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)
Date: 2020-05-29
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, veterinary medicinal product








C_2020181EN.01001301.xml










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






(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