Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Date: 2009-11-27
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, pharmaceutical product, veterinary drug, withdrawal from the market








C_2009288EN.01001101.xml










27.11.2009   


EN


Official Journal of the European Union


C 288/11





Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
 (1)
or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
 (2)
)

2009/C 288/02
-   Issuing, maintenance or modification of a national marketing authorisation










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




1.10.2009


Simponi


Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland


This Decision is addressed to the Member States


5.10.2009




1.10.2009


Ivermectin


See Annex I


See Annex I


5.10.2009




1.10.2009


Topamax


See Annex II


See Annex II


5.10.2009




1.10.2009


Cimzia


UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België


This Decision is addressed to the Member States


5.10.2009




2.10.2009


Avalox


See Annex III


See Annex III


6.10.2009




2.10.2009


Octegra


See Annex IV


See Annex IV


6.10.2009




5.10.2009


ChondroCelect


TiGenix NV, Romeinse straat 12/2, B-3001 Leuven, België


This Decision is addressed to the Member States


6.10.2009




6.10.2009


Fentrix


See Annex V


See Annex V


7.10.2009




15.10.2009


Meronem


See Annex VI


See Annex VI


19.10.2009




15.10.2009


Pulmotil AC


See Annex VII


See Annex VII


19.10.2009




15.10.2009


Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix


See Annex VIII


See Annex VIII


19.10.2009




16.10.2009


Nimesulide


See Annex IX


See Annex IX


19.10.2009




19.10.2009


Augmentin


See Annex X


See Annex X


21.10.2009




23.10.2009


ILARIS


Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


This Decision is addressed to the Member States


26.10.2009




23.10.2009


ARCALYST


Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom


This Decision is addressed to the Member States


26.10.2009







-   Revocation of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




30.10.2009


Fentrans


See Annex XI


See Annex XI


4.11.2009




30.10.2009


Matripain


See Annex XII


See Annex XII


4.11.2009




30.10.2009


Matrigesic


See Annex XIII


See Annex XIII


4.11.2009




30.10.2009


Fentador


See Annex XIV


See Annex XIV


4.11.2009




30.10.2009


Fentastad


See Annex XV


See Annex XV


4.11.2009






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State


Marketing Authorisation Holder and address


Invented name


Strengths


Animal species


Route of administration


Recommended dose




Austria







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Animec injection Injektionslöng für Rinder und Schweine


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Austria







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimectin


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Austria







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Austria







Laboratorios Calier SA




Barcelones




26 (Pla del Ramassa)




08520 Les Franqueses del Valles




Barcelona




Spain






Ivertin


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Austria







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec 10 mg/ml Injektionssuspension für Rinder, Schafe und Schweine


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Austria







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin – Injektionslösung für Tiere


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Austria







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Qualimec


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Austria







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC Injektionslösung Für Tiere: Rinder, Schafe, Schweine


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Austria







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectin
Injektionlösung für Rinder


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




Belgium







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






BOVIMEC B


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Belgium







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






ECOMECTIN 10 MG/ML


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Belgium







Laboratorios Calier SA




Barcelones




26 (Pla del Ramassa)




08520 Les Franqueses del Valles




Barcelona




Spain






IVERTIN CATTLE


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Belgium







MERIAL Belgium S.A.




Bld Sylvain Dupuis 243




1070 Bruxelles




Belgium






IVOMEC F


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Belgium







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Belgium







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC 1 % Solution injectable


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Belgium







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC F solution injectable


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Belgium







MERIAL Belgium S.A.




Bld Sylvain Dupuis 243




1070 Bruxelles




Belgium






Ivomec


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Belgium







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






QUALIMEC 10 MG/ML


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Belgium







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectin Oplossing voor
Injectie voor rundvee


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




Bulgaria







Intervet International B.V.




Wim de Korvrstraat 35,




5831 AA, Boxmeer,




The Netherlands






Ivotan LA


Ivermectin 10 mg/ml


Cattle, Sheep, Goats, Pigs


Subcutaneous








Cattle, Sheep, Goats:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Bulgaria







Ceva Sante Animale




La Ballastiere




B.P. 126




33501 Libourne Cedex




France






Cevamec 1 % injectable solution


Ivermectin 10 mg/ml


Cattle, Sheep, Goats, Pigs


Subcutaneous








Cattle, Sheep, Goats:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Bulgaria







Alfasan International B.V.,




P.O. Box 78,




3440 AB Woerden,




The Netherlands






Alfamec 1 %


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Bulgaria







BIOVET JSC




39 Petar Rakov Str.




4550 Pesthera




Bulgaria






Pandex 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Goats, Pigs


Subcutaneous








Cattle, Sheep, Goats:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Bulgaria







Centrovet Ltd.




Av.Los Cerrilos 602




Santiago,




Chile






Microdes Plus


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Bulgaria







Interchemie werken „de Adelaar” BV




Horsterweg 26A




5811 AC Castenray




The Netherlands






Intermectin


Ivermectin 10 mg/ml


Cattle, Sheep, Goats, Pigs


Subcutaneous








Cattle, Sheep, Goats:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Bulgaria







Invesa International S.A.




Esmeralda 19




08950 Esplugues de Llobregat




Barcelona




Spain






Promectine


Ivermectin 10 mg/ml


Cattle, pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Bulgaria







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Divamectin 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Cyprus







Panchris Feeds Ltd.




P.O.Box 40261,




6302 Larnaca




Cyprus






Bimectin Injection


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Cyprus







Vetagrica Ltd




3 Othellou Street,




2540 Dhali Industrial Estate




Nicosia




Cyprus






Ivomec Super Injection for Cattle


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Cyprus







Spyros Stavrinides Chemicals Ltd




28 Stasinou Avenue,




1060 Nicosia,




Cyprus






Noromectin injection


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Czech Republic







Vétoquinol s.r.o.,




Zámečnícka 411,




288 02 Nymburk,




Czech Republic






Biomectin 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Czech Republic







Bremer Pharma GmbH




Cherbourger Str. 25




27540 Bremerhaven




Germany






Bremamectin


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Czech Republic







CEVA Animal Health Slovakia, spol. s r.o.




Račianska 77




83 102 BRATISLAVA




Slovak Republic






Cevamec 1 % inj. ad us. vet.


Ivermectin 10 mg/ml


Cattle, Sheep, Goats, Pigs


Subcutaneous








Cattle, Sheep, Goats:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Czech Republic







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Czech Republic







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec 1 % inj. ad. us. vet.


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Czech Republic







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec Super inj. a.u.v.


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle, sheep


Subcutaneous


200 μg ivermectin/kg bw




Czech Republic







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Inj ad us vet


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Czech Republic







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec inj. ad us. vet.


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Czech Republic







Bioveta a.s.,




Komenského 212




683 23 Ivanovice na Hané




Czech Republic






Biomec 10 mg/ml
Injekční roztok


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Czech Republic







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectin injekční roztok pro skot


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




Denmark







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Vet


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Denmark







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Qualimec Vet


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Denmark







Bimeda (a division of Cross Vetpharm Group Limited)




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimec Vet


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Denmark







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomec vet.


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Denmark







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Ivermectin »Virbac« Vet., injektionsvæske, opløsning


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Denmark







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Coopermec Vet


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Denmark







Merial Norden A/S




Mileparken 20 E




2740 Skovlunde




Denmark






Ivomec vet., injektionsvæske 10 mg/ml


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Estonia







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Estonia







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec 1 %
injection, süstelahus


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Estonia







Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimectin injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Estonia







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Multi Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Estonia







Ceva Sante Animale




La Ballastiere




B.P. 126




33501 Libourne Cedex




France






Cevamec 1 % injectable solution


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Estonia







Bremer Pharma GmbH




Cherbourger Str. 25




27540 Bremerhaven




Germany






Bremamectin


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Estonia







Vetoquinol Biowet Sp. z o.o.,




ul. Kosynierów Gdyńskich 13-14,




66-400 Gorzów Wlkp.,




Poland






Biomectin 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Finland







Scanvet Eläinlääkkeet Oy




PL 27




13721 PAROLA




Finland






Animec vet


Ivermectin 10 mg/ml


Cattle, Reindeer, Pigs


Subcutaneous








Cattle, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Finland







Bimeda (a division of Cross Vetpharm Group Limited)




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimectin vet


Ivermectin 10 mg/ml


Cattle, Reindeer, Pigs


Subcutaneous








Cattle, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Finland







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec
10 mg/ml vet injektioneste, liuos


Ivermectin 10 mg/ml


Cattle, Reindeer, Pigs


Subcutaneous








Cattle, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Finland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Animec injection10 mg/ml solution for injection


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Finland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Vet 10mg/ml
Solution for Injection


Ivermectin 10 mg/ml


Cattle, Reindeer, Pigs


Subcutaneous








Cattle, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Finland







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC VET 10 mg/ml injektioneste, liuos


Ivermectin 10 mg/ml


Cattle, Reindeer, Pigs


Subcutaneous








Cattle, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








France







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




France







MERIAL




29 avenue Tony Garnier




69007 LYON




France






IVOMEC D


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




France







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC SOLUTION INJECTABLE POUR BOVINS


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




France







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC D SOLUTION INJECTABLE


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




France







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC Solution Injectable pour Bovins Porçins Ovins


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








France







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






IVERMECTINE ECO 10 MG/ML SOLUTION I NJECTABLE


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








France







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






QUALIMEC 10 MG/ML SOLUTION
INJECTABLE


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








France







Laboratorios Calier SA




Barcelones




26 (Pla del Ramassa)




08520 Les Franqueses del Valles




Barcelona




Spain






IVERTIN BOVIN


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




France







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






CEVAMEC BOVINS OVINS SOLUTION INJECTABLE


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




France







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Magamectine iInjectable, solution injectable


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








France







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Medimec Injectable, Solution Injectable


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








France







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin 1 % Solution Injectable Bovine, Porcins


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








France







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectine Solution Injectable pour bovins


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




France







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Divamectin 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Germany







MERIAL GmbH




Am Söldnermoos 6




D-85399 Hallbergmoos




Germany






Ivomec


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Germany







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Chanectin Injektion


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Germany







Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),




Broomhill Road




Tallaght




Dublin 24




Ireland






Diapec R


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Germany







Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),




Broomhill Road




Tallaght




Dublin 24




Ireland






Wedemec R


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Germany







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Sumex Injektion für Rinder


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Germany







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin 1 % Injektion


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Germany







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec
Inektionslösung


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Greece







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin 1 %
1 % Evέσiμo Δiάλuμa


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Greece







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Paramectin 1 %
1 % Evέσiμo Δiάλuμa


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Greece







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Greece







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






ECOMECTIN


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Greece







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Qualimec


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Greece







Chanelle Pharmaceuticals Manufacturing Ltd.,




Loughrea, Co. Galway,




Ireland






Animec Inj. Sol.


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Greece







VETERIN ABEE




Aspropyrgos Attikis




19300




Greece






VETERMEC


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Greece







PNG Gerolymatos S.A.




13, Asklipiou




145 68 KRYONERI, ATTICA




Greece






VALANEQ


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Greece







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






MAXIMEC


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Greece







SCHERING PLOUGH SA




65,Ag Dimitriou




17455, Athens




Greece






TIZOVAL


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Hungary







Chanelle Pharmaceuticals Manufacturing Ltd.,




Loughrea, Co. Galway,




Ireland






Animec Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







Bayer Hungária Ltd.




H-1123 Budapest




Alkotás u. 50.




Hungary






Baymec Trio 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







Vetoquinol Biowet Sp. z o.o.,




ul. Kosynierów Gdyńskich 13-14,




66-400 Gorzów Wlkp.,




Poland






Biomectin 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







Ceva-Phylaxia Oltóanyagtermelő Zrt.




Szállás u. 5




1107 Budapest




Hungary






Cevamec 1 % injekció A.U.V


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







Divasa Farmavic Hungaria Ltd.




H-6070 Izsák, Kossuth L. u. 60.




Hungary






ECOMECTIN


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







Bremer Pharma GmbH.




Werkstrasse 42




34414 Warburg-Scherfede




Germany






FROMMECTIN


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







Invesa International S.A.




Esmeralda 19




08950 Esplugues de Llobregat




Barcelona




Spain






IVERGEN PREMIUM LA


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







Veterina Polska Sp. Zo.o.




Ul. Mogilska 80,




31546 Krakow




Poland






Iverktin Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







Laboratorios Calier SA




Barcelones




26 (Pla del Ramassa)




08520 Les Franqueses del Valles




Barcelona




Spain






IVERTIN


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







VMD Animal Health Ltd.




Közraktár u. 22/b. II. 3.,




1093 Budapest




Hungary






IVERVETo 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec injekció A.U.V.


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec super injekció A.U.V.


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Hungary







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Hungary







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Vetimec 10 mg/ml solution for injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







C-Corp,




78 Coombe Road,




New Malden,




Surrey KT3 4QS,




United Kingdom






Kilo-mec 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







C-Corp,




78 Coombe Road,




New Malden,




Surrey KT3 4QS,




United Kingdom






Mastermectin 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







C-Corp,




78 Coombe Road,




New Malden,




Surrey KT3 4QS,




United Kingdom






Coopermec 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec Injectable Solution


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec for Cattle Swine and Sheep 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec Super Solution for Injection


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Ireland







Merial Animal Health Limited




Sandringham House




Harlow Business Park




Harlow




Essex CM19 5TG




United Kingdom






Panomec 1 % Solution for Injection for Cattle, Sheep and Pigs


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Merial Animal Health Limited




Sandringham House




Harlow Business Park




Harlow




Essex CM19 5TG




United Kingdom






Ivomec Classic Injection for Cattle and Sheep
1 % w/v


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Merial Animal Health Limited




Sandringham House




Harlow Business Park




Harlow




Essex CM19 5TG




United Kingdom






Ivomec Super Injection for Cattle


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Ireland







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Qualimec 10 mg/ml Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Fatromectin 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Divamectin 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Chanimec Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Animec 1 % solution Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Chanectin Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Sumex Injection for Cattle, 1 %, Solution for injection for cattle


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Anisec Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Aniject Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Chaniject Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Sumiject Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Medimec Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Topimec Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimectin 1,0 % w/v Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Mectaject 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Bovimectin 1 % solution for injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Maximec Injection for Cattle & Sheep


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Trimectin Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Bovimec 1 % w/v Solution for Injection for Cattle


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Paramectin 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Multi Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Primectin 1 % w/v Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectin Solution for Injection


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




Ireland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Enovex Injection 1 % w/v


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Ireland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closiver Injection


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




Iceland







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec vet.


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Italy







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Baymec 1 % Soluzione


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Italy







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Injection


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Italy







Laboratorios Calier SA




Barcelones




26 (Pla del Ramassa)




08520 Les Franqueses del Valles




Barcelona




Spain






Ivertin cattle


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Italy







INTERVET PRODUCTIONS SRL




Via Nettunense km 20, 300




04011 Aprilia




Italy






Ivogell


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Italy







Merial Italia S.p.A. a Socio Unico,




Via Vittor Pisani, 16




Milano




Italy






Ivomec


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Italy







Merial Italia S.p.A. a Socio Unico,




Via Vittor Pisani, 16




Milano




Italy






Ivomec Plus


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Italy







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Maximec iniettable


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Italy







Fatro




Via Emilia, 285




40064 Ozzano Emilia (Bologna)




Italy






Tolomec


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Italy







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC Soluzione iniettabile


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Italy







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC F soluzione iniettabile


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Italy







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectin Soluzione iniettabile per bovini


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




Italy







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Divamectin 1 % Solution for Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Latvia







Chanelle Pharmaceuticals Manufacturing Ltd.,




Loughrea, Co. Galway,




Ireland






Animec Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Latvia







Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimectin
Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Latvia







Vetoquinol Biowet Sp. z o.o.,




ul. Kosynierów Gdyńskich 13-14,




66-400 Gorzów Wlkp.,




Poland






Biomectin 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Latvia







Ceva Sante Animale




La Ballastiere




B.P. 126




33501 Libourne Cedex




France






Cevamec 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Latvia







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin 10 mg/ml


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Latvia







MERIAL




29 avenue Tony Garnier




69007 LYON




France






IVOMEC 1 % Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Latvia







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec Plus


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Latvia







Pharmaceutical Company




PFO „VETOS-FARMA” sp. z.o.o.,




Dzierzoniwska street 21




58-260 Bielawa




Poland






Iwermektyna 1 % Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Latvia







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Lithuania







MERIAL




29 avenue Tony Garnier




69007 LYON




France






IVOMEC PLUS, injekcinis tirpalas


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Lithuania







MERIAL




29 avenue Tony Garnier




69007 LYON




France






IVOMEC 1 %, injekcinis tirpalas


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Lithuania







Vetoquinol Biowet Sp. z o.o.,




ul. Kosynierów Gdyńskich 13-14,




66-400 Gorzów Wlkp.,




Poland






Biomectin 1 %, injekcinis tirpalas


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Lithuania







Ceva Sante Animale




La Ballastiere




B.P. 126




33501 Libourne Cedex




France






Cevamec 1 %, injekcinis tirpalas


Ivermectin 10 mg/ml


Cattle, Sheep, Goats, Pigs


Subcutaneous








Cattle, Sheep, Goats:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Lithuania







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Injekcinis tirpalas


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Lithuania







Invesa International S.A.




Esmeralda 19




08950 Esplugues de Llobregat




Barcelona




Spain






PROMECTINE


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Lithuania







Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),




Broomhill Road




Tallaght




Dublin 24




Ireland






BIMECTIN


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Lithuania







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






ECOMECTIN 10 mg/ml


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Luxembourg







MERIAL Belgium S.A.




Bld Sylvain Dupuis 243




1070 Bruxelles




Belgium






Ivomec solution pour injection


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Luxembourg







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin 1 %


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Luxembourg







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin 1 % inj.sol. bovine and porcine


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Luxembourg







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Paramectin 1 % solution for injection


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Luxembourg







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Qualimec 1 % solution for injection


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Luxembourg







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec solution pour injection bovine


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Malta







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimectin


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Malta







Laboratorios HIPRA S.A.




Avda. La Selva, 135




17170 Amer, Girona




Spain






Iveripra-I


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Malta







Interchemie werken „de Adelaar” BV




Horsterweg 26A




5811 AC Castenray




The Netherlands






Intermectin


Ivermectin 10 mg/ml


Cattle, Sheep, Goats, Pigs


Subcutaneous








Cattle, Sheep, Goats:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Malta







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Multi Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Malta







INDUSTRIAL VETERINARIA, S.A.




C/ Esmeralda, 19




08950 Esplugues de Llobregat




Barcelona




Spain






Promectine


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




The Netherlands







Merial B.V.




Kleermakerstraat 10




1991 JL Velserbroek




The Netherlands






Ivomec


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







Merial B.V.




Kleermakerstraat 10




1991 JL Velserbroek




The Netherlands






Ivomec Plus


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




The Netherlands







Merial B.V.




Kleermakerstraat 10




1991 JL Velserbroek




The Netherlands






Panomec Injectievloeistof


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Animec Injection


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Euromec Injectie


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Paramectin Injectie


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Injectie


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Maximec Injectie


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







Laboratorios Calier SA




Barcelones




26 (Pla del Ramassa)




08520 Les Franqueses del Valles




Barcelona




Spain






Ivertin Cattle


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




The Netherlands







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimectin Injectie


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec F


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




The Netherlands







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ges-o-mec 10 mg/ml oplossing voor injectie


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Qualimec 10 mg/g solution for injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








The Netherlands







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Iverveto 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Norway







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec vet, injeksjonsvæske, oppløsning 10 mg/ml


Ivermectin 10 mg/ml


Cattle, Sheep, Reindeer, Pigs


Subcutaneous








Cattle, Sheep, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Norway







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Vet Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Norway







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC VET


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Poland







Vetoquinol Biowet Sp. z o.o.,




ul. Kosynierów Gdyńskich 13-14,




66-400 Gorzów Wlkp.,




Poland






Biomectin 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Poland







Ceva Sante Animale




La Ballastiere




B.P. 126




33501 Libourne Cedex




France






Cevamec 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Poland







Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.




ul. Grójecka 6




05-651 Drwalew




Poland






Ivermina 1 % Inj


Ivermectin 10 mg/ml


Cattle, pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Poland







Pharmaceutical Company




PFO „VETOS-FARMA” sp. z.o.o.,




Dzierzoniwska street 21




58-260 Bielawa




Poland






Iwermektyna 1 % Iniekcja


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Poland







Agri- Biovet Sp. z o.o.




ul. Smocza 27




01-048 Warsaw




Poland






Pandex 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Poland







Scan Vet Poland Sp. z o.o.




