# C_2017328EN.01001401.xml

| 29.9.2017 | EN | Official Journal of the European Union | C 328/14 |
| --- | --- | --- | --- |

29.9.2017

EN

Official Journal of the European Union

C 328/14

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 2017

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

1

2

(2017/C 328/02)

| — | Issuing, maintenance or modification of a national marketing authorisation |
| --- | --- |

—

Issuing, maintenance or modification of a national marketing authorisation

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 7.8.2017 | Paracetamol/ibuprofen 500 mg/150 mg Film-coated tablets and associated names | paracetamol/ibuprofen | See Annex I | See Annex I | 8.8.2017 |
| 10.7.2017 | Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. | tylosin | See Annex II | See Annex II | 11.7.2017 |
| 19.7.2017 | Cardioxane | dexrazoxane | See Annex III | See Annex III | 24.7.2017 |
| 28.8.2017 | Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate) | Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate) | See Annex IV | See Annex IV | 30.8.2017 |
| 14.7.2017 | Denagard 45 % and associated names | Tiamulin hydrogen fumarate | See Annex V | See Annex V | 17.7.2017 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

7.8.2017

Paracetamol/ibuprofen 500 mg/150 mg Film-coated tablets and associated names

paracetamol/ibuprofen

See Annex I

See Annex I

8.8.2017

10.7.2017

Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.

tylosin

See Annex II

See Annex II

11.7.2017

19.7.2017

Cardioxane

dexrazoxane

See Annex III

See Annex III

24.7.2017

28.8.2017

Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate)

Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate)

See Annex IV

See Annex IV

30.8.2017

14.7.2017

Denagard 45 % and associated names

Tiamulin hydrogen fumarate

See Annex V

See Annex V

17.7.2017

| — | Refusal of a national marketing authorisation |
| --- | --- |

—

Refusal of a national marketing authorisation

Refusal of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 10.7.2017 | Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. | tylosin | See Annex II | See Annex II | 11.7.2017 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

10.7.2017

Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.

tylosin

See Annex II

See Annex II

11.7.2017

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

1

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

2

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ANNEX I

List of medicinal products and presentations

| Member State EU/EEA | Applicant | (Invented) Name | INN + Strength | Pharmaceutical form4 | Route of administration5 |
| --- | --- | --- | --- | --- | --- |
| Austria | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Ibucomb | 500 mg/150 mg | film
  coated tablet | oral |
| Belgium | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Combogesic | 500 mg/150 mg | film
  coated tablet | oral |
| Croatia | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Combogesic | 500 mg/150 mg | film
  coated tablet | oral |
| France | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracetamol/Ibuprofen Vale | 500 mg/150 mg | film
  coated tablet | oral |
| Germany | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracetamol/Ibuprofen Vale | 500 mg/150 mg | film
  coated tablet | oral |
| Ireland | Clonmel Healthcare
  Waterford Road
  Clonmel
  Co. Tipperary
  E91 D768
  Ireland | Easolief Duo | 500 mg/150 mg | film
  coated tablet | oral |
| Luxembourg | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracomb | 500 mg/150 mg | film
  coated tablet | oral |
| The Netherlands | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paraprofen | 500 mg/150 mg | film
  coated tablet | oral |
| Portugal | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Maxigesic | 500 mg/150 mg | film
  coated tablet | oral |
| Spain | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Dolostop Plus
  500 mg/150 mg comprimidos recubiertos con película | 500 mg/150 mg | film
  coated tablet | oral |
| United Kingdom
  (UK/H/6034/001/DC) | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracetamol/Ibuprofen 500 mg/150 mg film
  coated tablets | 500 mg/150 mg | film
  coated tablet | oral |
| United Kingdom (UK/H/6035/001/DC) | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracetamol/Ibuprofen 500 mg/150 mg film
  coated tablets | 500 mg/150 mg | film
  coated tablet | oral |
| United Kingdom (UK/H/6176/001/DC) | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Novogesic 500 mg/150 mg film coated tablets | 500 mg/150 mg | film
  coated tablet | oral |

