insectivex 50 mg/ml concentrate for emulsion and cutaneous application for bovine and non-food equine species

Cypermethrin

50 mg/ml

Concentrate for cutaneous spray, emulsion

Bovine species, horse

Cutaneous use

Malta

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Malta

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 5 — 10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Alfasan Nederland B.V. |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| The Netherlands |

Alfasan Nederland B.V.

Kuipersweg 9

3449 JA Woerden

The Netherlands

Antipyranal, 200 mg/ml, oplossing voor injectie voor honden

Phenylbutazone

200 mg/ml

Solution for injection

Dog

Intramuscular use

Netherlands

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg spot-on oplossing voor honden met een gewicht tot 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Netherlands

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg spot-on oplossing voor honden met een gewicht van 4 kg tot 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg spot-on oplossing voor honden met een gewicht van 10 kg tot 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Boehringer Ingelheim Animal Health Netherlands B.V. |
| --- |
| Comeniusstraat 6 |
| 1817 MS Alkmaar |
| The Netherlands |

Boehringer Ingelheim Animal Health Netherlands B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

Frontline Tri-act spot-on oplossing voor honden 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Boehringer Ingelheim Animal Health Netherlands B.V. |
| --- |
| Comeniusstraat 6 |
| 1817 MS Alkmaar |
| The Netherlands |

Boehringer Ingelheim Animal Health Netherlands B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

Frontline Tri-act spot-on oplossing voor honden 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Gujatal 100 mg/ml oplossing voor infusie voor paarden

Guaifenesin

100 mg/ml

Solution for infusion

Horse

Intravenous use

Netherlands

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Oxy L.A. INJ., 200 mg/ml oplossing voor injectie voor varkens en runderen

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Netherlands

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 20 mg spot-on oplossing voor kleine katten en kittens

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Netherlands

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 20 mg spot-on oplossing voor katten en kittens

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Netherlands

| Alfasan Nederland B.V. |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| The Netherlands |

Alfasan Nederland B.V.

Kuipersweg 9

3449 JA Woerden

The Netherlands

Sulfadimethoxine 20 % Pro inj, 200 mg per ml, voor runderen en varkens

Sulfadimethoxine sodium

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular, intravenous use

Poland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Poland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Poland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Poland

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Poland

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Poland

| ScanVet Poland Sp. z o.o. |
| --- |
| Gniezno, Skiereszewo |
| 62-200 Kiszkowska 9 |
| Poland |

ScanVet Poland Sp. z o.o.

Gniezno, Skiereszewo

62-200 Kiszkowska 9

Poland

Sul-Tridin 24 %

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular use

Poland

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 40/200 spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Poland

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 100/500 spot-on solution for dogs over 4 up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Poland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 0,4 ml spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Poland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 1 ml spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Poland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 0,4 ml spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Poland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 1 ml spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Portugal

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg solução para unção punctiforme para cães até 4 Kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Portugal

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg solução para unção punctiforme para cães com mais de 4 e até 10 Kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Portugal

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg solução para unção punctiforme para cães com mais de 10 e até 25 Kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11 |
| --- |
| 1800-294 Lisboa |
| Portugal |

Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Frontline Tri-Act Solução para unção puntiforme para cães 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11 |
| --- |
| 1800-294 Lisboa |
| Portugal |

Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Frontline Tri-Act Solução para unção puntiforme para cães 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Italy

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 500 mg/100 mg soluzione spot-on per cani oltre 4 kg fino a 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Italy

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 1250 mg/250 mg soluzione Spot-on per cani oltre 10 kg fino a 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 200 mg/40 mg solução para unção punctiforme para cães até 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 500 mg/100 mg solução para unção punctiforme para cães com mais de 4 e até 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Portugal

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 1250 mg/250 mg solução para unção punctiforme para cães com mais de 10 e até 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Romania

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Romania

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Romania

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40mg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Romania

| Belgica de Weerd B.V. |
| --- |
| Van de Reijtstraat 21 |
| 4814 NE Breda |
| The Netherlands |

Belgica de Weerd B.V.

Van de Reijtstraat 21

4814 NE Breda

The Netherlands

Belgafox 200 mg/ml

Norfloxacin

200 mg/ml

Oral solution

Pigeons- not used for human consumption

In drinking water use

Romania

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Oxy LA, inj, 200 mg/ml

Oxytetracycline

200 mg/ml

solution for injection

Cattle, pig

Intramuscular use

Romania

| Belgica de Weerd B.V. |
| --- |
| Van de Reijtstraat 21 |
| 4814 NE Breda |
| The Netherlands |

Belgica de Weerd B.V.

Van de Reijtstraat 21

4814 NE Breda

The Netherlands

Ornisol

Norfloxacin

120 mg/ml

Solution for use in drinking water

Pigeons- not used for human consumption

Oral use

Romania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Romania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act soluţie spot-on pentru câini de 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Slovak Republic

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg roztok na kvapkanie na kožu pre psov do 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Slovak Republic

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg roztok na kvapkanie na kožu pre psov od 4 kg do 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Slovak Republic

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg roztok na kvapkanie na kožu pre psov od 10 kg do 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Slovak Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on roztok na nakvapkanie na kožu pre psy 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Slovak Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on roztok na nakvapkanie na kožu pre psy 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act kožni nanos, raztopina za pse 2 — 5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act kožni nanos, raztopina za pse 5 — 10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg, kožni nanos, raztopina za pse do 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Slovenia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg, kožni nanos, raztopina za pse nad 4 kg do 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg, kožni nanos, raztopina za pse nad 10 kg do 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 40/200 spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Slovenia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 100/500 spot-on solution for dogs over 4 up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Spain

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 20 mg solucion spot-on para gatos pequenos

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Spain

| Boehringer Ingelheim Animal Health España S.A.U. |
| --- |
| C/Prat de la Riba, 50 |
| 08174 Sant Cugat del Valles (Barcelona) |
| Spain |

Boehringer Ingelheim Animal Health España S.A.U.

C/Prat de la Riba, 50

08174 Sant Cugat del Valles (Barcelona)

Spain

Frontline Tri-act Solucion spot-on para perros 2 — 5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

Spain

| Boehringer Ingelheim Animal Health España S.A.U. |
| --- |
| C/Prat de la Riba, 50 |
| 08174 Sant Cugat del Valles (Barcelona) |
| Spain |

Boehringer Ingelheim Animal Health España S.A.U.

C/Prat de la Riba, 50

08174 Sant Cugat del Valles (Barcelona)

Spain

Frontline Tri-act Solucion spot-on para perros 5 — 10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

Spain

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 40 mg/200 mg solución spot-on para perros de hasta 4 Kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Spain

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 100 mg/500 mg solución spot-on para perros de más de 4 kg hasta 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Spain

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Preventix 40 mg/200 mg solución spot-on para perros de hasta 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Spain

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Preventix 100 mg/500 mg solución spot-on para perros de más de 4 kg hasta 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg solucion para unción dorsal puntual para perros de hasta 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg solucion para unción dorsal puntual para perros de más de 4 kg hasta 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg solucion para unción dorsal puntual para perros de más de 10 kg hasta 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Spain

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 20 mg solucion spot-on para gatos y gatitos

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 200 mg/40 mg solucion para unción dorsal puntual para perros de hasta 4 Kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 500 mg/100 mg solucion para unción dorsal puntual para perros de más de 4 kg hasta 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 1250 mg/250 mg solucion para unción dorsal puntual para perros de más de 10 kg hasta 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Spain

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 0,4 ml Solucion spot-on para perros de hasta 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Spain

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 1 ml Solucion spot-on para perros de mas de 4 kg hasta 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Spain

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 0,4 ml solucion spot-on para perros de hasta 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

Spain

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 1 ml solucion spot-on para perros de mas de 4 kg hasta 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Daclotrix 200 mg/40 mg solucion para unción dorsal puntual para perros de hasta 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Spot-on use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Daclotrix 500 mg/100 mg solucion para unción dorsal puntual para perros de más de 4 kg hasta 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Daclotrix 1250 mg/250 mg solucion para unción dorsal puntual para perros de más de 10 kg hasta 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Spain

| Industrial Veterinaria, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat (Barcelona) |
| Spain |

Industrial Veterinaria, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat (Barcelona)

Spain

Oxitetraciclina Invesa 200 mg/ml L.A.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular use

Spain

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Insectivex

Cipermethrin

50 mg/ml

Concentrate for cutaneous spray, emulsion

Cattle, horse (non-food-producing)

Cutaneous use

Sweden

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Cutaneous use

Sweden

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Cutaneous use

UK/Northern Ireland1

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 200 mg/40 mg Spot-on Solution for Dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

UK/Northern Ireland1

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Pets Choice Limited |
| --- |
| Whitebirk Industrial Estate |
| Lower Philips Road, Blackburn BB1 5UD |
| United Kingdom |

Pets Choice Limited

Whitebirk Industrial Estate

Lower Philips Road, Blackburn BB1 5UD

United Kingdom

Bob Martin Clear Wormer 20mg Spot-on Solution for Cats and Kittens

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ezi-Wormer 20 mg spot-on solution for cats and kittens

Praziquantel

20 mg

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Boehringer Ingelheim Animal Health UK Limited |
| --- |
| Ellesfield Avenue |
| Bracknell RG12 8YS |
| United Kingdom |

Boehringer Ingelheim Animal Health UK Limited

Ellesfield Avenue

Bracknell RG12 8YS

United Kingdom

Frontline Tri-Act Spot-on Solution for Dogs 2-5 kg

Fipronil

Permethrin

33,8  mg/0,5 ml

252,4  mg/0,5 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Boehringer Ingelheim Animal Health UK Limited |
| --- |
| Ellesfield Avenue |
| Bracknell RG12 8YS |
| United Kingdom |

Boehringer Ingelheim Animal Health UK Limited

Ellesfield Avenue

Bracknell RG12 8YS

United Kingdom

Frontline Tri-Act Spot-on Solution for Dogs 5-10 kg

Fipronil

Permethrin

67,6  mg/ml

504,8  mg/ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Vetoquinol UK Limited |
| --- |
| Pury Hill Business Park, Steadings Barn |
| Towcester NN12 7LS |
| United Kingdom |

Vetoquinol UK Limited

Pury Hill Business Park, Steadings Barn

Towcester NN12 7LS

United Kingdom

Johnson's Easy Spot-On Solution Wormer for Cats & Kittens 20 mg

Praziquantel

20 mg

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Myorelax 100 mg/ml solution for infusion for horses

Guaifenesin

100 mg/ml

Solution for infusion

Horse

Intravenous use

UK/Northern Ireland1

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 20 mg spot-on solution for small cats and kittens

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Vetoquinol UK Limited |
| --- |
| Pury Hill Business Park, Steadings Barn |
| Towcester NN12 7LS |
| United Kingdom |

Vetoquinol UK Limited

Pury Hill Business Park, Steadings Barn

Towcester NN12 7LS

United Kingdom

Quantex 20 mg Spot-on Solution

Praziquantel

20 mg

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 20 mg spot-on solution for cats and kittens

Praziquantel

20 mg/0,5 ml

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

TapeNil 20 mg spot-on solution for cats and kittens

Praziquantel

20 mg

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Ceva Animal Health Ltd |
| --- |
| Unit 3, Anglo Office Park, White Lion Road |
| Amersham HP7 9FB |
| United Kingdom |

Ceva Animal Health Ltd

Unit 3, Anglo Office Park, White Lion Road

Amersham HP7 9FB

United Kingdom

Vectra 3D spot-on solution for dogs 1,5 –4 kg

Dinotefuran

Pyriproxyfen

Permethrin

44 mg/0,8 ml

3,9  mg/0,8 ml

317 mg/0,8 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Wormax 20 mg spot-on solution for cats and kittens

Praziquantel

20 mg

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

WormCat 20 mg spot-on solution for cats and kittens

Praziquantel

20 mg

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Vetoquinol UK Limited |
| --- |
| Pury Hill Business Park, Steadings Barn |
| Towcester NN12 7LS |
| United Kingdom |

Vetoquinol UK Limited

Pury Hill Business Park, Steadings Barn

Towcester NN12 7LS

United Kingdom

Wormclear praziquantel 20 mg spot-on solution for cats

Praziquantel

20 mg

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

WormIt 20 mg spot-on solution for cats and kittens

Praziquantel

20 mg

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 0,4 ml spot-on solution for dogs up to 4 kg

Imidacloprid

Permethrin

40 mg/0,4 ml

200 mg/0,4 ml

Spot-on solution

Dog

Cutaneous use

UK/Northern Ireland1

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 1 ml spot-on solution for dogs over 4 kg up to 10 kg

Imidacloprid

Permethrin

100 mg/ml

500 mg/ml

Spot-on solution

Dog

Cutaneous use

ANNEX IIC

List of nationally authorised veterinary medicinal products recommended for variation of the marketing authorisations (quantitative NMP concentration, target animal safety warnings and user safety warnings during application)

| Member State EU/EEA | Applicant/Marketing authorisation holder | Name | INN/Active substance | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Bayer Animal Health GmbH |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Member State EU/EEA

Applicant/Marketing authorisation holder

Name

INN/Active substance

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde über 10 kg bis 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Austria

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde über 25 kg bis 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Austria

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde über 40 kg bis 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Austria

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 20 mg/ml, Injektionslösung für Rinder, Schweine und Pferde

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Austria

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 5 mg/ml, injektionslösung für hunde und katzen

Meloxicam

5 mg/ml

Solution for injection

Dog, cat

Intravenous, subcutaneous use

Austria

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg lösung zum auftropfen für hunde über 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Austria

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès Barcelona |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès Barcelona

Spain

Cadorex 300 mg/ml Injektionslösung für Rinder, Schafe und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Austria

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Cyclosol L.A. 200 mg/ml, Injektionslösung, für Rinder und Schweine

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Austria

| Vana GmbH |
| --- |
| Wolfgang-Schmälzl-Gasse 6 |
| 1020 Wien |
| Austria |

Vana GmbH

Wolfgang-Schmälzl-Gasse 6

1020 Wien

Austria

Dexa ‘Vana’ 2 mg/ml — Injektionslösung für Tiere

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intrabursal, intramuscular, intravenous, periarticular, subcutaneous use

Austria

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml Injektionslösung

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Austria

| Vétoquinol SA |
| --- |
| Magny-Vernois, B.P. 189 |
| 70204 Lure Cedex |
| France |

Vétoquinol SA

Magny-Vernois, B.P. 189

70204 Lure Cedex

France

Droncit Spot-on 40 mg/ml Lösung zum Auftropfen auf die Haut für Katzen

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Austria

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 2,5 ml spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Austria

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 4 ml spot-on solution for dogs over 25 kg up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Austria

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 6 ml spot-on solution for dogs over 40 kg up to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Austria

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml Injektionslösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Austria

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Les Franqueses del Vallès (Barcelona) |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Les Franqueses del Vallès (Barcelona)

Spain

Florinject 300 mg/ml Injektionslösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Austria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act Lösung zum Auftropfen für Hunde 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Austria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act Lösung zum Auftropfen für Hunde 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Austria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act Lösung zum Auftropfen für Hunde 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Austria

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml lösung zum eingeben über das trinkwasser für schweine und hühner

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Austria

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol–T 20/100 mg/ml lösung zum eingeben für schweine und hühner

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken

Oral use

Austria

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol 300 mg/ml Injektionslösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Austria

| Intervet GesmbH |
| --- |
| Siemensstraße 107 |
| 1221 Vienna |
| Austria |

Intervet GesmbH

Siemensstraße 107

1221 Vienna

Austria

Nuflor 300 mg/ml Injektionslösung für Rinder und Schafe

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Austria

| Intervet GesmbH |
| --- |
| Siemensstraße 107 |
| 1221 Vienna |
| Austria |

Intervet GesmbH

Siemensstraße 107

1221 Vienna

Austria

Nuflor Schwein 300 mg/ml Injektionslösung

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Austria

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Prisulfan 24 % injektionslösung für tiere