Skiereszewo, ul. Kiszkowska 9




62-200 Gniezno




Poland






Paramectin 1 %


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Poland







Przedsiębiorstwo Wielobranżowe Vet Agro Sp. z o.o.




ul. Gliniana 32




20-616 Lublin




Poland






Vetamectin


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Portugal







Bimeda (a division of Cross Vetpharm Group Limited)




Broomhill Road




Tallaght




Dublin 24




Ireland






Tizoval Bovinos 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Portugal







Calier Portugal S.A




Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro




Estrada de Albarraque




2710 - 335 Sintra




Portugal






Ivertin


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Portugal







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Chanectin Injectável


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Portugal







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Maximec Injectável para bovinos e ovinos 1 %


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Portugal







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin 1 % Sol Injectável


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Portugal







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Vectimax 10 mg/Ml Sol. Inj.
Este é


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Portugal







Merial Portuguesa - Saúde Animal, Lda




AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas




2635-432 Rio de Mouro




Portugal






Ivomec F


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Portugal







Merial Portuguesa - Saúde Animal, Lda




AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas




2635-432 Rio de Mouro




Portugal






Ivomec 1 % Bovinos, Solução Injectável


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Portugal







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Paramectin Injectável 1 %


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Portugal







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Injectável 1 %


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Portugal







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec F, Solução Injectável
1mg/ml


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Portugal







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC, Solução injectavel


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Portugal







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectin FF, solução injectável para bovinos


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




Romania







ANTIBIOTICE IASI S.A.




Str. Valea Lupului, nr. 1, Iași, jud. Iași




Romania






Ivermectina 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







BIOWET GORZOW PHARMACEUTICALS




COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK




Poland






Biomectin 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







BIOVET JSC




39 Petar Rakov Str.




4550 Pesthera




Bulgaria






Pandex 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







Bioveta a.s.,




Komenského 212




683 23 Ivanovice na Hané




Czech Republic






Biomec inj.


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







Bremer Pharma GmbH




Cherbourger Str. 25




27540 Bremerhaven




Germany






Bremamectin


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







CEVA SANTE ANIMALE




Str. Chindiei, nr. 5




Sector 4




040185 București




Romania






Cevamec 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD.




Jordan NA UR 11710 PO BOX 285




Jordania






Ivodad 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







DUTCH FARM VETERINARY PHARMACEUTICALS




B.V.




Veemweg 1-3771 MT BARNEVELEND




The Netherlands






Dufamec 1 % inj.


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin 1 % injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







FARMAVET S.A.




Str. Petricani 198,




Chișinău




Republica Moldova






Ivermectina 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







HEMOFARM – HEMOVET




Beogradski Put BB




Vrsac




Serbia






Ivermektin S


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







Laboratorios HIPRA S.A.




Avda. La Selva, 135




17170 Amer, Girona




Spain






Iveripra I


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







Interchemie werken „de Adelaar” BV




Horsterweg 26A




5811 AC Castenray




The Netherlands






Intermectin


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







INTERVET PRODUCTIONS SRL




Via Nettunense km 20, 300




04011 Aprilia




Italy






Ivogell


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







INTERVET ROMANIA S.R.L.




Șoseaua de Centură, nr. 27-28,




077040 Chiajna, Ilfov




Romania






Ivotan LA


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







PANTEX




Ganzestaartsedijk 8 – 5525 KC Duizel




The Netherlands






Panmectin 10


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







PASTEUR – Filiala Filipești




Str. Principală, nr. 944, Filipeștii de Pădure,




Jud. Prahova




Romania






Evomec


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







S.C. ROMVAC COMPANY S.A.




Șos. Centurii, nr. 7, Voluntari




Romania






Romivermectin B1 1 %


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







SYVA




Av. Párroco Pablo Diez, 49 – 57




24010 – Leon




Spain






Zoomectin


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Romania







VMD Animal Health Ltd.




Közraktár u. 22/b. II. 3.,




1093 Budapest




Hungary






Iverveto 1 % Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Slovak Republic







Vétoquinol s.r.o.,




Zámečnícka 411,




288 02 Nymburk,




Czech Republic






Biomectin


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Slovak Republic







CEVA Animal Health Slovakia, spol. s r.o.




Račianska 77




83 102 BRATISLAVA




Slovak Republic






Cevamec 1 % inj. ad us. vet.


Ivermectin 10 mg/ml


Cattle, Sheep, Goats, Pigs


Subcutaneous








Cattle, Sheep, Goats:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Slovak Republic







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Injection ad us vet


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Slovak Republic







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec 1 % inj. ad us.vet.


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Slovak Republic







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec Super inj. ad us.vet.


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Slovak Republic







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Slovak Republic







Pharmagal spol.s.r.o.




Murgašova 5




949 01 Nitra




Slovak Republic






Galmectin


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Slovak Republic







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectin injekčny roztok pre hovädzi dobytok


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




Slovenia







VET4VET d.o.o.




Gerbičeva 50,




1000 Ljubljana




Slovenia






Animec Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Slovenia







VETERINA Plus d.o.o.,Dunajska 51,




1000 Ljubljana,




Slovenia






IVERKTIN 1 % solution for injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Slovenia







MERIAL




29 avenue Tony Garnier




69007 LYON




France






IVOMEC solution for injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Spain







DIVASA FARMAVIC, S.A.




Ctra. Sant Hipolit, km 71




08503 – Gurb-Vic




Barcelona




Spain






DIVAMECTIN 1 % SOLUCION


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




Spain







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin 1 % Solution Inyectable para Bovino y Porcino


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Spain







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






VIRBAMEC SOLUCIÓN INYECTABLE PARA BOVINOS


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Spain







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






TIZOVAL
VACUNO INYECTABLE


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Spain







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






CHANECTIN INYECTABLE


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Spain







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Paramectin Inyectable


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Spain







Laboratorios Calier SA




Barcelones




26 (Pla del Ramassa)




08520 Les Franqueses del Valles




Barcelona




Spain






IVERTIN BOVINO


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Spain







INDUSTRIAL VETERINARIA, S.A.




C/ Esmeralda, 19




08950 Esplugues de Llobregat




Barcelona




Spain






PROMECTINE


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Spain







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






SUMEX INYECTABLE BOVINO


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Spain







Laboratorios HIPRA S.A.




Avda. La Selva, 135




17170 Amer, Girona




Spain






IVERIPRA-I


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Spain







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






ECOMECTIN 10 MG/ML SOLUCION INYECTABLE


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Spain







Chemo Iberica




Gran Vía Carlos III, 98 – 7oth floor.




08028 Barcelona,




Spain






BOVECTIN


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Spain







MERIAL LABORATORIOS S.A




Tarragona, 161-Locales D/E




08014 Barcelona




Spain






Ivomec Inyectable Para Vacuno


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




Spain







MERIAL LABORATORIOS S.A




Tarragona, 161-Locales D/E




08014 Barcelona




Spain






Ivomec F Inyectable Para Vacuno


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




Spain







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectin Solucion inyectable para bovino


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




Sweden







MERIAL




29 avenue Tony Garnier




69007 LYON




France






Ivomec® vet.


Ivermectin 10 mg/ml


Cattle, Reindeer, Pigs


Subcutaneous








Cattle, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Sweden







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2




2080-104 Almeirim




Portugal






Virbamec vet. 10 mg/ml injektionsvätska, lösning


Ivermectin 10 mg/ml


Cattle, Reindeer, Pigs


Subcutaneous








Cattle, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Sweden







Bimeda (a division of Cross Vetpharm Group Limited)




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimectin® vet.


Ivermectin 10 mg/ml


Cattle, Reindeer, Pigs


Subcutaneous








Cattle, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Sweden







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin vet Solution for Injection 10 mg/ml


Ivermectin 10 mg/ml


Cattle, Reindeer, Pigs


Subcutaneous








Cattle, Reindeer:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Sweden







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin, 10 mg/ml, Injektionsvätska, lösning


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








Sweden







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Qualimec, 10 mg/ml, Injektionsvätska, lösning


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







Laboratorios Calier SA




Barcelones




26 (Pla del Ramassa)




08520 Les Franqueses del Valles




Barcelona




Spain






Ivertin Cattle


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




United Kingdom







Merial Animal Health Limited




Sandringham House




Harlow Business Park




Harlow




Essex CM19 5TG




United Kingdom






Ivomec Classic Injection for Cattle and Sheep


Ivermectin 10 mg/ml


Cattle, Sheep


Subcutaneous


200 μg ivermectin/kg bw




United Kingdom







Merial Animal Health Limited




Sandringham House




Harlow Business Park




Harlow




Essex CM19 5TG




United Kingdom






Ivomec Super Injection for Cattle


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




United Kingdom







Merial Animal Health Limited




Sandringham House




Harlow Business Park




Harlow




Essex CM19 5TG




United Kingdom






Panomec Injection for Cattle, Sheep and Pigs


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool




L1 9HZ




United Kingdom






Animec Injection


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec Injectable Solution For Cattle and Swine


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec Injectable Solution for Cattle, Swine and Sheep


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







VIRBAC DE PORTUGAL Laboratorios Lda




Rua Dionísio Saraiva, Lote 1,




1o Andar, Sala 2,




2080-104 Almeirim




Portugal






Virbamec Super


Ivermectin 10 mg/ml,
Clorsulon 100 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw




United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Enovex Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Noromectin Multi Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Paramectin Injection


Ivermectin 10 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw




United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Paramectin Multi Injection 1 % w/v Solution for Injection for Cattle, Sheep and Pigs


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Bimectin 1 % w/v Solution for Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Ecomec 1 % Injection


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







Cross Vetpharm Group Ltd,




Broomhill Road




Tallaght




Dublin 24




Ireland






Qualimintic 1 % Injection


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







Alstoe Ltd




Sheriff Hutton Industrial Park




Sheriff Hutton




York




YO60 6RZ




United Kingdom






Alstomec


Ivermectin 10 mg/ml


Cattle, Pigs


Subcutaneous








Cattle:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Ecomectin 10 mg/ml Solution for Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey KT3 4QS




United Kingdom






Qualimec 10 mg/ml Solution for Injection


Ivermectin 10 mg/ml


Cattle, Sheep, Pigs


Subcutaneous








Cattle, Sheep:


200 μg ivermectin/kg bw




Pigs:


300 μg ivermectin/kg bw








United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closamectin Injection


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Closiver Injection


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw




United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry BT35 6JP




Country Down




Northern Ireland






Norofas Solution for Injection


Ivermectin 5 mg/ml,
Closantel 125 mg/ml


Cattle


Subcutaneous


200 μg ivermectin/kg bw, 5 mg closantel/kg bw







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


(Invented) name


Strength


Pharmaceutical Form


Route of administration




Austria







Janssen-Cilag Pharma GmbH




Pfarrgasse 75 1232 Wien, Austria






Topamax 100 mg – Filmtabletten


100 milligram(s)


Film-coated tablet


Oral use




Austria







Janssen-Cilag Pharma GmbH




Pfarrgasse 75 1232 Wien, Austria






Topamax 200 mg - Filmtabletten


200 milligram(s)


Film-coated tablet


Oral use




Austria







Janssen-Cilag Pharma GmbH




Pfarrgasse 75 1232 Wien, Austria






Topamax 25 mg - Filmtabletten


25 milligram(s)


Film-coated tablet


Oral use




Austria







Janssen-Cilag Pharma GmbH




Pfarrgasse 75 1232 Wien, Austria






Topamax 50 mg - Filmtabletten


50 milligram(s)


Film-coated tablet


Oral use




Austria







Janssen-Cilag Pharma GmbH




Pfarrgasse 75 1232 Wien, Austria






Topamax 15 mg - Granulat in Kapseln


15 milligram(s)


granuals in capsule


Oral use




Austria







Janssen-Cilag Pharma GmbH




Pfarrgasse 75 1232 Wien, Austria






Topamax 25 mg - Granulat in Kapseln


25 milligram(s)


granuals in capsule


Oral use




Austria







Janssen-Cilag Pharma GmbH -




Pfarrgasse 75 A-1232 Wien, Austria






Topamax 50 mg - Granulat in Kapseln


50 milligram(s)


granuals in capsule


Oral use




Belgium







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax 15 mg harde capsules


15 milligram(s)


Capsule, hard


Oral use




Belgium







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax 25 mg harde capsules


25 milligram(s)


Capsule, hard


Oral use




Belgium







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax 50 mg harde capsules


50 milligram(s)


Capsule, hard


Oral use




Belgium







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax 100 mg tabletten


100 milligram(s)


Tablet


Oral use




Belgium







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax 200 mg tabletten


200 milligram(s)


Tablet


Oral use




Belgium







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax 25 mg tabletten


25 milligram(s)


Tablet


Oral use




Belgium







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax 50 mg tabletten


50 milligram(s)


Tablet


Oral use




Bulgaria







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI




Smartinska cesta 53, 1000 Ljubljana, Slovenia






TOPAMAX


15 milligram(s)


Capsule


Oral use




Bulgaria







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI




Smartinska cesta 53, 1000 Ljubljana, Slovenia






TOPAMAX


25 milligram(s)


Capsule


Oral use




Bulgaria







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI




Smartinska cesta 53, 1000 Ljubljana, Slovenia






TOPAMAX


100 milligram(s)


Tablet


Oral use




Bulgaria







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI




Smartinska cesta 53, 1000 Ljubljana, Slovenia






TOPAMAX


25 milligram(s)


Tablet


Oral use




Bulgaria







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI




Smartinska cesta 53, 1000 Ljubljana, Slovenia






TOPAMAX


50 milligram(s)


Tablet


Oral use




Cyprus







Janssen-Cilag International NV - BE




Turnhoutseweg 30, 2340 Beerse, Belgium






TOPAMAX 100 mg tabs


100 milligram(s)


Tablet


Oral use




Cyprus







Janssen-Cilag International NV - BE




Turnhoutseweg 30, 2340 Beerse, Belgium






TOPAMAX 200 mg tabs


200 milligram(s)


Tablet


Oral use




Cyprus







Janssen-Cilag International NV - BE




Turnhoutseweg 30, 2340 Beerse, Belgium






TOPAMAX 25 mg tabs


25 milligram(s)


Film-coated tablet


Oral use




Cyprus







Janssen-Cilag International NV - BE




Turnhoutseweg 30, 2340 Beerse, Belgium






TOPAMAX 50 mg tabs


50 milligram(s)


Film-coated tablet


Oral use




Cyprus







Janssen-Cilag International NV - BE




Turnhoutseweg 30, 2340 Beerse, Belgium






TOPAMAX 15 mg Sprinkles


15 milligram(s)


Sprinkle capsule


Oral use




Cyprus







Janssen-Cilag International NV - BE




Turnhoutseweg 30, 2340 Beerse, Belgium






TOPAMAX 25 mg Sprinkles


25 milligram(s)


Sprinkle capsule


Oral use




Cyprus







Janssen-Cilag International NV - BE




Turnhoutseweg 30, 2340 Beerse, Belgium






TOPAMAX 50 mg Sprinkles


50 milligram(s)


Sprinkle capsule


Oral use




Czech Republic







Janssen-Cilag s.r.o




Karla Engliše 3201/6




150 00 Praha 5






Topamax 100 mg


100 milligram(s)


Film-coated tablet


Oral use




Czech Republic







Janssen-Cilag s.r.o




Karla Engliše 3201/6




150 00 Praha 5






Topamax 25 mg


25 milligram(s)


Film-coated tablet


Oral use




Czech Republic







Janssen-Cilag s.r.o




Karla Engliše 3201/6




150 00 Praha 5






Topamax 50 mg


50 milligram(s)


Film-coated tablet


Oral use




Czech Republic







Janssen-Cilag s.r.o




Karla Engliše 3201/6




150 00 Praha 5






Topamax 15 mg


15 milligram(s)


Capsule


Oral use




Czech Republic







Janssen-Cilag s.r.o




Karla Engliše 3201/6




150 00 Praha 5






Topamax 25 mg


25 milligram(s)


Capsule


Oral use




Denmark







Janssen-Cilag A/S




Hammerbakken 19, 3460 Birkerød, Denmark






Topimax


15 milligram(s)


Capsule, hard


Oral use




Denmark







Janssen-Cilag A/S




Hammerbakken 19, 3460 Birkerød, Denmark






Topimax


25 milligram(s)


Capsule, hard


Oral use




Denmark







Janssen-Cilag A/S




Hammerbakken 19, 3460 Birkerød, Denmark






Topimax


50 milligram(s)


Capsule, hard


Oral use




Denmark







Janssen-Cilag A/S




Hammerbakken 19, 3460 Birkerød, Denmark






Topimax


100 milligram(s)


Film-coated tablet


Oral use




Denmark







Janssen-Cilag A/S




Hammerbakken 19, 3460 Birkerød, Denmark






Topimax


200 milligram(s)


Film-coated tablet


Oral use




Denmark







Janssen-Cilag A/S




Hammerbakken 19, 3460 Birkerød, Denmark






Topimax


25 milligram(s)


Film-coated tablet


Oral use




Denmark







Janssen-Cilag A/S




Hammerbakken 19, 3460 Birkerød, Denmark






Topimax


50 milligram(s)


Film-coated tablet


Oral use




Estonia







UAB Johnson & Johnson - LT




Geležinio Vilko g. 18A




LT-08104 Vilnius




Lithuania






TOPAMAX 100 mg


100 milligram(s)


Film-coated tablet


Oral use




Estonia







UAB Johnson & Johnson - LT




Geležinio Vilko g. 18A




LT-08104 Vilnius




Lithuania






TOPAMAX 200 mg


200 milligram(s)


Film-coated tablet


Oral use




Estonia







UAB Johnson & Johnson - LT




Geležinio Vilko g. 18A




LT-08104 Vilnius




Lithuania






TOPAMAX 25 mg


25 milligram(s)


Film-coated tablet


Oral use




Estonia







UAB Johnson & Johnson - LT




Geležinio Vilko g. 18A




LT-08104 Vilnius




Lithuania






TOPAMAX 50 mg


50 milligram(s)


Film-coated tablet


Oral use




Finland







Janssen-Cilag OY – FI




Metsänneidonkuja 8




02130 Espoo Finland






Topimax 15 mg kapseli, kova


15 milligram(s)


Capsule, hard


Oral use




Finland







Janssen-Cilag OY – FI




Metsänneidonkuja 8




02130 Espoo Finland






Topimax 100 mg tabletti, kalvopäällysteinen


100 milligram(s)


Film-coated tablet


Oral use




Finland







Janssen-Cilag OY – FI




Metsänneidonkuja 8




02130 Espoo Finland






Topimax 200 mg tabletti, kalvopäällysteinen


200 milligram(s)


Film-coated tablet


Oral use




Finland







Janssen-Cilag OY – FI




Metsänneidonkuja 8




02130 Espoo Finland






Topimax 25 mg tabletti, kalvopäällysteinen


25 milligram(s)


Film-coated tablet


Oral use




Finland







Janssen-Cilag OY – FI




Metsänneidonkuja 8




02130 Espoo Finland






Topimax 50 mg tabletti, kalvopäällysteinen


50 milligram(s)


Film-coated tablet


Oral use




Finland







Janssen-Cilag OY – FI




Metsänneidonkuja 8




02130 Espoo Finland






Topimax 25 mg kapseli, kova


25 milligram(s)


Capsule, hard


Oral use




Finland







Janssen-Cilag OY – FI




Metsänneidonkuja 8




02130 Espoo Finland






Topimax 50 mg kapseli, kova


50 milligram(s)