Member State EU/EEA

Applicant

(Invented) Name

INN + Strength

Pharmaceutical form4

Route of administration5

Austria

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Ibucomb

500 mg/150 mg

film

coated tablet

oral

Belgium

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Combogesic

500 mg/150 mg

film

coated tablet

oral

Croatia

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Combogesic

500 mg/150 mg

film

coated tablet

oral

France

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracetamol/Ibuprofen Vale

500 mg/150 mg

film

coated tablet

oral

Germany

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracetamol/Ibuprofen Vale

500 mg/150 mg

film

coated tablet

oral

Ireland

Clonmel Healthcare

Waterford Road

Clonmel

Co. Tipperary

E91 D768

Ireland

Easolief Duo

500 mg/150 mg

film

coated tablet

oral

Luxembourg

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracomb

500 mg/150 mg

film

coated tablet

oral

The Netherlands

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paraprofen

500 mg/150 mg

film

coated tablet

oral

Portugal

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Maxigesic

500 mg/150 mg

film

coated tablet

oral

Spain

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Dolostop Plus

500 mg/150 mg comprimidos recubiertos con película

500 mg/150 mg

film

coated tablet

oral

United Kingdom

(UK/H/6034/001/DC)

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracetamol/Ibuprofen 500 mg/150 mg film

coated tablets

500 mg/150 mg

film

coated tablet

oral

United Kingdom (UK/H/6035/001/DC)

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracetamol/Ibuprofen 500 mg/150 mg film

coated tablets

500 mg/150 mg

film

coated tablet

oral

United Kingdom (UK/H/6176/001/DC)

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Novogesic 500 mg/150 mg film coated tablets