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, sheep, dog

Intramuscular, intravenous, subcutaneous use

Austria

| Intervet GesmbH |
| --- |
| Siemensstraße 107 |
| 1221 Vienna |
| Austria |

Intervet GesmbH

Siemensstraße 107

1221 Vienna

Austria

Resflor 300/16,5  mg/ml Injektionslösung für Rinder

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Austria

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Riketron N 200 mg/ml + 40 mg/ml — Injektionslösung für Pferde, Rinder und Schweine

Trimethoprim

Sulfadimidine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous use

Austria

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml Injektionslösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Belgium

| Dechra Veterinary Products |
| --- |
| Achterstenhoek 48 |
| 2275 Lille |
| Belgium |

Dechra Veterinary Products

Achterstenhoek 48

2275 Lille

Belgium

Cyclosol 200 Long Acting

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Belgium

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Dexa 0,2  %

Dexamethasone

2 mg/ml

Solution for injection

Cattle

Intravenous use

Belgium

| Emdoka |
| --- |
| John Lijsenstraat 16 |
| 2321 Hoogstraten |
| Belgium |

Emdoka

John Lijsenstraat 16

2321 Hoogstraten

Belgium

Emdotrim 10 % SOL

Trimethoprim

Sulfadiazine

16,7  mg/ml

83,3  mg/ml

Solution for use in drinking water

Chicken

Oral use

Belgium

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Oxy-Kel 20 % Long Acting

Oxytetracycline

200 mg/ml

Solution for injection

Cattle

Intramuscular use

Belgium

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Prednisolone 1 %

Prednisolone

10 mg/ml

Solution for injection

Dog, cat

Intramuscular use

Belgium

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Prednisolone 2,5  %

Prednisolone

25 mg/ml

Solution for injection

Dog

Intramuscular use

Belgium

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Vetodexin 0,2  %

Dexamethasone

2,64  mg/ml

Solution for injection

Cattle, dog

Intramuscular use

Belgium

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 250/1250

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 400/2000

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 600/3000

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Ecomectin

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

Belgium

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Belgium

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Belgium

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Belgium

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor Minidose

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Belgium

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor swine

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Belgium

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor 300

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Belgium

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Belgium

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Belgium

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Les Franqueses del Vallès (Barcelona) |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Les Franqueses del Vallès (Barcelona)

Spain

Florinject

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Belgium

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Belgium

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Belgium

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S. Sol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Belgium

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Belgium

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Flodoex

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Belgium

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Belgium

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Bulgaria

| Kepro B.V., |
| --- |
| Maagdenburgstraat 17 |
| 7421 ZA Deventer |
| The Netherlands |

Kepro B.V.,

Maagdenburgstraat 17

7421 ZA Deventer

The Netherlands

Florum 20 % oral

Florfenicol

200 mg/ml

Solution for use in drinking water

Pig, chicken

In drinking water use

Bulgaria

| Crida Pharm S.R.L. |
| --- |
| Str. Intrarea Vagonetului, 2, 47 |
| Bucureşti |
| Romania |

Crida Pharm S.R.L.

Str. Intrarea Vagonetului, 2, 47

Bucureşti

Romania

Florcrid 10 % — BG

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Bulgaria

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml

solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Bulgaria

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Bulgaria

| Sudachim, Ltd |
| --- |
| str. Jordan Stubel 10A |
| 1700 Sofia |
| Bulgaria |

Sudachim, Ltd

str. Jordan Stubel 10A

1700 Sofia

Bulgaria

Florfenil 10 %

Florfenicol

100 mg/ml

Solution for use in drinking water

Pig, chicken

In drinking water use

Bulgaria

| Farma Vet Ltd. |
| --- |
| Shumen, 40 Otec Paisii str. |
| Bulgaria |

Farma Vet Ltd.

Shumen, 40 Otec Paisii str.

Bulgaria

Bisulvet

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, broiler

In drinking water use

Bulgaria

| Zavet JSC |
| --- |
| 7330 Zavet, 5, Kiril and Metodii str. |
| Bulgaria |

Zavet JSC

7330 Zavet, 5, Kiril and Metodii str.

Bulgaria

Florfenicol 10 % solution

Florfenicol

100 mg/ml

Oral solution

Pig, chicken

In drinking water use

Bulgaria

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

FlorFlu 300/16,5  mg/ml solution for injection for cattle

Florfenicol

Flunixin

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Bulgaria

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on solution for dogs over 10 up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Bulgaria

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on solution for dogs over 25 up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Bulgaria

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on solution for dogs over 40 kg up to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Bulgaria

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 20 mg/ml, solution for injection for cattle, pigs and horses

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Bulgaria

| Kepro B.V., |
| --- |
| Maagdenburgstraat 17 |
| 7421 ZA Deventer |
| The Netherlands |

Kepro B.V.,

Maagdenburgstraat 17

7421 ZA Deventer

The Netherlands

Kepcox 2,5  % oral

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

In drinking water use

Bulgaria

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml solution for injection for cattle, sheep and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Bulgaria

| Interchemie Werken De Adelaar BV |
| --- |
| Metalweeg 8 |
| 5804 CG Venray |
| The Netherlands |

Interchemie Werken De Adelaar BV

Metalweeg 8

5804 CG Venray

The Netherlands

Intertrim LA

Trimethoprim

Sulfadoxine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Bulgaria

| Interchemie Werken De Adelaar BV |
| --- |
| Metalweeg 8 |
| 5804 CG Venray |
| The Netherlands |

Interchemie Werken De Adelaar BV

Metalweeg 8

5804 CG Venray

The Netherlands

Introflor-100 oral

Florfenicol

100 mg/ml

Oral solution

Pig, chicken

In drinking water use

Bulgaria

| Asкlep-Pharma Ltd |
| --- |
| Lyulin 7, bl. 711A, shop. 3, |
| Sofia |
| Bulgaria |

Asкlep-Pharma Ltd

Lyulin 7, bl. 711A, shop. 3,

Sofia

Bulgaria

Norotrim Injection solution for injection for cattle, swine, horses, dogs and cats

Trimethoprim

Sulfadoxine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Bulgaria

| Asкlep-Pharma Ltd |
| --- |
| Lyulin 7, bl. 711A, shop. 3, |
| Sofia |
| Bulgaria |

Asкlep-Pharma Ltd

Lyulin 7, bl. 711A, shop. 3,

Sofia

Bulgaria

Norodine 24 injectable solution

Trimethoprim

Sulfadoxine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Bulgaria

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg spot-on solution for dogs over 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Bulgaria

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor, 300 mg/ml solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Bulgaria

| MSD Animal Health, Lda. |
| --- |
| Edifício Vasco da Gama, 19 |
| Quinta da Fonte, Porto Salvo |
| 2770-192 Paço de Arcos |
| Portugal |

MSD Animal Health, Lda.

Edifício Vasco da Gama, 19

Quinta da Fonte, Porto Salvo

2770-192 Paço de Arcos

Portugal

Resflor 300/16,5  mg/mL solution for injection for cattle

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Bulgaria

| Industrial Veterinaria, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat (Barcelona) |
| Spain |

Industrial Veterinaria, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat (Barcelona)

Spain

Promectine

Ivermectin

10 mg/ml

Solution for injection

Cattle, pig

Subcutaneous use

Bulgaria

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml solution for injection for cattle and swine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Bulgaria

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.-Sol

Trimethoprim

Sulfamethoxazole

20 mg/ml

80 mg/ml

Oral solution

Pig, chicken

In drinking water use

Bulgaria

| Vetprom AD |
| --- |
| 2400, Radomir, 26 Otetc Paisii str. |
| Bulgaria |

Vetprom AD

2400, Radomir, 26 Otetc Paisii str.

Bulgaria

Thiamphenicol — 20 % solutio pro injectionibus 100 ml

Thiamphenicol

Procain Hydrochloride

200 000 IU/ml

0,01  g/ml

Solution for injection

Cattle, chicken

Intramuscular, oral use

Bulgaria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Bulgaria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Bulgaria

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Bulgaria

| Vet Pro Komers Ltd |
| --- |
| 4000 Plovdiv, JK Trakia, bl. 189, vh. B, app. 2 |
| Bulgaria |

Vet Pro Komers Ltd

4000 Plovdiv, JK Trakia, bl. 189, vh. B, app. 2

Bulgaria

Inspector Quadro K

Fipronil

Praziquantel

Pyriproxyfen

Moxidectin

107 mg/ml

42,8  mg/ml

21,4  mg/ml

10,7  mg/ml

Spot-on solution

Cat

Cutaneous use

Bulgaria

| Vet Pro Komers Ltd |
| --- |
| 4000 Plovdiv, JK Trakia, bl. 189, vh. B, app. 2 |
| Bulgaria |

Vet Pro Komers Ltd

4000 Plovdiv, JK Trakia, bl. 189, vh. B, app. 2

Bulgaria

Inspector Quadro C

Fipronil

Praziquantel

Pyriproxyfen

Moxidectin

107 mg/ml

42,8  mg/ml

21,4  mg/ml

10,7  mg/ml

Spot-on solution

Dog

Cutaneous use

Croatia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on, otopina za nakapavanje, za pse od 10 do 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on, otopina za nakapavanje, za pse od 25 do 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on, otopina za nakapavanje, za pse od 40 do 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa, 2000 mg/400 mg, otopina za nakapavanje, za pse od 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex, 300 mg/mL, otopina za injekciju, za goveda, ovce i svinje

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Croatia

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/mL + 40 mg/mL, otopina za injekciju

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Croatia

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen, 300 mg/mL, otopina za injekciju, za goveda i svinje

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Croatia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, otopina za nakapavanje, za pse 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, otopina za nakapavanje, za pse 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, otopina za nakapavanje, za pse 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Croatia

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol, 300 mg/mL, otopina za injekciju, za goveda i svinje

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Croatia

| Intervet International B.V. |
| --- |
| Podružnica u RH Ivana Lučića 2a |
| 10000 Zagreb |
| Croatia |

Intervet International B.V.

Podružnica u RH Ivana Lučića 2a

10000 Zagreb

Croatia

Resflor, otopina za injekciju, za goveda

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Croatia

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Riketron N, 200 mg/mL + 40 mg/mL, otopina za injekciju za goveda, konje i svinje

Trimethoprim

Sulfadimidine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous use

Croatia

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/mL, otopina za injekciju, za goveda i svinje

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Croatia

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.-sol, 20/100 mg/mL, otopina za primjenu u vodi za piće, za svinje i kokoši

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Cyprus

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor 300/16,5  mg/ml ενέσιμο διάλυμα για βοοειδή

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Cyprus

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor swine injectable solution 300 mg/ml

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Cyprus

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Tetroxy LA 200 mg/ml solution for injection

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Cyprus

| Σπύρος Σταυρινίδης Κέμικαλς Λτδ |
| --- |
| Λεωφ. Στασίνου 28, |
| 1060 Λευκωσία, Κύπρος |
| Τηλ. 22 447464 |

Σπύρος Σταυρινίδης Κέμικαλς Λτδ

Λεωφ. Στασίνου 28,

1060 Λευκωσία, Κύπρος

Τηλ. 22 447464

Norodine 24 Ενέσιμο Διάλυμα

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Cyprus

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on διάλυμα για σκύλους από 25kg έως 40kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Cyprus

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on διάλυμα για σκύλους από 10kg έως 25kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Cyprus

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-on διάλυμα για σκύλους άνω των 40 kg έως 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Cyprus

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on διάλυμα επίχυσης για σκύλους 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Cyprus

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on διάλυμα επίχυσης για σκύλους 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Cyprus

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on διάλυμα επίχυσης για σκύλους 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Cyprus

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 20 mg/ml, ενέσιμο διάλυμα για βοοειδή, χοίρους και άλογα

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Cyprus

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml ενέσιμο διάλυμα για βοοειδή και χοίρους

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Cyprus

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml, ενέσιμο διάλυμα για βοοειδή, πρόβατα και χοίρους

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Cyprus

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300mg/ml ενέσιμο διάλυμα για βοοειδή και χοίρους

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Cyprus

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml, ενέσιμο διάλυμα για βοοειδή και χοίρους

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Czech Republic

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix roztok pro nakapání na kůži — spot-on pro psy od 40 kg do 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Czech Republic

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix roztok pro nakapání na kůži — spot-on pro psy od 10 do 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix roztok pro nakapání na kůži — spot-on pro psy od 25 kg do 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Czech Republic

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 20 mg/ml, injekční roztok pro skot, prasata a koně

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Czech Republic

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg roztok pro nakapání na kůži — spot-on pro psy nad 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml injekční roztok pro skot, ovce a prasata

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Czech Republic

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml injekční roztok pro skot a prasata

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Czech Republic

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml injekční roztok pro skot a prasata

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Czech Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act roztok pro nakapání na kůži — spot-on pro psy 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act roztok pro nakapání na kůži — spot-on pro psy 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act roztok pro nakapání na kůži — spot-on pro psy 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Czech Republic

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml roztok pro podání v pitné vodě pro prasata a kura domácího

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Czech Republic

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol 20/100 mg/ml roztok pro podání v pitné vodě pro prasata a kura domácího

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Czech Republic

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml injekční roztok pro skot a prasata

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Czech Republic

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol 300 mg/ml, injekční roztok pro skot a prasata

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Czech Republic

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 40/200 mg/ml injekční roztok

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Czech Republic

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor Minidose 450 mg/ml injekční roztok pro skot

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Czech Republic

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor 300 mg/ml injekční roztok

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Czech Republic

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor 300/16,5  mg/ml injekční roztok pro skot

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Czech Republic

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml injekční roztok pro skot a prasata

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Czech Republic

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Terralon 200 mg/ml LA injekční roztok

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Czech Republic

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Vetodexin 2 mg/ml injekční roztok

Dexamethasone

2 mg/ml

Solution for injection

Dog, cat

Intramuscular use

Denmark

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic Vet.

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Denmark

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic Vet. til hunde 10-25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Denmark

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic Vet. til hunde 25-40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Denmark

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex Vet.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Denmark

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Ecomectin pour-on vet.

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

Denmark

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Denmark

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Denmark

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect (til hunde 20-40 kg)

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Cutaneous use

Denmark

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect (til hunde 10-20 kg)

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Cutaneous use

Denmark

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect (til hunde 40-60 kg)

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Cutaneous use

Denmark

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Kelaflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Denmark

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Denmark

| ScanVet Animal Health A/S |
| --- |
| Kongevejen 66 |
| 3480 Fredensborg |
| Denmark |

ScanVet Animal Health A/S

Kongevejen 66

3480 Fredensborg

Denmark

Norodine Vet.

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Denmark

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor Minidose

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Denmark

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor Vet.

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Denmark

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor Vet.

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Denmark

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Denmark

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Suprim Vet

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Denmark

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Terralon Prolongatum Vet.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Denmark

| Bimeda Animal Health Limited |
| --- |
| Broomhill Road |
| Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

Broomhill Road

Dublin 24

Ireland

Tetroxy Prolongatum Vet.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Denmark

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Veticyclin Pronlongatum Vet.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Estonia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Estonia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Estonia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Spot-on use

Estonia

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Estonia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Estonia

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Estonia

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Estonia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Estonia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Estonia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Estonia

| Interchemie Werken De Adelaar Eesti AS |
| --- |
| Vanapere tee 14 |
| Viimsi 74013 Harjumaa |
| Estonia |

Interchemie Werken De Adelaar Eesti AS

Vanapere tee 14

Viimsi 74013 Harjumaa

Estonia

Introflor-300

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Estonia

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Metaxol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Estonia

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 24

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Estonia

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Estonia

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Estonia

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Tetroxy L.A.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Estonia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Estonia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Finland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa vet koirille, jotka painavat yli 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Finland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet koirille 10–25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Finland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet koirille 25–40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Finland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet koirille 40–60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Finland

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès Barcelona |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès Barcelona

Spain

Cadorex Vet.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Finland

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Florselect Vet.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Finland

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 10–20 kg:n painoiselle koiralle

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Cutaneous use

Finland

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 20–40 kg:n painoiselle koiralle

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Cutaneous use

Finland

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 40–60 kg:n painoiselle koiralle

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Cutaneous use

Finland

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor vet Minidose

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Finland

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor vet.