Capsule, hard


Oral use




France







Janssen-Cilag S.A. – FR




1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France






EPITOMAX 100 mg, COMPRIME PELLICULE


100 milligram(s)


Film-coated tablet


Oral use




France







Janssen-Cilag S.A. – FR




1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France






EPITOMAX 200 mg, COMPRIME PELLICULE


200 milligram(s)


Film-coated tablet


Oral use




France







Janssen-Cilag S.A. – FR




1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France






EPITOMAX 50 mg, COMPRIME PELLICULE


50 milligram(s)


Film-coated tablet


Oral use




France







Janssen-Cilag S.A. – FR




1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France






EPITOMAX 15 mg, GELULE


15 milligram(s)


Sprinkle capsule


Oral use




France







Janssen-Cilag S.A. – FR




1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France






EPITOMAX 25 mg, GELULE


25 milligram(s)


Sprinkle capsule


Oral use




France







Janssen-Cilag S.A. – FR




1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France






EPITOMAX 50 mg, GELULE


50 milligram(s)


Sprinkle capsule


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Cilag 25 mg Hartkapseln


25 milligram(s)


Capsule, hard


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Janssen 25 mg Hartkapseln


25 milligram(s)


Capsule, hard


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Cilag 50 mg Hartkapseln


50 milligram(s)


Capsule, hard


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Janssen 50 mg Hartkapseln


50 milligram(s)


Capsule, hard


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topamax 100 mg Filmtabletten


100 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Janssen 100 mg Filmtabletten


100 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






TOPAMAX MIGRÄNE 100 mg Filmtabletten


100 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat - Cilag 100 mg Filmtabletten


100 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Cilag 100 mg Filmtabletten


100 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topamax 200 mg Filmtabletten


200 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






TOPAMAX MIGRÄNE 200 mg Filmtabletten


200 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat - Cilag 200 mg Filmtabletten


200 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Cilag 200 mg Filmtabletten


200 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Janssen 200 mg Filmtabletten


200 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topamax 25 mg Filmtabletten


25 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






TOPAMAX MIGRÄNE 25 mg Filmtabletten


25 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Cilag 25 mg Filmtabletten


25 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Janssen 25 mg Filmtabletten


25 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topamax 50 mg Filmtabletten


50 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






TOPAMAX MIGRÄNE 50 mg Filmtabletten


50 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Cilag 50 mg Filmtabletten


50 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topiramat-Janssen 50 mg Filmtabletten


50 milligram(s)


Film-coated tablet


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topamax 25 mg Kapseln


25 milligram(s)


Capsule hard


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






TOPAMAX MIGRÄNE 25 mg Hartkapseln


25 milligram(s)


Capsule


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






Topamax 50 mg Kapseln


50 milligram(s)


Capsule hard


Oral use




Germany







Janssen-Cilag GmbH - DE




Raiffeisenstr. 8




41470 Neuss, Germany






TOPAMAX MIGRÄNE 50 mg Hartkapseln


50 milligram(s)


Capsule


Oral use




Greece







Janssen-Cilag Pharmaceutical S.A.C.I. – GR




56 Eirinis Avenue 56, Pefki, 15121, Greece






TOPAMAC


100 milligram(s)


Film-coated tablet


Oral use




Greece







Janssen-Cilag Pharmaceutical S.A.C.I. – GR




56 Eirinis Avenue 56, Pefki, 15121, Greece






TOPAMAC


200 milligram(s)


Film-coated tablet


Oral use




Greece







Janssen-Cilag Pharmaceutical S.A.C.I. – GR




56 Eirinis Avenue 56, Pefki, 15121, Greece






TOPAMAC


25 milligram(s)


Film-coated tablet


Oral use




Greece







Janssen-Cilag Pharmaceutical S.A.C.I. – GR




56 Eirinis Avenue 56, Pefki, 15121, Greece






TOPAMAC


50 milligram(s)


Film-coated tablet


Oral use




Greece







Janssen-Cilag Pharmaceutical S.A.C.I. – GR




56 Eirinis Avenue 56, Pefki, 15121, Greece






TOPAMAC


15 milligram(s)


Capsule, hard


Oral use




Greece







Janssen-Cilag Pharmaceutical S.A.C.I. – GR




56 Eirinis Avenue 56, Pefki, 15121, Greece






TOPAMAC


25 milligram(s)


Capsule, hard


Oral use




Greece







Janssen-Cilag Pharmaceutical S.A.C.I. – GR




56 Eirinis Avenue 56, Pefki, 15121, Greece






TOPAMAC


50 milligram(s)


Capsule, hard


Oral use




Hungary







Janssen-Cilag Kft. - HU




2045 Törökbálint Tó park, Hungary






Topamax 100 mg film-coated tablet


100 milligram(s)


Film-coated tablet


Oral use




Hungary







Janssen-Cilag Kft. - HU




2045 Törökbálint Tó park, Hungary






Topamax 200 mg film-coated tablets


200 milligram(s)


Film-coated tablet


Oral use




Hungary







Janssen-Cilag Kft. - HU




2045 Törökbálint Tó park, Hungary






Topamax 25 mg film-coated tablet


25 milligram(s)


Film-coated tablet


Oral use




Hungary







Janssen-Cilag Kft. - HU




2045 Törökbálint Tó park, Hungary






Topamax 50 mg film-coated tablet


50 milligram(s)


Film-coated tablet


Oral use




Iceland







Janssen-Cilag AB - SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 15 mg hylki, hörð


15 milligram(s)


Capsule, hard


Oral use




Iceland







Janssen-Cilag AB - SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 25 mg hylki, hörð


25 milligram(s)


Capsule, hard


Oral use




Iceland







Janssen-Cilag AB - SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 50 mg hylki, hörð


50 milligram(s)


Capsule, hard


Oral use




Iceland







Janssen-Cilag AB - SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 100 mg filmuhúðaðar töflur


100 milligram(s)


Film-coated tablet


Oral use




Iceland







Janssen-Cilag AB - SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 200 mg filmuhúðaðar töflur


200 milligram(s)


Film-coated tablet


Oral use




Iceland







Janssen-Cilag AB - SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 25 mg filmuhúðaðar töflur


25 milligram(s)


Film-coated tablet


Oral use




Iceland







Janssen-Cilag AB - SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 50 mg filmuhúðaðar töflur


50 milligram(s)


Film-coated tablet


Oral use




Ireland







Janssen-Cilag Limited - GB




Saunderton




High Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX 100 mg Tablets


100 milligram(s)


Film-coated tablet


Oral use




Ireland







Janssen-Cilag Limited - GB




Saunderton




High Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX 200 mg Tablets


200 milligram(s)


Film-coated tablet


Oral use




Ireland







Janssen-Cilag Limited - GB




Saunderton




High Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX 25 mg Tablets


25 milligram(s)


Film-coated tablet


Oral use




Ireland







Janssen-Cilag Limited - GB




Saunderton




High Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX 50 mg Tablets


50 milligram(s)


Film-coated tablet


Oral use




Ireland







Janssen-Cilag Limited - GB




Saunderton




High Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX Sprinkle Capsules 15 mg.


15 milligram(s)


Sprinkle capsule


Oral use




Ireland







Janssen-Cilag Limited - GB




Saunderton




High Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX Sprinkle Capsules 25 mg.


25 milligram(s)


Sprinkle capsule


Oral use




Ireland







Janssen-Cilag Limited - GB




Saunderton




High Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX Sprinkle Capsules 50 mg


50 milligram(s)


Sprinkle capsule


Oral use




Italy







Janssen-Cilag SpA – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano, Italy






TOPAMAX 15 mg capsule rigide, 60 capsule


15 milligram(s)


Capsule, hard


Oral use




Italy







Janssen-Cilag SpA – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano, Italy






TOPAMAX 100 mg compresse rivestite con film, 60 compresse


100 milligram(s)


Film-coated tablet


Oral use




Italy







J.C. Healthcare srl – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano,




Italy






EPITOMAX 100 mg compresse rivestite con film, 60 compresse


100 milligram(s)


Film-coated tablet


Oral use




Italy







Janssen-Cilag SpA – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano, Italy






TOPAMAX 200 mg compresse rivestite con film, 60 compresse


200 milligram(s)


Film-coated tablet


Oral use




Italy







J.C. Healthcare srl – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano,




Italy






EPITOMAX 200 mg compresse rivestite con film, 60 compresse


200 milligram(s)


Film-coated tablet


Oral use




Italy







Janssen-Cilag SpA – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano, Italy






TOPAMAX 25 mg compresse rivestite con film, 60 compresse


25 milligram(s)


Film-coated tablet


Oral use




Italy







J.C. Healthcare srl – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano,




Italy






EPITOMAX 25 mg compresse rivestite con film, 60 compresse


25 milligram(s)


Film-coated tablet


Oral use




Italy







Janssen-Cilag SpA – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano,




Italy






TOPAMAX 300 mg compresse rivestite con film, 60 compresse


300 milligram(s)


Film-coated tablet


Oral use




Italy







J.C. Healthcare srl – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano,




Italy






EPITOMAX 300 mg compresse rivestite con film, 60 compresse


300 milligram(s)


Film-coated tablet


Oral use




Italy







Janssen-Cilag SpA – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano, Italy






TOPAMAX 400 mg compresse rivestite con film, 60 compresse


400 milligram(s)


Film-coated tablet


Oral use




Italy







J.C. Healthcare srl – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano,




Italy






EPITOMAX 400 mg compresse rivestite con film, 60 compresse


400 milligram(s)


Film-coated tablet


Oral use




Italy







Janssen-Cilag SpA – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano, Italy






TOPAMAX 50 mg compresse rivestite con film, 60 compresse


50 milligram(s)


Film-coated tablet


Oral use




Italy







J.C. Healthcare srl – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano,




Italy






EPITOMAX 50 mg compresse rivestite con film, 60 compresse


50 milligram(s)


Film-coated tablet


Oral use




Italy







Janssen-Cilag SpA – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano, Italy






TOPAMAX 25 mg capsule rigide, 60 capsule


25 milligram(s)


Capsule, hard


Oral use




Italy







Janssen-Cilag SpA – IT




Via Michelangelo Buonarroti n. 23




Cologno Monzese, 20093, Milano, Italy






TOPAMAX 50 mg capsule rigide, 60 capsule


50 milligram(s)


Capsule, hard


Oral use




Latvia







UAB Johnson & Johnson - LT




Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania






Topamax 100 mg coated tablets


100 milligram(s)


Coated tablet


Oral use




Latvia







UAB Johnson & Johnson - LT




Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania






Topamax 25 mg coated tablets


25 milligram(s)


Coated tablet


Oral use




Latvia







UAB Johnson & Johnson - LT




Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania






Topamax 50 mg coated tablets


50 milligram(s)


Coated tablet


Oral use




Latvia







UAB Johnson & Johnson - LT




Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania






Topamax 15 mg sprinkle capsules


15 milligram(s)


Sprinkle capsule


Oral use




Latvia







UAB Johnson & Johnson - LT




Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania






Topamax 25 mg sprinkle capsules


25 milligram(s)


Sprinkle capsule


Oral use




Lithuania







UAB Johnson & Johnson




Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania






Topamax


100 milligram(s)


Tablet


Oral use




Lithuania







UAB Johnson & Johnson




Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania






Topamax


200 milligram(s)


Tablet


Oral use




Lithuania







UAB Johnson & Johnson




Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania






Topamax


25 milligram(s)


Tablet


Oral use




Lithuania







UAB Johnson & Johnson




Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania






Topamax


50 milligram(s)


Tablet


Oral use




Luxembourg







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax gélules 15 mg


15 milligram(s)


Capsule, hard


Oral use




Luxembourg







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax comprimés 100 mg


100 milligram(s)


Tablet


Oral use




Luxembourg







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax comprimés 200 mg


200 milligram(s)


Tablet


Oral use




Luxembourg







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax comprimés 25 mg


25 milligram(s)


Tablet


Oral use




Luxembourg







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax comprimés 50 mg


50 milligram(s)


Tablet


Oral use




Luxembourg







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax gélules 25 mg


25 milligram(s)


Capsule, hard


Oral use




Luxembourg







Janssen-Cilag NV – BE




Roderveldlaan 1 2600 Berchem, Belgium






Topamax gélules 50 mg


50 milligram(s)


Capsule, hard


Oral use




Malta







Janssen-Cilag International NV - BE




Turnhoutseweg 30, B-2340 Beerse, Belgium






Topamax


100 milligram(s)


Tablet


Oral use




Malta







Janssen-Cilag International NV - BE




Turnhoutseweg 30, B-2340 Beerse, Belgium






Topamax


200 milligram(s)


Tablet


Oral use




Malta







Janssen-Cilag International NV - BE




Turnhoutseweg 30, B-2340 Beerse, Belgium






Topamax


25 milligram(s)


Tablet


Oral use




Malta







Janssen-Cilag International NV - BE




Turnhoutseweg 30, B-2340 Beerse, Belgium






Topamax


50 milligram(s)


Tablet


Oral use




Malta







Janssen-Cilag International NV - BE




Turnhoutseweg 30, B-2340 Beerse, Belgium






Topamax


15 milligram(s)


Hard capsule


Oral use




Malta







Janssen-Cilag International NV - BE




Turnhoutseweg 30, B-2340 Beerse, Belgium






Topamax


25 milligram(s)


Hard capsule


Oral use




Malta







Janssen-Cilag International NV - BE




Turnhoutseweg 30, B-2340 Beerse, Belgium






Topamax


50 milligram(s)


Hard capsule


Oral use




Netherlands







Janssen-Cilag BV – NL




Dr. Paul Janssenweg 150




PO Box 90240




5000 LT Tilburg




The Netherlands






Topamax omhulde tabletten 100 mg, omhulde tabletten


100 milligram(s)


Coated tablet


Oral use




Netherlands







Janssen-Cilag BV – NL




Dr. Paul Janssenweg 150




PO Box 90240




5000 LT Tilburg




The Netherlands






Topamax omhulde tabletten 200 mg, omhulde tabletten


200 milligram(s)


Coated tablet


Oral use




Netherlands







Janssen-Cilag BV – NL




Dr. Paul Janssenweg 150




PO Box 90240




5000 LT Tilburg




The Netherlands






Topamax omhulde tabletten 25 mg, omhulde tabletten


25 milligram(s)


Coated tablet


Oral use




Netherlands







Janssen-Cilag BV – NL




Dr. Paul Janssenweg 150




PO Box 90240




5000 LT Tilburg




The Netherlands






Topamax omhulde tabletten 50 mg, omhulde tabletten


50 milligram(s)


Coated tablet


Oral use




Netherlands







Janssen-Cilag BV – NL




Dr. Paul Janssenweg 150




PO Box 90240




5000 LT Tilburg




The Netherlands






Topamax Sprinkle capsules 15 mg, capsules


15 milligram(s)


Capsule


Oral use




Netherlands







Janssen-Cilag BV – NL




Dr. Paul Janssenweg 150




PO Box 90240




5000 LT Tilburg




The Netherlands






Topamax Sprinkle capsules 25 mg, capsules


25 milligram(s)


Capsule


Oral use




Netherlands







Janssen-Cilag BV – NL




Dr. Paul Janssenweg 150




PO Box 90240




5000 LT Tilburg




The Netherlands






Topamax Sprinkle capsules 50 mg, capsules


50 milligram(s)


Capsule


Oral use




Norway







Janssen-Cilag AS – NO




Hoffsveien 1D




0275 Oslo Norway






Topimax 15 mg Kapsel, hard


15 milligram(s)


Capsule, hard


Oral use




Norway







Janssen-Cilag AS – NO




Hoffsveien 1D




0275 Oslo Norway






Topimax 25 mg Kapsel, hard


25 milligram(s)


Capsule, hard


Oral use




Norway







Janssen-Cilag AS – NO




Hoffsveien 1D




0275 Oslo Norway






Topimax 50 mg Kapsel, hard


50 milligram(s)


Capsule, hard


Oral use




Norway







Janssen-Cilag AS – NO




Hoffsveien 1D




0275 Oslo Norway






Topimax 100 mg Tabletter filmdrasjert


100 milligram(s)


Film-coated tablet


Oral use




Norway







Janssen-Cilag AS – NO




Hoffsveien 1D




0275 Oslo Norway






Topimax 200 mg Tabletter filmdrasjert


200 milligram(s)


Film-coated tablet


Oral use




Norway







Janssen-Cilag AS – NO




Hoffsveien 1D




0275 Oslo Norway






Topimax 25 mg Tabletter filmdrasjert


25 milligram(s)


Film-coated tablet


Oral use




Norway







Janssen-Cilag AS – NO




Hoffsveien 1D




0275 Oslo Norway






Topimax 50 mg Tabletter filmdrasjert


50 milligram(s)


Film-coated tablet


Oral use




Poland







Janssen-Cilag International NV - BE




Turnhoutseweg 30




B-2340 Beerse




Belgium






Topamax 100 mg tabletki powlekane


100 milligram(s)


Film-coated tablet


Oral use




Poland







Janssen-Cilag International NV - BE




Turnhoutseweg 30




B-2340 Beerse




Belgium






Topamax 200 mg tabletki powlekane


200 milligram(s)


Film-coated tablet


Oral use




Poland







Janssen-Cilag International NV - BE




Turnhoutseweg 30




B-2340 Beerse




Belgium






Topamax 25 mg tabletki powlekane


25 milligram(s)


Film-coated tablet


Oral use




Poland







Janssen-Cilag International NV - BE




Turnhoutseweg 30




B-2340 Beerse




Belgium






Topamax 50 mg tabletki powlekane


50 milligram(s)


Film-coated tablet


Oral use




Poland







Janssen-Cilag International NV - BE




Turnhoutseweg 30




B-2340 Beerse




Belgium






Topamax 15 mg kapsulki


15 milligram(s)


Capsule


Oral use




Poland







Janssen-Cilag International NV - BE




Turnhoutseweg 30




B-2340 Beerse




Belgium






Topamax 25 mg kapsulki


25 milligram(s)


Capsule


Oral use




Portugal







Janssen-Cilag Farmacêutica, Lda. – PT




Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal






Topamax


100 milligram(s)


Film-coated tablet


Oral use




Portugal







Janssen-Cilag Farmacêutica, Lda. – PT




Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal






Topamax


200 milligram(s)


Film-coated tablet


Oral use




Portugal







Janssen-Cilag Farmacêutica, Lda. – PT




Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal






Topamax


25 milligram(s)


Film-coated tablet


Oral use




Portugal







Janssen-Cilag Farmacêutica, Lda. – PT




Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal






Topamax


50 milligram(s)


Film-coated tablet


Oral use




Portugal







Janssen-Cilag Farmacêutica, Lda. – PT




Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal






Topamax


15 milligram(s)


capsule, hard


Oral use




Portugal







Janssen-Cilag Farmacêutica, Lda. – PT




Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal






Topamax


25 milligram(s)


capsule, hard


Oral use




Portugal







Janssen-Cilag Farmacêutica, Lda. – PT




Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal






Topamax


50 milligram(s)


capsule, hard


Oral use




Romania







Johnson & Johnson, d.o.o. – SI




Smartinska cesta 53,




Ljubljana,




Slovenia






TOPAMAX 100 tablets


100 milligram(s)


Tablet


Oral use




Romania







Johnson & Johnson, d.o.o. – SI




Smartinska cesta 53,




Ljubljana,




Slovenia






TOPAMAX 200 tablets


200 milligram(s)


Tablet


Oral use




Romania







Johnson & Johnson, d.o.o. – SI




Smartinska cesta 53,




Ljubljana,




Slovenia






TOPAMAX 25 tablets


25 milligram(s)


Tablet


Oral use




Romania







Johnson & Johnson, d.o.o. – SI




Smartinska cesta 53,




Ljubljana,




Slovenia






TOPAMAX 50 tablets


50 milligram(s)


Tablet


Oral use




Romania







Johnson & Johnson, d.o.o. – SI




Smartinska cesta 53,




Ljubljana,




Slovenia






TOPAMAX sprinkle caps


50 milligram(s)


Sprinkle capsule


Oral use




Slovak Republic







Johnson & Johnson, s.r.o – SK




Plynárenská 7/B




824 78 Bratislava




Slovak Republic






Topamax 15 mg cps


15 milligram(s)