500 mg/150 mg

film

coated tablet

oral

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ANNEX II

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

| Member State EU/EEA | Applicant/Marketing authorisation holder | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Austria | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Austria | Vana GmbH
  Wolfgang Schmälzl-Gasse 6
  1020 Wien
  Austria | Vanatyl 200 mg/ml — Injektionslösung für Tiere | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Calves Sheep Goats Pigs Dogs | IM |
| Belgium | Cross Vetpharma Group Ltd
  Broomhill Road, Tallagh Dublin 24
  Ireland | Bilovet | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Belgium | VETOQUINOL SA/NV
  Kontichsesteenweg 42
  2630 Aartselaar
  Belgium | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Bulgaria | Biovet JSC
  39, Petar Rakov Str.
  4550 Pesthera
  Bulgaria | PHARMASIN 200 mg/ml solution for injection for cattle, sheep, goats and pigs | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Croatia | VETOQUINOL SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/mL otopina za injekcije za goveda i svinje | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Cyprus | VETOQUINOL SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Denmark | Biovet JSC
  39, Petar Rakov Str.
  4550 Pesthera
  Bulgaria | Tylaxene | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Denmark | Huvepharma NV Uitbreidingstraat 80
  BE-2600 Antwerpen
  Belgium | Tylmasin | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Denmark | Vetoquinol Scandinavia AB Lyngbyvej 20
  DK-2100 København
  Denmark | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Estonia | Vétoquinol SA,
  Magny-Vernois
  70200 Lure
  France | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Finland | VETOQUINOL SA/NV
  Kontichsesteenweg 42
  2630 Aartselaar
  Belgium | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| France | LILLY France
  24 Boulevard Vital Bouhot
  92200 Neuilly Sur Seine
  France | TYLAN 200 | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| France | HUVEPHARMA
  Uitbredingstraat 53
  2600 Antwerp
  Belgium | PHARMASIN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS CAPRINS ET PORCINS | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| France | Biovet JSC
  39, Petar Rakov Str.
  4550 Pesthera
  Bulgaria | TYLAXEN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS, OVINS, CAPRINS ET PORCINS | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| France | CROSS VETPHARM GROUP
  Broomhill Road
  Dublin 24
  Tallaght
  Ireland | BILOVET 200 MG/ML SOLUTION INJECTABLE | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| France | VETOQUINOL
  Magny Vernois
  70200 Lure
  France | TYLUCYL 200 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Germany | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Germany | Vétoquinol GmbH
  Parkstr. 10
  88212 Ravensburg
  Germany | Tylucyl 200 mg/ml | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Germany | HUVEPHARMA NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Germany | Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd.
  Broomhill Road, Tallagh Dublin 24
  Ireland | Bilovet 200 mg/ml Injektionslösung für Rinder und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Greece | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Hungary | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Hungary | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Hungary | VETOQUINOL SA
  Magny Vernois
  70200 LURE
  France | Tylucyl 200 mg/ml oldatos injekció szarvasmarhák és sertések részére | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Ireland | Eli Lilly & Company Limited
  Elanco Animal Health
  Priestley Road
  Basingstoke
  Hampshire RG24 9NL
  United Kingdom | Tylan 200, 200 mg/ml Solution for Injection | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Ireland | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylaxen 200 mg/ml solution for injection for cattle, sheep, goats and pigs. | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Ireland | Huvepharma N.V.
  Uitbreidingsstraat 80
  2600 Antwerpen
  Belgium | Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Ireland | Cross Vetpharm Group Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml Solution for Injection for cattle and pigs. | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Italy | Vetoquinol Italia S.r.l.
  Via Piana 265
  47032 Bertinoro (FC)
  Italy | TYLUCYL 200 mg/ml soluzione iniettabile per bovini e suini | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Italy | FATRO S.p.A.
  Via Emilia 285
  40064 Ozzano Emilia (BO)
  Italy | VETIL | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs Dogs | IM |
| Italy | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml soluzione iniettabile | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Italy | ELI LILLY ITALIA S.p.A.
  Via Gramsci, 731/733
  50019 Sesto Fiorentino
  Firenze
  Italy | TYLAN 200 | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Italy | HUVEPHARMA NV
  Uitbreidingstraat 80
  2600 Anversa
  Belgium | PHARMASIN 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Latvia | Vetoquinol S.A.
  Magny-Vernois B.P. 189
  Lure Cedex
  France | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| The Netherlands | CROSS VETPHARM GROUP Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | BILOVET 200 mg/ml oplossing voor injectie voor runderen en varkens | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Poland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpia
  Belgium | Pharmasin | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Poland | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylaxen | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Poland | Aniserve UG Geyerspergerstrasse 27
  80689 Munich
  Germany | Bilovet 200 | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Poland | Vetoquinol Biowet Sp. z o.o.
  ul. Kosynierów Gdyńskich 13-14
  66-400 Gorzów Wielkopolski
  Poland | Tylucyl 200 mg/ml solution for injection | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Portugal | Vetoquinol S.A.
  Magny-Vernois B.P. 189
  Lure Cedex
  France | Tylucyl 200 mg/ml, solução injetável para bovinos e suínos | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Portugal | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Portugal | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Portugal | Lilly Portugal — Produtos Farmacêuticos, Lda

  R. Cesário Verde, 5 — piso 4
  Linda-a-Pastora
  2790-326 Queijas
  Portugal | Tylan 200 mg/ml Solução injetável para bovinos e suínos | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Romania | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylaxen 200 mg/ml | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Romania | Cross Vetpharm Group Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Slovak Republic | Vétoquinol s.r.o.
  Zámečnická 411
  288 02 Nymburk
  Czech Republic | TYLUCYL 200 mg/ml injekčný roztok pre hovädzí dobytok a ošípané | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Slovak Republic | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLOVET B-200 mg/ml injekčný roztok | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Slovenia | VETOQUINOL SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Spain | CROSS VETPHARM GROUP LIMITED.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | BILOVET 200 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Spain | VETOQUINOL ESPECIALIDADES VETERINARIAS, S.A.
  A. Fuencarral Alcobendas km 15 700 Edificio Europa I Portal 3 2o5
  28108 Alcobendas (Madrid)
  Spain | TYLUCIL 200 mg/ml SOLUCIÓN INYECTABLE | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Spain | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PO | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Spain | Biovet JSC,
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PORC | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Sweden | Vetoquinol Scandinavia AB
  Box 9
  265 21 Åstorp
  Sweden | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| United Kingdom | Cross Vetpharm Group Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml Solution for Injection for Cattle and Pigs | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| United Kingdom | Eli Lilly & Company Ltd
  Elanco Animal Health
  Priestley Road
  Basingstoke
  Hampshire RG24 9NL
  United Kingdom | Tylan 200, 200 mg/ml Solution for Injection | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| United Kingdom | Vetoquinol UK Ltd
  Vetoquinol House
  Great Slade
  Buckingham Industrial Park Buckingham MK18 1PA
  United Kingdom | Tylucyl 200 mg/ml solution for injection for cattle and pigs | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |