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

France

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Cyclosol 200 LA

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

France

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Terralon 20 % LA

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

France

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Panadia

Tetracyclin (as hydrochloride)

Procain (as hydrochloride)

80 mg/mL

17,30  mg/ml

Powder and solvent for solution for injection

Cattle

Intramuscular use

France

| Vétoquinol SA |
| --- |
| Magny-Vernois, B.P. 189 |
| 70204 Lure Cedex |
| France |

Vétoquinol SA

Magny-Vernois, B.P. 189

70204 Lure Cedex

France

Longicine

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

France

| Dopharma France |
| --- |
| 23 Rue du Prieure |
| 44150 Vair sur Loire |
| France |

Dopharma France

23 Rue du Prieure

44150 Vair sur Loire

France

Remacycline L.A.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

France

| Intervet |
| --- |
| Rue Olivier de Serres |
| 49071 Beaucouze Cedex |
| France |

Intervet

Rue Olivier de Serres

49071 Beaucouze Cedex

France

Resflor solution injectable

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Floron 450 mg/ml solution injectable pour bovins

Florfenicol

450 mg/ml

Solution for injection

Cattle

Subcutaneous use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act solution pour spot-on pour chiens 10 — 20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act solution pour spot-on pour chiens 20 — 40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act solution pour spot-on pour chiens 40 — 60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontect solution pour spot-on pour chiens 10 — 20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Cutaneous use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontect solution pour spot-on pour chiens 20 — 40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Cutaneous use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontect solution pour spot-on pour chiens 40 — 60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Cutaneous use

France

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix chien moyen

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

France

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix grand chien

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg solution pour spot-on pour chiens de plus de 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

France

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml solution injectable pour bovins ovins et porcins

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

France

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Les Franqueses del Vallès (Barcelona) |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Les Franqueses del Vallès (Barcelona)

Spain

Calflor 300 mg/ml solution injectable pour bovins et porcins

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

France

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml solution injectable

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

France

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House, Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House, Barrow Street

Dublin 4, D04 TR29

Ireland

Divamectin pour-on

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

France

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Endectine Pour-on

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

France

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml solution injectable pour bovins et porcins

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

France

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml solution injectable pour bovins et porcins

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

France

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis 300 mg/ml solution injectable pour bovins

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Florflu 300/16,5  mg/ml solution injectable pour bovins

Florfenicol

Flunixin

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

France

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol 20/100 mg/ml, solution pour utilisation dans l'eau de boisson pour porcs et poulets

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

France

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml solution injectable pour bovins et porcins

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

France

| Intervet |
| --- |
| Rue Olivier de Serres |
| 49071 Beaucouze Cedex |
| France |

Intervet

Rue Olivier de Serres

49071 Beaucouze Cedex

France

Nuflor 300 mg/ml solution injectable pour bovins et ovins

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

France

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor 450 solution injectable pour bovins

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

France

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Permetrix biocanina 2000 mg/400 mg solution pour spot-on pour chiens de plus de 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

France

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 60 mg solution pour spot-on pour chats de grande taille

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

France

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Qualimec pour-on

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

France

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 40 mg solution pour spot-on pour chats moyens

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

France

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 60 mg solution pour spot-on pour grands chats

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

France

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

France

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| The Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

T.s.-sol 20/100 mg/ml solution pour administration dans l'eau de boisson pour porcs et poulets

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Germany

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde über 10 kg bis 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Germany

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde über 25 kg bis 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Germany

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on Lösung zum Auftropfen auf die Haut für Hunde über 40 kg bis 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Germany

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 20 mg/ml

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Germany

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 5 mg/ml

Meloxicam

5 mg/ml

Solution for injection

Dog, cat

Intravenous, subcutaneous use

Germany

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg lösung zum auftropfen für hunde über 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Germany

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Bigram

Trimethoprim

Sulfadimidine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous use

Germany

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès Barcelona |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès Barcelona

Spain

Cadorex 300 mg/ml Injektionslösung für Rinder, Schafe und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Germany

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 2000 mg/400 mg lösung zum auftropfen für hunde über 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Germany

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Diatrim 200 mg/ml + 40 mg/ml Injektionslösung

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Germany

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Dophamec 5 mg/ml rind pour-on

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

Germany

| Vétoquinol SA |
| --- |
| Magny-Vernois, B.P. 189 |
| 70204 Lure Cedex |
| France |

Vétoquinol SA

Magny-Vernois, B.P. 189

70204 Lure Cedex

France

Droncit Spot-on 40 mg/ml

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Germany

| Ceva Tiergesundheit GmbH |
| --- |
| Kanzlerstr. 4 |
| 40472 Düsseldorf |
| Germany |

Ceva Tiergesundheit GmbH

Kanzlerstr. 4

40472 Düsseldorf

Germany

Fletic spot on Maxi

Permethrin

744 mg/ml

Spot-on solution

Dog

Spot-on use

Germany

| Ceva Tiergesundheit GmbH |
| --- |
| Kanzlerstr. 4 |
| 40472 Düsseldorf |
| Germany |

Ceva Tiergesundheit GmbH

Kanzlerstr. 4

40472 Düsseldorf

Germany

Fletic spot on Mini

Permethrin

744 mg/ml

Spot-on solution

Dog

Spot-on use

Germany

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml Injektionslösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Germany

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml Injektionslösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Germany

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis 300 mg/ml Injektionslösung für Rinder, Schafe und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Germany

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

FlorFlu

Florfenicol

Flunixin

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Germany

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Les Franqueses del Vallès (Barcelona) |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Les Franqueses del Vallès (Barcelona)

Spain

Florinject 300 mg/ml Injektionslösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Germany

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55216 Ingelheim |
| Germany |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55216 Ingelheim

Germany

Frontline Tri-Act Lösung zum Auftropfen für Hunde 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Germany

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55216 Ingelheim |
| Germany |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55216 Ingelheim

Germany

Frontline Tri-Act Lösung zum Auftropfen für Hunde 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Germany

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55216 Ingelheim |
| Germany |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55216 Ingelheim

Germany

Frontline Tri-Act Lösung zum Auftropfen für Hunde 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Germany

| Bremer Pharma Gmbh |
| --- |
| Werkstrasse 42 |
| 34414 Warburg |
| Germany |

Bremer Pharma Gmbh

Werkstrasse 42

34414 Warburg

Germany

Hefrotrim

Trimethoprim

Sulfadimidine sodium

40 mg/ml

215,8  mg/ml

Solution for injection

Cattle, pig

Intramuscular, intravenous use

Germany

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml lösung zum eingeben über das trinkwasser für schweine und hühner

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Germany

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml Injektionslösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Germany

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol 300 mg/ml Injektionslösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| 85716 Unterschleißheim |
| Germany |

Intervet Deutschland GmbH

Feldstr. 1a

85716 Unterschleißheim

Germany

Nuflor Minidose

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Germany

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 60 mg lösung zum auftropfen für große katzen

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Germany

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Qualimec Rind Pour-on

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| 85716 Unterschleißheim |
| Germany |

Intervet Deutschland GmbH

Feldstr. 1a

85716 Unterschleißheim

Germany

Resflor

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Germany

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 40 mg lösung zum auftropfen für mittelgroße katzen

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Germany

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 60 mg Lösung zum Auftropfen für große Katzen

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Germany

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Riketron N Injektionslösung

Trimethoprim

Sulfadimidine sodium

40 mg/ml

215,8  mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous use

Germany

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml Injektionlösung für Rinder und Schweine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Germany

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.Sol 20/100 mg/ml

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Germany

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

TMPS oral

Trimethoprim

Sulfamethoxazole

20 mg/ml

80 mg/ml

Solution for use in drinking water

Chicken

Oral use

Germany

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Trimethosel

Trimethoprim

Sulfadimidine sodium

40 mg/ml

215,8  mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous use

Germany

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| 31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

31303 Burgdorf

Germany

Vitamin D3 1,000 .000 I.E. ad us. vet.

Colecalciferol

25 mg/ml

Solution for injection

Cattle

Intramuscular, intravenous use

Germany

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol-T 20/100 mg/ml

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Oral solution

Pig, broiler

In drinking water use

Germany

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 2,5 ml spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Germany

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 4 ml spot-on solution for dogs over 25 kg up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Germany

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 6 ml spot-on solution for dogs over 40 kg up to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Germany

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 250 mg/1250 mg spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Germany

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 400 mg/2000 mg spot-on solution for dogs over 25 kg up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Germany

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 2,5 ml spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Germany

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 4 ml spot-on solution for dogs over 25 kg up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Germany

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 6 ml spot-on solution for dogs over 40 kg up to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Greece

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Greece

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Greece

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Greece

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Greece

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen Inj.Sol 300 mg/ml

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Greece

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Greece

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Greece

| Bimeda Chemicals Ltd |
| --- |
| Broomhill Road |
| Dublin 24 |
| Ireland |

Bimeda Chemicals Ltd

Broomhill Road

Dublin 24

Ireland

Hostacyclin

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Greece

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Greece

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Greece

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Greece

| Intervet Hellas A.E. |
| --- |
| Ag. Dimitriou 63 |
| 174 55 Alimos, Athens |
| Greece |

Intervet Hellas A.E.

Ag. Dimitriou 63

174 55 Alimos, Athens

Greece

Nuflor Minidose

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Greece

| Intervet Hellas A.E. |
| --- |
| Ag. Dimitriou 63 |
| 174 55 Alimos, Athens |
| Greece |

Intervet Hellas A.E.

Ag. Dimitriou 63

174 55 Alimos, Athens

Greece

Nuflor Inj.Sol 300 mg/ml

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Greece

| Intervet Hellas A.E. |
| --- |
| Ag. Dimitriou 63 |
| 174 55 Alimos, Athens |
| Greece |

Intervet Hellas A.E.

Ag. Dimitriou 63

174 55 Alimos, Athens

Greece

Nuflor swine

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Greece

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Oxylong

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Greece

| Intervet Hellas A.E. |
| --- |
| Ag. Dimitriou 63 |
| 174 55 Alimos, Athens |
| Greece |

Intervet Hellas A.E.

Ag. Dimitriou 63

174 55 Alimos, Athens

Greece

Resflor

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Greece

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan Inj.Sol

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Greece

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S-Sol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Greece

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Greece

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act spot-on.so (135,2 + 1 009,6 )mg/2ml pipette

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Greece

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act spot-on.so (270,4 + 2 019,2 )mg/4ml

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Greece

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-act spot-on.so (405,6 + 3 028,8 )mg/6ml pipette

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Greece

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix spot-on.so

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Greece

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix spot-on.so

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Greece

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Greece

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Greece

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Greece

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Greece

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Cyclosol LA

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Greece

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Divamectin

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

Greece

| Γ. ΤΡΑΪΚΟΥΔΗΣ & ΣΙΑ ΕΠΕ (Δ.Τ. FARMA-MIX ΕΠΕ) |
| --- |
| 17 km Thessalonikis-Drymos |
| Serron Drymos 57200 |
| Greece |

Γ. ΤΡΑΪΚΟΥΔΗΣ & ΣΙΑ ΕΠΕ (Δ.Τ. FARMA-MIX ΕΠΕ)

17 km Thessalonikis-Drymos

Serron Drymos 57200

Greece

Farma Mix Florfarm

Florfenicol

100 mg/ml

Solution for use in drinking water

Broiler

Oral use

Greece

| Intervet Hellas A.E. |
| --- |
| Ag. Dimitriou 63 |
| 174 55 Alimos, Athens |
| Greece |

Intervet Hellas A.E.

Ag. Dimitriou 63

174 55 Alimos, Athens

Greece

Florvetol Cattle

Florfenicol

300 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Greece

| Intervet Hellas A.E. |
| --- |
| Ag. Dimitriou 63 |
| 174 55 Alimos, Athens |
| Greece |

Intervet Hellas A.E.

Ag. Dimitriou 63

174 55 Alimos, Athens

Greece

Florvetol Swine

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Greece

| Bremer Pharma Gmbh |
| --- |
| Werkstrasse 42 |
| 34414 Warburg |
| Germany |

Bremer Pharma Gmbh

Werkstrasse 42

34414 Warburg

Germany

Hefrotrim

Trimethoprim

Sulfadimidine

40 mg/ml

215,8  mg/ml

Solution for injection

Calf, pig

Intramuscular, intravenous use

Hungary

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot on 10-25 kg közötti kutyáknak A.U.V.

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Hungary

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot on 25-40 kg közötti kutyáknak A.U.V.

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Hungary

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot on 40-60 kg közötti kutyáknak A.U.V.

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Hungary

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan 20 mg/ml oldatos injekció szarvasmarhák, sertések és lovak számára A.U.V.

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Hungary

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg rácsepegtető oldat 25 kg feletii kutyáknak A.U.V.

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Hungary

| Dr. Jozsef Varga |
| --- |
| 7100 Szekszárd, Rozsnyai Matyas u. 15 |
| Hungary |

Dr. Jozsef Varga

7100 Szekszárd, Rozsnyai Matyas u. 15

Hungary

Bobi bolhairtó sampon kutyák részére A.U.V.

Permethrin

Tetrametrin

933 mg/100 ml

23,5  mg/100 ml

Shampoo

Dog

External use

Hungary

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml oldatos injekció szarvasmarhák, juhok és sertések számára A.U.V.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Hungary

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Cyclosol LA 200 mg/ml oldatos injekció A.U.V.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Hungary

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml oldatos injekció

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Hungary

| Univet Limited |
| --- |
| Tullyvin |
| Cootehill, Co. Cavan |
| Ireland |

Univet Limited

Tullyvin

Cootehill, Co. Cavan

Ireland

Diaziprim oldatos injekció szarvasmarhák és sertések részére A.U.V.

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Suspension for injection

Cattle, pig

Intramuscular use

Hungary

| Cenavisa, S.L. |
| --- |
| Camí Pedra Estela s/n |
| 43205 Reus |
| Spain |

Cenavisa, S.L.

Camí Pedra Estela s/n

43205 Reus

Spain

Doxycen belsőleges oldat

Doxycycline hyclate

200 mg/ml

Oral solution

Pig, chicken

In drinking water use

Hungary

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml oldatos injekció szarvasmarhák és sertések számára A.U.V.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Hungary

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml oldatos injekció szarvasmarhák és sertések számára A.U.V.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Hungary

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis 300 mg/ml oldatos injekció szarvasmarhák, juhok és sertések részére A.U.V.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Hungary

| Merial |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Merial

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act rácsepegtető oldat 10-20 kg-os kutyáknak

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Hungary

| Merial |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Merial

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act rácsepegtető oldat 20-40 kg-os kutyáknak

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Hungary

| Merial |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Merial

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act rácsepegtető oldat 40-60 kg-os kutyáknak

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Hungary

| Industrial Veterinaria, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat (Barcelona) |
| Spain |

Industrial Veterinaria, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat (Barcelona)

Spain

Ivergen Premium L.A. oldatos injekció szarvasmarhák, sertések és juhok részére A.U.V.

