# Official Journal C 181/29 M

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 181 |
| | |
| English edition | Information and Notices | Volume 6329 May 2020 |

ISSN 1977-091X

Official Journal

of the European Union

C 181

English edition

Information and Notices

Volume 6329 May 2020

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2020/C 181/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2020 to 30 April 2020(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2020/C 181/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2020 to 30 April 2020(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 13 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2020/C 181/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2020 to 30 April 2020(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2020/C 181/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2020 to 30 April 2020(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

13

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.5.2020 | EN | Official Journal of the European Union | C 181/1 |
| --- | --- | --- | --- |

29.5.2020

EN

Official Journal of the European Union

C 181/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2020 to 30 April 2020

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

(2020/C 181/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.4.2020 | Arsenic trioxide Mylan | arsenic trioxide | Mylan Ireland Limited
  Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | EU/1/20/1427 | Concentrate and solvent for solution for infusion | L01XX27 | 2.4.2020 |
| 1.4.2020 | Nilemdo | bempedoic acid | FGK Representative Service GmbH
  Heimeranstraße 35, 80339 München, Deutschland | EU/1/20/1425 | Film-coated tablet | C10AX15 | 2.4.2020 |
| 1.4.2020 | Ruxience | rituximab | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique
  Pleinlaan 17, 1050 Brussel, België | EU/1/20/1431 | Concentrate for solution for infusion | L01XC02 | 6.4.2020 |
| 1.4.2020 | Vaxchora | Cholera vaccine (recombinant, live, oral) | Emergent Netherlands B.V.
  Strawinskylaan 411, 1077 XX Amsterdam, Nederland | EU/1/20/1423 | Effervescent powder and powder for oral suspension. | J07AE02 | 15.4.2020 |
| 3.4.2020 | Budesonide/Formoterol Teva Pharma B.V. | budesonide/formoterol fumarate dihydrate | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/19/1403 | Inhalation powder | R03AK07 | 7.4.2020 |
| 3.4.2020 | Cinacalcet Accordpharma | cinacalcet | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/20/1429 | Film-coated tablet | H05BX01 | 7.4.2020 |
| 3.4.2020 | Rybelsus | semaglutide | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/20/1430 | Tablet | A10BJ06 | 7.4.2020 |
| 3.4.2020 | Trepulmix | treprostinil sodium | SciPharm Sàrl
  7, Fausermillen, 6689 Mertert, Luxembourg | EU/1/19/1419 | Solution for infusion | B01AC21 | 7.4.2020 |
| 17.4.2020 | Tigecycline Accord | tigecycline | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/19/1394 | Powder for solution for infusion | J01AA12 | 20.4.2020 |
| 23.4.2020 | Fetcroja | cefiderocol | Shionogi B.V.
  Kingsfordweg 151, 1043 GR Amsterdam, Nederland | EU/1/20/1434 | Powder for concentrate for solution for infusion | J01DI04 | 24.4.2020 |

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

1.4.2020

Arsenic trioxide Mylan

arsenic trioxide

Mylan Ireland Limited

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

EU/1/20/1427

Concentrate and solvent for solution for infusion

L01XX27

2.4.2020

1.4.2020

Nilemdo

bempedoic acid

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/20/1425

Film-coated tablet

C10AX15

2.4.2020

1.4.2020

Ruxience

rituximab

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique

Pleinlaan 17, 1050 Brussel, België

EU/1/20/1431

Concentrate for solution for infusion

L01XC02

6.4.2020

1.4.2020

Vaxchora

Cholera vaccine (recombinant, live, oral)

Emergent Netherlands B.V.

Strawinskylaan 411, 1077 XX Amsterdam, Nederland

EU/1/20/1423

Effervescent powder and powder for oral suspension.

J07AE02

15.4.2020

3.4.2020

Budesonide/Formoterol Teva Pharma B.V.

budesonide/formoterol fumarate dihydrate

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/19/1403

Inhalation powder

R03AK07

7.4.2020

3.4.2020

Cinacalcet Accordpharma

cinacalcet

Accord Healthcare S.L.U.

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

EU/1/20/1429

Film-coated tablet

H05BX01

7.4.2020

3.4.2020

Rybelsus

semaglutide

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1430

Tablet

A10BJ06

7.4.2020

3.4.2020

Trepulmix

treprostinil sodium

SciPharm Sàrl

7, Fausermillen, 6689 Mertert, Luxembourg

EU/1/19/1419

Solution for infusion

B01AC21

7.4.2020

17.4.2020

Tigecycline Accord

tigecycline

Accord Healthcare S.L.U.