Prolonged-release capsule, hard


Oral use




Slovak Republic







Johnson & Johnson, s.r.o – SK




Plynárenská 7/B




824 78 Bratislava




Slovak Republic






Topamax 25 mg cps


25 milligram(s)


Prolonged-release capsule, hard


Oral use




Slovak Republic







Johnson & Johnson, s.r.o – SK




Plynárenská 7/B




824 78 Bratislava




Slovak Republic






Topamax 100


100 milligram(s)


Film-coated tablet


Oral use




Slovak Republic







Johnson & Johnson, s.r.o – SK




Plynárenská 7/B




824 78 Bratislava




Slovak Republic






Topamax 200


200 milligram(s)


Film-coated tablet


Oral use




Slovak Republic







Johnson & Johnson, s.r.o – SK




Plynárenská 7/B




824 78 Bratislava




Slovak Republic






Topamax 25


25 milligram(s)


Film-coated tablet


Oral use




Slovak Republic







Johnson & Johnson, s.r.o – SK




Plynárenská 7/B




824 78 Bratislava




Slovak Republic






Topamax 50


50 milligram(s)


Film-coated tablet


Oral use




Slovenia







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI




Šmartinska 53, Ljubljana, Slovenia






TOPAMAX 100 mg filmsko oblozene tablete


100 milligram(s)


Film-coated tablet


Oral use




Slovenia







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI




Šmartinska 53, Ljubljana, Slovenia






TOPAMAX 200 mg filmsko oblozene tablete


200 milligram(s)


Film-coated tablet


Oral use




Slovenia







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI




Šmartinska 53, Ljubljana, Slovenia






TOPAMAX 25 mg filmsko oblozene tablete


25 milligram(s)


Film-coated tablet


Oral use




Slovenia







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI




Šmartinska 53, Ljubljana, Slovenia






TOPAMAX 50 mg filmsko oblozene tablete


50 milligram(s)


Film-coated tablet


Oral use




Slovenia







Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI




Šmartinska 53, Ljubljana, Slovenia






TOPAMAX 15 mg kapsule


15 milligram(s)


hard capsule


Oral use




Spain







Janssen-Cilag S.A. – ES




Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain






TOPAMAX 100 mg Comprimidos recubiertos


100 milligram(s)


Coated tablet


Oral use




Spain







Janssen-Cilag S.A. – ES




Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain






TOPAMAX 200 mg Comprimidos recubiertos


200 milligram(s)


Coated tablet


Oral use




Spain







Janssen-Cilag S.A. – ES




Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain






TOPAMAX 25 mg Comprimidos recubiertos


25 milligram(s)


Coated tablet


Oral use




Spain







Janssen-Cilag S.A. – ES




Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain






TOPAMAX 50 mg Comprimidos recubiertos


50 milligram(s)


Coated tablet


Oral use




Spain







Janssen-Cilag S.A. – ES




Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain






TOPAMAX DISPERSABLE 15 mg, cápsulas


15 milligram(s)


Sprinkle capsule


Oral use




Spain







Janssen-Cilag S.A. – ES




Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain






TOPAMAX DISPERSABLE 25 mg, cápsulas


25 milligram(s)


Sprinkle capsule


Oral use




Spain







Janssen-Cilag S.A. – ES




Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain






TOPAMAX DISPERSABLE 50 mg, cápsulas


50 milligram(s)


Sprinkle capsule


Oral use




Sweden







Janssen-Cilag AB – SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 15 mg kapslar, hårda


15 milligram(s)


Capsule, hard


Oral use




Sweden







Janssen-Cilag AB – SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 25 mg kapslar, hårda


25 milligram(s)


Capsule, hard


Oral use




Sweden







Janssen-Cilag AB – SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 50 mg kapslar, hårda


50 milligram(s)


Capsule, hard


Oral use




Sweden







Janssen-Cilag AB – SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 100 mg tabletter, filmdragerade


100 milligram(s)


Film-coated tablet


Oral use




Sweden







Janssen-Cilag AB – SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 200 mg tabletter, filmdragerade


200 milligram(s)


Film-coated tablet


Oral use




Sweden







Janssen-Cilag AB – SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 25 mg tabletter, filmdragerade


25 milligram(s)


Film-coated tablet


Oral use




Sweden







Janssen-Cilag AB – SE




Box 7073 192 07 Sollentuna, Sverige






Topimax 50 mg tabletter, filmdragerade


50 milligram(s)


Film-coated tablet


Oral use




United Kingdom







Janssen-Cilag Limited – GB




Saunderton




High-Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX 100 mg Tablets


100 milligram(s)


Tablet


Oral use




United Kingdom







Janssen-Cilag Limited – GB




Saunderton




High-Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX 200 mg Tablets


200 milligram(s)


Tablet


Oral use




United Kingdom







Janssen-Cilag Limited – GB




Saunderton




High-Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX 25 mg Tablets


25 milligram(s)


Tablet


Oral use




United Kingdom







Janssen-Cilag Limited – GB




Saunderton




High-Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX 50 mg Tablets


50 milligram(s)


Tablet


Oral use




United Kingdom







Janssen-Cilag Limited – GB




Saunderton




High-Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX Sprinkle Capsules 15 mg


15 milligram(s)


Sprinkle capsule


Oral use




United Kingdom







Janssen-Cilag Limited – GB




Saunderton




High-Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX Sprinkle Capsules 25 mg


25 milligram(s)


Sprinkle capsule


Oral use




United Kingdom







Janssen-Cilag Limited – GB




Saunderton




High-Wycombe




Buckinghamshire HP14 4HJ




United Kingdom






TOPAMAX Sprinkle Capsules 50 mg


50 milligram(s)


Sprinkle capsule


Oral use







ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES













Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration


Content
(concentration)




Austria







Bayer Austria GmbH




Herbststraße 6-10




1160 Wien




Austria






 


Avelox 400 mg - Infusionslösung


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Belgium







Bayer SA-NV




Avenue Louise 143 Louizalaan




B-1050 Brussel




Belgium






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Cyprus


 







Bayer Hellas S.A.




Sorou 18-20




151 25 Marousi - Athens




Greece






Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Czech Republic


 







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






Avelox 400 mg/ 250 ml infuzní roztok


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Denmark







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Estonia







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Finland







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




France


 







Bayer Santé




13, rue Jean Jaurès




92807 Puteaux Cedex




France






Izilox 400 mg / 250 ml, solution pour perfusion


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Germany







Bayer Vital GmbH




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






 


Avalox 400 mg / 250 ml Infusionslösung


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Greece







Bayer Hellas S.A.




Sorou 18-20




151 25 Marousi - Athens




Greece






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Hungary







Bayer Hungária Kft




Alkotás ut.50




1123 Budapest




Hungary






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Ireland







Bayer Limited




The Atrium




Blackthorn Road




Dublin 18




Ireland






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Italy


 







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






Avalox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Látvia







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Lithuania







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Luxembourg







Bayer SA-NV




Avenue Louise 143 Louizalaan




B-1050 Brussel




Belgium






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Malta







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






 


Avalox 400 mg/250 ml Solution for Infusion


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Netherlands







Bayer BV




Energieweg 1




3641 RT Mijdrecht




Netherlands






 


Avelox 400 mg/250 ml oplossing voor infusie


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Poland


 







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Portugal


 







BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.




Rua Quinta do Pinheiro, 5




2794-003 Carnaxide




Portugal






Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Slovak Republic







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






 


AVELOX 400 mg/250 ml infúzny roztok


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Slovenia







BAYER d.o.o.




Bravničarjeva 13




1000 Ljubljana




Slovenia






 


Avelox 400 mg/250 ml raztopina za infundiranje


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Spain


 







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






Muzolil


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Sweden







Bayer HealthCare AG




Kaiser Wilhelm Allee




51368 Leverkusen




Germany






 


Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




United Kingdom


 







Bayer plc




Bayer House




Strawberry Hill




Newbury




Berkshire RG14 1JA




United Kingdom






Avelox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml







ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES













Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration


Content
(concentration)




Austria







Bayer HealthCare AG




51368 Leverkusen




Germany






 


Octegra 400 mg - Infusionslösung


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Belgium







Bayer HealthCare AG




51368 Leverkusen




Germany






 


Proflox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




France


 







Bayer HealthCare AG




51368 Leverkusen




Germany






Octegra 400 mg / 250 ml, solution pour perfusion


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Germany







Bayer HealthCare AG




51368 Leverkusen




Germany






 


Octegra 400 mg / 250 ml Infusionslösung


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Greece







Elpen Pharmaceutical Co, Inc




95, Marathonos Avenue




190-09 Pikermi




Greece






 


Octegra


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Luxembourg







Bayer HealthCare AG




51368 Leverkusen




Germany






 


Proflox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Netherlands







Bayer HealthCare AG




51368 Leverkusen




Germany






 


Octegra 400 mg/250 ml oplossing voor infusie


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml




Portugal


 







Bialfar - Produtos Farmacêuticos S.A.




À Av. da Siderurgia Nacional




4745-457 S. Mamede do Coronado




Portugal






Proflox


400 mg


Solution for infusion


Intravenous use


400 mg / 250 ml







ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Austria


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm 25 Mikrogramm/h Transdermales Pflaster


25 μg/h


transdermal patch


transdermal route




Austria


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm 50 Mikrogramm/h Transdermales Pflaster


50 μg/h


transdermal patch


transdermal route




Austria


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm 75 Mikrogramm/h Transdermales Pflaster


75 μg/h


transdermal patch


transdermal route




Austria


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm 100 Mikrogramm/h Transdermales Pflaster


100 μg/h


transdermal patch


transdermal route




Belgium


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm Pharmaceuticals 25 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster


25 μg/h


transdermal patch


transdermal route




Belgium


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm Pharmaceuticals 50 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster


50 μg/h


transdermal patch


transdermal route




Belgium


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm Pharmaceuticals 75 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster


75 μg/h


transdermal patch


transdermal route




Belgium


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm Pharmaceuticals 100 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster


100 μg/h


transdermal patch


transdermal use




Germany


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentrix 25 μ/h Transdermales Pflaster


25 μg/h


transdermal patch


transdermal use




Germany


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentrix 50 μ/h Transdermales Pflaster


50 μg/h


transdermal patch


transdermal use




Germany


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentrix 75 μ/h Transdermales Pflaster


75 μg/h


transdermal patch


transdermal use




Germany


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentrix 100 μ/h Transdermales Pflaster


100 μg/h


transdermal patch


transdermal use




Italy


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm 25 μg/h cerotto transdermico


25 μg/h


transdermal patch


transdermal use




Italy


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm 50 μg/h cerotto transdermico


50 μg/h


transdermal patch


transdermal use




Italy


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm 75 μg/h cerotto transdermico


75 μg/h


transdermal patch


transdermal use




Italy


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanyl Helm 100 μg/h cerotto transdermico


100 μg/h


transdermal patch


transdermal use




Netherlands


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentrix 25 μg/h Pleister voor transderaal gebruik


25 μg/h


transdermal patch


transdermal use




Netherlands


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentrix 50 μg/h Pleister voor transderaal gebruik


50 μg/h


transdermal patch


transdermal use




Netherlands


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentrix 75 μg/h Pleister voor transderaal gebruik


75 μg/h


transdermal patch


transdermal use




Netherlands


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentrix 100 μg/h Pleister voor transderaal gebruik


100 μg/h


transdermal patch


transdermal use




Portugal


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanilo Helm


25 μg/h


transdermal patch


transdermal use




Portugal


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanilo Helm


50 μg/h


transdermal patch


transdermal use




Portugal


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanilo Helm


75 μg/h


transdermal patch


transdermal use




Portugal


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanilo Helm


100 μg/h


transdermal patch


transdermal use




Slovenia


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanil HELM 25 mikrogramov/h transdermalni obliži


25 μg/h


transdermal patch


transdermal use




Slovenia


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanil HELM 50 mikrogramov/h transdermalni obliži


50 μg/h


transdermal patch


transdermal use




Slovenia


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanil HELM 75 mikrogramov/h transdermalni obliži


75 μg/h


transdermal patch


transdermal use




Slovenia


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanil HELM 100 mikrogramov/h transdermalni obliži


100 μg/h


transdermal patch


transdermal use




Spain


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanilo Matrix Helm 25 microgramos/hora parches transdérmicos EFG


25 μg/h


transdermal patch


transdermal use




Spain


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanilo Matrix Helm 50 microgramos/hora parches transdérmicos EFG


50 μg/h


transdermal patch


transdermal use




Spain


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanilo Matrix Helm 75 microgramos/hora parches transdérmicos EFG


75 μg/h


transdermal patch


transdermal use




Spain


 







Helm Pharmaceuticals GmbH




Nordkanalstrasse 28




20097 Hamburg




Germany






Fentanilo Matrix Helm 100 microgramos/hora parches transdérmicos EFG


100 μg/h


transdermal patch


transdermal use







ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


(Invented) name


Strength


Pharmaceutical Form


Route of administration


Content
(concentration)




Austria







AstraZeneca Österreich GmbH,




Schwarzenbergplatz 7




A-1037 Wien




Austria






Optinem i.v. 500 mg - Trockenstechampullen


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20ml




Austria







AstraZeneca Österreich GmbH,




Schwarzenbergplatz 7




A-1037 Wien




Austria






Optinem i.v. 1 g - Trockenstechampullen


1 g


Powder for solution for injection or infusion


Intravenous use


1 g /30 ml




Belgium







NV AstraZeneca SA




Rue Egide Van Ophemstraat 110




1180 Brussel




Belgium






Meronem IV 500 mg


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Belgium







NV AstraZeneca SA




Rue Egide Van Ophemstraat 110




1180 Brussel




Belgium






Meronem IV 1 g


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Bulgaria







AstraZeneca UK Limited




600 Capability Green




Luton LU1 3LU




United Kingdom






Meronem


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Bulgaria







AstraZeneca UK Limited




600 Capability Green




Luton LU1 3LU




United Kingdom






Meronem


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Cyprus







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Cyprus







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Czech Republic







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem


500 mg


Powder for solution for injection


Intravenous use


500 mg/20 ml




Czech Republic







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem


1 g


Powder for solution for injection


Intravenous use


1 g/30 ml




Denmark







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Meronem


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Denmark







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Meronem


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Estonia







AstraZeneca UK Limited




15 Stanhope Gate




London W1K 1LN




United Kingdom






Meronem


500mg


Powder for solution for injection or infusion


Intravenous use


500 mg/10 ml




Estonia







AstraZeneca UK Limited




15 Stanhope Gate




London W1K 1LN




United Kingdom






Meronem


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/20 ml




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Meronem 500 mg


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Meronem 1 g


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




France







AstraZeneca




1, Place Renault




92844 RUEIL-MALMAISON Cédex




France






Meronem
500 mg poudre pour solution injectable IV


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




France







AstraZeneca




1, Place Renault




92844 RUEIL-MALMAISON Cédex




France






Meronem
1 g poudre pour solution injectable IV


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Germany







AstraZeneca GmbH




Tinsdaler Weg 183




22880 Wedel




Germany






Meronem 500 mg


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/10 ml
5 mg / ml




Germany







AstraZeneca GmbH




Tinsdaler Weg 183




22880 Wedel




Germany






Meronem 1 000 mg


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/20 ml
5 mg / ml




Greece







”CANA” SA Pharmaceutical laboratories




446 Irakliou Ave.




14122 Iraklio Attikis




Greece






Meronem


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Greece







”CANA” SA Pharmaceutical laboratories




446 Irakliou Ave




14122 Iraklio Attikis




Greece






Meronem


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Hungary







AstraZeneca Kft.




H-2045 Törökbálint




Park u. 3.




Hungary






Meronem 500 mg intravenas injekcio


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Hungary







AstraZeneca Kft.




H-2045 Törökbálint




Park u. 3.




Hungary






Meronem 1 g intravenas injekcio


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Iceland







AstraZeneca UK Ltd.




Alderley Park




Macclesfield




Cheshire SK10 4TG




United Kingdom






Meronem 500 mg stungulyfs-/innrennslisstofn, lausn.


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Iceland







AstraZeneca UK Ltd.




Alderley Park




Macclesfield




Cheshire SK10 4TG




United Kingdom






Meronem 1 g stungulyfs-/innrennslisstofn, lausn.


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Ireland







AstraZeneca UK Limited




600 Capability Green




Luton




Bedfordshire LU1 3LU




United Kingdom






Meronem IV 0.5 g powder for solution for injection or infusion.


0,5 g


Powder for solution for injection or infusion.


Intravenous use


500 mg/20 ml




Ireland







AstraZeneca UK Limited




600 Capability Green




Luton




Bedfordshire LU1 3LU




United Kingdom






Meronem IV 1 g powder for solution for injection or infusion.


1 g


Powder for solution for injection or infusion.


Intravenous use


1 g/30 ml




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio (MI)




Italy






MERREM


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio (MI)




Italy






MERREM


1 g


Powder for solution for injection or infusion


Intravenous use


1 g




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio (MI)




Italy






MERREM


500 mg


Powder and solvent for solution for injection


Intramuscular use


500 mg/2 ml
(not marketed)




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio (MI)




Italy






MERREM


250 mg


Powder and solvent for solution for injection or infusion


Intravenous use


250 mg/5 ml
(not marketed)




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio (MI)




Italy






MERREM


500 mg


Powder and solvent for solution for injection or infusion


Intravenous use


500 mg/10 ml
(not marketed)




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio (MI)




Italy






MERREM


1 g


Powder and solvent for solution for injection or infusion


Intravenous use


1 g/20 ml
(not marketed)




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio (MI)




Italy






MERREM


250 mg


Powder and solvent for solution for infusion


Intravenous use


250 mg/100 ml
(not marketed)




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio (MI)




Italy






MERREM


500 mg


Powder and solvent for solution for infusion


Intravenous use


500 mg/100 ml
(not marketed)




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio (MI)




Italy






MERREM


1 g


Powder and solvent for solution for infusion


Intravenous use


1 g/100 ml
(not marketed)




Latvia







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem 500 mg


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Latvia







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem 1 g


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Lithuania







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem IV


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/10 ml




Lithuania







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem IV


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/20 ml




Luxembourg







NV AstraZeneca SA




Rue Egide Van Ophemstraat 110




1180 Brussel




Belgium






Meronem IV 500 mg


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Luxembourg







NV AstraZeneca SA




Rue Egide Van Ophemstraat 110




1180 Brussel




Belgium






Meronem IV 1 g


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Malta







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem IV 0,5 g powder for solution for injection or infusion.


0,5 g


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Malta







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem IV 1 g powder for solution for injection or infusion.


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Netherlands







AstraZeneca BV




at the Louis Pasteurlaan 5




2719 EE, Zoetermeer, Netherlands






Meronem i.v.


250 mg


Powder for solution for injection or infusion


Intravenous use


In the process of being cancelled




Netherlands







AstraZeneca BV




at the Louis Pasteurlaan 5




2719 EE, Zoetermeer, Netherlands






Meronem i.v.


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Netherlands







AstraZeneca BV




at the Louis Pasteurlaan 5




2719 EE, Zoetermeer, Netherlands






Meronem i.v.


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Norway







AstraZeneca AS




Hoffsveien 70




B/Postboks 200




Vinderen




0319 OSLO




Norway






Meronem


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Norway







AstraZeneca AS




Hoffsveien 70




B/Postboks 200




Vinderen




0319 OSLO




Norway






Meronem


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Poland







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem


500 mg


Powder for solution for injection


Intravenous use


500 mg/20 ml




Poland







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem


1 g


Powder for solution for injection


Intravenous use


1 g/30 ml




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, n.o 7, Valejas




2745-663 Barcarena, Portugal






Meronem


500 mg


Powder for solution for injection


Intramuscular use


500 mg/2 ml
(not marketed)




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, n.o 7, Valejas




2745-663 Barcarena, Portugal






Meronem


500 mg


Powder for solution infusion


Intravenous use


500 mg/20 ml




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, n.o 7, Valejas




2745-663 Barcarena, Portugal






Meronem


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Romania







AstraZeneca UK Limited




600 Capability Green




Luton




Bedfordshire LU1 3LU




United Kingdom






Meronem i.v. 500 mg


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Romania







AstraZeneca UK Limited




600 Capability Green




Luton




Bedfordshire LU1 3LU




United Kingdom






Meronem i.v. 1 g


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Slovak Republic







AstraZeneca UK Ltd.