Ivermectin

10 mg/ml

Solution for injection

Cattle, pig, sheep

Subcutaneous use

Hungary

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml oldat ivóvízbe keveréshez sertések és házityúkok számára A.U.V.

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Hungary

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol T 20/100 mg/ml oldat ivóvízbe keveréshez sertések és házityúkok számára A.U.V.

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken

Oral use

Hungary

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml oldatos injekció szarvasmarhák és sertések számára A.U.V.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Hungary

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Neocyclin LA injekció A.U.V.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle

Intramuscular, intravenous use

Hungary

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol 300 mg/ml oldatos injekció szarvasmarha és sertés részére

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Hungary

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 200/40 mg/ml oldatos injekció A.U.V.

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Hungary

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor injekció A.U.V.

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Hungary

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor Minidose 450 mg/ml injekció szarvasmarha részére

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Hungary

| Alfasan International B.V. |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| The Netherlands |

Alfasan International B.V.

Kuipersweg 9

3449 JA Woerden

The Netherlands

Primaphenon 200 mg/ml oldatos injekció kutyák részére A.U.V.

Phenylbutazone

200 mg/ml

Solution for injection

Dog

Intravenous use

Hungary

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Remacycline L.A. 200 mg/ml oldatos injekció A.U.V.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Hungary

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor 300/16,5  mg/ml injekció szarvasmarhák részére A.U.V.

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Hungary

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml oldatos injekció szarvasmarha és sertés részére A.U.V.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Hungary

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.-sol 20/100 mg/ml oldat ivóvízbe keveréshez sertések és házityúkok számára A.U.V.

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Hungary

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Terralon 20 % L.A. injekció A.U.V.

Oxytetracycline

20 g/100 ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular, subcutaneous use

Iceland

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Florselect vet. 300 mg/ml Stungulyf, lausn Nautgripir og svín

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Ireland

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis 300 mg/ml solution for injection for cattle, sheep and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 60 mg spot-on solution for large cats

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 40 mg spot-on solution for medium cats

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 60 mg spot-on solution for large cats

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Ireland

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 20 mg/ml, solution for injection for cattle, pigs and horses

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Ireland

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml solution for injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Ireland

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on solution for dogs over 40 kg up to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Ireland

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml solution for injection for cattle, sheep and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Ireland

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml solution for use in drinking water for pigs and chickens

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg spot-on solution for dogs over 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Ireland

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml Solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Ireland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol 300 mg/ml solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Ireland

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Les Franqueses del Vallès (Barcelona) |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Les Franqueses del Vallès (Barcelona)

Spain

Florinject 300 mg/ml solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Ireland

| Intervet Ireland Limited |
| --- |
| Magna Business Park, Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited

Magna Business Park, Citywest Road

Dublin 24

Ireland

Nuflor 300 mg/ml solution for injection for cattle and sheep

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Ireland

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Ireland

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Ireland

| Pharmaq AS |
| --- |
| Skogmo Industriområde |
| Industrivegen 50 |
| 7863 Overhalla |
| Norway |

Pharmaq AS

Skogmo Industriområde

Industrivegen 50

7863 Overhalla

Norway

AMX 10 mg/ml concentrate for solution for fish treatment

Deltamethrin

10 mg/ml

Concentrate for solution for fish treatment

Atlantic salmon, Rainbow trout

Water-borne use

Ireland

| Intervet Ireland Limited |
| --- |
| Magna Business Park, Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited

Magna Business Park, Citywest Road

Dublin 24

Ireland

Nuflor Minidose 450 mg/ml solution for injection for cattle

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Ireland

| Interchem (Ireland) Ltd. |
| --- |
| 29 Cookstown Industrial Estate |
| Dublin 24 |
| Ireland |

Interchem (Ireland) Ltd.

29 Cookstown Industrial Estate

Dublin 24

Ireland

Sulphamet 40/200 Solution for Injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Ireland

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml solution for injection for cattle and swine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Ireland

| Intervet Ireland Limited |
| --- |
| Magna Business Park, Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited

Magna Business Park, Citywest Road

Dublin 24

Ireland

Resflor 300/16,5  mg/mL solution for injection for cattle

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Ireland

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Acomec 5 mg/ml Pour-On Solution for Cattle

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

Ireland

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Fatromectin 5 mg/ml pour-on solution for cattle

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

Ireland

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Ireland

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Advantix Spot-on solution for dogs over 25 kg up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Ireland

| Intervet Ireland Limited |
| --- |
| Magna Business Park, Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited

Magna Business Park, Citywest Road

Dublin 24

Ireland

Nuflor Swine 300 mg/ml solution for injection

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Ireland

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Imec 5 mg/ml pour-on solution for cattle

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

Ireland

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Qualimec Cattle Pour-on

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

Ireland

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Bimectin 0,5  % cattle pour-on solution

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

Ireland

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Kilo-mec 0,5  % pour-on solution for cattle

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

Ireland

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Mastermectin 0,5  % pour-on solution for cattle

Ivermectin

0,5  % w/v/ml

Pour-on solution

Cattle

Topical use

Ireland

| AlfaMed Ltd. |
| --- |
| Unit 6, Fermoy Enterprise Park |
| Fermoy, Co. Cork |
| Ireland |

AlfaMed Ltd.

Unit 6, Fermoy Enterprise Park

Fermoy, Co. Cork

Ireland

Alfatrim 40/200 Solution for Injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Ireland

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Osmonds Lineout 0,5  % Pour-on

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

Ireland

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Ecomectin 5 mg/ml pour-on solution for cattle

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

Ireland

| Chem-Pharm Ltd. |
| --- |
| Ballyvaughan, Co. Clare |
| Ireland |

Chem-Pharm Ltd.

Ballyvaughan, Co. Clare

Ireland

Intertrim solution for injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Ireland

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Oxycomplex NS Solution for Injection

Oxytetracycline

Flunixin Meglumine

100 mg/ml

20 mg/ml

Solution for injection

Cattle

Intramuscular, intravenous use

Ireland

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Primidoxine solution for injection

Trimethoprim

Sulfadoxine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Ireland

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Co-Trimoxazole 24 % w/v solution for injection

Trimethoprim

Sulfamethoxazole

40 mg/ml

200 mg/ml

Solution for injection

Cattle

Intramuscular use

Ireland

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Oxytetracycline 20 % w/v L.A. Solution for Injection.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle

Intramuscular use

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Chanoprim solution for injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Ireland

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Cyclosol LA 200 mg/ml solution for injection

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Ireland

| Univet Limited |
| --- |
| Tullyvin |
| Cootehill, Co. Cavan |
| Ireland |

Univet Limited

Tullyvin

Cootehill, Co. Cavan

Ireland

Aquaprim Solution for Injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Ireland

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Tetroxy LA 200 mg/ml Solution for Injection

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Ireland

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 24 % solution for injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 2000 mg/400 mg spot-on solution for dogs over 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Ireland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 2,5 millilitre(s) spot-on solution

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Ireland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 4,0 millilitre(s) spot-on solution

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Ireland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 6,0 millilitre(s) spot-on solution

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Ireland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 2,5 ml spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Ireland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 4 ml spot-on solution for dogs over 25 kg up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Ireland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Daclotrix 2000 mg/400 mg spot-on solution for dogs over 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Ireland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 6 ml spot-on solution for dogs over 40 kg up to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Advantix Spot-on per cani oltre 10 kg fino a 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Advantix Spot-on per cani oltre 25 kg fino a 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Advantix Spot-on per cani oltre 40 kg fino a 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Italy

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan 20 mg/ml, soluzione iniettabile per bovini, suini e cavalli

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Italy

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg soluzione spot-on per cani oltre 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Italy

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml soluzione iniettabile per bovini, ovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Italy

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 24 soluzione iniettabile per bovini, equini, suini, cani e gatti

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intravenous, subcutaneous use

Italy

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 40 mg soluzione spot-on per gatti di taglia media.

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Italy

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 60 mg soluzione spot-on per gatti di taglia grande

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Italy

| Fatro S.p.A. |
| --- |
| Via Emilia, 285 |
| Ozzano Emilia (BO) |
| Italy |

Fatro S.p.A.

Via Emilia, 285

Ozzano Emilia (BO)

Italy

Denfus spray, spray cutaneo per bovini

Thiamphenicol

3,750  g

Cutaneous spray, solution

Cattle

Cutaneous use

Italy

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml soluzione iniettabile

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Italy

| Vétoquinol SA |
| --- |
| Magny-Vernois, B.P. 189 |
| 70204 Lure Cedex |
| France |

Vétoquinol SA

Magny-Vernois, B.P. 189

70204 Lure Cedex

France

Droncit Spot-on 20 mg soluzione spot-on per gatti

Praziquantel

20 mg

Spot-on Solution

Cat

Spot-on use

Italy

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Ecomectin 5 mg/ml pour-on bovini

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

Italy

| Fatro S.p.A. |
| --- |
| Via Emilia, 285 |
| Ozzano Emilia (BO) |
| Italy |

Fatro S.p.A.

Via Emilia, 285

Ozzano Emilia (BO)

Italy

Effe 70 300  mg/ml soluzione iniettabile per bovini, ovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Italy

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Fatromectin 5 mg/ml soluzione pour-on per bovini

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

Italy

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml soluzione iniettabile per bovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Italy

| Unione Commerciale Lombarda S.p.A. |
| --- |
| Via G. Di Vittorio, 36 |
| 25125 Brescia |
| Italy |

Unione Commerciale Lombarda S.p.A.

Via G. Di Vittorio, 36

25125 Brescia

Italy

Florfen 300 mg/ml soluzione iniettabile per bovini, suini di peso superiore a 35 kg e scrofe.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Italy

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml soluzione iniettabile per bovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Italy

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Florflu 300/16,5  mg/ml soluzione iniettabile per bovini

Florfenicol

Flunixin

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Italy

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Barcelona |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Barcelona

Spain

Florinject 300 mg/ml soluzione iniettabile per bovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Italy

| Laboratorios Karizoo, S.A. |
| --- |
| Pol. Industrial La Borda |
| Mas Pujades, 11-12 |
| 08140 Barcelona |
| Spain |

Laboratorios Karizoo, S.A.

Pol. Industrial La Borda

Mas Pujades, 11-12

08140 Barcelona

Spain

Florfeksyl 300 mg/ml soluzione iniettabile per bovini, ovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Italy

| Intervet |
| --- |
| Rue Olivier de Serres |
| 49071 Beaucouze Cedex |
| France |

Intervet

Rue Olivier de Serres

49071 Beaucouze Cedex

France

Florvetol bovini iniettabile

Florfenicol

300 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Italy

| Intervet |
| --- |
| Rue Olivier de Serres |
| 49071 Beaucouze Cedex |
| France |

Intervet

Rue Olivier de Serres

49071 Beaucouze Cedex

France

Florvetol suini

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Italy

| Boehringer Ingelheim Animal Health Italia S.p.A. |
| --- |
| Via Lorenzini 8 |
| 20139 Milano |
| Italy |

Boehringer Ingelheim Animal Health Italia S.p.A.

Via Lorenzini 8

20139 Milano

Italy

Frontline Tri-Act soluzione spot-on per cani 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog (10-20 kg)

Spot-on use

Italy

| Boehringer Ingelheim Animal Health Italia S.p.A. |
| --- |
| Via Lorenzini 8 |
| 20139 Milano |
| Italy |

Boehringer Ingelheim Animal Health Italia S.p.A.

Via Lorenzini 8

20139 Milano

Italy

Frontline Tri-Act soluzione spot-on per cani 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog (20-40 kg)

Spot-on use

Italy

| Boehringer Ingelheim Animal Health Italia S.p.A. |
| --- |
| Via Lorenzini 8 |
| 20139 Milano |
| Italy |

Boehringer Ingelheim Animal Health Italia S.p.A.

Via Lorenzini 8

20139 Milano

Italy

Frontline Tri-Act soluzione spot-on per cani 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog (40- 60 kg)

Spot-on use

Italy

| Laboratorios Karizoo, S.A. |
| --- |
| Pol. Industrial La Borda |
| Mas Pujades, 11-12 |
| 08140 Caldes De Montbui (Barcelona) |
| Spain |

Laboratorios Karizoo, S.A.

Pol. Industrial La Borda

Mas Pujades, 11-12

08140 Caldes De Montbui (Barcelona)

Spain

K-Flor 300 mg/ml soluzione iniettabile per bovini, ovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Italy

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml soluzione per uso nell'acqua da bere per suini e polli

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Italy

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol 20/100 mg/ml soluzione per uso in acqua da bere per suini e polli

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Italy

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml, soluzione iniettabile per bovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Italy

| Fatro S.p.A. |
| --- |
| Via Emilia, 285 |
| Ozzano Emilia (BO) |
| Italy |

Fatro S.p.A.

Via Emilia, 285

Ozzano Emilia (BO)

Italy

Neopridimet soluzione orale, 200 mg + 40 mg/ml, per uso in acqua da bere per polli da carne e conigli.

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for use in drinking water

Broiler, rabbit

Oral use

Italy

| MSD Animal Health S.r.l |
| --- |
| Via Fratelli Cervi snc |
| Palazzo Canova |
| 20054 Segrate (MI) |
| Italy |

MSD Animal Health S.r.l

Via Fratelli Cervi snc

Palazzo Canova

20054 Segrate (MI)

Italy

Nuflor 300 mg/ml soluzione iniettabile per bovini e ovini

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Italy

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor minidose 450 mg/ml, soluzione iniettabile per bovini

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Italy

| MSD Animal Health S.r.l |
| --- |
| Via Fratelli Cervi snc |
| Palazzo Canova |
| 20054 Segrate (MI) |
| Italy |

MSD Animal Health S.r.l

Via Fratelli Cervi snc

Palazzo Canova

20054 Segrate (MI)

Italy

Nuflor Suini Iniettabile

300 mg/ml soluzione iniettabile

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Italy

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

OxyTF Long Acting, 200 mg/ml soluzione iniettabile per bovini e suini

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petcuten Spot-on per cani oltre 10 kg fino a 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petcuten Spot-on per cani oltre 25 kg fino a 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petcuten soluzione spot-on per cani oltre 40 kg fino a 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petsidill spot-on per cani oltre 10 kg fino a 25 Kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on Solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petsidill Spot-on per cani oltre 25 kg fino a 40 Kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on Solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Petsidill spot-on per cani oltre 40 Kg fino a 60 Kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on Solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Poli-Ecto soluzione spot-on per cani oltre 10 kg fino a 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Poli-Ecto soluzione spot-on per cani oltre 25 kg fino a 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Italy

| Elanco Italia S.p.A. |
| --- |
| Via dei Colatori, 12 |
| 50019 Sesto Fiorentino (FI) |
| Italy |

Elanco Italia S.p.A.

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Poli-Ecto soluzione spot-on per cani oltre 40 kg fino a 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Italy

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 60 mg soluzione spot-on per gatti di taglia grande

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Italy

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Preventix soluzione spot-on per cani oltre 10 kg fino a 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Italy

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Preventix soluzione spot-on per cani oltre 25 kg fino a 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Italy

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix soluzione spot-on per cani oltre 10 kg fino a 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Italy

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix soluzione spot-on per cani oltre 25 kg fino a 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Italy

| Intervet |
| --- |
| Rue Olivier de Serres |
| 49071 Beaucouze Cedex |
| France |

Intervet

Rue Olivier de Serres

49071 Beaucouze Cedex

France

Resflor 300/16,5  mg/ml soluzione iniettabile per bovini

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Italy

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml, soluzione iniettabile, per bovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Italy

| Dox-al Italia S.p.A. |
| --- |
| Piazzale Cadorna 10 |
| 20123 Milano |
| Italy |

Dox-al Italia S.p.A.

