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 or Article 38 of Directive 2001/82/EC)
Date: 2017-09-29
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2017328EN.01001401.xml










29.9.2017   


EN


Official Journal of the European Union


C 328/14





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))
(2017/C 328/02)






—



Issuing, maintenance or modification of a national marketing authorisation















Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




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















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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


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







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)







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







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







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