Silk Road Business Park 1




Macclesfield




Cheshire SK10 2NA




United Kingdom






Meronem 500 mg i.v.


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Slovenia







AstraZeneca UK Limited




15 Stanhope Gate




London W1K 1LN




United Kingdom






Meronem 500 mg prasek za raztopino za injiciranje ali infundiranje


500 mg


Powder for solution for injection or infusion


Intravenous use


50 mg/ml




Slovenia







AstraZeneca UK Limited




15 Stanhope Gate




London W1K 1LN




United Kingdom






Meronem 1 g prasek za raztopino za injiciranje ali infundiranje


1 g


Powder for solution for injection or infusion


Intravenous use


50 mg/ml




Spain







AstraZeneca Farmacéutica Spain, S.A.




C/ Serrano Galvache




56 Edificio Roble




28033 Madrid




Spain






Meronem I.V., 500


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




Spain







AstraZeneca Farmacéutica Spain, S.A.




C/ Serrano Galvache




56 Edificio Roble




28033 Madrid




Spain






Meronem I.V., 1 000


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml




Sweden







AstraZeneca AB




151 85 Södertälje




Sweden






Meronem


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/10 ml
for injection or variable concentration for infusion




Sweden







AstraZeneca AB




151 85 Södertälje




Sweden






Meronem


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/20 ml
for injection or variable concentration for infusion




United Kingdom







AstraZeneca UK Limited




600 Capability Green




Luton




Bedfordshire LU1 3LU




United Kingdom






Meronem IV 500 mg


500 mg


Powder for solution for injection or infusion


Intravenous use


500 mg/20 ml




United Kingdom







AstraZeneca UK Limited




600 Capability Green




Luton




Bedfordshire LU1 3LU




United Kingdom






Meronem IV 1 g


1 g


Powder for solution for injection or infusion


Intravenous use


1 g/30 ml







ANNEX VII

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


Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Route of administration




Austria







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Pulmotil AC


Oral solution


Tilmicosin 250 mg/ml


Chickens
Turkeys
Pigs
Calves


Oral




Belgium







Eli Lilly Benelux N.V.




Elanco Animal Health




Rue del’Etuve 52-Bte




1Stoofstraat 52




1000 Brussel




Belgium






Pulmotil AC


Oral solution


Tilmicosin 250 mg/ml


Chickens
Turkeys
Pigs
Calves


Oral




Cyprus







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil AC


Oral solution


Tilmicosin
250 mg/ml


Chickens
Pigs


Oral




Czech Republic







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil AC sol. ad us. vet.


Oral solution


Tilmicosin
250 mg/ml


Chickens (broilers)
Pigs
Calves


Oral




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




Germany






Pulmotil AC


Oral solution


Tilmicosin 250 mg/ml


Cattle (calves)
Pigs for fattening
Chickens


Oral




Greece







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil AC


Oral solution


Tilmicosin 250 mg/ml


Chickens
Turkeys
Pigs
Calves


Oral




Spain







Elanco Valquímica, S.A.




Avenida de la Industría, 30




28108 – Alcobendas




Madrid




Spain






PULMOTIL AC


Oral solution


Tilmicosin 250 mg/ml


Pigs
Poultry (except laying hens)
Turkeys
Cattle


Oral




France







Lilly France SA




Départament Elanco Santé Animale




13 Rue Pagès




92158 Suresnes Cedex




France






PULMOTIL AC


Oral solution


Tilmicosin 250 mg/ml


Pigs
Calves
Chickens
Turkeys


Oral




Hungary







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil AC oral solution


Oral solution


Tilmicosin 250 mg/ml


Cattle (calf)
Pigs
Chickens
Turkeys


Oral




Ireland







Elanco Animal Health




Eli Lilly and Company Ltd




Priestley Road




Basingstoke




Hampshire




RG24 9NL




United Kingdom






Pulmotil AC


Oral Solution


Tilmicosin 250 mg/ml


Chicken
Turkeys
Pigs


Oral




United Kingdom







Elanco Animal Health




Eli Lilly and Company Ltd




Priestley Road




Basingstoke




Hampshire




RG24 9NL




United Kingdom






Pulmotil AC


Oral solution


Tilmicosin 250 mg/ml


Chickens
Turkeys


Oral




Italy







Eli Lilly Italia




Elanco Animal Health




Via A. Gramsci, 731-733




50019 Sesto Fiorentino




Florence




Italia






Pulmotil AC


Oral Solution


Tilmicosin 250 mg/ml


Chickens
Turkeys
Pigs
Calves


Oral




Luxembourg







Eli Lilly Benelux N.V.




Elanco Animal Health




Rue del’Etuve 52-Bte




1Stoofstraat 52




1000 Brussel




Belgium






Pulmotil AC


Oral Solution


Tilmicosin 250 mg/ml


Chickens
Turkeys
Pigs
Calves


Oral




The Netherlands







Eli Lilly Nederland B.V.




Elanco Animal Health




Grootslag 1-5




3991 RA Houten




The Netherlands






Pulmotil AC


Oral solution


Tilmicosin 250 mg/ml


Chicken
Turkey
Pig
Calves


Oral




Portugal







Lilly Portugal - Produtos Farmacêuticos, Lda




Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,




Miraflores 1495-016 Algés




Portugal






Pulmotil AC


Oral Solution


Tilmicosin 250 mg/ml


Chickens
Turkeys
Pigs
Calves


Oral




Poland







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil AC


Oral solution


Tilmicosin 250 mg/ml


Chickens
Pigs
Calves


Oral




Slovak Republic







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil AC


Oral solution


Tilmicosin 250 mg/ml


Chickens
Pigs
Calves


Oral




Romania







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil AC


Oral solution


Tilmicosin 250 mg/ml


Pigs
Broilers
Calves


Oral







ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATE


40 g tilmicosin per 1 000 g












Member State


Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Route of administration




Belgium







Eli Lilly Benelux N.V.




Elanco Animal Health




Rue de l’Etuve 52




Stoofstraat 52




1000 Brussel




Belgium






Pulmotil 40 VET Premix


Premix for medicated feeding stuff


40 g tilmicosin per 1 000 g


Pigs


Oral




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




Germany






Pulmotil G 40 AMV


Premix for medicated feeding stuff


40 g tilmicosin per 1 000 g


Pigs


Oral




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




Germany






Pulmotil G 40 Granulat


Premix for medicated feeding stuff


40 g tilmicosin per 1 000 g


Pigs


Oral




Denmark







Eli Lilly Danmark A/S




Elanco Animal Health




Nybrovej 110




2800 Lyngby




Denmark






Pulmotil Vet


Premix for medicated feeding stuff


40 g tilmicosin per 1 000 g


Pigs


Oral




Spain







Elanco Valquímica, S.A.




Avenida de la Industría, 30




28108 – Alcobendas




Madrid




Spain






PULMOTIL 40


Premix for medicated feeding stuff


40 g tilmicosin per 1 000 g


Pigs


Oral




France







Lilly France SA




Départament Elanco Santé Animale




13 Rue Pagès




92158 Suresnes Cedex




France






Pulmotil Tilmicosine 40 Porcins


Premix for medicated feeding stuff


40 g tilmicosin per 1 000 g


Pigs


Oral




Ireland







Elanco Animal Health




Eli Lilly and Company Ltd




Priestley Road




Basingstoke




Hampshire




RG24 9NL




United Kingdom






Pulmotil G40 Premix


Premix for medicated feeding stuff


40 g tilmicosin per 1 000 g


Pigs


Oral




The Netherlands







Eli Lilly Nederland B.V.




Elanco Animal Health




Grootslag 1-5




3991 RA Houten




The Netherlands






Pulmotil G40 premix


Premix for medicated feeding stuff


40 g tilmicosin per 1 000 g


Pigs


Oral




Portugal







Lilly Portugal — Produtos Farmacêuticos, Lda




Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,




Miraflores 1495-016 Algés




Portugal






PULMOTIL G40 Pré Mistura para alimento medicamentoso


Premix for medicated feeding stuff


40 g tilmicosin per 1 000 g


Pigs


Oral








100 g tilmicosin per 1 000 g












Member State


Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Route of administration




Austria







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






PULMOTIL Prämix 10 % — Granulat für Schweine


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Belgium







Eli Lilly Benelux N.V.




Elanco Animal Health




Rue de l’Etuve 52




Stoofstraat 52




1000 Brussel




Belgium






Pulmotil 100 VET Premix


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Belgium







Eli Lilly Benelux N.V.




Elanco Animal Health




Rue de l’Etuve 52-Bte




Stoofstraat 52




1000 Brussel




Belgium






Pulmotil 100 Granules


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




Germany






Pulmotil G 100 AMV


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




Germany






Pulmotil G 100


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Denmark







Eli Lilly Danmark A/S




Elanco Animal Health




Nybrovej 110




2800 Lyngby




Denmark






Pulmotil Vet


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Denmark







Eli Lilly Danmark A/S




Elanco Animal Health




Nybrovej 110




2800 Lyngby




Denmark






Pulmotil Vet Oralt pulver


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Spain







Elanco Valquímica, S.A.




Avenida de la Industría, 30




28108 – Alcobendas




Madrid




Spain






PULMOTIL 100


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Ireland







Elanco Animal Health




Eli Lilly and Company Ltd




Priestley Road




Basingstoke




Hampshire




RG24 9NL




United Kingdom






Pulmotil G100 Premix


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Italy







Eli Lilly Italia




Elanco Animal Health




Via A. Gramsci, 731-733




50019 Sesto Fiorentino




Florence




Italia






PULMOTIL G100 PREMIX


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Luxembourg







Eli Lilly Benelux N.V.




Elanco Animal Health




Rue del’Etuve 52-Bte




1Stoofstraat 52




1000 Brussel




Belgium






Pulmotil 100 Vet Premix


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




The Netherlands







Eli Lilly Nederland B.V.




Elanco Animal Health




Grootslag 1-5




3991 RA Houten




The Netherlands






Pulmotil G100 premix


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




Portugal







Lilly Portugal — Produtos Farmacêuticos, Lda




Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,




Miraflores 1495-016 Algés




Portugal






PULMOTIL G100 Pré Mistura para alimento medicamentoso


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral




United Kingdom







Elanco Animal Health




Eli Lilly and Company Ltd




Priestley Road




Basingstoke




Hampshire




RG24 9NL




United Kingdom






Pulmotil G100 Premix


Premix for medicated feeding stuff


100 g tilmicosin per 1 000 g


Pigs


Oral








200 g tilmicosin per 1 000 g












Member State


Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Route of administration




Austria







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Pulmotil Prämix 20 %


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs, Rabbit


Oral




Belgium







Eli Lilly Benelux N.V.




Elanco Animal Health




Rue de l’Etuve 52




Stoofstraat 52




1000 Brussel




Belgium






Pulmotil 200 VET Premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs, Rabbits


Oral




Czech Republic







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






PULMOTIL 200 prm. ad us. vet.


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Cyprus







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil G200
Premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




Germany






Pulmotil G 20 % AMV


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




Germany






Pulmotil G 20 %


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Denmark







Eli Lilly Danmark A/S




Elanco Animal Health




Nybrovej 110




2800 Lyngby




Denmark






Pulmotil Vet


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Greece







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil 200 medicated premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Spain







Elanco Valquímica, S.A.




Avenida de la Industría, 30




28108 – Alcobendas




Madrid




Spain






PULMOTIL 200


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Hungary







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil G 200 premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Ireland







Elanco Animal Health




Eli Lilly and Company Ltd




Priestley Road




Basingstoke




Hampshire




RG24 9NL




United Kingdom






Pulmotil G200 Premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Italy







Eli Lilly Italia




Elanco Animal Health




Via A. Gramsci, 731-733




50019 Sesto Fiorentino




Florence




Italia






PULMOTIL G200 PREMIX


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs, Rabbits


Oral




Latvia







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil 200 premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Luxembourg







Eli Lilly Benelux N.V.




Elanco Animal Health




Rue del’Etuve 52-Bte




1Stoofstraat 52




1000 Brussel




Belgium






Pulmotil 200 Vet Premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs, Rabbits


Oral




The Netherlands







Eli Lilly Nederland B.V.




Elanco Animal Health




Grootslag 1-5




3991 RA Houten




The Netherlands






Pulmotil G200 premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Poland







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmontil 200


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Portugal







Lilly Portugal — Produtos Farmacêuticos, Lda




Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,




Miraflores 1495-016 Algés




Portugal






PULMOTIL G200 Pré Mistura para alimento medicamentoso


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Romania







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






Pulmotil 200 Vet Premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral




Slovak Republic







Eli Lilly Regional Operation Ges.m.b.H.




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




Austria






PULMOTIL G 200


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Fattening pigs


Oral




United Kingdom







Elanco Animal Health




Eli Lilly and Company Ltd




Priestley Road




Basingstoke




Hampshire




RG24 9NL




United Kingdom






Pulmotil G200 Premix


Premix for medicated feeding stuff


200 g tilmicosin per 1 000 g


Pigs


Oral







ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND











Member State


Marketing Authorisation Holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria


CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna


Aulin 100 mg - Tabletten


100 mg


Tablet


oral use




Austria


CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna


Aulin 100 mg - Granulat


100 mg


Granules for oral suspension


oral use




Austria


CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna


Aulin 100 mg - Suppositorien


100 mg


Suppository


rectal use




Austria


CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna


Aulin 200 mg - Suppositorien


200 mg


Suppository


rectal use




Austria


CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna


Mesulid 100 mg - Tabletten


100 mg


Tablet


oral use




Austria


CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna


Mesulid 100 mg - Granulat


100 mg


Granules for oral suspension


oral use




Austria


CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna


Mesulid 100 mg - Suppositirien


100 mg


Suppository


rectal use




Austria


CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna


Mesulid 200 mg - Suppositorien


200 mg


Suppository


rectal use




Belgium







THERABEL PHARMA S.A.,




Rue E.Van Ophem, 108 B-1180 Uccle






AULIN 100 MG


100 mg


Tablet


oral use




Belgium







THERABEL PHARMA S.A.,




Rue E.Van Ophem, 108 B-1180 Uccle






AULIN 100 MG


100 mg


Granules for oral suspension


oral use




Belgium







THERABEL PHARMA S.A.,




Rue E.Van Ophem, 108 B-1180 Uccle






MESULID


100 mg


Granules for oral suspension


oral use




Belgium







THERABEL PHARMA S.A.,




Rue E.Van Ophem, 108 B-1180 Uccle






MESULID 100 MG


100 mg


Tablet


oral use




Bulgaria


Tchaika Pharma Sofia 1172 1, G. M. Dimitrov Blvd


AllGone


100 mg


Effervescent tablet


oral use




Bulgaria


Sopharma Sofia 122016, Iliensko shosse


Ameolin


100 mg


Tablet


oral use




Bulgaria


CSC Pharmaceuticals Sofia 159210, Assen Jordanov street


 


100 mg


Tablet


oral use




Bulgaria


CSC Pharmaceuticals Sofia 159210, Assen Jordanov street


Aulin 100


100 mg


Granules


oral use




Bulgaria


Inbioteh Sofia 1000 5, Triaditza street ‘Sofia palace’


Biolin


100 mg


Tablet


oral use




Bulgaria


ZentivaSofia 140725, N.Vaptzarov Blvd


Coxtral


100 mg


Tablet


oral use




Bulgaria


Actavis Sofia 1000 2, Kniaginia Maria Luisa Blvd


Enetra


100 mg


Tablet


oral use




Bulgaria


Medochemie Sofia 111320, Fr. Jolio Currie street


Aponil


100 mg


Tablet


oral use




Bulgaria


CSC Pharmaceuticals Sofia 159210, Assen Jordanov street


Nimed


100 mg


Tablet


oral use




Bulgaria


Laboratori Guidotti S.p.A.(Menarini Group) Sofia 111317, Kosta Lultchev street


Nimesil


100 mg


Granules


oral use




CZ - Czech Republic







MEDICOM INTERNATIONAL S.R.O.,




Páteřní 7




635 00 Brno, Czech Republic






AULIN


100 mg


Granules for oral solution


Oral use




CZ - Czech Republic







MEDICOM INTERNATIONAL S.R.O.,




Páteřní 7




635 00 Brno, Czech Republic






AULIN


100 mg


Tablet


Oral use




CZ - Czech Republic







ZENTIVA, a.s.




Empiria Palace




Na strži 63




140 62 Praha 4, Czech Republic






COXTRAL 100 MG TABLETY


100 mg


Tablet


Oral use




CZ - Czech Republic


CSC Pharmaceuticals Handels GmbH Gewerbestrasse 18-20 A-2102 Bisamberg, Austria


MESULID


100 mg


Granules for oral solution


Oral use




CZ - Czech Republic







MEDICOM INTERNATIONAL S.R.O.,




Páteřní 7




635 00 Brno, Czech Republic






NIMED


100 mg


Tablet


Oral use




CZ - Czech Republic







LABORATORI GUIDOTTI S.p.A., Via Livornese 897,




I - 56010 La Vettola, PISA, Italy






NIMESIL


100 mg


Granules for oral suspension


Oral use




Cyprus


MEDOCHEMIE LTD, POBOX 51409, 3505 LEMESOS, CYPRUS


APONIL


100 mg


Tablet


ORAL




Cyprus


CDL PHARMACEUTICAL LTD, POBOX 40981, 6308 LARNACA, CYPRUS


ELINAP


100 mg


Tablet


ORAL




Cyprus


CHR. K. UNIMED LTD, 21 DAVLOU, PLATI, 2114 AGLANTZIA, LEFKOSIA, CYPRUS


FLOGOSTOP


100 mg


Tablet


ORAL




Cyprus


PT HADJIGEORGIOU CO LTD, POBOX 53158, 3301 LEMESOS, CYPRUS


NIMELIDE


100 mg


Tablet


ORAL




Cyprus


CODAL SYNTO LTD, POBOX 51785, 3508 LEMESOS, CYPRUS


NIMM


100 mg


Tablet


ORAL




Cyprus


THE STAR MEDICINES IMPORTERS & CO LTD, POBOX 50151, 3601 LEMESOS, CYPRUS


RITAMINE


100 mg


Tablet


ORAL




Cyprus


COSMED HOLDINGS LTD, P.O.BOX 42145, 6531 LARNACA, CYPRUS


SPECILID


100 mg


Tablet


ORAL




Estonia







Zentiva a.s. U Kabelovny 130




Dolni Mecholupy




102 37 Praque 10






COXTRAL


100 mg


Tablet


oral use




France







THERABEL LUCIEN PHARMA




123 rue Jules Guesde




92309 LEVALLOIS-PERRET Cedex




France






NEXEN


100 mg


Tablet


Oral




France







THERABEL LUCIEN PHARMA




123 rue Jules Guesde




92309 LEVALLOIS-PERRET Cedex




France






NEXEN


100 mg


Granules for oral solution


Oral




France







HELSINN BIREX PHARMACEUTICALS Ltd




Damastown Mulhuddart




DUBLIN 15




IRELAND






OXETIAN


100 mg


Tablet


Oral




France







HELSINN BIREX PHARMACEUTICALS Ltd




Damastown Mulhuddart




DUBLIN 15




IRELAND






OXETIAN


100 mg


Granules for oral solution


Oral




Greece







BOEHRINGER INGELHEIM HELLAS S.A.




5TH Km PAEANIAS-MARKOPOULO AVENUE




KOROPI, ATTIKIS, 19400






MESULID


100 mg


Tablet


ORAL




Greece







BOEHRINGER INGELHEIM HELLAS S.A.




5TH Km PAEANIAS-MARKOPOULO AVENUE




KOROPI, ATTIKIS, 19400






MESULID


200 mg


Suppository


RECTAL




Greece







BOEHRINGER INGELHEIM HELLAS S.A.