Member State EU/EEA

Applicant/Marketing authorisation holder

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Austria

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Austria

Vana GmbH

Wolfgang Schmälzl-Gasse 6

1020 Wien

Austria

Vanatyl 200 mg/ml — Injektionslösung für Tiere

Tylosin

Solution for injection

200,000 IU/ml

Cattle Calves Sheep Goats Pigs Dogs

IM

Belgium

Cross Vetpharma Group Ltd

Broomhill Road, Tallagh Dublin 24

Ireland

Bilovet

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Belgium

VETOQUINOL SA/NV

Kontichsesteenweg 42

2630 Aartselaar

Belgium

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Bulgaria

Biovet JSC

39, Petar Rakov Str.

4550 Pesthera

Bulgaria

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Croatia

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/mL otopina za injekcije za goveda i svinje

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Cyprus

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Denmark

Biovet JSC

39, Petar Rakov Str.

4550 Pesthera

Bulgaria

Tylaxene

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Denmark

Huvepharma NV Uitbreidingstraat 80

BE-2600 Antwerpen

Belgium

Tylmasin

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Denmark

Vetoquinol Scandinavia AB Lyngbyvej 20

DK-2100 København

Denmark

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Estonia

Vétoquinol SA,

Magny-Vernois

70200 Lure

France

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Finland

VETOQUINOL SA/NV

Kontichsesteenweg 42

2630 Aartselaar

Belgium

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

France

LILLY France

24 Boulevard Vital Bouhot

92200 Neuilly Sur Seine

France

TYLAN 200

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

France

HUVEPHARMA

Uitbredingstraat 53

2600 Antwerp

Belgium

PHARMASIN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS CAPRINS ET PORCINS

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

France

Biovet JSC

39, Petar Rakov Str.

4550 Pesthera

Bulgaria

TYLAXEN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS, OVINS, CAPRINS ET PORCINS

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

France

CROSS VETPHARM GROUP

Broomhill Road

Dublin 24

Tallaght

Ireland

BILOVET 200 MG/ML SOLUTION INJECTABLE

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

France

VETOQUINOL

Magny Vernois

70200 Lure

France

TYLUCYL 200 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Germany

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Germany

Vétoquinol GmbH

Parkstr. 10

88212 Ravensburg

Germany

Tylucyl 200 mg/ml

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Germany

HUVEPHARMA NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Germany

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

Broomhill Road, Tallagh Dublin 24

Ireland

Bilovet 200 mg/ml Injektionslösung für Rinder und Schweine

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Greece

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Hungary

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Hungary

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Hungary

VETOQUINOL SA

Magny Vernois

70200 LURE

France

Tylucyl 200 mg/ml oldatos injekció szarvasmarhák és sertések részére

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Ireland

Eli Lilly & Company Limited

Elanco Animal Health

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Tylan 200, 200 mg/ml Solution for Injection

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Ireland

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Ireland

Huvepharma N.V.

Uitbreidingsstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Ireland

Cross Vetpharm Group Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml Solution for Injection for cattle and pigs.

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Italy

Vetoquinol Italia S.r.l.

Via Piana 265

47032 Bertinoro (FC)

Italy

TYLUCYL 200 mg/ml soluzione iniettabile per bovini e suini

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Italy

FATRO S.p.A.

Via Emilia 285

40064 Ozzano Emilia (BO)

Italy

VETIL

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs Dogs

IM

Italy

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN 200 mg/ml soluzione iniettabile

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Italy

ELI LILLY ITALIA S.p.A.