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

EU/1/19/1394

Powder for solution for infusion

J01AA12

20.4.2020

23.4.2020

Fetcroja

cefiderocol

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/20/1434

Powder for concentrate for solution for infusion

J01DI04

24.4.2020

—   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 |
| --- | --- | --- | --- | --- |
| 1.4.2020 | Advate | Takeda Manufacturing Austria AG
  Industriestraße 67, 1221 Wien, Österreich | EU/1/03/271 | 9.4.2020 |
| 1.4.2020 | Alunbrig | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/18/1264 | 2.4.2020 |
| 1.4.2020 | Defitelio | Gentium S.r.I.
  Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia | EU/1/13/878 | 6.4.2020 |
| 1.4.2020 | Dovato | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/19/1370 | 7.4.2020 |
| 1.4.2020 | Dynastat | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique
  Pleinlaan 17, 1050 Brussel, België | EU/1/02/209 | 8.4.2020 |
| 1.4.2020 | Intrarosa | Endoceutics S.A.
  Rue Belliard 40, 1040 Brussels, Belgium | EU/1/17/1255 | 3.4.2020 |
| 1.4.2020 | Isturisa | Recordati Rare Diseases
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/19/1407 | 2.4.2020 |
| 1.4.2020 | Juluca | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/18/1282 | 7.4.2020 |
| 1.4.2020 | Lonsurf | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/16/1096 | 2.4.2020 |
| 1.4.2020 | Lutathera | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/17/1226 | 6.4.2020 |
| 1.4.2020 | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | EU/1/13/904 | 6.4.2020 |
| 1.4.2020 | Mvasi | Amgen Technology (Ireland) UC
  Pottery Road, Dun Laoghaire, Co. Dublin, Ireland | EU/1/17/1246 | 3.4.2020 |
| 1.4.2020 | Odefsey | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1112 | 2.4.2020 |
| 1.4.2020 | Ondexxya | Portola Netherlands B.V.
  Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands | EU/1/18/1345 | 10.4.2020 |
| 1.4.2020 | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 2.4.2020 |
| 1.4.2020 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 3.4.2020 |
| 1.4.2020 | TAVLESSE | Instituto Grifols, S.A.
  Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa | EU/1/19/1405 | 3.4.2020 |
| 1.4.2020 | Trecondi | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/18/1351 | 2.4.2020 |
| 1.4.2020 | Triumeq | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/14/940 | 7.4.2020 |
| 1.4.2020 | Vemlidy | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1154 | 2.4.2020 |
| 1.4.2020 | Zoledronic acid Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/12/786 | 3.4.2020 |
| 3.4.2020 | AFSTYLA | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/16/1158 | 7.4.2020 |
| 3.4.2020 | Alecensa | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/16/1169 | 6.4.2020 |
| 3.4.2020 | Avastin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/04/300 | 6.4.2020 |
| 3.4.2020 | Bortezomib Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1019 | 6.4.2020 |
| 3.4.2020 | Elmiron | bene-Arzneimittel GmbH
  Herterichstraße 1-3, 81479 München, Deutschland | EU/1/17/1189 | 20.4.2020 |
| 3.4.2020 | Glivec | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/198 | 8.4.2020 |
| 3.4.2020 | Jinarc | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland | EU/1/15/1000 | 7.4.2020 |
| 3.4.2020 | Lorviqua | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique
  Pleinlaan 17, 1050 Brussel, België | EU/1/19/1355 | 8.4.2020 |
| 3.4.2020 | Naglazyme | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork P43 R298, Ireland | EU/1/05/324 | 6.4.2020 |
| 3.4.2020 | NULOJIX | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/11/694 | 6.4.2020 |
| 3.4.2020 | Pregabalin Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/997 | 7.4.2020 |
| 3.4.2020 | Pregabalin Mylan Pharma | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/998 | 7.4.2020 |
| 8.4.2020 | Insuman | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/97/030 | 23.4.2020 |
| 8.4.2020 | Otezla | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/14/981 | 14.4.2020 |
| 8.4.2020 | Pifeltro | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1332 | 23.4.2020 |
| 8.4.2020 | Pregabalin Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1027 | 14.4.2020 |
| 8.4.2020 | Tamiflu | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/02/222 | 14.4.2020 |
| 8.4.2020 | Tivicay | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/13/892 | 14.4.2020 |
| 8.4.2020 | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 15.4.2020 |
| 8.4.2020 | Vidaza | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/488 | 14.4.2020 |
| 8.4.2020 | Xaluprine | Nova Laboratories Ireland Limited
  3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland | EU/1/11/727 | 14.4.2020 |
| 14.4.2020 | Repatha | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1016 | 16.4.2020 |
| 17.4.2020 | Cystagon | Recordati Rare Diseases
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/97/039 | 23.4.2020 |
| 17.4.2020 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 20.4.2020 |
| 17.4.2020 | Rubraca | Clovis Oncology Ireland Limited
  Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland | EU/1/17/1250 | 20.4.2020 |
| 17.4.2020 | Zerbaxa | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1032 | 23.4.2020 |
| 23.4.2020 | Bevespi Aerosphere | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/18/1339 | 5.5.2020 |
| 23.4.2020 | Bridion | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/466 | 24.4.2020 |
| 23.4.2020 | Carbaglu | Recordati Rare Diseases
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/02/246 | 5.5.2020 |
| 23.4.2020 | Cresemba | Basilea Pharmaceutica Deutschland GmbH
  Marie-Curie-Strasse 8, 79539 Loerrach, Baden-Wuerttemberg, Deutschland | EU/1/15/1036 | 24.4.2020 |
| 23.4.2020 | Cystadane | Recordati Rare Diseases
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/06/379 | 24.4.2020 |
| 23.4.2020 | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, 80636 München, Deutschland | EU/1/13/875 | 27.4.2020 |
| 23.4.2020 | Descovy | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1099 | 24.4.2020 |
| 23.4.2020 | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/17/1210 | 24.4.2020 |
| 23.4.2020 | Kanuma | Alexion Europe SAS
  103-105 rue Anatole France, 92300 Levallois-Perret, France | EU/1/15/1033 | 24.4.2020 |
| 23.4.2020 | Lumark | IDB Holland B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | EU/1/15/1013 | 30.4.2020 |
| 23.4.2020 | Onivyde pegylated liposomal | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/16/1130 | 5.5.2020 |
| 23.4.2020 | OPDIVO | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/15/1014 | 24.4.2020 |
| 23.4.2020 | Pedea | Recordati Rare Diseases
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/04/284 | 24.4.2020 |
| 23.4.2020 | Respreeza | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/15/1006 | 27.4.2020 |
| 23.4.2020 | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/99/110 | 24.4.2020 |
| 23.4.2020 | Tysabri | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/06/346 | 24.4.2020 |
| 23.4.2020 | Ultibro Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/862 | 24.4.2020 |
| 23.4.2020 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/11/714 | 24.4.2020 |
| 28.4.2020 | Abilify | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland | EU/1/04/276 | 29.4.2020 |
| 28.4.2020 | ABILIFY MAINTENA | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland | EU/1/13/882 | 30.4.2020 |
| 28.4.2020 | Aripiprazole Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1029 | 6.5.2020 |
| 28.4.2020 | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 29.4.2020 |
| 28.4.2020 | Cayston | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/09/543 | 29.4.2020 |
| 28.4.2020 | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 30.4.2020 |
| 28.4.2020 | Docetaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/611 | 29.4.2020 |
| 28.4.2020 | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | 7.5.2020 |
| 28.4.2020 | Farydak | Secura Bio Limited
  32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland | EU/1/15/1023 | 30.4.2020 |
| 28.4.2020 | Fycompa | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/12/776 | 1.5.2020 |
| 28.4.2020 | Humira | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/03/256 | 29.4.2020 |
| 28.4.2020 | Intelence | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/468 | 29.4.2020 |
| 28.4.2020 | Kevzara | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/17/1196 | 30.4.2020 |
| 28.4.2020 | Kineret | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/02/203 | 30.4.2020 |
| 28.4.2020 | Lokelma | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1173 | 5.5.2020 |
| 28.4.2020 | Myalepta | Amryt Pharmaceuticals DAC
  90 Harcourt Street, Dublin 2, Ireland | EU/1/18/1276 | 29.4.2020 |
| 28.4.2020 | Nitisinone MDK | MendeliKABS Europe Limited
  Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland | EU/1/17/1217 | 1.5.2020 |
| 28.4.2020 | OCALIVA | Intercept Pharma International Limited
  Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland | EU/1/16/1139 | 29.4.2020 |
| 28.4.2020 | Ruconest | Pharming Group N.V.
  Darwinweg 24, 2333 CR Leiden, Nederland | EU/1/10/641 | 29.4.2020 |
| 28.4.2020 | Strensiq | Alexion Europe SAS
  103-105 rue Anatole France, 92300 Levallois-Perret, France | EU/1/15/1015 | 29.4.2020 |
| 28.4.2020 | Zynteglo | bluebird bio (Netherlands) B.V.
  Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland | EU/1/19/1367 | 30.4.2020 |

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

1.4.2020

Advate

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/03/271

9.4.2020

1.4.2020

Alunbrig

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/18/1264

2.4.2020

1.4.2020

Defitelio

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

6.4.2020

1.4.2020

Dovato

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/19/1370

7.4.2020

1.4.2020

Dynastat

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique

Pleinlaan 17, 1050 Brussel, België

EU/1/02/209

8.4.2020

1.4.2020

Intrarosa

Endoceutics S.A.

Rue Belliard 40, 1040 Brussels, Belgium

EU/1/17/1255

3.4.2020

1.4.2020

Isturisa

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/19/1407

2.4.2020

1.4.2020

Juluca

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/18/1282

7.4.2020

1.4.2020

Lonsurf

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/16/1096

2.4.2020

1.4.2020

Lutathera

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/17/1226

6.4.2020

1.4.2020

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

6.4.2020

1.4.2020

Mvasi

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

3.4.2020

1.4.2020

Odefsey

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1112

2.4.2020

1.4.2020

Ondexxya

Portola Netherlands B.V.

Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands

EU/1/18/1345

10.4.2020

1.4.2020

RoActemra

Roche Registration GmbH

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

EU/1/08/492

2.4.2020

1.4.2020

Synjardy

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

3.4.2020

1.4.2020

TAVLESSE

Instituto Grifols, S.A.

Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa

EU/1/19/1405

3.4.2020

1.4.2020

Trecondi

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/18/1351

2.4.2020

1.4.2020

Triumeq

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/14/940

7.4.2020

1.4.2020

Vemlidy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1154

2.4.2020

1.4.2020

Zoledronic acid Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/12/786

3.4.2020

3.4.2020

AFSTYLA

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/16/1158

7.4.2020

3.4.2020

Alecensa

Roche Registration GmbH

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

EU/1/16/1169

6.4.2020

3.4.2020

Avastin

Roche Registration GmbH

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

EU/1/04/300

6.4.2020

3.4.2020

Bortezomib Accord

Accord Healthcare S.L.U.

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

EU/1/15/1019

6.4.2020

3.4.2020

Elmiron

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

20.4.2020

3.4.2020

Glivec

Novartis Europharm Limited

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

EU/1/01/198

8.4.2020

3.4.2020

Jinarc

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/15/1000

7.4.2020

3.4.2020

Lorviqua

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique

Pleinlaan 17, 1050 Brussel, België

EU/1/19/1355

8.4.2020

3.4.2020

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

6.4.2020

3.4.2020

NULOJIX

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/694

6.4.2020

3.4.2020

Pregabalin Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/997

7.4.2020

3.4.2020

Pregabalin Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/998

7.4.2020

8.4.2020

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

23.4.2020

8.4.2020

Otezla

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/14/981

14.4.2020

8.4.2020

Pifeltro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1332

23.4.2020

8.4.2020

Pregabalin Accord

Accord Healthcare S.L.U.

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

EU/1/15/1027

14.4.2020

8.4.2020

Tamiflu

Roche Registration GmbH

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

EU/1/02/222

14.4.2020

8.4.2020

Tivicay

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/13/892

14.4.2020

8.4.2020

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

15.4.2020

8.4.2020

Vidaza

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/488

14.4.2020

8.4.2020

Xaluprine

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland

EU/1/11/727

14.4.2020

14.4.2020

Repatha

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

16.4.2020

17.4.2020

Cystagon

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/97/039

23.4.2020

17.4.2020

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

20.4.2020

17.4.2020

Rubraca

Clovis Oncology Ireland Limited

Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland

EU/1/17/1250

20.4.2020

17.4.2020

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

23.4.2020

23.4.2020

Bevespi Aerosphere

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1339

5.5.2020

23.4.2020

Bridion

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/466

24.4.2020

23.4.2020

Carbaglu

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/02/246

5.5.2020

23.4.2020

Cresemba

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Baden-Wuerttemberg, Deutschland

EU/1/15/1036

24.4.2020

23.4.2020

Cystadane

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/06/379

24.4.2020

23.4.2020

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

27.4.2020

23.4.2020

Descovy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1099

24.4.2020

23.4.2020

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/17/1210

24.4.2020

23.4.2020

Kanuma

Alexion Europe SAS

103-105 rue Anatole France, 92300 Levallois-Perret, France

EU/1/15/1033

24.4.2020

23.4.2020

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

30.4.2020

23.4.2020

Onivyde pegylated liposomal

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/16/1130

5.5.2020

23.4.2020

OPDIVO

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

24.4.2020

23.4.2020

Pedea

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/04/284

24.4.2020

23.4.2020

Respreeza

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/15/1006

27.4.2020

23.4.2020

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

24.4.2020

23.4.2020

Tysabri

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/06/346

24.4.2020

23.4.2020

Ultibro Breezhaler

Novartis Europharm Limited

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

EU/1/13/862

24.4.2020

23.4.2020

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/714

24.4.2020

28.4.2020

Abilify

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/04/276

29.4.2020

28.4.2020

ABILIFY MAINTENA

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/13/882

30.4.2020

28.4.2020

Aripiprazole Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1029

6.5.2020

28.4.2020

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

29.4.2020

28.4.2020

Cayston

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/09/543

29.4.2020

28.4.2020

Cosentyx

Novartis Europharm Limited

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

EU/1/14/980

30.4.2020

28.4.2020

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/611

29.4.2020

28.4.2020

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

7.5.2020

28.4.2020

Farydak

Secura Bio Limited

32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland

EU/1/15/1023

30.4.2020

28.4.2020

Fycompa

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/12/776

1.5.2020

28.4.2020

Humira

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

29.4.2020

28.4.2020

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/468

29.4.2020

28.4.2020

Kevzara

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1196

30.4.2020

28.4.2020

Kineret

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

30.4.2020

28.4.2020

Lokelma

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

5.5.2020

28.4.2020

Myalepta

Amryt Pharmaceuticals DAC

90 Harcourt Street, Dublin 2, Ireland

EU/1/18/1276

29.4.2020

28.4.2020

Nitisinone MDK

MendeliKABS Europe Limited

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

EU/1/17/1217

1.5.2020

28.4.2020

OCALIVA

Intercept Pharma International Limited

Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland

EU/1/16/1139

29.4.2020

28.4.2020

Ruconest

Pharming Group N.V.

Darwinweg 24, 2333 CR Leiden, Nederland

EU/1/10/641

29.4.2020

28.4.2020

Strensiq

Alexion Europe SAS

103-105 rue Anatole France, 92300 Levallois-Perret, France

EU/1/15/1015

29.4.2020

28.4.2020

Zynteglo

bluebird bio (Netherlands) B.V.

Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland

EU/1/19/1367

30.4.2020

—   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 |
| --- | --- | --- | --- | --- |
| 14.4.2020 | Osseor | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/04/287 | 15.4.2020 |
| 14.4.2020 | Protelos | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/04/288 | 15.4.2020 |

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

14.4.2020

Osseor

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/04/287

15.4.2020

14.4.2020

Protelos

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/04/288

15.4.2020

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

| Date of the decision | Name of the medicinal product | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 24.4.2020 | Tulaven | tulathromycin | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/20/251 | Solution for injection | QJ01FA94 | 27.4.2020 |
| 24.4.2020 | Tulissin | tulathromycin | VIRBAC
  1ère avenue 2065 m LID, 06516 Carros, France | EU/2/20/252 | Solution for injection | QJ01FA94 | 27.4.2020 |
| 24.4.2020 | Vectormune FP ILT + AE | Fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) and avian encephalomyelitis vaccine (live) | Ceva-Phylaxia Co. Ltd.
  Szállás u. 5, 1107 Budapest, Magyarország | EU/2/20/250 | Lyophilisate and solvent for suspension for injection | Pending | 27.4.2020 |

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

24.4.2020

Tulaven

tulathromycin

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/251

Solution for injection

QJ01FA94

27.4.2020

24.4.2020

Tulissin

tulathromycin

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

Solution for injection

QJ01FA94

27.4.2020

24.4.2020

Vectormune FP ILT + AE

Fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) and avian encephalomyelitis vaccine (live)