5TH Km PAEANIAS-MARKOPOULO AVENUE




KOROPI, ATTIKIS, 19400






MESULID


100 mg


Granules for oral solution


ORAL




Greece







FARMEDIA A.E.




ATHINAS 22 & APOLLONOS




GERAKAS, ATTIKIS, 15344






MULTIFORMIL


100 mg


Tablet


ORAL




Greece







PHARMATHEN INTERNATIONAL S.A. GREECE,




DERVENAKIWN 4, PALLINI, ATTIKIS 15351






BIOXIDOL


100 mg


Tablet


ORAL




Greece







ALET PHARMACEUTICALS




M. ALEXANDER 121, AGIA VARVARA, 12351






SPECILID


100 mg


Tablet


ORAL




Greece







BIOSPRAY ABEE




18TH Km MARATHONOS AVENUE, PALLINI, 15344






FLOGOSTOP


100 mg


Tablet


ORAL




Greece







BIOMEDICA-CHEMICA A.E.




G. LYRA 25, KATW KIFISSIA






NIMESULIDE/BIOMEDICA CHEMICA


100 mg


Tablet


ORAL




Greece







LEOVAN, M. LEWN & SIA EE




ARGONAFTWN 22, ARGYROUPOLI, 16452






RISTOLZIT


100 mg


Tablet


ORAL




Greece







NORMA HELLAS A.E.




MENANDROU 54, ATHENS, 10431






MYXINA


100 mg


Tablet


ORAL




Greece







GENEPHARM A.E.




18TH Km MARATHONOS AVENUE, PALLINI, ATTIKIS, 15351






NIMELIDE


100 mg


Tablet


ORAL




Greece







BROS EPE




AVGIS & GALLINIS 15, N. KIFISSIA






DISCORID


100 mg


Tablet


ORAL




Greece







RAFARM AEBE




KORINTHOU 12, N. PSYCHIKO, 15451






VENTOR


100 mg


Tablet


ORAL




Greece







RAFARM AEBE




KORINTHOU 12, N. PSYCHIKO, 15451






VENTOR


100 mg


Granules for oral solution


ORAL




Greece







ARMEDICA A.E.




AGIAS MARKELLIS 17, ATHENS, 11855






ALENCAST


100 mg


Tablet


ORAL




Greece







GAP A.E.




AGISILAOU 46, AGIOS DIMITRIOS, 17341






G-REVM


100 mg


Tablet


ORAL




Greece







VIOFAR EPE




ETHNIKIS ANTISTASEOS & TRIFYLLIAS, AHARNAI, 13671






VOLONTEN


100 mg


Tablet


ORAL




Greece







KLEVA EPE




PARNITHOS AVENUE 189,




AHARNAI, ATTIKIS, 13671






ELINAP


100 mg


Powder for oral solution


ORAL




Greece







KLEVA EPE




PARNITHOS AVENUE 189,




AHARNAI, ATTIKIS, 13671






ELINAP


100 mg


Tablet


ORAL




Greece







MINERVA PHARMAKEFTIKI A.E.




KIFISSOU AVENUE 132, PERISTERI, 12131






MIN-A-PON


100 mg


Tablet


ORAL




Greece







ANFARM HELLAS A.E.




K. PALEOLOGOU & PERIKLEOUS 27, HALANDRI, 15232






LEMESIL


100 mg


Tablet


ORAL




Greece







ELPEN A.E. PHARMACEUTICAL INDUSTRY,




MARATHONOS AVENUE 95, PIKERMI, 19009






ROLAKET


100 mg


Tablet


ORAL




Greece







ELPEN A.E. PHARMACEUTICAL INDUSTRY,




MARATHONOS AVENUE 95, PIKERMI, 19009






ROLAKET


200 mg


Suppository


RECTAL




Greece







ANTOR EPE




P. MAVROMIHALI 1, VRILISSIA, 15235






MELIMONT


100 mg


Tablet


ORAL




Greece







HELP ABEE




VALAORITOU 10, METAMORFOSI, ATTIKIS, 14452






MOSUOLIT


100 mg


Tablet


ORAL




Greece







FINIXFARM EPE




DERVENAKION 38 & SAHINI, GERAKAS, 15344






KARTAL


100 mg


Tablet


ORAL




Greece







PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS




DILOU 9, PERISTERI, ATTIKIS, 12134






FLADALGIN


100 mg


Tablet


ORAL




Greece







REMEK PHARMACEUTICALS ABEE




PENTELIS 34, PALAIO FALIRO, ATTIKIS, 17564






MESUPON


100 mg


Tablet


ORAL




Greece







FARMANIC CHEMIPHARMA S.A.




FYLIS 137, KAMATERO, ATTIKIS, 13451






CHEMISULIDE


100 mg


Tablet


ORAL




Greece







REMEDINA ABEE




GOUNARI 25 & AREOS, KAMATERO, ATTIKIS, 13451






AMOCETIN


100 mg


Tablet


ORAL




Greece







COSMOPHARM EPE




P.O. BOX 42, KORINTHOS, 20100






LIZEPAT


100 mg


Tablet


ORAL




Greece







DEMO ABEE




21ST Km NATIONAL HIGHWAY ATHENS-LAMIA, 14565






RITAMINE


100 mg


Tablet


ORAL




Greece







BALU EPE




30 Km ATHENS-LAVRION, MARKOPOULO






NIBERAN


100 mg


Tablet


ORAL




Greece







SANDOZ GMBH, KUNDL, AUSTRIA




BIOCHEMIESTRASSE 10, A-6250, KUNDL AUSTRIA






NIMESULIDE / HEXAL


100 mg


Tablet


ORAL




Greece







SANDOZ GMBH, KUNDL, AUSTRIA




BIOCHEMIESTRASSE 10, A-6250, KUNDL AUSTRIA






NIMESULIDE / HEXAL


100 mg


Powder for oral solution


ORAL




Greece







VELKA HELLAS AEBE




KAPODISTRIOU & KORINTHOU 12, NEO PSYCHIKO, 15451






NAOFID


100 mg


Tablet


ORAL




Greece







DOCTUM A.E. K.T. GIOKARIS & SIA




1 Km PAEANIAS-MARKOPOULOU AVENUE, PAEANIA, ATTIKIS, 19002






ERLECIT


100 mg


Tablet


ORAL




Greece







VOCATE PHARMAKEFTIKI A.E.




GOUNARI 150, GLYFADA, 16674






TRANZICALM


100 mg


Tablet


ORAL




Greece







MEDICHROM A.E.




6 Km MARKOPOULOU-KOROPI AVENUE, MARKOPOULO, MESOGEION, 19003






NIMESUL


100 mg


Tablet


ORAL




Greece







FARAN ABEE




PRODUCTION AND TRADING MEDICINES




AVEROF 19A, ATHENS, 10433






AFLOGEN


100 mg


Tablet


ORAL




Greece







GEROLYMATOS P.N. AEBE




ASKLEPIOU, KRYONERI, ATTIKIS






EDRIGYL


100 mg


Tablet


ORAL




Greece







GEROLYMATOS P.N. AEBE




ASKLEPIOU, KRYONERI, ATTIKIS






EDRIGYL


100 mg


Granules for oral solution


ORAL




Greece







GEROLYMATOS P.N. AEBE




ASKLEPIOU, KRYONERI, ATTIKIS






EDRIGYL


200 mg


Suppository


RECTAL




Greece







S.J.A. PHARM O.E.




ARKOLEON 11, KATO PATISSIA, 10445






CLIOVYL


100 mg


Tablet


ORAL




Greece







COUP ABEE




AGIAS VARVARAS 53-55, DAFNI, ATHENS, 17235






MELICAT


100 mg


Tablet


ORAL




Greece







PHARMACYPRIA HELLAS A.E.




PASTER 6, AMPELOKIPOI, 11521






LALIDE


100 mg


Tablet


ORAL




Greece







PHARMACYPRIA HELLAS A.E.




PASTER 6, AMPELOKIPOI, 11521






LALIDE


50 mg /5 ml


Oral suspension


ORAL




Greece







INTERMED ABEE




KALYFTAKI 27, ATHENS






DOLOSTOP


100 mg


Tablet


ORAL




Greece







INTERMED ABEE




KALYFTAKI 27, ATHENS






DOLOSTOP


100 mg


Effervescent tablets


ORAL




Greece







INTERMED ABEE




KALYFTAKI 27, ATHENS






DOLOSTOP


100 mg


Granules for oral solution


ORAL




Greece







INTERMED ABEE




KALYFTAKI 27, ATHENS






DOLOSTOP


200 mg


Suppository


RECTAL




Greece







EVAGGELOS KALOFOLIAS & SIA O.E.




MENANDROU 54, ATHENS, 10431






ALGOVER


100 mg


Tablet


ORAL




Greece







FARMILIA E.E.




FAVIEROU 48, ATHENS






AUROMELID


100 mg


Tablet


ORAL




Greece







AURORA PHARMACEUTICALS EPE




EVROU & MESSINIAS, GERAKAS, 15344






SUDINET


100 mg


Tablet


ORAL




Greece







LEOVAN M. LEON & SIA E.E.




ARGONAFTON 22, ARGYROUPOLI, 16452






LASAZIN


100 mg


Tablet


ORAL




Greece







PHARMACHEM EPE




YMITOU 73, VRILISSIA, ATTIKIS, 15235






NIMESULIDE / PHARMACHEM


100 mg


Tablet


ORAL




Greece







ANTONIOS POLYCHRONIS OF MARINOU




IONIAS 29, NEO PSYCHIKO, 15451






OMNIBUS


100 mg


Tablet


ORAL




Greece







ZWITTER PHARMACEUTICALS EPE, GREECE




PENTELIS AVENUE 34-36, ATHENS, 15234






RHEMID


100 mg


Tablet


ORAL




Greece







MED-ONE S.A., HELLAS




PARNITHOS AVENUE 211, AHARNAI, 13671






ALGOSULID


100 mg


Tablet


ORAL




Greece







MED-ONE S.A., HELLAS




PARNITHOS AVENUE 211, AHARNAI, 13671






ALGOSULID


100 mg


Powder for oral solution


ORAL




Greece







LAMDA PHARMAKEFTIKI A.E.




EVRIPIDOU 18, ATHENS, 10559






NIMESORAL


100 mg


Tablet


ORAL




Greece







MEDARTE FARMAKEFTIKI ABEE




SPYROU VRETTOU 10, METAMORFOSI, 14452






NIMESULIDE / MEDICON


100 mg


Tablet


ORAL




Greece







FARMAMUST EPE




PANTAZOPOULOU SQUARE 7, KOLONOS, ATTIKIS, 10443






LOVIREM


100 mg


Tablet


ORAL




Greece







B.I. FARMA A.E.




ARISTOTELOUS 79-81, ATHENS, 10434






NIMESULIDE / B.I. FARMA


100 mg


Tablet


ORAL




Greece







LAVIPHARM HELLAS A.E.




AGIAS MARINAS, PAEANIA, ATTIKIS, 19002






AULIN


100 mg


Tablet


ORAL




Greece







LAVIPHARM HELLAS A.E.




AGIAS MARINAS, PAEANIA, ATTIKIS, 19002






AULIN


200 mg


Suppository


RECTAL




Greece







LAVIPHARM HELLAS A.E.




AGIAS MARINAS, PAEANIA, ATTIKIS, 19002






AULIN


100 mg


Granules for oral solution


ORAL




Hungary


Chinoin Zrt.1045 Budapest, Tó u.1-5


Winsulid


100 mg


Granules


oral




Hungary


Chinoin Zrt.1045 Budapest, Tó u.1-5


Winsulid


100 mg


Tablet


oral




Hungary


Sanofi-Aventis 1045 Budapest, Tó u.1-5


Mesulid


100 mg


Granules


oral




Hungary


Sanofi-Aventis 1045 Budapest, Tó u.1-5


Mesulid


100 mg


Tablet


oral




Hungary


PannonPharma Gyógyszergyártó Kft. 1016 Budapest Derék u.2


Nimelid


100 mg


Tablet


oral




Hungary


Eurodrug Lab.BV 4032 Debrecen,Bartha Boldizsár u. 7


Nidol


100 mg


Tablet


oral




Hungary


Lab.Guidotti S.p.A. 2040 Budaörs,Terrapark, Neumann János u.1/B tömb, D ép


Xilox


100 mg


Granules


oral




Ireland


Helsinn Birex Pharm. Ltd. Damastown Mulhuddart Dublin 15 Ireland


Aulin


100 mg


Tablet


Oral




Ireland


Helsinn Birex Pharm. Ltd. Damastown Mulhuddart Dublin 15 Ireland


Aulin


100 mg


Granules


Oral




Ireland


Helsinn Birex Therapeutics Ltd. Damastown Mulhuddart Dublin 15 Ireland


Mesulid


100 mg


Tablet


Oral




Ireland


Helsinn Birex Therapeutics Ltd. Damastown Mulhuddart Dublin 15 Ireland


Mesulid


100 mg


Granules


Oral




Ireland


Pinewood Laboratories Ltd Ballymacarbry Clonmel Co. Tipperary Ireland


Mesine


100 mg


Tablet


Oral




Ireland


PCO Manufacturing Ltd. Unit 222 Western Industrial Estate, Naas Road, Dublin 12 Ireland


Aulin


100 mg


Tablet


Oral




Ireland


B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, United Kingdom


Aulin


100 mg


Granules


Oral




Ireland


B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, United Kingdom


Aulin


100 mg


Tablet


Oral




Italy


FRANCIA FARMAC.IND.FAR.BIO.SRL VIA DEI PESTAGALLI, 7 20138 MILANO


ALGIMESIL


100 mg


Granules


oral use




Italy


FRANCIA FARMAC.IND.FAR.BIO.SRL VIA DEI PESTAGALLI, 7 20138 MILANO


ALGIMESIL


100 mg


Tablet


oral use




Italy


SIAR PHARMA Srl, VIA VERDI 33, 20060 BUSSERO


ALGOLIDER


100 mg


Granules


oral use




Italy


SIAR PHARMA Srl, VIA VERDI 33, 20060 BUSSERO


ALGOLIDER


100 mg


Tablet


oral use




Italy


SELVI LABORAT.BIOTERAPICO SpA, VIA PROCOIO, 28, 00065 FIANO ROMANO


ANTALGO


100 mg


Granules


oral use




Italy


ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA


AREUMA


200 mg


Suppository


rectal use




Italy


ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA


AREUMA


100 mg


Granules


oral use




Italy


ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA


AREUMA


100 mg


Tablet


oral use




Italy


ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO


AULIN


200 mg


Suppository


rectal use




Italy


ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO


AULIN


100 mg


Granules


oral use




Italy


ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO


AULIN


100 mg


Tablet


oral use




Italy


ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO


AULIN BETA


400 mg


Granules


oral use




Italy


ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO


AULIN BETA


400 mg


Tablet


oral use




Italy


ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO


AULIN MITE


50 mg


Granules


oral use




Italy


AGIPS FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO


DELFOS


100 mg


Granules


oral use




Italy


AGIPS FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO


DELFOS


100 mg


Tablet


oral use




Italy


SARDA PHARMACEUTICA Srl, VIA CASTIGLIONE 92/B 09100 CAGLIARI


DIMESUL


100 mg


Granules


oral use




Italy


SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA


DOMES


100 mg


Granules


oral use




Italy


SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA


DOMES


100 mg


Tablet


oral use




Italy


SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA


DOMES


100 mg


Orodispersible tablet


oral use




Italy


SIFI SpA, VIA ERCOLE PATTI 36, 95020 LAVINAIO - ACI S.ANTONIO


EDEMAX


100 mg


Granules


oral use




Italy


SIFI SpA, VIA ERCOLE PATTI 36, 95020 LAVINAIO - ACI S.ANTONIO


EDEMAX


100 mg


Tablet


oral use




Italy


AESCULAPIUS FARMACEUTICI Srl,VIA COZZAGLIO, 24, 25125 BRESCIA


EFRIDOL


100 mg


Granules


oral use




Italy


AESCULAPIUS FARMACEUTICI Srl,VIA COZZAGLIO, 24, 25125 BRESCIA


EFRIDOL


100 mg


Tablet


oral use




Italy


I.B.N. SAVIO Srl, VIA E.BAZZANO, 14, 16019 RONCO SCRIVIA


EUDOLENE


100 mg


Granules


oral use




Italy


NCSN FARMACEUTICI Srl, VIA SVETONIO, 6, 00136 ROMA


FANSIDOL


100 mg


Granules


oral use




Italy


NCSN FARMACEUTICI Srl, VIA SVETONIO, 6, 00136 ROMA


FANSIDOL


100 mg


Capsule


oral use




Italy


SOFAR SpA, VIA ISONZO, 8, 20100 MILANO


FANSULIDE


100 mg


Granules


oral use




Italy


SOFAR SpA, VIA ISONZO, 8, 20100 MILANO


FANSULIDE


100 mg


Tablet


oral use




Italy


PRODOTTI FORMENTI Srl, VIA CORREGGIO, 43, 20149 MILANO


FLAMINIDE


100 mg


Granules


oral use




Italy


PRODOTTI FORMENTI Srl, VIA CORREGGIO, 43, 20149 MILANO


FLAMINIDE


100 mg


Tablet


oral use




Italy


C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO


FLOLID


100 mg


Suppository


rectal use




Italy


C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO


FLOLID


100 mg


Granules


oral use




Italy


C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO


FLOLID


100 mg


Tablet


oral use




Italy


ALMUS Srl, VIA CESAREA, 11/10, 16121 GENOVA


IDEALID


100 mg


Tablet


oral use




Italy


MAGIS FARMACEUTICI SpA, VIA CACCIAMALI, 34-36-38/B, 25125 BRESCIA


ISODOL


100 mg


Granules


oral use




Italy


MAGIS FARMACEUTICI SpA, VIA CACCIAMALI, 34-36-38/B, 25125 BRESCIA


ISODOL


100 mg


Tablet


oral use




Italy


BONISCONTRO & GAZZONE Srl, VIA PAVIA,6, 20136 MILANO


LEDOREN


100 mg


Granules


oral use




Italy


BONISCONTRO & GAZZONE Srl, VIA PAVIA,6, 20136 MILANO


LEDOREN


100 mg


Tablet


oral use




Italy


ALTA CARE LAB.ITALIA Srl, VIALE DELLE MILIZIE, 134, 00192 ROMA


LIDERSOLV


100 mg


Granules


oral use




Italy


ALTA CARE LAB.ITALIA Srl, VIALE DELLE MILIZIE, 134, 00192 ROMA


LIDERSOLV


100 mg


Tablet


oral use




Italy


HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO


MESULID


200 mg


Suppository


rectal use




Italy


HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO


MESULID


100 mg


Granules


oral use




Italy


HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO


MESULID


100 mg


Tablet


oral use




Italy


HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO


MESULID FAST


400 mg


Granules


oral use




Italy


HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO


MESULID MITE


50 mg


Granules


oral use




Italy


NEW RESEARCH Srl, V.DELLA TENUTA DI TORRENOVA142, 00133 ROMA


NERELID


100 mg


Granules


oral use




Italy


NEW RESEARCH Srl, V.DELLA TENUTA DI TORRENOVA142, 00133 ROMA


NERELID


100 mg


Capsule


oral use




Italy


I.BIR.N Srl Ist.Biot.Nazionale, VIA VITTORIO GRASSI, 9/15, 00155 ROMA


NIDE


100 mg


Granules


oral use




Italy


I.BIR.N Srl Ist.Biot.Nazionale, VIA VITTORIO GRASSI, 9/15, 00155 ROMA


NIDE


100 mg


Capsule


oral use




Italy


MOLTENI & C. F.LLI ALITTI SpA, STR.STATALE 67, LOC.GRANATIERI, 50018 SCANDICCI


NIDEMOL


200 mg


Suppository


rectal use




Italy


MOLTENI & C. F.LLI ALITTI SpA, STR.STATALE 67, LOC.GRANATIERI, 50018 SCANDICCI


NIDEMOL


100 mg


Granules


oral use




Italy


ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO


NIMEDEX


400 mg


Granules


oral use




Italy


ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO


NIMEDEX


400 mg


Tablet


oral use




Italy


ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO


NIMEDEX


400 mg


Granules


oral use




Italy


KRUGHER PHARMA Srl, VIA VOLTURNO, 10/12, 50019 SESTO FIORENTINO


NIMENOL


100 mg


Granules


oral use




Italy


KRUGHER PHARMA Srl, VIA VOLTURNO, 10/12, 50019 SESTO FIORENTINO


NIMENOL


100 mg


Granules


oral use




Italy


LAB.GUIDOTTI SpA, VIA LIVORNESE, 89, 56010 LA VETTOLA - PISA


NIMESULENE


200 mg


Suppository


rectal use




Italy


LAB.GUIDOTTI SpA, VIA LIVORNESE, 89, 56010 LA VETTOLA - PISA


NIMESULENE


100 mg


Granules


oral use




Italy


LAB.GUIDOTTI SpA, VIA LIVORNESE, 89, 56010 LA VETTOLA - PISA


NIMESULENE


100 mg


Tablet


oral use




Italy


ANGENERICO SpA, VIA NOCERA UMBRA, 75, 00181 ROMA


NIMESULIDE


200 mg


Suppository


rectal use




Italy


DOROM Srl, VIA GIULIO RICHARD, 7, 20143 MILANO


NIMESULIDE


200 mg


Suppository


rectal use




Italy


TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO


NIMESULIDE


200 mg


Suppository


rectal use




Italy


MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, CINISELLO BALSAMO


NIMESULIDE


200 mg


Suppository


rectal use




Italy


DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO


NIMESULIDE


200 mg


Suppository


rectal use




Italy


EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO


NIMESULIDE


100 mg


Chewable tablet


oral use




Italy


BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA


NIMESULIDE


100 mg


Granules


oral use




Italy


BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA


NIMESULIDE


100 mg


Granules


oral use




Italy


MIPHARM SpA, VIA QUARANTA, 12, 20141 MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