Via Gramsci, 731/733

50019 Sesto Fiorentino

Firenze

Italy

TYLAN 200

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Italy

HUVEPHARMA NV

Uitbreidingstraat 80

2600 Anversa

Belgium

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Latvia

Vetoquinol S.A.

Magny-Vernois B.P. 189

Lure Cedex

France

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

The Netherlands

CROSS VETPHARM GROUP Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Poland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpia

Belgium

Pharmasin

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Poland

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylaxen

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Poland

Aniserve UG Geyerspergerstrasse 27

80689 Munich

Germany

Bilovet 200

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Poland

Vetoquinol Biowet Sp. z o.o.

ul. Kosynierów Gdyńskich 13-14

66-400 Gorzów Wielkopolski

Poland

Tylucyl 200 mg/ml solution for injection

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Portugal

Vetoquinol S.A.

Magny-Vernois B.P. 189

Lure Cedex

France

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Portugal

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Portugal

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Portugal

Lilly Portugal — Produtos Farmacêuticos, Lda

R. Cesário Verde, 5 — piso 4

Linda-a-Pastora

2790-326 Queijas

Portugal

Tylan 200 mg/ml Solução injetável para bovinos e suínos

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Romania

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylaxen 200 mg/ml

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Romania

Cross Vetpharm Group Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Slovak Republic

Vétoquinol s.r.o.

Zámečnická 411

288 02 Nymburk

Czech Republic

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Slovak Republic

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLOVET B-200 mg/ml injekčný roztok

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Slovenia

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Spain

CROSS VETPHARM GROUP LIMITED.

Broomhill Road, Tallaght

Dublin 24

Ireland

BILOVET 200 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Spain

VETOQUINOL ESPECIALIDADES VETERINARIAS, S.A.

A. Fuencarral Alcobendas km 15 700 Edificio Europa I Portal 3 2o5

28108 Alcobendas (Madrid)

Spain

TYLUCIL 200 mg/ml SOLUCIÓN INYECTABLE

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Spain

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PO

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Spain

Biovet JSC,

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PORC

Tylosin

Solution for injection

200,000 IU/ml

Cattle

sheep

Goats

Pigs

IM

slow IV (cattle)

Sweden

Vetoquinol Scandinavia AB

Box 9

265 21 Åstorp

Sweden

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

United Kingdom

Cross Vetpharm Group Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml Solution for Injection for Cattle and Pigs

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

United Kingdom

Eli Lilly & Company Ltd

Elanco Animal Health

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Tylan 200, 200 mg/ml Solution for Injection

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

United Kingdom

Vetoquinol UK Ltd

Vetoquinol House

Great Slade

Buckingham Industrial Park Buckingham MK18 1PA

United Kingdom

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

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

---

ANNEX III

List of medicinal products and presentations

| Member State EU/EEA | Marketing authorisation holder | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Czech Republic | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| France | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| Germany | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| Italy | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| The Netherlands | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| Poland | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| Spain | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane 500 mg polvo para solución para perfusión | 500 mg | Powder for solution for infusion | Intravenous use |
| United Kingdom | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |

Member State EU/EEA

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Czech Republic

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

France

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Germany

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Italy

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

The Netherlands

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Poland

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Spain

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane 500 mg polvo para solución para perfusión

500 mg

Powder for solution for infusion

Intravenous use

United Kingdom

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

---

ANNEX IV

List of nationally authorised medicinal products

| Member state | Marketing Authorisation Holder | Short name of the Medicinal Product | Active substance + Strength | Pharmaceutical Form |
| --- | --- | --- | --- | --- |
| Austria | Symbiopharm Gmbh | Symbioflor E. Coli | Escherichia Coli 15 — 45 Mega Cells/ml | Oral Drops, Suspension |
| Germany | Symbiopharm Gmbh | Symbioflor 2 | Escherichia Coli 15 — 45 Mega Cells/ml | Oral Drops, Suspension |
| Hungary | Symbiopharm Gmbh | Symbioflor Escherichia | Escherichia Coli 15 — 45 Mega Cells/ml | Oral Drops, Suspension |