Piazzale Cadorna 10

20123 Milano

Italy

Sulfatrimdox 200 g/l + 40 g/l soluzione orale per uso in acqua da bere per polli da carne e conigli

Trimethoprim

Sulfadiazine

40 g/l

200 g/l

Oral solution

Broiler, rabbit

In drinking water use

Italy

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Syvaflor 300 mg/ml soluzione iniettabile per bovini, ovini e suini

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Italy

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.-sol 20/100 mg/ml, soluzione per uso nell’acqua da bere per suini e polli

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Italy

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Terralon 20 % L.A. 200 mg/ml soluzione iniettabile per bovini, suini, ovini e caprini.

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular, intravenous use

Italy

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Italy

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Italy

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Italy

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Italy

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Italy

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Latvia

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Terralon LA 200 mg/ml šķīdums injekcijām liellopiem, aitām, kazām un cūkām

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular, subcutaneous use

Latvia

| Bremer Pharma Gmbh |
| --- |
| Werkstrasse 42 |
| 34414 Warburg |
| Germany |

Bremer Pharma Gmbh

Werkstrasse 42

34414 Warburg

Germany

Hefrotrim šķīdums injekcijām zirgiem, liellopiem, cūkām, suņiem, kaķiem

Trimethoprim

Sulfadimidine sodium

40 mg/ml

215,8  mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous use

Latvia

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml šķīdums injekcijām liellopiem un cūkām

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Latvia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act šķīdums pilināšanai uz ādas suņiem 10 — 20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog (10-20 kg)

Spot-on use

Latvia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act šķīdums pilināšanai uz ādas suņiem 20 — 40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog (20-40 kg)

Spot-on use

Latvia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act šķīdums pilināšanai uz ādas suņiem 40 — 60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog (40- 60 kg)

Spot-on use

Latvia

| Bremer Pharma Gmbh |
| --- |
| Werkstrasse 42 |
| 34414 Warburg |
| Germany |

Bremer Pharma Gmbh

Werkstrasse 42

34414 Warburg

Germany

Trimethosulf šķīdums injekcijām liellopiem, aitām, cūkām, suņiem, kaķiem

Trimethoprim

Sulfathiazole

Sulfadiazine

Sulfamerazine

40 mg/ml

40 mg/ml

60 mg/ml

100 mg/ml

Solution for injection

Cattle, pig, sheep, dog, cat

Intramuscular use

Latvia

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Barcelona |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Barcelona

Spain

Cadorex 300 mg/ml šķīdums injekcijām liellopiem, aitām un cūkām

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Latvia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix šķīdums pilināšanai uz ādas suņiem 40 — 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Spot-on use

Latvia

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 24 šķīdums injekcijām zirgiem, liellopiem, cūkām, suņiem un kaķiem

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Latvia

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml šķīdums injekcijām liellopiem un cūkām

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Latvia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg šķīdums pilināšanai uz ādas suņiem virs 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg)

Spot-on use

Latvia

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Tetroxy L.A. 200 mg/ml šķīdums injekcijām liellopiem, aitām un cūkām

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Latvia

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan 20 mg/ml šķīdums injekcijām liellopiem, cūkām un zirgiem

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Latvia

| UAB Interchemie werken De Adelaar LT |
| --- |
| Terminalo g.13, Biruliškės |
| LT-54469, Kauno r. |
| Lithuania |

UAB Interchemie werken De Adelaar LT

Terminalo g.13, Biruliškės

LT-54469, Kauno r.

Lithuania

LV Tiamulin Oral 125 mg/ml šķīdums lietošanai ar dzeramo ūdeni cūkām, vistām un tītariem

Tiamulin hydrogen fumarate

125 mg/ml

Solution for use in drinking water

Pig, chicken, turkey

In drinking water use

Latvia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 250 mg/1250 mg šķīdums pilināšanai uz ādas suņiem no 10 kg līdz 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Latvia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 400 mg/2000 mg šķīdums pilināšanai uz ādas suņiem no 25 kg līdz 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Lithuania

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 24, injekcinis tirpalas

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Lithuania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix, užlašinamasis tirpalas > 40–60 kg svorio šunims

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix, užlašinamasis tirpalas > 10-25 kg svorio šunims

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix, užlašinamasis tirpalas > 25-40 kg svorio šunims

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Tetroxy LA 200 mg/ml injekcinis tirpalas

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Lithuania

| UAB Interchemie werken De Adelaar LT |
| --- |
| Terminalo g.13, Biruliškės |
| LT-54469, Kauno r. |
| Lithuania |

UAB Interchemie werken De Adelaar LT

Terminalo g.13, Biruliškės

LT-54469, Kauno r.

Lithuania

Introflor-100, 100 mg/ml geriamasis tirpalas kiaulėms ir paukščiams

Florfenicol

10 mg/ml

Oral solution

Pig, chicken

In drinking water use

Lithuania

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Terralon LA, 200 mg/ml, injekcinis tirpalas galvijams, avims, ožkoms ir kiaulėms

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular, subcutaneous use

Lithuania

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Remacycline L.A.200 mg/ml injekcinis tirpalas galvijams, avims ir kiaulėms

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Lithuania

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Dexa-Kel 02, injekcinis tirpalas

Dexamethasone

2,64  mg/ml

Solution for injection

Cattle, horse, dog

Intramuscular, intravenous, intraarticular use

Lithuania

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.-SOL, geriamasis tirpalas

Trimethoprim

Sulfamethoxazole

20 mg/ml

80 mg/ml

Oral solution

Pig, chicken

In drinking water use

Lithuania

| Industrial Veterinaria, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Barcelona |
| Spain |

Industrial Veterinaria, S.A.

C/ Esmeralda, 19

08950 Barcelona

Spain

Promectine 10 mg/ml, injekcinis tirpalas galvijams ir kiaulėms

Ivermectin

10 mg/ml

Solution for injection

Cattle, pig

Subcutaneous use

Lithuania

| UAB Interchemie werken De Adelaar LT |
| --- |
| Terminalo g.13, Biruliškės |
| LT-54469, Kauno r. |
| Lithuania |

UAB Interchemie werken De Adelaar LT

Terminalo g.13, Biruliškės

LT-54469, Kauno r.

Lithuania

Intertrim 200/40 mg/ml injekcinis tirpalas

Trimethoprim

Sulfamethoxazole

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular use

Lithuania

| UAB Interchemie werken De Adelaar LT |
| --- |
| Terminalo g.13, Biruliškės |
| LT-54469, Kauno r. |
| Lithuania |

UAB Interchemie werken De Adelaar LT

Terminalo g.13, Biruliškės

LT-54469, Kauno r.

Lithuania

Tiasan 100 mg/ml injekcinis tirpalas kiaulėms

Tiamulin

100 mg/ml

Solution for injection

Pig

Intramuscular use

Lithuania

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Cyclosol LA 200 mg/ml, injekcinis tirpalas

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Lithuania

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml, injekcinis tirpalas galvijams ir kiaulėms

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Lithuania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, užlašinamasis tirpalas 40-60 kg šunims

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, užlašinamasis tirpalas 10-20 kg šunims

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act, užlašinamasis tirpalas 20-40 kg šunims

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg užlašinamasis tirpalas šunims, sveriantiems daugiau kaip 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Lithuania

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml injekcinis tirpalas galvijams ir kiaulėms

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Lithuania

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml tirpalas, skirtas naudoti su geriamuoju vandeniu

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Lithuania

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan 20 mg/ml, injekcinis tirpalas galvijams, kiaulėms ir arkliams

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Lithuania

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor, 300 mg +16,5  mg/ml injekcinis tirpalas galvijams

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Lithuania

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 250/1250 spot-on solution for dogs over 10 up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Lithuania

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 400/2000 spot-on solution for dogs over 25 up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Luxembourg

| Dechra Veterinary Products |
| --- |
| Achterstenhoek 48 |
| 2275 Lille |
| Belgium |

Dechra Veterinary Products

Achterstenhoek 48

2275 Lille

Belgium

Cyclosol 200 Long Acting

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Luxembourg

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Dexa 0,2  %

Dexamethasone

2 mg/ml

Solution for injection

Cattle

Intravenous use

Luxembourg

| Emdoka |
| --- |
| John Lijsenstraat 16 |
| 2321 Hoogstraten |
| Belgium |

Emdoka

John Lijsenstraat 16

2321 Hoogstraten

Belgium

Emdotrim 10 % SOL

Trimethoprim

Sulfadiazine

16,7  mg/ml

83,3  mg/ml

Solution for use in drinking water

Chicken

Oral use

Luxembourg

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Oxy-Kel 20 % Long Acting

Oxytetracycline

200 mg/ml

Solution for injection

Cattle

Intramuscular use

Luxembourg

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Prednisolone 1 %

Prednisolone

10 mg/ml

Solution for injection

Dog, cat

Intramuscular use

Luxembourg

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Prednisolone 2,5  %

Prednisolone

25 mg/ml

Solution for injection

Dog

Intramuscular use

Luxembourg

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Vetodexin 0,2  %

Dexamethasone

2,64  mg/ml

Solution for injection

Cattle, dog

Intramuscular use

Luxembourg

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 250/1250

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 400/2000

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Dog 600/3000

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontline Protect voor honden 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Ecomectin

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

Luxembourg

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Luxembourg

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Luxembourg

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Luxembourg

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor Minidose

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Luxembourg

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor swine

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Luxembourg

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor 300

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Luxembourg

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Luxembourg

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Luxembourg

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Barcelona |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Barcelona

Spain

Florinject

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Luxembourg

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium S.A. |
| --- |
| Arnaud Fraiteurlaan 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium S.A.

Arnaud Fraiteurlaan 15-23

1050 Brussels

Belgium

Frontect voor honden 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Luxembourg

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Luxembourg

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S. Sol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Luxembourg

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Luxembourg

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Barcelona |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Barcelona

Spain

Flodoex

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Luxembourg

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Luxembourg

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Malta

| Kepro B.V., |
| --- |
| Maagdenburgstraat 17 |
| 7421 ZA Deventer |
| The Netherlands |

Kepro B.V.,

Maagdenburgstraat 17

7421 ZA Deventer

The Netherlands

Florum 20 % Oral

Florfenicol

200 mg/ml

Solution for use in drinking water

Pig, poultry (broiler)

Oral use

Malta

| Kepro B.V., |
| --- |
| Maagdenburgstraat 17 |
| 7421 ZA Deventer |
| The Netherlands |

Kepro B.V.,

Maagdenburgstraat 17

7421 ZA Deventer

The Netherlands

Kepcox 2,5  % Oral

Toltrazuril

25 mg/ml

Oral solution

Chicken (pullets, breeders), turkey

In drinking water use

Malta

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Riketron, 200 mg/ml + 40 mg/ml, solution for injection for horses, cattle, pigs

Trimethoprim

Sulfadimidine sodium

40 mg/ml

215,8  mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous use

Malta

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Vetodexin 0,2  % solution for injection

Dexamethasone

2,64  mg/ml

Solution for injection

Cattle, dog

Intramuscular use

Malta

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml solution for injection for cattle and swine

Florfenicol

300 mg/ml

Solution for injection

Cattle, swine

Intramuscular use

Malta

| Cenavisa, S.L. |
| --- |
| Camí Pedra Estela s/n |
| 43205 Reus |
| Spain |

Cenavisa, S.L.

Camí Pedra Estela s/n

43205 Reus

Spain

Florfenicen 300 mg/ml injectable solution for cattle, sheep and pig

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Malta

| Interchemie Werken De Adelaar Eesti AS |
| --- |
| Vanapere tee 14 |
| Viimsi 74013 Harjumaa |
| Estonia |

Interchemie Werken De Adelaar Eesti AS

Vanapere tee 14

Viimsi 74013 Harjumaa

Estonia

Introflor-300 solution for injection for cattle and sheep

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Malta

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 10- 20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Malta

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 20- 40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Malta

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on solution for dogs 40 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot-on oplossing voor honden vanaf 10 kg tot 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot-on oplossing voor honden vanaf 25 kg tot 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot-on solution voor honden van meer dan 40 kg tot 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Netherlands

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 20 mg/ml, oplossing voor injectie voor rundvee, varkens en paarden

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Netherlands

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg spot-on oplossing voor honden met een gewicht van meer dan 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml oplossing voor injectie voor runderen, schaapen en varken

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Cyclosol LA, 200 mg/ml oplossing voor injectie

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml oplossing voor injectie

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml oplossing voor injectie

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, subcutaneous use

Netherlands

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Dophamec cattle pour-on, pour-on oplossing voor runderen

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Far tmps 20/80 mg, oplossing voor oraal gebruik in drinkwater voor vleeskuikens

Trimethoprim

Sulfamethoxazole

20 mg/ml

80 mg/ml

Solution for use in drinking water

Chicken (broiler)

In drinking water use

Netherlands

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml oplossing voor injectie voor runderen en varkens

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Netherlands

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml, oplossing voor injectie voor runderen en varkens

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Netherlands

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis 300 mg/ml oplossing voor injectie voor runderen, schapen en varkens

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Netherlands

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Les Franqueses del Vallès (Barcelona) |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Les Franqueses del Vallès (Barcelona)

Spain

Florinject 300 mg/ml oplossing voor injectie voor rund en varken

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Netherlands

| Boehringer Ingelheim Animal Health Netherlands B.V. |
| --- |
| Comeniusstraat 6 |
| 1817 MS Alkmaar |
| The Netherlands |

Boehringer Ingelheim Animal Health Netherlands B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

Frontline Tri-act spot-on oplossing voor honden 10–20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Boehringer Ingelheim Animal Health Netherlands B.V. |
| --- |
| Comeniusstraat 6 |
| 1817 MS Alkmaar |
| The Netherlands |

Boehringer Ingelheim Animal Health Netherlands B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

Frontline Tri-act spot-on oplossing voor honden 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Boehringer Ingelheim Animal Health Netherlands B.V. |
| --- |
| Comeniusstraat 6 |
| 1817 MS Alkmaar |
| The Netherlands |

Boehringer Ingelheim Animal Health Netherlands B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

Frontline Tri-act spot-on oplossing voor honden 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml oplossing voor gebruik in drinkwater voor varkens en kippen

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol 20/100 mg/ml oplossing voor gebruik in drinkwater voor varkens en kippen

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol-T 20/100 mg/ml orale oplossing voor varkens en slachtkuikens

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Oral solution

Pig, broiler

In drinking water use

Netherlands

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml oplossing voor injectie voor runderen en varkens

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Netherlands

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol 300 mg/ml oplossing voor injectie voor runderen en varkens

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Netherlands

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 24, 40/200 mg, oplossing voor injectie

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, calf, pig, dog, cat

Intramuscular use

Netherlands

| Intervet Nederland BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet Nederland BV

Wim de Körverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor Minidose 450 mg/ml oplossing voor injectie voor runderen

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Netherlands

| Intervet Nederland BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet Nederland BV

Wim de Körverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor swine injectable 300 mg/ml oplossing voor injectie

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Netherlands

| Intervet Nederland BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet Nederland BV

Wim de Körverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor 300 mg/ml oplossing voor injectie voor runderen en schapen

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Petcuten spot-on oplossing voor honden van meer dan 10 kg tot en met 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Petcuten spot-on oplossing voor honden van meer dan 25 kg tot en met 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Netherlands

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Petcuten spot-on oplossing voor honden van meer dan 40 kg tot en met 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Netherlands

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 60 mg spot-on oplossing voor grote katten

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Netherlands

| Intervet Nederland BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet Nederland BV

Wim de Körverstraat 35

5831 AN Boxmeer

Netherlands

Resflor 300/16,5  mg/ml oplossing voor injectie voor runderen

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Netherlands

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 40 mg spot-on oplossing voor middelgrote katten

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Netherlands

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 60 mg spot-on oplossing voor grote katten

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Netherlands

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml, oplossing voor injectie voor runderen en varkens.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Netherlands

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T. S. Sol 20/100 mg/ml, oplossing voor gebruik in drinkwater voor varkens en kippen

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Netherlands

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.-Sol, oplossing voor drinkwatermedicatie voor varkens en slachtkippen

Trimethoprim

Sulfamethoxazole

20 mg/ml

80 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Netherlands

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.-Sol 20/100, oplossing voor orale toediening voor vleesvarkens en vleeskuikens.