FARMAC.FORMENTI SpA, VIA CORREGGIO, 43, 20149 MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


SANDOZ SpA, L.GO U.BOCCIONI, 1, 21040 ORIGGIO


NIMESULIDE


100 mg


Granules


oral use




Italy


LABORATORI ALTER Srl, VIA EGADI, 7, 20144 MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


ANGENERICO SpA, VIA NOCERA UMBRA, 75, 00181 ROMA


NIMESULIDE


100 mg


Granules


oral use




Italy


DOROM Srl, VIA GIULIO RICHARD, 7, 20143 MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


POLIFARMA SpA, VIALE DELL'ARTE, 69, 00144 ROMA


NIMESULIDE


100 mg


Granules


oral use




Italy


TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, 20092 CINISELLO BALSAMO


NIMESULIDE


100 mg


Granules


oral use




Italy


GET Srl, 'VIA DANTE ALIGHIERI, 73, 18038 SANREMO


NIMESULIDE


100 mg


Granules


oral use




Italy


JET GENERICI Srl, VIA MARIO LALLI, 8, 56127 PISA


NIMESULIDE


100 mg


Granules


oral use




Italy


ROBIN Srl, P.LE DURANTE FRANCESCO, 11, MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121 MILANO


NIMESULIDE


100 mg


Granules


oral use




Italy


PLIVA PHARMA SpA, VIA TRANQUILLO CREMONA, 10, 20092 CINISELLO BALSAMO


NIMESULIDE


100 mg


Granules


oral use




Italy


ALMUS Srl, VIA CESAREA, 11/10, 16121 GENOVA


NIMESULIDE


100 mg


Granules


oral use




Italy


HEXAL SpA, VIA PARACELSO, 16, 20041 AGRATE BRIANZA


NIMESULIDE


100 mg


Granules


oral use




Italy


UNION HEALTH Srl, VIA ROCCAMANDOLFI, 1, 00156 ROMA


NIMESULIDE


100 mg


Granules


oral use




Italy


BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA


NIMESULIDE


100 mg


Tablet


oral use




Italy


MIPHARM SpA, VIA QUARANTA, 12, 20141 MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


FARMAC.FORMENTI SpA, VIA CORREGGIO, 43, 20149 MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


LABORATORI ALTER Srl, VIA EGADI, 7, 20144 MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, 20092 CINISELLO BALSAMO


NIMESULIDE


100 mg


Tablet


oral use




Italy


GET Srl, 'VIA DANTE ALIGHIERI, 73, 18038 SANREMO


NIMESULIDE


100 mg


Tablet


oral use




Italy


ROBIN Srl, P.LE DURANTE FRANCESCO, 11, MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO


NIMESULIDE


100 mg


Tablet


 




Italy


RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121 MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


PLIVA PHARMA SpA, VIA TRANQUILLO CREMONA, 10, 20092 CINISELLO BALSAMO


NIMESULIDE


100 mg


Tablet


oral use




Italy


HEXAL SpA, VIA PARACELSO, 16, 20041 AGRATE BRIANZA


NIMESULIDE


100 mg


Tablet


oral use




Italy


UNION HEALTH Srl, VIA ROCCAMANDOLFI, 1, 00156 ROMA


NIMESULIDE


100 mg


Tablet


oral use




Italy


EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO


NIMESULIDE


100 mg


Tablet


oral use




Italy


SANDOZ SpA, L.GO U.BOCCIONI, 1, 21040 ORIGGIO


NIMESULIDE


100 mg


Capsule


oral use




Italy


FARMAC.CABER SpA, VIALE CITTA' D'EUROPA, 681, ROMA


NIMS


100 mg


Granules


oral use




Italy


LEVOFARMA Srl, VIA CONFORTI, 42, 84083 CASTEL SAN GIORGIO


NOALGOS


100 mg


Granules


oral use




Italy


LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122 MILANO


NOXALIDE


100 mg


Granules


oral use




Italy


LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122 MILANO


NOXALIDE


60 ml 5 %


Drops


oral use




Italy


TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO


ORONIME


100 mg


Orodispersible tablet


oral use




Italy


PANTAFARM Srl, VIA PALESTRO, 14, 00185 ROMA


PANTAMES


100 mg


Orodispersible tablet


oral use




Italy


VECCHI & PIAM Sapa, VIA PADRE G.SEMERIA, 5, 16131 GENOVA


REMOV


100 mg


Granules


oral use




Italy


VECCHI & PIAM Sapa, VIA PADRE G.SEMERIA, 5, 16131 GENOVA


REMOV


100 mg


Tablet


oral use




Italy


IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA


RESULIN


200 mg


Suppository


rectal use




Italy


IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA


RESULIN


100 mg


Granules


oral use




Italy


IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA


RESULIN


100 mg


Tablet


oral use




Italy


NOVARTIS CONSUMER HEALTH SpA, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO


REUMALIDE


200 mg


Suppository


rectal use




Italy


NOVARTIS CONSUMER HEALTH SpA, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO


REUMALIDE


100 mg


Granules


oral use




Italy


MDM SpA, VIALE PAPINIANO, 22/B, 20100 MILANO


SOLVING


100 mg


Granules


oral use




Italy


MDM SpA, VIALE PAPINIANO, 22/B, 20100 MILANO


SOLVING


100 mg


Tablet


oral use




Italy


FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI


SULIDAMOR


100 mg


Granules


oral use




Italy


FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI


SULIDAMOR


100 mg


Tablet


oral use




Italy


FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI


SULIDAMOR


100 mg


Granules


oral use




Italy


FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI


SULIDAMOR


100 mg


Tablet


oral use




Italy


TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO


SULIDE


100 mg


Granules


oral use




Italy


TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO


SULIDE


100 mg


Tablet


oral use




Italy


ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO


SULMEDIL


200 mg


Suppository


rectal use




Italy


ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO


SULMEDIL


100 mg


Granules


oral use




Italy


ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO


SULMEDIL


100 mg


Tablet


oral use




Latvia


Helsinn Birex Pharmaceutical Ltd., Damastown, Mulhurddart, Dublin 15, Ireland


Mesulid


100 mg


Tablet


Oral




Latvia


Laboratori Guidotti S. P. A., Via Trieste 40, I-56126 Pisza, Italy


Nimesil


100 mg


granules for oral suspension


Oral




Latvia


Medochemie Ltd., P. O. Box 51409, CY-3505 Limassol, Cyprus


Aponil


100 mg


Tablet


Oral




Latvia


Zentiva a. S., Nitrianska 100, 92027 Hlohovec, Slovakia


Coxtral


100 mg


Tablet


Oral




Lithuania


Medochemie Ltd., P. O. Box 51409 CY-3505 Limassol, Cyprus


Aponil


100 mg


Tablet


oral use




Lithuania


Zentiva a. s., U kabelovny 130102 37 Praha 10 Dolni Mecholupy, Czech Republic


Coxtral


100 mg


Tablet


oral use




Lithuania


Helsinn Birex Pharmaceuticals Ltd., Damastown Mulhuddart Dublin 15, Ireland


Mesulid


100 mg


Tablet


oral use




Lithuania


Laboratori Guidotti S.p.A., Via Livornese, 897-56010 Pisa-La Viettola, Italy


Nimesil


100 mg


granules for oral suspension


oral use




Malta


Vecchi & C Piam S A, Via Padre G Semeria, 5, Genoa 16131, Italy


Remov


100 mg


Tablet


Oral




Poland







Zentiva a.s. U Kabelovny 130




Dolni Mecholupy




102 37 Praque 10






COXTRAL


100 mg


tablet


oral use




Poland


Medicom International s.r.o., Paterni 7, Brno, 63500 Czech Republik


AULIN


100 mg


Granules for oral use


oral use




Poland


LABORATORI GUIDOTTI S.p.A. Via Livornese 897 I - 56010 San Piero a Grado PISA, Italy


NIMESIL


100 mg


Tablet


oral use




Poland


Medicom International s.r.o., Paterni 7, Brno, 63500 Czech Republik


AULIN


100 mg


Granules for oral use


oral use




Portugal







Angelini Farmacêutica, Lda.




Rua João Chagas, 53 - 3o





1495-764 Cruz Quebrada - Dafundo






Aulin


100 mg


Tablet


Oral




Portugal







Angelini Farmacêutica, Lda.




Rua João Chagas, 53 - 3o





1495-764 Cruz Quebrada - Dafundo






Aulin


100 mg


Powder for oral suspension


Oral




Portugal







Angelini Farmacêutica, Lda.




Rua João Chagas, 53 - 3o





1495-764 Cruz Quebrada - Dafundo






Aulin


200 mg


Suppository


Rectal




Portugal







Rega Farma - Promoção de




Produtos Farmacêuticos, S.A.




Rua João Chagas, 53 - 3o





1495-764 Cruz Quebrada






Donulide


100 mg


Tablet


Oral




Portugal







Rega Farma - Promoção de




Produtos Farmacêuticos, S.A.




Rua João Chagas, 53 - 3o





1495-764 Cruz Quebrada






Donulide


100 mg


Powder for oral suspension


Oral




Portugal







Labesfal - Laboratórios Almiro,




S.A. 3465-051 Campo de Besteiros






Nimalge


200 mg


Suppository


Rectal




Portugal







Vida - Produtos Farmacêuticos,




S.A. Vala do Carregado 2600-726 Castanheira do Ribatejo






Nimartin


100 mg


Coated tablet


Oral




Portugal







Sanofi-Aventis - Produtos




Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo






Nimed


100 mg


Coated tablet


Oral




Portugal







Sanofi-Aventis - Produtos




Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo






Nimed


100 mg


Powder for oral solution


Oral




Portugal







Sanofi-Aventis - Produtos




Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo






Nimed


200 mg


Suppository


Rectal




Portugal


Laboratori Guidotti, S.p.A. Via Trieste, 40 I-56126 Pisa


Nimesulene


100 mg


Powder for oral suspension


Oral




Portugal







Alter, S.A. Estrada Marco do




Grilo - Zemouto 2830 Coina






Nimesulida Alter 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Arrowblue Produtos Farmacêuticos




S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa






Nimesulida Arrowblue


100 mg


Tablet


Oral




Portugal







Farmoquímica Baldacci, S.A.




Rua Duarte Galvão, 44 1549-005 Lisboa






Nimesulida Baldacci 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Bluepharma - Indústria Farmacêutica,




S.A. São Martinho do Bispo 3045-016 Coimbra






Nimesulida Bluepharma 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Ciclum Farma Unipessoal, Lda.




Rua Alfredo da Silva, 16 2610-016 Amadora






Nimesulida Ciclum 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal


Edol Themaxis - Produtos Farmacêuticos S.A. Avenida 25 de Abril, no 6 - 6A 2795-195 Linda-a-Velha


Nimesulida Edol


100 mg


Tablet


Oral




Portugal







Farmoz - Sociedade Técnico-Medicinal




S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho






Nimesulida Farmoz 100 mg Comprimidos


100 mg


Coated tablet


Oral




Portugal







Generis Farmacêutica, S.A.




Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra






Nimesulida Generis 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Generis Farmacêutica, S.A.




Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra






Nimesulida Generis 100 mg Granulado para Solução Oral


100 mg


Powder for oral solution


Oral




Portugal


Companhia Portuguesa Higiene Pharma - Produtos Farmacêuticos, S.A. Rua dos Bem Lembrados, 141 - Manique 2645-471 Alcabideche


Nimesulida Gerilide 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal


Companhia Portuguesa Higiene Pharma - Produtos Farmacêuticos, S.A. Rua dos Bem Lembrados, 141 - Manique 2645-471 Alcabideche


Nimesulida Gerilide 100 mg Granulado para Solução Oral


100 mg


Powder for oral solution


Oral




Portugal







Germed Farmacêutica, Lda.




Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide






Nimesulida Germed 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Germed Farmacêutica, Lda.




Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide






Nimesulida Germed 100 mg Granulado para suspensão oral


100 mg


Powder for oral suspension


Oral




Portugal







gp - genéricos portugueses, Lda.




Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora






Nimesulida gp 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Laboratórios Inibsa, S.A.




Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra






Nimesulida Inibsa 100 mg comprimidos


100 mg


Tablet


Oral




Portugal







Laboratórios Inibsa, S.A.




Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra






Nimesulida Inibsa 100 mg granulado para suspensão oral


100 mg


Powder for oral suspension


Oral




Portugal







Tecnimede - Sociedade Técnico-Medicinal




S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho






Nimesulida Isartrox 100 mg Comprimidos


100 mg


Coated tablet


Oral




Portugal







Jaba Farmacêutica, S.A.




Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra






Nimesulida Jabasulide 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Jaba Farmacêutica, S.A.




Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra






Nimesulida Jabasulide 100 mg Granulado Para Solução Oral


100 mg


Powder for oral solution


Oral




Portugal







Labesfal - Laboratórios




Almiro, S.A. 3465-051 Campo de Besteiros






Nimesulida Labesfal


200 mg


Suppository


Rectal




Portugal







Labesfal - Laboratórios




Almiro, S.A. 3465-051 Campo de Besteiros






Nimesulida Labesfal 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Labesfal - Laboratórios




Almiro, S.A. 3465-051 Campo de Besteiros






Nimesulida Labesfal 100 mg Granulado para Suspensão Oral


100 mg


Powder for oral suspension


Oral




Portugal







Vetiquima -




Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela






21994 83 00


100 mg


Tablet


Oral




Portugal







Vetiquima -




Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela






21994 83 00


100 mg


Powder for oral suspension


Oral




Portugal







Medicamed -




Produtos Médicos e Farmacêuticos, S.A. Av. D. Afonso Henriques, 1462 - Edifício Olympus 4450-013 Matosinhos






Nimesulida Medicamed 100 mg Comprimidos


100 mg


Coated tablet


Oral




Portugal







Medineo - Comercialização




de Produtos Farmacêuticos, Lda. Rua Teófilo Braga, 14 2775-290 Parede






Nimesulida Medineo 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Mepha - Investigação,




Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora






Nimesulida Mepha 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Mepha - Investigação,




Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora






Nimesulida Mepha 100 mg Granulado para Suspensão Oral


100 mg


Powder for oral suspension


Oral




Portugal


Merck Genéricos - Produtos Farmacêuticos, Lda. Rua Alfredo da Silva, 3 C - 4o 1300-040 Lisboa


 


100 mg


Tablet


Oral




Portugal


Merck Genéricos - Produtos Farmacêuticos, Lda. Rua Alfredo da Silva, 3 C - 4o 1300-040 Lisboa


Nimesulida Merck Genéricos 100 mg Granulado para solução oral


100 mg


Powder for oral solution


Oral




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho


Nimesulida Neuride 100 mg Comprimidos


100 mg


Coated tablet


Oral




Portugal


Labesfal - Laboratórios Almiro, S.A. 3465-051 Campo de Besteiros


Nimesulida Nilmide 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal


Labesfal - Laboratórios Almiro, S.A. 3465-051 Campo de Besteiros


Nimesulida Nilmide 100 mg Granulado Para Suspensão Oral


100 mg


Powder for oral suspension


Oral




Portugal







Pharmakern Portugal -




Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Av. José Gomes Ferreira, 11 - 3o, Sala 31 - Edifício Atlas II 1495-139 Miraflores - Algés






Nimesulida Pharmakern 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Ranbaxy Portugal -




Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto






Nimesulida Ranbaxy


100 mg


Tablet


Oral




Portugal







Ranbaxy Portugal -




Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto






Nimesulida Ranbaxy


100 mg


Powder for oral suspension


Oral




Portugal







Ratiopharm - Comércio e




Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide






Nimesulida Ratiopharm 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal







Quiraus - Comércio




Produtos Químicos e Tecnologia Farmacêutica, Lda. Av. Salvador Allende, 12 - 1o 2780-163 Oeiras






Nimesulida Reumesul 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal


Sandoz Farmacêutica, Lda. Rua do Centro Empresarial - Edifício 3 - Loja 1 - Quinta da Beloura 2710-693 Sintra


Nimesulida Sandoz 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal


Decafarma - Comércio de Produtos Farmacêuticos, Lda Centro Empresarial Sintra Estoril, V, Armazém E 3 2710-144 Sintra


Nimesulida Sulimed 100 mg Comprimidos


100 mg


Tablet


Oral




Portugal


Laboratórios Atral, S.A Vala do Carregado 2600-726 Castanheira do Ribatejo


Ribantil


100 mg


Coated tablet


Oral




Portugal







Pharmout - Farmacêutica




Internacional, Lda. Rua da Quinta das Romeiras, 104 - 7o 1495-236 Algés






Vitolide


100 mg


Tablet


Oral




Romania


Faran Laboratories SA/Imedica SA, Sos. Bucuresti – Ploiesti Nr. 141D Sector 1, Bucuresti