Ceva-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/20/250

Lyophilisate and solvent for suspension for injection

Pending

27.4.2020

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.4.2020 | Comfortis | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/10/115 | 3.4.2020 |
| 1.4.2020 | Nobivac LeuFel | VIRBAC
  1ère avenue 2065 m LID, 06516 Carros, France | EU/2/17/217 | 3.4.2020 |
| 8.4.2020 | Acticam | Ecuphar NV
  Legeweg 157-i, 8020 Oostkamp, België | EU/2/08/088 | 22.4.2020 |
| 8.4.2020 | Fevaxyn Pentofel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/96/002 | 15.4.2020 |
| 8.4.2020 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/11/134 | 15.4.2020 |
| 8.4.2020 | MiPet Easecto | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/220 | 16.4.2020 |
| 8.4.2020 | RESPIPORC FLUpan H1N1 | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/17/209 | 14.4.2020 |
| 8.4.2020 | Vectra 3D | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/13/156 | 14.4.2020 |
| 8.4.2020 | Versican Plus DHPPi | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/169 | 15.4.2020 |
| 8.4.2020 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/164 | 15.4.2020 |
| 8.4.2020 | Versican Plus DHPPi/L4R | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/163 | 15.4.2020 |
| 8.4.2020 | Versican Plus L4 | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/171 | 15.4.2020 |
| 8.4.2020 | Versican Plus Pi | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/168 | 15.4.2020 |
| 8.4.2020 | Versican Plus Pi/L4 | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/172 | 15.4.2020 |
| 8.4.2020 | Versican Plus Pi/L4R | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/173 | 15.4.2020 |
| 16.4.2020 | Arti-Cell Forte | Global Stem cell Technology (G.S.T.) NV
  Noorwegenstraat 4, 9940 Evergem, België | EU/2/18/228 | 17.4.2020 |
| 24.4.2020 | Canigen L4 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/15/183 | 27.4.2020 |
| 24.4.2020 | Innovax-ILT | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/15/182 | 28.4.2020 |
| 24.4.2020 | SevoFlo | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/02/035 | 27.4.2020 |
| 24.4.2020 | Sileo | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/2/15/181 | 29.4.2020 |

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

1.4.2020

Comfortis

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/10/115

3.4.2020

1.4.2020

Nobivac LeuFel

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/17/217

3.4.2020

8.4.2020

Acticam

Ecuphar NV

Legeweg 157-i, 8020 Oostkamp, België

EU/2/08/088

22.4.2020

8.4.2020

Fevaxyn Pentofel

Zoetis Belgium S.A.

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

EU/2/96/002

15.4.2020

8.4.2020

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

15.4.2020

8.4.2020

MiPet Easecto

Zoetis Belgium S.A.

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

EU/2/17/220

16.4.2020

8.4.2020

RESPIPORC FLUpan H1N1

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/209

14.4.2020

8.4.2020

Vectra 3D

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/13/156

14.4.2020

8.4.2020

Versican Plus DHPPi

Zoetis Belgium S.A.

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

EU/2/14/169

15.4.2020

8.4.2020

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

15.4.2020

8.4.2020

Versican Plus DHPPi/L4R

Zoetis Belgium S.A.

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

EU/2/14/163

15.4.2020

8.4.2020

Versican Plus L4

Zoetis Belgium S.A.

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

EU/2/14/171

15.4.2020

8.4.2020

Versican Plus Pi

Zoetis Belgium S.A.

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

EU/2/14/168

15.4.2020

8.4.2020

Versican Plus Pi/L4

Zoetis Belgium S.A.

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

EU/2/14/172

15.4.2020

8.4.2020

Versican Plus Pi/L4R

Zoetis Belgium S.A.

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

EU/2/14/173

15.4.2020

16.4.2020

Arti-Cell Forte

Global Stem cell Technology (G.S.T.) NV

Noorwegenstraat 4, 9940 Evergem, België

EU/2/18/228

17.4.2020

24.4.2020

Canigen L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/183

27.4.2020

24.4.2020

Innovax-ILT

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/182

28.4.2020

24.4.2020

SevoFlo

Zoetis Belgium S.A.

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

EU/2/02/035

27.4.2020

24.4.2020

Sileo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

29.4.2020

—   Withdrawal of a marketing authorisation (Article 38 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 |
| --- | --- | --- | --- | --- |
| 8.4.2020 | Suvaxyn PCV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/099 | 15.4.2020 |

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

8.4.2020

Suvaxyn PCV

Zoetis Belgium S.A.

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

EU/2/09/099

15.4.2020

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.

---

| 29.5.2020 | EN | Official Journal of the European Union | C 181/13 |
| --- | --- | --- | --- |

29.5.2020

EN

Official Journal of the European Union

C 181/13

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2020 to 30 April 2020

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

(2020/C 181/02)

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 17.4.2020 | Veterinary medicinal products containing tylosin base (as a single active substance) presented as solutions for injection for intramuscular use in pigs | Tylosin base | See Annex | See Annex | 20.4.2020 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

17.4.2020

Veterinary medicinal products containing tylosin base (as a single active substance) presented as solutions for injection for intramuscular use in pigs