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Oral solution

Pig (fattening pigs), chicken (broiler)

In drinking water use

Netherlands

| Veterinaire Groothandel Wijchen B.V. |
| --- |
| Graafschap Hornelaan 137A |
| 6001 AC Weert |
| Nederland |

Veterinaire Groothandel Wijchen B.V.

Graafschap Hornelaan 137A

6001 AC Weert

Nederland

Advantix 250/1250 spot-on oplossing voor honden

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Netherlands

| Veterinaire Groothandel Wijchen B.V. |
| --- |
| Graafschap Hornelaan 137A |
| 6001 AC Weert |
| Nederland |

Veterinaire Groothandel Wijchen B.V.

Graafschap Hornelaan 137A

6001 AC Weert

Nederland

Advantix 400/2000 spot-on oplossing voor honden

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Netherlands

| Polymeds B.V. |
| --- |
| Osloweg 99A |
| 9723BK Groningen |
| Nederland |

Polymeds B.V.

Osloweg 99A

9723BK Groningen

Nederland

Advantix spot-on oplossing voor honden vanaf 10 kg tot 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Netherlands

| Polymeds B.V. |
| --- |
| Osloweg 99A |
| 9723BK Groningen |
| Nederland |

Polymeds B.V.

Osloweg 99A

9723BK Groningen

Nederland

Advantix spot-on oplossing voor honden vanaf 25 kg tot 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Netherlands

| Polymeds B.V. |
| --- |
| Osloweg 99A |
| 9723BK Groningen |
| Nederland |

Polymeds B.V.

Osloweg 99A

9723BK Groningen

Nederland

Advantix spot-on oplossing voor honden vanaf 10 kg tot 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Norway

| Pharmaq AS |
| --- |
| Postboks 267 Skøyen |
| 0213 Oslo |
| Norway |

Pharmaq AS

Postboks 267 Skøyen

0213 Oslo

Norway

Alpha Max

Deltamethrin

10 mg/ml

Concentrate for solution for fish treatment

Atlantic salmon, Rainbow trout

Water-borne use

Norway

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Norway

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Norway

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Bayvantic vet

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Norway

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor vet

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Norway

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Florselect vet

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Poland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-On (250 mg + 1250 mg)/2,5 ml; roztwór do nakrapiania

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Poland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix Spot-On (400 mg + 2000 mg)/4 ml; roztwór do nakrapiania

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Poland

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan

Meloxicam

5 mg/ml

Solution for injection

Dog, cat

Intravenous, subcutaneous use

Poland

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Poland

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Poland

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Barcelona |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Barcelona

Spain

Cadorex

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Poland

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Poland

| Biofaktor Sp. z o.o. |
| --- |
| Skierniewice 96-100 |
| Czysta 4 |
| Poland |

Biofaktor Sp. z o.o.

Skierniewice 96-100

Czysta 4

Poland

Ditrisol

Trimethoprim

Sulfamethoxazole

20 mg/ml

80 mg/ml

Oral solution

Pig, chicken

In drinking water use

Poland

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Poland

| Przedsiębiorstwo Farmaceutyczne Okoniewscy ‘Vetos-Farma’ Sp. z o.o. |
| --- |
| Bielawa 58-260 Dzierżoniowska 21 |
| Poland |

Przedsiębiorstwo Farmaceutyczne Okoniewscy ‘Vetos-Farma’ Sp. z o.o.

Bielawa 58-260 Dzierżoniowska 21

Poland

Florfenikol Vetos-Farma

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Poland

| Przedsiębiorstwo Farmaceutyczne Okoniewscy ‘Vetos-Farma’ Sp. z o.o. |
| --- |
| Bielawa 58-260 Dzierżoniowska 21 |
| Poland |

Przedsiębiorstwo Farmaceutyczne Okoniewscy ‘Vetos-Farma’ Sp. z o.o.

Bielawa 58-260 Dzierżoniowska 21

Poland

Florfenikol Vetos-Farma

Florfenicol

26,75  mg/ml

(2,5  g/100 g)

Oral solution

Chicken

In drinking water use

Poland

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Poland

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Poland

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Poland

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Poland

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Kelaflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Poland

| Lovapharm Consulting B.V. |
| --- |
| Eindhoven 5645 KH Rijsven 3 |
| The Netherlands |

Lovapharm Consulting B.V.

Eindhoven 5645 KH Rijsven 3

The Netherlands

Lovaflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Poland

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Poland

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Poland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Poland

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor 300 mg/ml roztwór do wstrzykiwań dla bydła i świń

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Poland

| Mevet, S.A.U. |
| --- |
| Av. Industria, Pol. Industrial El Segre, parcela 409-410, |
| 25191 Lleida |
| Spain |

Mevet, S.A.U.

Av. Industria, Pol. Industrial El Segre, parcela 409-410,

25191 Lleida

Spain

Pulmovall

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Poland

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor 300/16,5  mg/ml roztwór do wstrzykiwań dla bydła

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Poland

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml roztwór do wstrzykiwań dla bydła i świń

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Poland

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Trimsulfasol

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Poland

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Trimsulfasol, (80 mg + 20 mg)/ ml, roztwór doustny dla świń i kur

Trimethoprim

Sulfamethoxazole

20 mg/ml

80 mg/ml

Oral solution

Pig, chicken

In drinking water use

Poland

| Laboratorios Karizoo, S.A. |
| --- |
| Pol. Industrial La Borda |
| Mas Pujades, 11-12 |
| 08140 Barcelona |
| Spain |

Laboratorios Karizoo, S.A.

Pol. Industrial La Borda

Mas Pujades, 11-12

08140 Barcelona

Spain

Florfeksyl 300 mg/ml solution for injection for cattle, sheep and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Poland

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 250/1250 spot-on solution for dogs over 10 up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Poland

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 400/2000 spot-on solution for dogs over 25 up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Poland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 2,5 ml spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Poland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 4 ml spot-on solution for dogs over 25 kg up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Poland

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 6 ml spot-on solution for dogs over 40 kg up to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Poland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 2,5 ml spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Poland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 4 ml spot-on solution for dogs over 25 kg up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Poland

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 6 ml spot-on solution for dogs over 40 kg up to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Poland

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot-on (600 mg + 3000 mg)/6 ml; roztwór do nakrapiania

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Portugal

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solução para unção punctiforme para cães com mais de 10 kg até 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solução para unção punctiforme para cães com mais de 25 kg até 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Portugal

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solução para unção punctiforme para cães com mais de 40 kg até 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Portugal

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan 20 mg/ml, solução injetável para bovinos, suínos e equinos

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Portugal

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg solução para unção punctiforme para cães com mais de 25 Kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml, solução injetável para bovinos, ovinos e suínos

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Portugal

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml solução injetável para bovinos e suínos

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Portugal

| Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11 |
| --- |
| 1800-294 Lisboa |
| Portugal |

Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Frontline Tri-Act Solução para unção puntiforme para cães 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11 |
| --- |
| 1800-294 Lisboa |
| Portugal |

Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Frontline Tri-Act Solução para unção puntiforme para cães 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11 |
| --- |
| 1800-294 Lisboa |
| Portugal |

Boehringer Ingelheim Animal Health Portugal Unipessoal, Lda. Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Frontline Tri-Act Solução para unção puntiforme para cães 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml solução para administração na água de bebida para suínos e frangos

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Portugal

| MSD Animal Health, Lda. |
| --- |
| Edifício Vasco da Gama, 19 |
| Quinta da Fonte, Porto Salvo |
| 2770-192 Paço de Arcos |
| Portugal |

MSD Animal Health, Lda.

Edifício Vasco da Gama, 19

Quinta da Fonte, Porto Salvo

2770-192 Paço de Arcos

Portugal

Resflor 300/16,5  mg/ml Solução Injetável para Bovinos

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Portugal

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml, solução injectável para bovinos e suínos

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Italy

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Terralon LA 200 mg/ml šķīdums injekcijām liellopiem, aitām, kazām un cūkām

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular, subcutaneous use

Italy

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 2000 mg/400 mg soluzione Spot-on per cani oltre 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 2000 mg/400 mg solução para unção punctiforme para cães com mais de 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Portugal

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml solução injetável

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Portugal

| Cenavisa, S.L. |
| --- |
| Camí Pedra Estela s/n |
| 43205 Reus |
| Spain |

Cenavisa, S.L.

Camí Pedra Estela s/n

43205 Reus

Spain

Doxycen 200 mg/ml solução oral para suínos e frangos de engorda

Doxycycline

200 mg/ml

Oral solution

Pig, broiler

In drinking water use

Portugal

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis 300 mg/ml Solução injetável para bovinos, ovinos e suínos

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Portugal

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml solução injetável para bovinos e suínos

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Portugal

| Mevet, S.A.U. |
| --- |
| Av. Industria, Pol. Industrial El Segre, parcela 409-410, |
| 25191 Lleida |
| Spain |

Mevet, S.A.U.

Av. Industria, Pol. Industrial El Segre, parcela 409-410,

25191 Lleida

Spain

Pulmovall 300 mg/ml solução injetável para bovinos, ovinos e suínos

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Portugal

| MSD Animal Health, Lda. |
| --- |
| Edifício Vasco da Gama, 19 |
| Quinta da Fonte, Porto Salvo |
| 2770-192 Paço de Arcos |
| Portugal |

MSD Animal Health, Lda.

Edifício Vasco da Gama, 19

Quinta da Fonte, Porto Salvo

2770-192 Paço de Arcos

Portugal

Nuflor Minidose 450 mg/ml solução injetável para bovinos

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Portugal

| Calier Portugal, S.A. |
| --- |
| Centro Empresarial Sintra Estoril II |
| 2710 — 335 Sintra |
| Portugal |

Calier Portugal, S.A.

Centro Empresarial Sintra Estoril II

2710 — 335 Sintra

Portugal

Florinject 300 mg/ml solução injetável para bovinos e suínos

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Portugal

| Cenavisa, S.L. |
| --- |
| Camí Pedra Estela s/n |
| 43205 Reus |
| Spain |

Cenavisa, S.L.

Camí Pedra Estela s/n

43205 Reus

Spain

Cenflor 300 mg/ml solução injetável para bovinos, ovinos e suínos

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Portugal

| MSD Animal Health, Lda. |
| --- |
| Edifício Vasco da Gama, 19 |
| Quinta da Fonte, Porto Salvo |
| 2770-192 Paço de Arcos |
| Portugal |

MSD Animal Health, Lda.

Edifício Vasco da Gama, 19

Quinta da Fonte, Porto Salvo

2770-192 Paço de Arcos

Portugal

Nuflor 300 mg/ml solução injetável para bovinos e ovinos

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Portugal

| MSD Animal Health, Lda. |
| --- |
| Edifício Vasco da Gama, 19 |
| Quinta da Fonte, Porto Salvo |
| 2770-192 Paço de Arcos |
| Portugal |

MSD Animal Health, Lda.

Edifício Vasco da Gama, 19

Quinta da Fonte, Porto Salvo

2770-192 Paço de Arcos

Portugal

Nuflor 300 mg/ml solução injetável para suínos

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Portugal

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Portugal

| Eco Animal Health Europe Limited |
| --- |
| 6th Floor, South Bank House |
| Barrow Street |
| Dublin 4, D04 TR29 |
| Ireland |

Eco Animal Health Europe Limited

6th Floor, South Bank House

Barrow Street

Dublin 4, D04 TR29

Ireland

Ecomectin

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

Romania

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Romania

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Les Franqueses del Vallès (Barcelona) |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Les Franqueses del Vallès (Barcelona)

Spain

Florinject 300 mg/ml solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Romania

| Crida Pharm S.R.L. |
| --- |
| Str. Intrarea Vagonetului, 2, 47 |
| Bucureşti |
| Romania |

Crida Pharm S.R.L.

Str. Intrarea Vagonetului, 2, 47

Bucureşti

Romania

Florcrid Inj.

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Romania

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Remacycline LA, 200 mg/ml

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Romania

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Romania

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Dexaveto 0,2  %

Dexamethasone sodium phosphate

2,64  mg/ml

Solution for injection

Cattle, horse, pig, goat, dog, cat

Intramuscular, intravenous, intraarticular use

Romania

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml solution for injection for cattle, sheep and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Romania

| Mevet, S.A.U. |
| --- |
| Av. Industria, Pol. Industrial El Segre, parcela 409-410, |
| 25191 Lleida |
| Spain |

Mevet, S.A.U.

Av. Industria, Pol. Industrial El Segre, parcela 409-410,

25191 Lleida

Spain

Pulmoval 300 mg/ml solution for injection for cattle, sheep and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Romania

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis 300 mg/ml solution for injection for cattle, sheep and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Romania

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

FlorFlu 300/16,5

Florfenicol

Flunixin

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Romania

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.-SOL 20/100 mg/ml

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Romania

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Romania

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor 300/16,5  mg/ml

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Romania

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor 300 mg/ml

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Romania

| S.C. Delos Impex '96 S.R.L. |
| --- |
| Str. Horia, Cloşca şi Crişan, nr. 81 |
| Otopeni, Jud. Ilfov, 075100 |
| Romania |

S.C. Delos Impex '96 S.R.L.

Str. Horia, Cloşca şi Crişan, nr. 81

Otopeni, Jud. Ilfov, 075100

Romania

Florfenidem 300

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Romania

| Belgica de Weerd B.V. |
| --- |
| Van de Reijtstraat 21 |
| 4814 NE Breda |
| The Netherlands |

Belgica de Weerd B.V.

Van de Reijtstraat 21

4814 NE Breda

The Netherlands

Cobel 12,5  mg

Colistin sulfat

250 000 UI/ml

Solution for use in drinking water

Pigeons- not used for human consumption

Oral use

Romania

| Crida Pharm S.R.L. |
| --- |
| Str. Intrarea Vagonetului, 2, 47 |
| Bucureşti |
| Romania |

Crida Pharm S.R.L.

Str. Intrarea Vagonetului, 2, 47

Bucureşti

Romania

Sulfatrim

Trimethoprim

Sulfamethoxazole

20 mg/ml

80 mg/ml

Oral solution

Pig, chicken (broiler)

In drinking water use

Romania

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

T.S.-SOL

Trimethoprim

Sulfamethoxazole

20 mg/ml

80 mg/ml

Oral solution

Pig, poultry (hen)

In drinking water use

Romania

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 24

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, sheep, dog, cat

Intramuscular, intravenous, subcutaneous use

Romania

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml solution for injection for cattle and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Romania

| S.C. Delos Impex '96 S.R.L. |
| --- |
| Str. Horia, Cloşca şi Crişan,nr. 81 |
| Otopeni, Jud. Ilfov, 075100 |
| Romania |

S.C. Delos Impex '96 S.R.L.