Member state

Marketing Authorisation Holder

Short name of the Medicinal Product

Active substance + Strength

Pharmaceutical Form

Austria

Symbiopharm Gmbh

Symbioflor E. Coli

Escherichia Coli 15 — 45 Mega Cells/ml

Oral Drops, Suspension

Germany

Symbiopharm Gmbh

Symbioflor 2

Escherichia Coli 15 — 45 Mega Cells/ml

Oral Drops, Suspension

Hungary

Symbiopharm Gmbh

Symbioflor Escherichia

Escherichia Coli 15 — 45 Mega Cells/ml

Oral Drops, Suspension

---

ANNEX V

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

| Member State EU/EEA | Marketing authorisation holders | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g Granulat zum Eingeben über das Trinkwasser | Tiamulin hydrogen fumarate | 450 mg/g | Granules | Pigs, chickens, turkeys | Oral |
| Belgium | VMD nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Tiamutin 45 % Pigs | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs | Oral |
| Belgium | VMD nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Tiamutin 45 % Chicken-Turkey | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Chickens, turkeys | Oral |
| Belgium | VMD nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Tiamutin 45 % Pigs-Chicken-Turkey | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs, chickens, turkeys | Oral |
| Czech Republic | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 450 mg/g granule pro přípravu perorálního roztoku | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs, chickens (broilers, pullets, layers and breeders), turkeys (fattening and breeding birds) | Oral |
| Finland | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard vet 450 mg/g rakeet | Tiamulin hydrogen fumarate | 450 mg/g | Granules | Pigs | Oral to be administered in drinking water |
| Germany | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % Granulat | Tiamulin hydrogen fumarate | 45 % w/w
  (36,4  % tiamulin w/w) | Granules | Pigs, chickens, turkeys | In drinking water |
| Germany | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % oral | Tiamulin hydrogen fumarate | 45 % w/w
  (36,4  % tiamulin w/w) | Granules | Pigs | Use in drinking water or in feed |
| Greece | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 45 %, κοκκία για πόσιμο διάλυμα | Tiamulin hydrogen fumarate | 450 mg/g | Granules for oral solution | Pigs, chickens, turkeys | Oral |
| Hungary | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % granulátum belsőleges oldathoz A.U.V. | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs, chickens, turkeys | In drinking water use |
| Italy | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 45 % | Tiamulin hydrogen fumarate | 450 mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Latvia | Novartis Animal Health d.o.o.
  Verovškova 57
  1000 Ljubljana
  Slovenia | Denagard 45 % WSG | Tiamulin hydrogen fumarate | 450 mg/g | Water soluble granules | Pigs, chickens, turkeys | In drinking water use |
| Lithuania | Novartis Animal Health d.o.o.
  Verovškova 57
  1000 Ljubljana
  Slovenia | DENAGARD 45 %, vandenyje tirpios granulės | Tiamulin hydrogen fumarate | 450 mg/g, corresponds to 365 mg tiamulin/g | Water soluble granules | Pigs, chickens (broiler, replacement pullet, layer/breeder), turkeys (grower and breeder) | Oral |
| The Netherlands | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 45 % W.S.G. voor varkens en kippen | Tiamulin hydrogen fumarate | 450 mg/g | Granulate for administration through the drinking water | Pigs, chickens | Oral |
| Poland | Novartis Animal Health d.o.o.
  Verovškova 57
  1000 Ljubljana
  Slovenia | Denagard 45 % granulat dla świń, kur i indyków | Tiamulin hydrogen fumarate | 450 mg/g | Granules | Pigs, chickens, turkeys | Oral use |
| Portugal | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g granulado oral para suínos, galinhas e perus | Tiamulin hydrogen fumarate | 450 mg/g | Oral granules | Swine, chickens (broilers, rearing of broilers, layers/breeders), turkeys (for fattening and breeding) | Oral, administered in drinking water |
| Romania | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % | Tiamulin hydrogen fumarate | 45 mg tiamulin hydrogen fumarate/g product | Granules for use in drinking water | Pigs, chickens (broiler, replacement pullet, layer/breeder), turkeys (grower and breeder) | In drinking water |
| Slovak Republic | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g granulát na perorálny roztok | Tiamulin hydrogen fumarate | 450 mg/g | Granules for oral solution | Pigs, chickens (broilers, laying and breeding hens), turkeys | Oral |
| Spain | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g Granulado Oral | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs, chickens, turkeys | Oral |