Tylosin base

See Annex

See Annex

20.4.2020

---

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

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

---

ANNEX

List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States

| Member State EU/EEA | Applicant/Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Axentyl 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Austria | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tiljet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Austria | Richter Pharma AG
  Feldgasse 19
  4600 Wels
  Austria | Tylan 200 mg/ml — Injektionslösung für Rinder und Schweine | Tylosin base | 200 mg/ml | solution for injection | Pigs | Intramuscular use |
| Austria | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Austria | Vetoquinol Österreich GmbH
  Gußhausstraße 14/5
  1040 Vienna
  Austria | Tylucyl 200 mg/ml Injektionslösung für Rinder und Schweine | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Belgium | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tyljet 200 mg/ml | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Belgium | Cross Vetpharm Group Ltd.
  Broomhill Road
  Tallaght, Dublin 24
  Ireland | Bilovet 200 mg/ml | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Belgium | Eli Lilly Benelux NV
  Division Elanco Animal Health
  Markiesstraat 1
  B-1000 Brussel
  Belgium | Tylan 200 | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Belgium | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Belgium | Vetoquinol NV/SA
  Kontichsesteenweg 42
  2630 Aartselaar
  Belgium | Tylucyl 200 | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Bulgaria | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Pharmasin 50 solution for injection | Tylosin base | 50 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Bulgaria | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylovet B - 50 solution for injection for cattle, sheep, goats, swine, dogs and cats | Tylosin base | 50 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Bulgaria | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylovet B - 200 solution for injection for cattle, sheep, goats, swine and dogs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Bulgaria | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Bulgaria | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tyljet 200 mg/ml solution for injection for cattle, sheep, goats and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Bulgaria | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pighs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Croatia | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tyljet, 200 mg/ml, otopina za injekciju za goveda i svinje | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Croatia | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl, 200 mg/mL, otopina za injekciju za goveda i svinje | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Cyprus | Cross Vetpharm Group Ltd.
  Broomhill Road
  Tallaght, Dublin 24
  Ireland | Bilosin 200 mg/ml Solution for Injection for pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Cyprus | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml ενέσιμο διάλυμα για βοοειδή και χοίρους | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Czech Republic | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tiljet, 200 mg/ml, Injekční roztok pro skot a prasata | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Czech Republic | Vétoquinol s. r. o.
  Zámečnická 411
  288 02 Nymburk
  Czech Republic | Tylucyl 200 mg/ml injekční roztok pro skot a prasata | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Denmark | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylovet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Denmark | Ceva Animal Health A/S
  Ladegårdsvej 2
  DK-7100 Vejle
  Denmark | Tiljet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Denmark | Elanco Animal Health A/S
  Lyskær 3E, 2. tv.
  2730 Herlev
  Denmark | Tylan Vet. | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Denmark | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Tylamasin | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Denmark | Vetoquinol Scandinavia AB
  Lyngbyvej 20
  2100 København Ø
  Denmark | Tylucyl | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Estonia | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tyljet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Estonia | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Estonia | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Finland | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tyljet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Finland | Elanco Animal Health A/S
  Lyskær 3E, 2. tv.
  2730 Herlev
  Denmark | Tylan vet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| France | Aniserve GmbH
  Geyerspergerstr. 27
  80689 Munchen
  Germany | Tylovectin 200 solution injectable pour bovins, caprins et porcins | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| France | Bimeda Animal Health Limited
  2, 3 & 4 Airton Close
  Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml solution injectable | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| France | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Axentyl 200 mg/ml solution injectable pour bovins, ovins, caprins et porcins | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| France | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tiljet 200 mg/ml solution injectable pour bovins ovins caprins et porcins | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| France | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tylosine Ceva 200 Mg/Ml Solution Injectable Pour Bovins Ovins Caprins Et Porcins | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| France | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml solution injectable pour bovis ovins caprins et porcins | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| France | Lilly France
  24 Boulevard Vital Bouhot
  92200 Neuilly Sur Seine
  France | Tylan 200 | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| France | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml solution injectable pour bovins et porcins | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Germany | Bela-Pharm GmbH & Co.KG
  Lohner Str. 19
  49377 Vechta
  Germany | Tylobel 25 % | Tylosin base | 250 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Germany | Bimeda Chemicals
  Broomhill Road
  Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml Injektionslösung für Rinder und Schweine | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Germany | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Germany | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goates | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Germany | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Germany | Lilly Deutschland GmbH
  Abteilung Elanco Animal Health
  Werner-Reimers-Str. 2-4
  D-61352 Bad Homburg
  Germany | Tylan 200 | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Germany | Selectavet Dr Otto Fischer
  Am Kögelberg 5
  D-83629 Weyarn/Holzolling
  Germany | Tylosel-200 | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Germany | Vetoquinol GmbH
  Reichenbachstr. 1
  D-85737 Ismaning
  Germany | Tylucyl 200 mg/ml | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Greece | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylmasin | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Greece | Ceva Hellas LLC
  15 Agiou Nikolaou Street
  17455 Alimos
  Greece | Tiljet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Greece | Eli Lilly Regional Operations GmbH,
  Elanco Animal Health,
  Kölblgasse 8 — 10,
  1030 Vienna,
  Austria | Tylan 200 | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Greece | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Greece | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Hungary | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylmasin 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Hungary | Ceva-Phylaxia Zrt.
  Szállás u. 5.
  1107 Budapest
  Hungary | Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goats | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Hungary | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Hungary | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml oldatos injekció szarvasmarhák és sertések részére | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Ireland | Bimeda Chemicals
  Broomhill Road
  Tallaght
  Dublin 24
  Ireland | Bilosin 200 mg/ml, solution for injection | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Ireland | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylosin Biovet JSC 200 mg/ml solution for injection for cattle, sheep, goats and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Ireland | Cross Vetpharm Group Ltd.
  Broomhill Road
  Tallaght, Dublin 24
  Ierland | Bilovet 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Ireland | Elanco GmbH,
  Heinz-Lohmann-Strasse 4
  27472 Cuxhaven
  Germany | Tylan 200, 200 mg/ml solution for injection | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Ireland | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Ireland | Vetoquinol Ireland Limited
  First Floor, Segrave House
  19-20 Earlsfort Terrace
  Dublin 2
  Ireland | Tylucyl 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Italy | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Axentyl 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Italy | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tiljet 20, 200 mg/ml, soluzione iniettabile per bovini, suini, cani. | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Italy | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tylosine Ceva | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Italy | Cross Vetpharm Group Ltd.
  Broomhill Road
  Tallaght, Dublin 24
  Ierland | Bilovet 200 mg/ml soluzione iniettabile per bovini e suini | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Italy | Eli Lilly Italia SpA
  Via Gramsci 731-733,
  50019 Sesto Fiorentino — FI
  Italy | Tylan® 200, 200 mg/ml soluzione iniettabile, per bovini e suini. | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Italy | FATRO S.P.A.
  Via Emilia, 285
  40064 Ozzano Dell’Emilia (Bologna)
  Italy | Supratil 200 mg/ml soluzione iniettabile per bovini e suini | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Italy | FATRO S.P.A.