Str. Horia, Cloşca şi Crişan,nr. 81

Otopeni, Jud. Ilfov, 075100

Romania

Florfenidem 10 %, 100 mg/ml

Florfenicol

100 mg/ml

Solution for use in drinking water

Pig, bird (broiler, breeders, pullets replacement)

Oral use

Romania

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan, 300 mg/ml

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Romania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix soluţie spot-on pentru câini cu greutatea de la 10 kg până la 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Romania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix soluţie spot-on pentru câini cu greutatea de la 25 kg până la 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Romania

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix soluţie spot-on pentru câini cu greutatea de peste 40 kg până la 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Spot-on use

Romania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act soluţie spot-on pentru câini de 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Romania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act soluţie spot-on pentru câini de 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Romania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act soluţie spot-on pentru câini de 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Romania

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Dexa-Kel 0,2

Dexamethasone sodium phosphate

2,64  mg/ml

Solution for injection

Cattle, horse, pig, goat, dog

Intramuscular, intravenous, intraarticular use

Romania

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Slovak Republic

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix spot-on roztok pre psy nad 40 kg do 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Slovak Republic

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 20 mg/ml, roztok na injekcie pre hovädzí dobytok, ošípané a kone

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Slovak Republic

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg roztok na kvapkanie na kožu pre psov nad 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Slovak Republic

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml injekčný roztok pre hovädzí dobytok, ovce a ošípané

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Slovak Republic

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Norodine 40 mg/200 mg/ml injekčný roztok

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Slovak Republic

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor 300 mg/ml injekčný roztok pre hovädzí dobytok a ošípané

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Slovak Republic

| Virbac S.A. |
| --- |
| 1ere Avenue 2065 M L.I.D. |
| 06516 Carros |
| France |

Virbac S.A.

1ere Avenue 2065 M L.I.D.

06516 Carros

France

Terralon LA 200 mg/ml injekčný roztok

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Slovak Republic

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor injekčný roztok pre hovädzí dobytok

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Slovak Republic

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml, injekčný roztok pre hovädzí dobytok a ošípané

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Slovak Republic

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml injekčný roztok pre hovädzí dobytok a ošípané

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Slovak Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on roztok na nakvapkanie na kožu pre psy 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Slovak Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on roztok na nakvapkanie na kožu pre psy 20- 40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Slovak Republic

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act spot-on roztok na nakvapkanie na kožu pre psy 40- 60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Slovak Republic

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol 300 mg/ml injekčný roztok pre hovädzí dobytok a ošípané

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Slovak Republic

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml injekčný roztok pre hovädzí dobytok a ošípané

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Slovak Republic

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml roztok na podanie v pitnej vode pre ošípané a kuru domácu

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Slovak Republic

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol 20/100 mg/ml roztok na použitie v pitnej vode pre ošípané a kurčatá

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Slovak Republic

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml injekčný roztok pre hovädzí dobytok a ošípané

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Slovenia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act kožni nanos, raztopina za pse 10 — 20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act kožni nanos, raztopina za pse 20 — 40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Frontline Tri-Act kožni nanos, raztopina za pse 40 — 60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml raztopina za injiciranje za govedo, ovce in prašiče

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Slovenia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg, kožni nanos, raztopina za pse nad 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor Minidose 450 mg/ml, raztopina za injiciranje za govedo

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Slovenia

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml raztopina za injiciranje za govedo in prašiče

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Slovenia

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml raztopina za injiciranje

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Slovenia

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

FlorFlu 300/16,5  mg/ml raztopina za injiciranje za govedo

Florfenicol

Flunixin

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Slovenia

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Resflor 300/16,5  mg/ml raztopina za injiciranje za govedo

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Slovenia

| Intervet International B.V. |
| --- |
| Wim de Kôrverstraat 35 |
| 5831 AN Boxmeer |
| Netherlands |

Intervet International B.V.

Wim de Kôrverstraat 35

5831 AN Boxmeer

Netherlands

Nuflor 300 mg/ml raztopina za injiciranje

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Slovenia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix kožni nanos, raztopina za pse od 10 kg do 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix kožni nanos, raztopina za pse od 25 do 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix kožni nanos, raztopina za pse od 40 do 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Spot-on use

Slovenia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 250/1250 spot-on solution for dogs over 10 up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Slovenia

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 400/2000 spot-on solution for dogs over 25 up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Spain

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Kelaflor 300 mg/ml solucion inyectable para bovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Spain

| MSD Animal Health, S.L. |
| --- |
| Pol. Ind. El Montalvo I, C/ Zeppelin, 6. Parcela 38 |
| 37008 Salamanca |
| Spain |

MSD Animal Health, S.L.

Pol. Ind. El Montalvo I, C/ Zeppelin, 6. Parcela 38

37008 Salamanca

Spain

Flomac 450 mg/ml solucion inyectable para bovino

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

Spain

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan 20 mg/ml solucion inyectable para bovino, porcino y caballos

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

Spain

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 40 mg solucion spot-on para gatos medianos

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Spain

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Ridaworm 60 mg Solucion spot-on para gatos grandes

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Spain

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Barcelona |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Barcelona

Spain

Cadorex 300 mg/ml solucion inyectable para bovino, ovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Spain

| Mevet, S.A.U. |
| --- |
| Av. Industria, Pol. Industrial El Segre, parcela 409-410, |
| 25191 Lleida |
| Spain |

Mevet, S.A.U.

Av. Industria, Pol. Industrial El Segre, parcela 409-410,

25191 Lleida

Spain

Pulmovall 300 mg/ml solucion inyectable para bovino, ovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Spain

| Laboratorios Syva, S.A.U. |
| --- |
| Avda. Párroco Pablo Díez, 49-57 |
| 24010 León |
| Spain |

Laboratorios Syva, S.A.U.

Avda. Párroco Pablo Díez, 49-57

24010 León

Spain

Florfenis 300 mg/ml Solucion inyectable para bovino, ovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Spain

| MSD Animal Health, S.L. |
| --- |
| Pol. Ind. El Montalvo I, C/ Zeppelin, 6. Parcela 38 |
| 37008 Salamanca |
| Spain |

MSD Animal Health, S.L.

Pol. Ind. El Montalvo I, C/ Zeppelin, 6. Parcela 38

37008 Salamanca

Spain

Resflor solucion inyectable

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Spain

| Boehringer Ingelheim Animal Health España S.A.U. |
| --- |
| C/Prat de la Riba, 50 |
| 08174 Barcelona |
| Spain |

Boehringer Ingelheim Animal Health España S.A.U.

C/Prat de la Riba, 50

08174 Barcelona

Spain

Frontline Tri-act Solucion spot-on para perros 10 — 20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

Spain

| Boehringer Ingelheim Animal Health España S.A.U. |
| --- |
| C/Prat de la Riba, 50 |
| 08174 Barcelona |
| Spain |

Boehringer Ingelheim Animal Health España S.A.U.

C/Prat de la Riba, 50

08174 Barcelona

Spain

Frontline Tri-act Solucion spot-on para perros 20 — 40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

Spain

| Boehringer Ingelheim Animal Health España S.A.U. |
| --- |
| C/Prat de la Riba, 50 |
| 08174 Barcelona |
| Spain |

Boehringer Ingelheim Animal Health España S.A.U.

C/Prat de la Riba, 50

08174 Barcelona

Spain

Frontline Tri-act Solucion spot-on para perros 40 — 60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

Spain

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 250 mg/1250 mg solución spot-on para perros de más de 10 kg hasta 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Spain

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Protectix 400 mg/2000 mg solución spot-on para perros de más de 25 kg hasta 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Spain

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Preventix 250/1250 mg solución spot-on para perros de más de 10 kg hasta 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Spain

| Beaphar B.V. |
| --- |
| Drostenkamp 3 |
| 8101 BX Raalte |
| The Netherlands |

Beaphar B.V.

Drostenkamp 3

8101 BX Raalte

The Netherlands

Preventix 400 mg/2000 mg solución spot-on para perros de más de 25 kg hasta 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Spain

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml Solucion inyectable para bovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Spain

| MSD Animal Health, S.L. |
| --- |
| Pol. Ind. El Montalvo I, C/ Zeppelin, 6. Parcela 38 |
| 37008 Salamanca |
| Spain |

MSD Animal Health, S.L.

Pol. Ind. El Montalvo I, C/ Zeppelin, 6. Parcela 38

37008 Salamanca

Spain

Nuflor 300 mg/ml solucion inyectable para bovino y ovino

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

Spain

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol 300 mg/ml solucion inyectable para bovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg solucion para uncion dorsal puntual para perros de más de 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Spain

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor 300 mg/ml solucion inyectable para bovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Spain

| MSD Animal Health, S.L. |
| --- |
| Pol. Ind. El Montalvo I, C/ Zeppelin, 6. Parcela 38 |
| 37008 Salamanca |
| Spain |

MSD Animal Health, S.L.

Pol. Ind. El Montalvo I, C/ Zeppelin, 6. Parcela 38

37008 Salamanca

Spain

Nuflor 300 mg/ml solucion inyectable porcino

Florfenicol

300 mg/ml

Solution for injection

Pig

Intramuscular use

Spain

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 60 mg solucion spot-on para gatos grandes

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Damtix 2000 mg/400 mg solucion para uncion dorsal puntual para perros de más de 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Spain

| Vetpharma Animal Health S.L. |
| --- |
| Gran Via De Carles III 98 7th Floor |
| 08028 (Barcelona) |
| Spain |

Vetpharma Animal Health S.L.

Gran Via De Carles III 98 7th Floor

08028 (Barcelona)

Spain

Filmtix 2,5 ml spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Spain

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 4 ml solucion spot-on para perros de mas de 25 kg hasta 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Spain

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 6 ml Solucion spot-on para perros de mas de 40 kg hasta 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Spain

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 2,5 ml solucion spot-on para perros de mas de 10 kg hasta 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

Spain

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 4 ml solucion spot-on para perros de mas de 25 kg hasta 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

Spain

| AB7 Santé |
| --- |
| 9 Chemin des Monges |
| 31450 Deyme |
| France |

AB7 Santé

9 Chemin des Monges

31450 Deyme

France

Pulsix 6 ml solucion spot-on para perros de mas de 40 kg hasta 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Daclotrix 2000 mg/400 mg solucion para uncion dorsal puntual para perros de mas de 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solucion spot-on para perros de mas de 40 kg hasta 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solucion spot-on para perros de mas de 10 hasta 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Advantix solucion spot-on para perros de mas de 25 hasta 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Poli-ecto Solucion spot-on para perros de mas de 10 hasta 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog (over 10 kg up to 25 kg)

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Poli-ecto Solucion spot-on para perros de mas de 25 hasta 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

Spain

| Bayer Animal Health GmbH |
| --- |
| Kaiser-Wilhelm-Allee 20 |
| 51373 Leverkusen |
| Germany |

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 20

51373 Leverkusen

Germany

Poli-ecto Solucion spot-on para perros de mas de 40 kg hasta 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

Spain

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol 20/100 mg/ml solucion para administración en agua de bebida para porcino y pollos

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

Spain

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml solucion para administración en agua de bebida para porcino y pollos

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Spain

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Trimsulfasol 20/100 mg/ml solucion para administración en agua de bebida para porcino y pollos

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

Spain

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml Solucion inyectable

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Spain

| Cenavisa, S.L. |
| --- |
| Camí Pedra Estela s/n |
| 43205 Reus |
| Spain |

Cenavisa, S.L.

Camí Pedra Estela s/n

43205 Reus

Spain

Florfenicen 300 mg/ml solucion inyectable para bovino, ovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Spain

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Les Franqueses del Vallès (Barcelona) |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Les Franqueses del Vallès (Barcelona)

Spain

Florinject 300 mg/ml Solucion inyectable para bovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Spain

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml solucion inyectable para bovino y porcino

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Spain

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Florflu 300/16,5  mg/ml Solucion inyectable para bovino

Florfenicol

Flunixin

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

Spain

| Industrial Veterinaria, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat (Barcelona) |
| Spain |

Industrial Veterinaria, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat (Barcelona)

Spain

Flodoex 300 mg/ml solucion inyectable

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Spain

| Laboratorios e industrias Iven, S.A. |
| --- |
| Luis I, 56. Pol. Industrial Vallecas |
| 28031 Madrid |
| Spain |

Laboratorios e industrias Iven, S.A.

Luis I, 56. Pol. Industrial Vallecas

28031 Madrid

Spain

Oxiciven L.A. 200 mg/ml Solucion inyectable

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular use

Spain

| Cenavisa, S.L. |
| --- |
| Camí Pedra Estela s/n |
| 43205 Reus |
| Spain |

Cenavisa, S.L.

Camí Pedra Estela s/n

43205 Reus

Spain

Censulfatrim solucion inyectable

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

Spain

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Trimacrol Gan

Trimethoprim

Sulfadiazine

80 mg/ml

400 mg/ml

Suspension for injection

Cattle, horse, pig, sheep, goat

Intramuscular use

Spain

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Neumovex

Trimethoprim

Sulfadiazine

25 mg/ml

136 mg/ml

Solution for use in drinking water

Piglets

In drinking water use

Spain

| Industrial Veterinaria, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat (Barcelona) |
| Spain |

Industrial Veterinaria, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat (Barcelona)

Spain

Suictine

Ivermectin

10 mg/ml

Solution for injection

Pig

Subcutaneous use

Spain

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Florvex 300 mg/ml Solucion inyectable

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

Spain

| Virbac España, S.A. |
| --- |
| Angel Guimera, 179-181 |
| 08950 Esplugues de Llobregat (Barcelona) |
| Spain |

Virbac España, S.A.

Angel Guimera, 179-181

08950 Esplugues de Llobregat (Barcelona)

Spain

Terralon 200 mg/ml LA

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, Sheep

Intramuscular use

Spain

| Cenavisa, S.L. |
| --- |
| Camí Pedra Estela s/n |
| 43205 Reus |
| Spain |

Cenavisa, S.L.

Camí Pedra Estela s/n

43205 Reus

Spain

Oxycen L.A. 200 mg/ml Solucion inyectable

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular use

Spain

| Laboratorios e industrias Iven, S.A. |
| --- |
| Luis I, 56. Pol. Industrial Vallecas |
| 28031 Madrid |
| Spain |

Laboratorios e industrias Iven, S.A.

Luis I, 56. Pol. Industrial Vallecas

28031 Madrid

Spain

Oxiretard 200 mg/ml L. A. Solucion inyectable

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep, goat

Intramuscular use

Spain

| Mevet, S.A.U. |
| --- |
| Av. Industria, Pol. Industrial El Segre, parcela 409-410, |
| 25191 Lleida |
| Spain |

Mevet, S.A.U.

Av. Industria, Pol. Industrial El Segre, parcela 409-410,

25191 Lleida

Spain

Pulmovall 300 mg/ml Solucion inyectable

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

Spain

| Industrial Veterinaria, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat (Barcelona) |
| Spain |

Industrial Veterinaria, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat (Barcelona)

Spain

Promectine

Ivermectin

10 mg/ml

Solution for injection

Cattle

Subcutaneous use

Sweden

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate |
| H18 W620 Monaghan |
| Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate

H18 W620 Monaghan

Ireland

Hippotrim vet

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous use

Sweden

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Tetroxy prolongatum vet

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

Sweden

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Florselect vet

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

Sweden

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Cutaneous use

Sweden

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Cutaneous use

Sweden

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Frontect 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Cutaneous use

UK/Northern Ireland1

| Vetoquinol UK Limited |
| --- |
| Pury Hill Business Park, Steadings Barn |
| Towcester NN12 7LS |
| United Kingdom |

Vetoquinol UK Limited

Pury Hill Business Park, Steadings Barn

Towcester NN12 7LS

United Kingdom

Droncit Spot-on 20 mg solution

Praziquantel

20 mg

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Elanco Europe Ltd. |
| --- |
| Form 2 Bartley Way |
| Hook RG27 9XA |
| United Kingdom |

Elanco Europe Ltd.

Form 2 Bartley Way

Hook RG27 9XA

United Kingdom

Advantix Spot-on Solution for Dogs over 10 kg

up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Elanco Europe Ltd. |
| --- |
| Form 2 Bartley Way |
| Hook RG27 9XA |
| United Kingdom |

Elanco Europe Ltd.

