# C_2020181EN.01001301.xml

| 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

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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

(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

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

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

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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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