  Via Emilia, 285
  40064 Ozzano Dell’Emilia (Bologna)
  Italy | Vetil, 200 mg/ml, soluzione iniettabile per bovini, suini e cani | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Italy | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Italy | Vetoquinol Italia S.r.l.
  Via Piana 265
  47032 Bertinoro (FC)
  Italy | Tylucyl 200 mg/ml soluzione iniettabile per bovini e suini | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Latvia | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tylosine Ceva 200 mg/ml šķīdums injekcijām liellopiem un cūkām | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Latvia | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml šķīdums injekcijām liellopiem, aitām, kazām un cūkām | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Latvia | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml šķīdums injekcijām liellopiem un cūkām | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Lithuania | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tilject 200 mg/ml injekcinis tirpals galvijams ir kiaulėms. | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Lithuania | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml injekcinis tirpalas kiaulėms, galvijams, avims ir ožkoms | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Lithuania | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 50 mg/ml injekcinis tirpalas kiaulėms, galvijams, avims, ožkoms, šunims ir katėms | Tylosin base | 50 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Lithuania | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml injekcinis tirpalas galvijams ir kiaulėms | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Luxembourg | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tyljet 200 mg/ml | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Luxembourg | Cross Vetpharm Group Ltd.
  Broomhill Road
  Tallaght, Dublin 24
  Ireland | Bilovet 200 mg/ml | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Luxembourg | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Luxembourg | Vetoquinol NV/SA
  Kontichsesteenweg 42
  2630 Aartselaar
  Belgium | Tylucyl 200 | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Netherlands | Aniserve
  Geyerspergerstrasse 27
  80689 Munchen
  Germany | Tylovectin 200 mg oplossing voor injectie voor runderen, geitenen varkens | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Netherlands | Bimeda Animal Health Limited
  2, 3 & 4 Airton Close Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml oplossing voor injectie voor runderen en varkens | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Netherlands | Elanco GmbH,
  Heinz-Lohmann-Strasse 4
  27472 Cuxhaven
  Germany | Tylan 200 injectie oplossing voor injectie voor rund, kalf en varken | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Netherlands | Floris Veterinaire Produkten B.V.
  Kempenlandstraat 33-35
  5262 GK Vught
  The Netherlands | Tylosine 20 % P.I. | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Netherlands | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml oplossing voor injectie voor runderen en varkens | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Netherlands | Vetoquinol B.V.
  Postbus 3191
  Hertogenbosch
  5232 DD’s Hertogenbosch
  The Netherlands | Tylucyl 200 mg/ml oplossing voor injectie voor runderen en varkens. | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Norway | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tyljet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Poland | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylozyna Biovet JSC | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Poland | Ceva Animal Health Polska Sp. z o.o.
  Ul. Okrzei 1a
  03-715 Warsaw
  Poland | Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goats | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Poland | Cross Vetpharm Group Ltd.
  Broomhill Road
  Tallaght, Dublin 24
  Ireland | Bilovet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Poland | Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.
  6 Grójecka str.
  05-651 Drwalew
  Poland | Biotyl 200 | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Poland | Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.
  6 Grójecka str.
  05-651 Drwalew
  Poland | Biotyl 50 | Tylosin base | 50 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Poland | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Poland | Vetoquinol Biowet Sp. z o.o.
  ul. Kosynierów Gdyńskich 13-14
  66-400 Gorzów Wielkopolski
  Poland | Tylucyl | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Portugal | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylmasin 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Portugal | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Portugal | Laboratorios Syva S.A.U
  Av. del Parroco Pablo Diez, 49
  24010 San Andrés del Rabanedo
  Léon
  Spain | Jectyl 200 mg/ml solução injetável para bovinos, suínos e cães | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Portugal | Lilly Portugal, Produtos Farmacêuticos, Lda
  Torre Ocidente
  Rua Galileu Galilei, N.o 2, Piso 7 Fração A/D
  1500-392 Lisboa
  Portugal | Tylan 200 mg/ml Solução injetável para bovinos e suínos | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Portugal | Vétoquinol, Unipessoal Lda.
  Rua Consigliéri Pedroso, 123– Edifício H
  2730-056 Barcarena
  Portugal | Tylucyl 200 mg/ml, solução injetável para bovinos e suínos | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Romania | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylmasin | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Romania | Cross Vetpharm Group Ltd.
  Broomhill Road
  Tallaght, Dublin 24
  Ireland | Bilovet 200 mg/ml | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Romania | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Romania | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Slovak Republic | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tylovet B- 200 mg/ml injekčný roztok pre hovädzí dobytok a ošípané | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Slovak Republic | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tyljet 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Slovak Republic | Vétoquinol s.r.o
  Zámečnická 411
  288 02 Nymburg
  Česká Republika | Tylucil 200 mg/ml injekčný roztok pre hovädzí dobytok a ošípané | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Slovenia | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tiljet 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Slovenia | Vetoquinol SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Spain | Bimeda Animal Health Limited
  2, 3 & 4 Airton Close
  Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml solucion inyectable para bovino y porcino | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Spain | Biovet JSC
  39, Petar Racov Str.
  4550 Peshtera
  Bulgaria | Tilosina Biovet JSC 200 mg/ml solucion inyectable para bovino ovino caprino y porcino | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Spain | Ceva Salud Animal, S.A.
  Avinguda Diagonal, 609 — 615
  08028 Barcelona
  Spain | Tyljet 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Spain | Elanco GmbH,
  Heinz-Lohmann-Strasse 4
  27472 Cuxhaven
  Germany | Trelacon 200.000 UI/ml solucion inyectable | Tylosin base | 200 mg/ml | Solution for Injection | Pigs | Intramuscular use |
| Spain | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml solucion inyectable para bovino ovino caprino y porcino | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Spain | Industrial Veterinaria, S.A.
  Esmeralda, 19
  08950 Esplugues de Llobregat
  Barcelona
  Spain | Tilosina 200 mg/ml Ganadexil solucion inyectable | Tylosin base | 200 mg/ml | Solution for Injection | Pigs | Intramuscular use |
| Spain | Laboratorios e Industrias Iven, S.A.
  Calle de Luis I, 56
  28031 Madrid
  Spain | Tilosiven 200 mg/ml solucion inyectable | Tylosin base | 200 mg/ml | Solution for Injection | Pigs | Intramuscular use |
| Spain | Laboratorios e Industrias Iven, S.A.
  Calle de Luis I, 56
  28031 Madrid
  Spain | Tisergen 200 mg/ml | Tylosin base | 200 mg/ml | Solution for Injection | Pigs | Intramuscular use |
| Spain | Laboratorios Syva S.A.U
  Av. del Parroco Pablo Diez, 49
  24010 San Andrés del Rabanedo
  Léon
  Spain | Tilosul | Tylosin base | 200 mg/ml | Solution for Injection | Pigs | Intramuscular use |
| Spain | Mevet
  Polígono Ind El Segre
  Avenida de la Industria, Parc 410
  25191 Lleida, Lérida
  Spain | Tilovall 200 mg/ml solución inyectable | Tylosin base | 200 mg/ml | Solution for Injection | Pigs | Intramuscular use |
| Spain | Vetoquinol Especialidades Veterinarias S.A.
  Carreta de Fuencarral, 24
  Edificio Europa I
  28108 Madrid
  Spain | Tylucyl 200 mg/ml solucion inyectable para bovino y cerdos | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Sweden | Ceva Animal Health AB
  Annedalsvägen 9
  227 64 Lund
  Sweden | Tiljet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Sweden | Elanco Animal Health A/S
  Lyskær 3E, 2. tv.
  2730 Herlev
  Denmark | Tylan Vet | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| Sweden | Vetoquinol Scandinavia AB
  Torgattan 2
  26521 Åstorp
  Sweden | Tylucyl | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| United Kingdom | Aniserve
  Geyerspergerstrasse 27
  80689 Munchen
  Germany | Tylovectin 200 solution for injection for cattle, goats and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| United Kingdom | Bimeda Animal Health Limited
  2, 3 & 4 Airton Close
  Tallaght
  Dublin 24
  Ireland | Bilosin 200 mg/ml, solution for injection | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| United Kingdom | Bimeda Animal Health Limited
  2, 3 & 4 Airton Close
  Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| United Kingdom | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Tiljet 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| United Kingdom | Eli Lilly and Company Limited
  Elanco Animal Health
  Priestley Road
  Basingstoke
  Hampshire RG24 9NL
  UK | Tylan 200, 200 mg/ml solution for injection | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |
| United Kingdom | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen (Berchen)
  Belgium | Pharmasin 200 mg/ml solution for injection for cattle and pigs | Tylosin base | 200 mg/ml | Solution for injection | Pigs | Intramuscular use |