Member State EU/EEA

Marketing authorisation holders

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g Granulat zum Eingeben über das Trinkwasser

Tiamulin hydrogen fumarate

450 mg/g

Granules

Pigs, chickens, turkeys

Oral

Belgium

VMD nv

Hoge Mauw 900

2370 Arendonk

Belgium

Tiamutin 45 % Pigs

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs

Oral

Belgium

VMD nv

Hoge Mauw 900

2370 Arendonk

Belgium

Tiamutin 45 % Chicken-Turkey

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Chickens, turkeys

Oral

Belgium

VMD nv

Hoge Mauw 900

2370 Arendonk

Belgium

Tiamutin 45 % Pigs-Chicken-Turkey

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs, chickens, turkeys

Oral

Czech Republic

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 450 mg/g granule pro přípravu perorálního roztoku

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs, chickens (broilers, pullets, layers and breeders), turkeys (fattening and breeding birds)

Oral

Finland

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard vet 450 mg/g rakeet

Tiamulin hydrogen fumarate

450 mg/g

Granules

Pigs

Oral to be administered in drinking water

Germany

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 % Granulat

Tiamulin hydrogen fumarate

45 % w/w

(36,4  % tiamulin w/w)

Granules

Pigs, chickens, turkeys

In drinking water

Germany

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 % oral

Tiamulin hydrogen fumarate

45 % w/w

(36,4  % tiamulin w/w)

Granules

Pigs

Use in drinking water or in feed

Greece

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 45 %, κοκκία για πόσιμο διάλυμα

Tiamulin hydrogen fumarate

450 mg/g

Granules for oral solution

Pigs, chickens, turkeys

Oral

Hungary

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 % granulátum belsőleges oldathoz A.U.V.

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs, chickens, turkeys

In drinking water use

Italy

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 45 %

Tiamulin hydrogen fumarate

450 mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Latvia

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

Denagard 45 % WSG

Tiamulin hydrogen fumarate

450 mg/g

Water soluble granules

Pigs, chickens, turkeys

In drinking water use

Lithuania

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

DENAGARD 45 %, vandenyje tirpios granulės

Tiamulin hydrogen fumarate

450 mg/g, corresponds to 365 mg tiamulin/g

Water soluble granules

Pigs, chickens (broiler, replacement pullet, layer/breeder), turkeys (grower and breeder)

Oral

The Netherlands

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 45 % W.S.G. voor varkens en kippen

Tiamulin hydrogen fumarate

450 mg/g

Granulate for administration through the drinking water

Pigs, chickens

Oral

Poland

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

Denagard 45 % granulat dla świń, kur i indyków

Tiamulin hydrogen fumarate

450 mg/g

Granules

Pigs, chickens, turkeys

Oral use

Portugal

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g granulado oral para suínos, galinhas e perus

Tiamulin hydrogen fumarate

450 mg/g

Oral granules

Swine, chickens (broilers, rearing of broilers, layers/breeders), turkeys (for fattening and breeding)

Oral, administered in drinking water

Romania

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 %

Tiamulin hydrogen fumarate

45 mg tiamulin hydrogen fumarate/g product

Granules for use in drinking water

Pigs, chickens (broiler, replacement pullet, layer/breeder), turkeys (grower and breeder)

In drinking water

Slovak Republic

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g granulát na perorálny roztok

Tiamulin hydrogen fumarate

450 mg/g

Granules for oral solution

Pigs, chickens (broilers, laying and breeding hens), turkeys

Oral

Spain

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g Granulado Oral

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs, chickens, turkeys

Oral

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