Form 2 Bartley Way

Hook RG27 9XA

United Kingdom

Advantix Spot-on Solution for Dogs over 25 kg

up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog (over 25 kg up to 40 kg)

Spot-on use

UK/Northern Ireland1

| Elanco Europe Ltd. |
| --- |
| Form 2 Bartley Way |
| Hook RG27 9XA |
| United Kingdom |

Elanco Europe Ltd.

Form 2 Bartley Way

Hook RG27 9XA

United Kingdom

Advantix Spot-on Solution for Dogs over 40 kg up

to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog (over 40 kg up to 60 kg)

Spot-on use

UK/Northern Ireland1

| Pharmaq AS |
| --- |
| Skogmo Industriområde |
| Industrivegen 50 |
| 7863 Overhalla |
| Norway |

Pharmaq AS

Skogmo Industriområde

Industrivegen 50

7863 Overhalla

Norway

AMX 10 mg/ml concentrate for solution for fish treatment

Deltamethrin

10 mg/ml

Concentrate for solution for fish treatment

Atlantic salmon, Rainbow trout

Water-borne use

UK/Northern Ireland1

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan, 20 mg/ml, solution for injection for cattle, pigs and horses

Meloxicam

20 mg/ml

Solution for injection

Cattle, horse, pig

Intramuscular, intravenous, subcutaneous use

UK/Northern Ireland1

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Animeloxan 5 mg/ml solution for injection for dogs and cats

Meloxicam

5 mg/ml

Solution for Injection

Dog, cat

Intravenous, subcutaneous use

UK/Northern Ireland1

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Ataxxa 2000 mg/400 mg spot-on solution for dogs over 25 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Eco Animal Health Ltd. |
| --- |
| 78 Coombe Road |
| New Malden KT3 4QS |
| United Kingdom |

Eco Animal Health Ltd.

78 Coombe Road

New Malden KT3 4QS

United Kingdom

Bimectin 5 mg/ml Pour-on Solution for Cattle

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

UK/Northern Ireland1

| Livisto Int'l S.L. |
| --- |
| Av. Universitat Autònoma 29 |
| 08290 Cerdanyol del Vallès (Barcelona) |
| Spain |

Livisto Int'l S.L.

Av. Universitat Autònoma 29

08290 Cerdanyol del Vallès (Barcelona)

Spain

Cadorex 300 mg/ml solution for injection for cattle, sheep and pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular, subcutaneous use

UK/Northern Ireland1

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Cyclosol LA, 200 mg/ml solution for injection

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

UK/Northern Ireland1

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Diatrim 200 mg/ml + 40 mg/ml Solution for Injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

UK/Northern Ireland1

| Zoetis UK Limited |
| --- |
| 1st Floor, Birchwood Building |
| Springfield Drive |
| Leatherhead KT22 7LP |
| United Kingdom |

Zoetis UK Limited

1st Floor, Birchwood Building

Springfield Drive

Leatherhead KT22 7LP

United Kingdom

Duphatrim IS Injectable Solution

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

UK/Northern Ireland1

| Eco Animal Health Ltd. |
| --- |
| 78 Coombe Road |
| New Malden KT3 4QS |
| United Kingdom |

Eco Animal Health Ltd.

78 Coombe Road

New Malden KT3 4QS

United Kingdom

Ecomectin 5 mg/ml Pour-on solution for cattle

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Pour-on use

UK/Northern Ireland1

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Flordofen 300 mg/ml Solution for Injection for Cattle and Pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

UK/Northern Ireland1

| Kela N.V. |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Florfenikel 300 mg/ml Solution for Injection for Cattle and Pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

UK/Northern Ireland1

| Laboratorios Calier, S.A. |
| --- |
| C/ Barcelonès, 26 |
| 08520 Les Franqueses del Vallès (Barcelona) |
| Spain |

Laboratorios Calier, S.A.

C/ Barcelonès, 26

08520 Les Franqueses del Vallès (Barcelona)

Spain

Florinject 300 mg/ml Solution for Injection for Cattle and Pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

UK/Northern Ireland1

| Krka d.d. Novo Mesto |
| --- |
| Smarjeska Cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo Mesto

Smarjeska Cesta 6

8501 Novo Mesto

Slovenia

Flovuxin 300/16,5  mg/ml Solution for Injection for Cattle

Florfenicol

Flunixin

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

UK/Northern Ireland1

| Boehringer Ingelheim Animal Health UK Limited |
| --- |
| Ellesfield Avenue |
| Bracknell RG12 8YS |
| United Kingdom |

Boehringer Ingelheim Animal Health UK Limited

Ellesfield Avenue

Bracknell RG12 8YS

United Kingdom

Frontline Tri-Act Spot-on Solution for Dogs 10-20 kg

Fipronil

Permethrin

135,2  mg/2 ml

1 009,6  mg/2 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Boehringer Ingelheim Animal Health UK Limited |
| --- |
| Ellesfield Avenue |
| Bracknell RG12 8YS |
| United Kingdom |

Boehringer Ingelheim Animal Health UK Limited

Ellesfield Avenue

Bracknell RG12 8YS

United Kingdom

Frontline Tri-Act Spot-on Solution for Dogs 20-40 kg

Fipronil

Permethrin

270,4  mg/4 ml

2 019,2  mg/4 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Boehringer Ingelheim Animal Health UK Limited |
| --- |
| Ellesfield Avenue |
| Bracknell RG12 8YS |
| United Kingdom |

Boehringer Ingelheim Animal Health UK Limited

Ellesfield Avenue

Bracknell RG12 8YS

United Kingdom

Frontline Tri-Act Spot-on Solution for Dogs 40-60 kg

Fipronil

Permethrin

405,6  mg/6 ml

3 028,8  mg/6 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Melovem 30 mg/ml solution for injection for cattle and pigs

Meloxicam

30 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

UK/Northern Ireland1

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Metaxol 20/100 mg/ml Solution for Use in Drinking Water for Pigs and Chickens

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

UK/Northern Ireland1

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Netherlands

Methoxasol 20/100 mg/ml solution for use in drinking water for pigs and chickens

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig, chicken (broiler)

In drinking water use

UK/Northern Ireland1

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km.4,1 |
| 43330 Riudoms (Tarragona) |
| Spain |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, km.4,1

43330 Riudoms (Tarragona)

Spain

Mycoflor, 300 mg/ml Solution for Injection for Cattle and Pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

UK/Northern Ireland1

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Nifencol 300 mg/ml Solution for Injection for Cattle and Pigs

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular, subcutaneous use

UK/Northern Ireland1

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Newry BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Newry BT35 6JP

Northern Ireland

Norodine 24 solution for injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

UK/Northern Ireland1

| MSD Animal Health UK Limited |
| --- |
| Walton Manor, Walton |
| Milton Keynes MK7 7AJ |
| United Kingdom |

MSD Animal Health UK Limited

Walton Manor, Walton

Milton Keynes MK7 7AJ

United Kingdom

Nuflor 300 mg/ml solution for injection for cattle and sheep

Florfenicol

300 mg/ml

Solution for injection

Cattle, sheep

Intramuscular, subcutaneous use

UK/Northern Ireland1

| MSD Animal Health UK Limited |
| --- |
| Walton Manor, Walton |
| Milton Keynes MK7 7AJ |
| United Kingdom |

MSD Animal Health UK Limited

Walton Manor, Walton

Milton Keynes MK7 7AJ

United Kingdom

Nuflor Minidose 450 mg/ml Solution for Injection for Cattle

Florfenicol

450 mg/ml

Solution for injection

Cattle

Intramuscular, subcutaneous use

UK/Northern Ireland1

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 60 mg spot-on solution for large cats

Praziquantel

60 mg/1,5 ml

Spot-on solution

Cat

Spot-on use

UK/Northern Ireland1

| Eco Animal Health Ltd. |
| --- |
| 78 Coombe Road |
| New Malden KT3 4QS |
| United Kingdom |

Eco Animal Health Ltd.

78 Coombe Road

New Malden KT3 4QS

United Kingdom

Qualimec 5 mg/ml pour-on solution for cattle

Ivermectin

5 mg/ml

Pour-on solution

Cattle

Topical use

UK/Northern Ireland1

| MSD Animal Health UK Limited |
| --- |
| Walton Manor, Walton |
| Milton Keynes MK7 7AJ |
| United Kingdom |

MSD Animal Health UK Limited

Walton Manor, Walton

Milton Keynes MK7 7AJ

United Kingdom

Resflor 300/16,5  mg/ml solution for injection for cattle

Florfenicol

Flunixin (as flunixin meglumine)

300 mg/ml

16,5  mg/ml

Solution for injection

Cattle

Subcutaneous use

UK/Northern Ireland1

| Laboratorios Hipra S.A. |
| --- |
| Avinguda La Selva 135 |
| 17170 Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avinguda La Selva 135

17170 Amer (Girona)

Spain

Selectan 300 mg/ml Solution for Injection for Cattle and Swine

Florfenicol

300 mg/ml

Solution for injection

Cattle, pig

Intramuscular use

UK/Northern Ireland1

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Tetroxy L.A. 200 mg/ml Oxytetracycline solution for injection

Oxytetracycline

200 mg/ml

Solution for injection

Cattle, pig, sheep

Intramuscular use

UK/Northern Ireland1

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Newry BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Newry BT35 6JP

Northern Ireland

Trimacare 24 % solution for injection

Trimethoprim

Sulfadiazine

40 mg/ml

200 mg/ml

Solution for injection

Cattle, horse, pig, dog, cat

Intramuscular, intravenous, subcutaneous use

UK/Northern Ireland1

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

Netherlands

Trimsulfasol 20/100 mg/ml solution for use in drinking water for pigs and chickens

Trimethoprim

Sulfamethoxazole

20 mg/ml

100 mg/ml

Solution for use in drinking water

Pig (fattening pigs), chicken (broiler)

In drinking water use

UK/Northern Ireland1

| Ceva Animal Health Ltd |
| --- |
| Unit 3, Anglo Office Park, White Lion Road |
| Amersham HP7 9FB |
| United Kingdom |

Ceva Animal Health Ltd

Unit 3, Anglo Office Park, White Lion Road

Amersham HP7 9FB

United Kingdom

Vectra 3D Spot-on Solution for Dogs > 40 kg

Dinotefuran

Pyriproxyfen

Permethrin

436 mg/8 ml

38,7  mg/8 ml

3,175  mg/8 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Ceva Animal Health Ltd |
| --- |
| Unit 3, Anglo Office Park, White Lion Road |
| Amersham HP7 9FB |
| United Kingdom |

Ceva Animal Health Ltd

Unit 3, Anglo Office Park, White Lion Road

Amersham HP7 9FB

United Kingdom

Vectra 3D spot-on solution for dogs > 10–25 kg

Dinotefuran

Pyriproxyfen

Permethrin

196 mg/3,6 ml

17,4  mg/3,6 ml

1,429  mg/3,6 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Ceva Animal Health Ltd |
| --- |
| Unit 3, Anglo Office Park, White Lion Road |
| Amersham HP7 9FB |
| United Kingdom |

Ceva Animal Health Ltd

Unit 3, Anglo Office Park, White Lion Road

Amersham HP7 9FB

United Kingdom

Vectra 3D spot-on solution for dogs > 25–40 kg

Dinotefuran

Pyriproxyfen

Permethrin

256 mg/4,7 ml

22,7  mg/4,7 ml

1,865  mg/4,7 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Ceva Animal Health Ltd |
| --- |
| Unit 3, Anglo Office Park, White Lion Road |
| Amersham HP7 9FB |
| United Kingdom |

Ceva Animal Health Ltd

Unit 3, Anglo Office Park, White Lion Road

Amersham HP7 9FB

United Kingdom

Vectra 3D spot-on solution for dogs > 4–10 kg

Dinotefuran

Pyriproxyfen

Permethrin

87 mg/1,6 ml

7,7  mg/1,6 ml

635 mg/1,6 ml

Spot-on solution

Dog

Spot-on use

UK/Northern Ireland1

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 2,5 ml spot-on solution for dogs over 10 kg up to 25 kg

Imidacloprid

Permethrin

250 mg/2,5 ml

1250 mg/2,5 ml

Spot-on solution

Dog

Cutaneous use

UK/Northern Ireland1

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 4 ml spot-on solution for dogs over 25 kg up to 40 kg

Imidacloprid

Permethrin

400 mg/4 ml

2000 mg/4 ml

Spot-on solution

Dog

Cutaneous use

UK/Northern Ireland1

| Vetpharma Animal Health S.L. |
| --- |
| Carrer De Les Corts 23 |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.

Carrer De Les Corts 23

08028 Barcelona

Spain

Filmtix 6 ml spot-on solution for dogs over 40 kg up to 60 kg

Imidacloprid

Permethrin

600 mg/6 ml

3000 mg/6 ml

Spot-on solution

Dog

Cutaneous use

ANNEX IID

List of nationally authorised veterinary medicinal products recommended for variation of the marketing authorisations (quantitative NMP concentration, target animal safety warnings and user safety warnings both during application and post-application)

| Member State EU/EEA | Applicant/Marketing authorisation holder | Name | INN/Active substance | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Bulgaria | Farma Vet Ltd. |
| Shumen, 40 Otec Paisii str. |
| Bulgaria |

Member State EU/EEA

Applicant/Marketing authorisation holder

Name

INN/Active substance

Strength

Pharmaceutical form

Animal species

Route of administration

Bulgaria

Farma Vet Ltd.

Shumen, 40 Otec Paisii str.

Bulgaria

Deltapharm

Deltamethrin

50 mg/ml

Concentrate for cutaneous solution

Cattle, sheep, dog

Cutaneous use

Cyprus

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Ecofleece 10 % w/w, συμπύκνωμα για εμβάπτιση, για πρόβατα

Cypermethrin

10 % w/w

Concentrate for dip solution

Sheep

Topical use

France

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 40 mg solution pour spot-on pour chats de taille moyenne

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Germany

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 40 mg lösung zum auftropfen für mittelgroße katzen

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Ireland

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 40 mg spot-on solution for medium cats

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Ireland

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Cyperguard concentrate for dip emulsion

Cypermethrin

10 % w/w/ml

Concentrate for dip emulsion

Sheep

Topical use

Ireland

| Bimeda Animal Health Limited |
| --- |
| 2, 3 & 4 Airton Close |
| Tallaght, Dublin 24 |
| Ireland |

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght, Dublin 24

Ireland

Ecofleece 10 % w/w sheep dip concentrate

Cypermethrin

10 % w/w

Concentrate for dip suspension

Sheep

Topical use

Italy

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 40 mg soluzione spot-on per gatti di taglia media

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Malta

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

2370 Arendonk

Belgium

Deltaveto-5 EC Liquid

Deltamethrin

50 g/l

Cutaneous emulsion

Cattle, horse, pig, sheep, goat, dog

External use

Netherlands

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 40 mg spot-on oplossing voor middelgrote katten

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Spain

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 40 mg solucion spot-on para gatos medianos

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

Spain

| Divasa Farmavic, S.A. |
| --- |
| Ctra. Sant Hipolit, Km. 71 |
| 08503 Gurb, Vic |
| Spain |

Divasa Farmavic, S.A.

Ctra. Sant Hipolit, Km. 71

08503 Gurb, Vic

Spain

Cloramivet spray

Chloramphenicol

30 mg/g

Cutaneous spray, solution

Dog, cat

Cutaneous use

UK/Northern Ireland1

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Dublin Road, Loughrea, Co Galway |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Dublin Road, Loughrea, Co Galway

Ireland

Prazpronto 40 mg spot-on solution for medium cats

Praziquantel

40 mg/ml

Spot-on solution

Cat

Spot-on use

---