Member State EU/EEA

Applicant/Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Axentyl 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Austria

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tiljet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Austria

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Tylan 200 mg/ml — Injektionslösung für Rinder und Schweine

Tylosin base

200 mg/ml

solution for injection

Pigs

Intramuscular use

Austria

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Austria

Vetoquinol Österreich GmbH

Gußhausstraße 14/5

1040 Vienna

Austria

Tylucyl 200 mg/ml Injektionslösung für Rinder und Schweine

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Belgium

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tyljet 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Belgium

Cross Vetpharm Group Ltd.

Broomhill Road

Tallaght, Dublin 24

Ireland

Bilovet 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Belgium

Eli Lilly Benelux NV

Division Elanco Animal Health

Markiesstraat 1

B-1000 Brussel

Belgium

Tylan 200

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Belgium

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Belgium

Vetoquinol NV/SA

Kontichsesteenweg 42

2630 Aartselaar

Belgium

Tylucyl 200

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Bulgaria

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Pharmasin 50 solution for injection

Tylosin base

50 mg/ml

Solution for injection

Pigs

Intramuscular use

Bulgaria

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylovet B - 50 solution for injection for cattle, sheep, goats, swine, dogs and cats

Tylosin base

50 mg/ml

Solution for injection

Pigs

Intramuscular use

Bulgaria

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylovet B - 200 solution for injection for cattle, sheep, goats, swine and dogs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Bulgaria

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Bulgaria

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tyljet 200 mg/ml solution for injection for cattle, sheep, goats and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Bulgaria

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pighs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Croatia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tyljet, 200 mg/ml, otopina za injekciju za goveda i svinje

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Croatia

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl, 200 mg/mL, otopina za injekciju za goveda i svinje

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Cyprus

Cross Vetpharm Group Ltd.

Broomhill Road

Tallaght, Dublin 24

Ireland

Bilosin 200 mg/ml Solution for Injection for pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Cyprus

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/ml ενέσιμο διάλυμα για βοοειδή και χοίρους

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Czech Republic

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tiljet, 200 mg/ml, Injekční roztok pro skot a prasata

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Czech Republic

Vétoquinol s. r. o.

Zámečnická 411

288 02 Nymburk

Czech Republic

Tylucyl 200 mg/ml injekční roztok pro skot a prasata

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Denmark

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylovet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Denmark

Ceva Animal Health A/S

Ladegårdsvej 2

DK-7100 Vejle

Denmark

Tiljet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Denmark

Elanco Animal Health A/S

Lyskær 3E, 2. tv.

2730 Herlev

Denmark

Tylan Vet.

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Denmark

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Tylamasin

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Denmark

Vetoquinol Scandinavia AB

Lyngbyvej 20

2100 København Ø

Denmark

Tylucyl

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Estonia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tyljet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Estonia

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Estonia

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Finland

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tyljet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Finland

Elanco Animal Health A/S

Lyskær 3E, 2. tv.

2730 Herlev

Denmark

Tylan vet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

France

Aniserve GmbH

Geyerspergerstr. 27

80689 Munchen

Germany

Tylovectin 200 solution injectable pour bovins, caprins et porcins

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

France

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml solution injectable

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

France

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Axentyl 200 mg/ml solution injectable pour bovins, ovins, caprins et porcins

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

France

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tiljet 200 mg/ml solution injectable pour bovins ovins caprins et porcins

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

France

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tylosine Ceva 200 Mg/Ml Solution Injectable Pour Bovins Ovins Caprins Et Porcins

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

France

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml solution injectable pour bovis ovins caprins et porcins

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

France

Lilly France

24 Boulevard Vital Bouhot

92200 Neuilly Sur Seine

France

Tylan 200

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

France

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/ml solution injectable pour bovins et porcins

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Germany

Bela-Pharm GmbH & Co.KG

Lohner Str. 19

49377 Vechta

Germany

Tylobel 25 %

Tylosin base

250 mg/ml

Solution for injection

Pigs

Intramuscular use

Germany

Bimeda Chemicals

Broomhill Road

Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml Injektionslösung für Rinder und Schweine

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Germany

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Germany

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goates

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Germany

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Germany

Lilly Deutschland GmbH

Abteilung Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

Germany

Tylan 200

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Germany

Selectavet Dr Otto Fischer

Am Kögelberg 5

D-83629 Weyarn/Holzolling

Germany

Tylosel-200

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Germany

Vetoquinol GmbH

Reichenbachstr. 1

D-85737 Ismaning

Germany

Tylucyl 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Greece

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylmasin

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Greece

Ceva Hellas LLC

15 Agiou Nikolaou Street

17455 Alimos

Greece

Tiljet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Greece

Eli Lilly Regional Operations GmbH,

Elanco Animal Health,

Kölblgasse 8 — 10,

1030 Vienna,

Austria

Tylan 200

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Greece

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Greece

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Hungary

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylmasin 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Hungary

Ceva-Phylaxia Zrt.

Szállás u. 5.

1107 Budapest

Hungary

Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goats

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Hungary

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Hungary

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/ml oldatos injekció szarvasmarhák és sertések részére

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Ireland

Bimeda Chemicals

Broomhill Road

Tallaght

Dublin 24

Ireland

Bilosin 200 mg/ml, solution for injection

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Ireland

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylosin Biovet JSC 200 mg/ml solution for injection for cattle, sheep, goats and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Ireland

Cross Vetpharm Group Ltd.

Broomhill Road

Tallaght, Dublin 24

Ierland

Bilovet 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Ireland

Elanco GmbH,

Heinz-Lohmann-Strasse 4

27472 Cuxhaven

Germany

Tylan 200, 200 mg/ml solution for injection

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Ireland

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Ireland

Vetoquinol Ireland Limited

First Floor, Segrave House

19-20 Earlsfort Terrace

Dublin 2

Ireland

Tylucyl 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Italy

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Axentyl 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Italy

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tiljet 20, 200 mg/ml, soluzione iniettabile per bovini, suini, cani.

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Italy

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tylosine Ceva

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Italy

Cross Vetpharm Group Ltd.

Broomhill Road

Tallaght, Dublin 24

Ierland

Bilovet 200 mg/ml soluzione iniettabile per bovini e suini

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Italy

Eli Lilly Italia SpA

Via Gramsci 731-733,

50019 Sesto Fiorentino — FI

Italy

Tylan® 200, 200 mg/ml soluzione iniettabile, per bovini e suini.

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Italy

FATRO S.P.A.

Via Emilia, 285

40064 Ozzano Dell’Emilia (Bologna)

Italy

Supratil 200 mg/ml soluzione iniettabile per bovini e suini

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Italy

FATRO S.P.A.

Via Emilia, 285

40064 Ozzano Dell’Emilia (Bologna)

Italy

Vetil, 200 mg/ml, soluzione iniettabile per bovini, suini e cani

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Italy

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Italy

Vetoquinol Italia S.r.l.

Via Piana 265

47032 Bertinoro (FC)

Italy

Tylucyl 200 mg/ml soluzione iniettabile per bovini e suini

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Latvia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tylosine Ceva 200 mg/ml šķīdums injekcijām liellopiem un cūkām

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Latvia

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml šķīdums injekcijām liellopiem, aitām, kazām un cūkām

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Latvia

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/ml šķīdums injekcijām liellopiem un cūkām

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Lithuania

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tilject 200 mg/ml injekcinis tirpals galvijams ir kiaulėms.

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Lithuania

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml injekcinis tirpalas kiaulėms, galvijams, avims ir ožkoms

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Lithuania

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 50 mg/ml injekcinis tirpalas kiaulėms, galvijams, avims, ožkoms, šunims ir katėms

Tylosin base

50 mg/ml

Solution for injection

Pigs

Intramuscular use

Lithuania

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/ml injekcinis tirpalas galvijams ir kiaulėms

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Luxembourg

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tyljet 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Luxembourg

Cross Vetpharm Group Ltd.

Broomhill Road

Tallaght, Dublin 24

Ireland

Bilovet 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Luxembourg

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Luxembourg

Vetoquinol NV/SA

Kontichsesteenweg 42

2630 Aartselaar

Belgium

Tylucyl 200

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Netherlands

Aniserve

Geyerspergerstrasse 27

80689 Munchen

Germany

Tylovectin 200 mg oplossing voor injectie voor runderen, geitenen varkens

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Netherlands

Bimeda Animal Health Limited

2, 3 & 4 Airton Close Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml oplossing voor injectie voor runderen en varkens

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Netherlands

Elanco GmbH,

Heinz-Lohmann-Strasse 4

27472 Cuxhaven

Germany

Tylan 200 injectie oplossing voor injectie voor rund, kalf en varken

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Netherlands

Floris Veterinaire Produkten B.V.

Kempenlandstraat 33-35

5262 GK Vught

The Netherlands

Tylosine 20 % P.I.

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Netherlands

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml oplossing voor injectie voor runderen en varkens

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Netherlands

Vetoquinol B.V.

Postbus 3191

Hertogenbosch

5232 DD’s Hertogenbosch

The Netherlands

Tylucyl 200 mg/ml oplossing voor injectie voor runderen en varkens.

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Norway

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tyljet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Poland

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylozyna Biovet JSC

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Poland

Ceva Animal Health Polska Sp. z o.o.

Ul. Okrzei 1a

03-715 Warsaw

Poland

Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goats

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Poland

Cross Vetpharm Group Ltd.

Broomhill Road

Tallaght, Dublin 24

Ireland

Bilovet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Poland

Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.

6 Grójecka str.

05-651 Drwalew

Poland

Biotyl 200

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Poland

Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.

6 Grójecka str.

05-651 Drwalew

Poland

Biotyl 50

Tylosin base

50 mg/ml

Solution for injection

Pigs

Intramuscular use

Poland

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Poland

Vetoquinol Biowet Sp. z o.o.

ul. Kosynierów Gdyńskich 13-14

66-400 Gorzów Wielkopolski

Poland

Tylucyl

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Portugal

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylmasin 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Portugal

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Portugal

Laboratorios Syva S.A.U

Av. del Parroco Pablo Diez, 49

24010 San Andrés del Rabanedo

Léon

Spain

Jectyl 200 mg/ml solução injetável para bovinos, suínos e cães

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Portugal

Lilly Portugal, Produtos Farmacêuticos, Lda

Torre Ocidente

Rua Galileu Galilei, N.o 2, Piso 7 Fração A/D

1500-392 Lisboa

Portugal

Tylan 200 mg/ml Solução injetável para bovinos e suínos

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Portugal

Vétoquinol, Unipessoal Lda.

Rua Consigliéri Pedroso, 123– Edifício H

2730-056 Barcarena

Portugal

Tylucyl 200 mg/ml, solução injetável para bovinos e suínos

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Romania

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylmasin

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Romania

Cross Vetpharm Group Ltd.

Broomhill Road

Tallaght, Dublin 24

Ireland

Bilovet 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Romania

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Romania

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl 200

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Slovak Republic

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tylovet B- 200 mg/ml injekčný roztok pre hovädzí dobytok a ošípané

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Slovak Republic

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tyljet 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Slovak Republic

Vétoquinol s.r.o

Zámečnická 411

288 02 Nymburg

Česká Republika

Tylucil 200 mg/ml injekčný roztok pre hovädzí dobytok a ošípané

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Slovenia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tiljet 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Slovenia

Vetoquinol SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Spain

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml solucion inyectable para bovino y porcino

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Spain

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Tilosina Biovet JSC 200 mg/ml solucion inyectable para bovino ovino caprino y porcino

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Spain

Ceva Salud Animal, S.A.

Avinguda Diagonal, 609 — 615

08028 Barcelona

Spain

Tyljet 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Spain

Elanco GmbH,

Heinz-Lohmann-Strasse 4

27472 Cuxhaven

Germany

Trelacon 200.000 UI/ml solucion inyectable

Tylosin base

200 mg/ml

Solution for Injection

Pigs

Intramuscular use

Spain

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml solucion inyectable para bovino ovino caprino y porcino

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Spain

Industrial Veterinaria, S.A.

Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona

Spain

Tilosina 200 mg/ml Ganadexil solucion inyectable

Tylosin base

200 mg/ml

Solution for Injection

Pigs

Intramuscular use

Spain

Laboratorios e Industrias Iven, S.A.

Calle de Luis I, 56

28031 Madrid

Spain

Tilosiven 200 mg/ml solucion inyectable

Tylosin base

200 mg/ml

Solution for Injection

Pigs

Intramuscular use

Spain

Laboratorios e Industrias Iven, S.A.

Calle de Luis I, 56

28031 Madrid

Spain

Tisergen 200 mg/ml

Tylosin base

200 mg/ml

Solution for Injection

Pigs

Intramuscular use

Spain

Laboratorios Syva S.A.U

Av. del Parroco Pablo Diez, 49

24010 San Andrés del Rabanedo

Léon

Spain

Tilosul

Tylosin base

200 mg/ml

Solution for Injection

Pigs

Intramuscular use

Spain

Mevet

Polígono Ind El Segre

Avenida de la Industria, Parc 410

25191 Lleida, Lérida

Spain

Tilovall 200 mg/ml solución inyectable

Tylosin base

200 mg/ml

Solution for Injection

Pigs

Intramuscular use

Spain

Vetoquinol Especialidades Veterinarias S.A.

Carreta de Fuencarral, 24

Edificio Europa I

28108 Madrid

Spain

Tylucyl 200 mg/ml solucion inyectable para bovino y cerdos

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Sweden

Ceva Animal Health AB

Annedalsvägen 9

227 64 Lund

Sweden

Tiljet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Sweden

Elanco Animal Health A/S

Lyskær 3E, 2. tv.

2730 Herlev

Denmark

Tylan Vet

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

Sweden

Vetoquinol Scandinavia AB

Torgattan 2

26521 Åstorp

Sweden

Tylucyl

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

United Kingdom

Aniserve

Geyerspergerstrasse 27

80689 Munchen

Germany

Tylovectin 200 solution for injection for cattle, goats and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

United Kingdom

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght

Dublin 24

Ireland

Bilosin 200 mg/ml, solution for injection

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

United Kingdom

Bimeda Animal Health Limited

2, 3 & 4 Airton Close

Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

United Kingdom

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Tiljet 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

United Kingdom

Eli Lilly and Company Limited

Elanco Animal Health

Priestley Road

Basingstoke

Hampshire RG24 9NL

UK

Tylan 200, 200 mg/ml solution for injection

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

United Kingdom

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen (Berchen)

Belgium

Pharmasin 200 mg/ml solution for injection for cattle and pigs

Tylosin base

200 mg/ml

Solution for injection

Pigs

Intramuscular use

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