AFLOGEN


100 mg


Tablet


oral use




Romania


Medochemie LTD, Str. Prof. Dr. Ion Cantacuzino nr. 5, sector 1, Bucuresti


Aponil


100 mg


Tablet


oral use




Romania


C.S.C. PHARMACEUTICALS, Drumul Sarii nr. 108, sector 6 Bucuresti


Aulin


100 mg


granules for oral suspension


oral use




Romania


C.S.C. PHARMACEUTICALS, Drumul Sarii nr. 108, sector 6 Bucuresti


Aulin


100 mg


Tablet


oral use




Romania


Zentiva AS, B-dul Theodor Pallady nr. 50, 032266 Bucuresti


Coxtral


100 mg


Tablet


oral use




Romania


ANFARM HELLAS SA/Imedica, Sos. Bucuresti – Ploiesti Nr. 141D Sector 1, Bucuresti


Lemesil


100 mg


Tablet


oral use




Romania







LABORATORI GUIDOTTI S.p.A., Via Livornese 897,




I - 56010 La Vettola, PISA, Italy






Nimesil


100 mg


granules for oral suspension


oral use




Romania


Terapia SA, Str. Fabricii Nr. 124, 3400 Cluj Napoca, Jud. Cluj


Nimesulid


100 mg


Tablet


oral use




Romania


LABORMED PHARMA SRL,Splaiul Independentei Nr. 319, Sector 6, Bucuresti


Nimesulid LPH 100 mg


100 mg


Tablet


oral use




Romania


MAGISTRA C & C, Str. Aviator Belghiru Nr. 9, 8700 Constanta, Jud. Constanta


Nimesulid 100 mg


100 mg


Tablet


oral use




Romania


ARENA GROUP SA, Str. Stefan Mihaileanu Nr.31, Sector 2, 73101 Bucuresti


Nimesulid Arena 100 mg


100 mg


Tablet


oral use




Romania


SLAVIA PHARM SRL, Str. Stirbei Voda Nr.53-55, Sector 1, Bucuresti


Nimesulid Slavia


100 mg


Tablet


oral use




Romania


FARMACEUTICI DAMUR SPA, Calea Dorobantilor Nr.113 Ap.35, Cluj, Jud. Cluj


Sulidamor


100 mg


Powder for oral suspension


powder for oral suspension




Slovak Republic


Medicom International s.r.o., Brno, Czech Republik


AULIN 100 mg granulát


100 mg


Granules for oral use


oral use




Slovak Republic


Medicom International s.r.o., Brno, Czech Republik


AULIN 100 mg tablety


100 mg


Tablet


oral use




Slovak Republic


Zentiva a.s. , Praha, Czech Republik


COXTRAL


100 mg


Tablet


oral use




Slovak Republic


CSC Pharmaceuticals Handels GmbH, Wien, Austria


MESULID


100 mg


Tablet


oral use




Slovak Republic


Medicom International s.r.o., Brno, Czech Republik


NIMED


100 mg


Tablet


oral use




Slovak Republic


Laboratori Guidotti S. P. A., Via Livornese 897, La Vettola, 56010 Pisa, Italy


Nimesil


100 mg


Granules for oral suspension


oral use




Slovenia


CSC Pharma d.o.o. JANA HUSA 1a, SI-1000 Ljubljana Slovenia


Aulin


100 mg


Tablet


oral




Slovenia


CSC Pharma d.o.o. JANA HUSA 1a, SI-1000 Ljubljana Slovenia


Aulin


100 mg


Powder for oral suspension


oral




Spain


HELSINN BIREX PHARMACEUTICALS LTD Damastown Mulhuddart, County Dublin,15 Ireland


GUAXAN 100 mg comprimidos


100 mg


Tablet


oral use







ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


(Invented) name


Strength


Pharmaceutical Form


Route of administration


Content
(concentration)




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien






Augmentin intravenös 550 mg – Trockenstechampullen


500/50 mg


Powder for solution for injection or infusion


Intravenous use


500 mg: 50 mg/vial




Augmentin intravenös 1,1 g - Trockensubstanz zur Infusionsbereitung


1 000/100 mg


Powder for solution for infusion


Intravenous use


1 000 mg: 100 mg/vial




Augmentin intravenös 2,2 g - Trockensubstanz zur Infusionsbereitung


2 000/200 mg


Powder for solution for infusion


Intravenous use


2 000 mg: 200 mg/vial




Augmentin 625 mg - lösliche Tabletten


500/125 mg


Dispersible tablet


Oral use


 




Augmentin
625 mg – Filmtabletten


500/125 mg


Film-coated Tablet


Oral use


 




Augmentin 1 g – Filmtabletten


875/125 mg


Film-coated Tablet


Oral use


 




Augmentin 457 mg/5 ml – Trockensaft


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml









Sandoz GmbH, Biochemiestr. 10,




A - 6250 Kundl






Clavamox intravenös 550 mg – Trockenstechampullen


500/50 mg


Powder for solution for injection or infusion


Intravenous use


500 mg: 50mg/10,5 ml




Clavamox intravenös 1,1 g - Trockensubstanz zur Infusionsbereitung


1 000/100 mg


Powder for solution for infusion


Intravenous use


1 000 mg: 100 mg/100 ml




Clavamox intravenös 2,2 g - Trockensubstanz zur Infusionsbereitung


2 000/200 mg


Powder for solution for infusion


Intravenous use


2 000 mg: 200 mg/100 ml




Clavamox 625 mg - lösliche Tabletten


500/125 mg


Dispersible tablet


Oral use


 




Clavamox 625 mg – Filmtabletten


500/125 mg


Film-coated Tablet


Oral use


 




Clavamox 1 g – Filmtabletten


875/125 mg


Film-coated Tablet


Oral use


 




Clavamox 156,25 mg/5 ml – Trockensaft


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125/31,25 mg/5 ml




Clavamox 312,5 mg/5 ml – Trockensaft


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250/62,5 mg/5 ml




Clavamox Duo – Trockensaft


400/57 mg/5 ml


Powder for oral suspension


Oral use


400/57 mg/5 ml




Belgium







GlaxoSmithKline s.a./n.v.




Rue du Tilleul 13




1332 Genval






Augmentin P


500/50 mg


Powder for injection or infusion


Intravenous use


500 mg: 50 mg/10,5 ml or 25 ml




Augmentin P


1 000/100 mg


Powder for infusion


Intravenous use


1 000 mg:100 mg/50 ml




Augmentin


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20 ml




Augmentin


2 000/200 mg


Powder for infusion


Intravenous use


2 000 mg: 200 mg/100 ml




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Augmentin


500/125 mg


Powder for oral suspension


Oral use


 




Augmentin Retard


1 000/62,5 mg


Modified release tablet


Oral use


 




Bulgaria







GlaxoSmithKline EOOD




Ivan Vasov Complex




Dimitar Manov street, bl.10, 1408 Sofia, Bulgaria






Augmentin


250/125 mg


Film-coated tablet


Oral use


 




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Augmentin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml




Augmentin SR


1 000/62,5 mg


Prolonged release tablet


Oral use


 




Cyprus







SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex TW8 9GS




UK






Augmentin


500/100 mg


Powder for injection or infusion


Intravenous use


500 mg: 100 mg/10,5 ml or 60 ml




Augmentin


1 000/200 mg


Powder for injection or infusion


Intravenous use


1 000 mg: 200 mg/20,9 ml or 120 ml




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Augmentin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml




 


Augmentin SR


1 000/62,5 mg


Film-coated tablet


Oral use


 









Laboratórios BIAL




À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado




Portugal






Noprilam


500/125 mg


Film-coated tablet


Oral use


 




Noprilam DT


875/125 mg


Film-coated tablet


Oral use


 




Noprilam


156,23 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,23 mg/5 ml




Noprilam


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg:62,5 mg/5 ml




Noprilam DT


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Czech Republic







SmithKline Beecham plc trading as




SmithKline Beecham Pharmaceuticals




980 Great West Road,




Brentford, Middlesex




TW8 9GS




United Kingdom






Augmentin 600 mg


500/100 mg


Powder for injection or infusion


Intravenous use


500 mg: 100 mg/10,5 ml or 60 ml




Augmentin 1,2 g


1 000/200 mg


Powder for injection or infusion


Intravenous use


1 000 mg: 200 mg/20,9 ml or 120 ml









SmithKline Beecham plc trading as




SmithKline Beecham Pharmaceuticals




980 Great West Road,




Brentford, Middlesex




TW8 9GS




United Kingdom






Augmentin 375 mg


250/125 mg


Film-coated tablet


Oral use


 




Augmentin 625 mg


500/125 mg


Film-coated tablet


Oral use


 




Augmentin 1 g


875/125 mg


Film-coated tablet


Oral use


 




Augmentin 156 mg/5 ml


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin 312 mg/5 ml


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Augmentin Duo


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin SR


1 000/62,5 mg


modified-release tablet


Oral use


 




Denmark







Meda AS




Solvang 8




DK-3450 Allerød




Denmark






Spektramox


500/125 mg


Film-coated tablet


Oral use


 




Spektramox


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Spektramox


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Spektramox 2:1


250/125 mg


Film-coated tablet


Oral use


 




Spektraforte


875/125 mg


Film-coated tablet


Oral use


 




Estonia







SmithKline Beecham plc.




980 Great West Road, Brentford




Middlesex TW8 9GS




United Kingdom






Augmentin


1 000/200 mg


Powder for injection or infusion


Intravenous use


1 000 mg: 200 mg/20,9 ml or 120 ml




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Finland







SmithKline Beecham plc




980 Great West Road




Brentford, Middlesex TW8 9GS




UK






Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin (80/11.97 mg/ml)


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Orion-yhtymä Oyj, Orionintie 1, 02200 Espoo


Clavurion


875/125 mg


Film-coated tablet


Oral use


 




Clavurion


200/28,5 mg/5 ml


Powder for oral suspension


Oral use


200 mg:28,5 mg/5 ml




Clavurion


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




France







Laboratoire GlaxoSmithKline




100, route de Versailles – 78163 Marly-le-Roi Cedex






Augmentin IV
ENFANTS
NOURRISSONS


500/50 mg


Powder for solution for injection
AND Powder and solvent for solution for injection


Intravenous use


500 mg: 50 mg




Augmentin IV
ADULTES


500/100 mg


Powder for solution for injection


Intravenous use


500 mg:100 mg




Augmentin IV
ENFANTS


1 000/100 mg


Powder for solution for injection


Intravenous use


1 000 mg: 100 mg




Augmentin IV
ADULTES


1 000/200 mg


Powder for solution for injection
AND Powder and solvent for solution for injection


Intravenous use


1 000 mg: 200 mg




Augmentin IV
ADULTES


2 000/200 mg


Powder for solution for injection


Intravenous use


2 000 mg: 200 mg




Augmentin
ADULTES


500/62,5 mg


Film-coated tablet


Oral use


 




Augmentin
ENFANTS


100/12,5 mg/ml


Powder for oral suspension


Oral use


100 mg: 12,5 mg/ml




Augmentin
NOURRISSONS


100/12,5 mg/ml


Powder for oral suspension


Oral use


100 mg/12,5 mg/ml




Augmentin
NOURRISSONS


250/31,25 mg


Powder for oral suspension


Oral use


 




Augmentin
ENFANTS


500/62,5 mg


Powder for oral suspension


Oral use


 




Augmentin
ADULTES


1 000/125 mg


Powder for oral suspension


Oral use


 




Duamentin
ADULTES


1 000/62,5 mg


Film-coated tablet


Oral use


 




Germany







GlaxoSmithKline GmbH & Co. KG




Theresienhöhe 11




80339 München






Augmentan i.v. pro infantibus 275 mg


250/25 mg


Powder for solution for infusion


Intravenous use


250 mg: 25 mg




Augmentan i.v. 600 mg


500/100 mg


Powder for solution for injection or infusion


Intravenous use


500 mg: 100 mg




Augmentan i.v. 1,2 g


1 000/200 mg


Powder for solution for infusion or infusion


Intravenous use


1 000 mg: 200 mg




Augmentan i.v. 2,2 g


2 000/200 mg


Powder for solution for infusion


Intravenous use


2 000 mg: 200 mg




Augmentan Tabs Tabletten


500/125 mg


Dispersible tablet


Oral use


 




Augmentan Filmtabletten 875/125 mg


875/125 mg


Film-coated tablet


Oral use


 




Augmentan Tropfen 50 mg/12,5 mg pro ml für Säuglinge


50/12,5 mg/ml


Powder for oral suspension


Oral use


50 mg: 12,5 mg/ml




Augmentan Trockensaft 25 mg/6,25 mg pro ml


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentan forte Trockensaft 50 mg/12,5 mg pro ml


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Augmentan Kindersaft


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens






Augmentin


500/100 mg


Powder for injection


Intravenous use


500 mg: 100 mg/10,5 ml




Augmentin


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


500/125 mg


Dispersible tablet


Oral use


 




Augmentin


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Augmentin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin SR


1 000/62,5 mg


Film-coated tablet


Oral use


 




Augmentin ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43




Hungary






Augmentin


500/100 mg


Powder for injection


Intravenous use


500 mg: 100 mg/10,5 ml




Augmentin


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin


250/125 mg


Film-coated tablet


Oral use


 




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml









GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.






Augmentin Duo


875/125 mg


Film-coated tablet


Oral use


 




Augmentin Duo


500/125 mg


Film-coated tablet


Oral use


 




Augmentin Duo


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin Extra


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml




Augmentin Extra


1 000/62,5 mg


Film-coated tablet


Oral use


 




Iceland







GlaxoSmithKline ehf.




Þverholti 14




105 Reykjavík.






Augmentin IV


500/100 mg


Powder for injection


Intravenous use


500 mg: 100 mg/10,5 ml




Augmentin IV


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin


500/125 mg


tablet


Oral use


 




Augmentin


875/125 mg


tablet


Oral use


 




Augmentin


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Augmentin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham,




Dublin 16






Augmentin
Intravenous 500 mg/100 mg Powder for Solution for Injection or Infusion


500/100 mg


Powder for solution for injection or infusion


Intravenous use


500 mg: 100 mg/10,5 ml




Augmentin
Intravenous 1 000 mg/200 mg Powder for Solution for Injection or Infusion


1 000/200 mg


Powder for solution for injection or infusion


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin Tablets 250 mg/125 mg


250/125 mg


Film-coated tablet


Oral use


 




Augmentin Dispersible Tablets 250 mg/125 mg


250/125 mg


Dispersible Tablet


Oral use


 




Augmentin Duo Tablets 500/125 mg


500/125 mg


Film-coated tablet


Oral use


 




Augmentin 500/125 mg Film-Coated Tablets


500/125 mg


Film-coated tablet


Oral use


 




Augmentin
875 mg/125 mg Film Coated Tablets


875/125 mg


Film-coated tablet


Oral use


 




Augmentin
Paediatric Suspension


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin
Junior Suspension


125/62,5 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 62,5 mg/5 ml




Augmentin Duo
Suspension 400 mg/57 mg


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml









Clonmel Healthcare Limited




Waterford Road




Clonmel




Tipperary




Ireland






Clavamel 250 mg/125 mg Tablets


250/125 mg


Film-coated tablet


Oral use


 




Clavamel 125 mg/31.25 mg Paediatric Powder for Oral Suspension


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Clavamel 125 mg/62,5 mg Junior Powder for Oral Suspension


125/62,5 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 62,5 mg/5 ml




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona






Augmentin


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20 ml




Augmentin


2 000/200 mg


Powder for infusion


Intravenous use


2 000 mg: 200 mg




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin


400/57 mg


Powder for oral suspension


Oral use


 




Augmentin


875/125 mg


Powder for oral suspension


Oral use


 









Valeas S.p.A.




via Vallisneri 10




20133 Milano






Neoduplamox


875/125 mg


Film-coated tablet


Oral use


 




Neoduplamox


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Neoduplamox


400/57 mg


Powder for oral suspension


Oral use


 




Neoduplamox


875/125 mg


Powder for oral suspension


Oral use


 









Solvay Pharma S.p.A.




Via della Libertà, 30




10095 Grugliasco (TO)






Clavulin


875/125 mg


Film-coated tablet


Oral use


 




Clavulin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Clavulin


400/57 mg


Powder for oral suspension


Oral use


 




Clavulin


875/125 mg


Powder for oral suspension


Oral use


 




Latvia







GlaxoSmithKline Latvia SIA




Bruninieku 5, Riga, LV-1001, Latvia






Augmentin


1 000/200 mg


Powder for solution for injection


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml




Augmentin SR


1 000/62,5 mg


Film-coated tablet


Oral use


 




Lithuania







Beecham Group plc.




980 Great West Road




Brentford




Middlesex TW8 9GS




United Kingdom






Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


200/28,5 mg/5 ml


Powder for oral suspension


Oral use


200 mg/28,5 mg/5 ml




Augmentin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg/57 mg/5 ml









UAB „GlaxoSmithKline Lietuva“




A. Goštauto g. 40A




LT-01112 Vilnius, Lithuania






Augmentin ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg/42,9 mg/5 ml




Luxembourg







GlaxoSmithKline s.a. / n.v.




Rue du Tilleul 13




1332 Genval






Augmentin P


500/50 mg


Powder for injection or infusion


Intravenous use


500 mg/50 mg/10,5 ml or 25 ml




Augmentin P


1 000/100 mg


Powder for infusion


Intravenous use


1 000 mg/100 mg/50 ml




Augmentin


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg/200 mg/20 ml




Augmentin


2 000/200 mg


Powder for infusion


Intravenous use


2 000 mg/200 mg/100 ml




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Augmentin


500/125 mg


Powder for oral suspension


Oral use


 




Augmentin Retard,


1 000/62,5 mg


Modified release tablet


Oral use


 




Malta







Beecham Group plc




980 Great West Road,




Brentford, Middlesex




TW8 9GS




United Kingdom






Augmentin Intravenous 600 mg


500/100 mg


Powder for solution for injection or infusion


Intravenous use


500 mg: 100 mg/10,5 ml




Augmentin Intravenous 1,2 g


1 000/200 mg


Powder for solution for injection or infusion


Intravenous use


1 000 mg: 200 mg/20,9 ml









GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham




Dublin 16




Ireland






Augmentin 250/125 mg


250/125 mg


Film-coated tablet


Oral use


 




Augmentin Duo 500/125 tablets


500/125 mg


Film-coated tablet


Oral use


 




Augmentin 875/125 mg tablets


875/125 mg


Film-coated tablet


Oral use


 









SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex




TW8 9GS






Augmentin Duo 400/57


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml









Laboratórios BIAL




Portela & Ca, S.A.




À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado




Portugal






Noprilam


500/125 mg


Coated tablet


Oral use


 




Noprilam DT


875/125 mg


Coated tablet


Oral use


 




Noprilam DT


400/57 mg/5 ml


Powder for oral suspension


Oral use


400/57 mg/5 ml




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




THE NETHERLANDS






Augmentin


250/25 mg


Powder for injection


Intravenous use


250 mg: 25 mg/5,2 ml




Augmentin


500/50 mg


Powder for injection


Intravenous use


500 mg: 50 mg/10,5 ml




Augmentin


500/100 mg


Powder for injection


Intravenous use


500 mg: 100 mg/10,5 ml




Augmentin


1 000/100 mg


Powder for injection


Intravenous use


1 000 mg: 100 mg/20,9 ml




Augmentin


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin


2 000/200 mg


Powder for infusion


Intravenous use


2 000 mg: 200 mg/120 ml




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


100/12,5 mg/ml


Powder for oral suspension


Oral use


100 mg: 12,5 mg/ml




Augmentin


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml









Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




THE NETHERLANDS






amoxicilline/clavulaanzuur


250/62,5 mg


Powder for oral suspension


Oral use


 




Poland







GlaxoSmithKline Export Ltd




980 Great West Road




Brentford, Middlesex, TW8 9GS




UK






Augmentin


500/100 mg


Powder for injection


Intravenous use


500 mg: 100 mg/10,5 ml




Augmentin


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin


2 000/200 mg


Powder for infusion


Intravenous use


2 000 mg: 200 mg/120 ml




Augmentin


250/125 mg


Film-coated tablet


Oral use


 




Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg:31,25 mg/5 ml




Augmentin


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg:62,5 mg/5 ml




Augmentin


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml




Augmentin SR


1 000/62,5 mg


Prolonged release tablet


Oral use


 




Portugal







GlaxoSmithKline – Produtos Farmacêuticos Lda




Rua Dr. António Loureiro Borges, 3




Aquiparque – Miraflores




1495 – 131 Algés






Augmentin


500/125 mg


Film-coated tablet


Oral use


 




Augmentin Duo


875/125 mg


Film-coated tablet


Oral use


 




Augmentin


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin Forte


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg:62,5 mg/5 ml




Augmentin Duo


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml









Bial - Portela & Ca, S.A




À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado




Portugal






Clavamox 125


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Clavamox 250


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Clavamox 500


500/125 mg


Film-coated tablet


Oral use


 




Clavamox DT


875/125 mg


Film-coated tablet


Oral use


 




Clavamox DT 400


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Clavamox ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml




Noprilam


500/125 mg


Film-coated tablet


Oral use


 




Noprilam


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Noprilam


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Noprilam DT


875/125 mg


Film-coated tablet


Oral use


 









Laboratórios Vitória, S.A. Rua Elias Garcia, 28 – Venda Nova




2700-327 Amadora




(Sob licença GlaxoSmithKline – Produtos Farmacêuticos, Lda.)






Penilan


500/125 mg


Film-coated tablet


Oral use


 




Penilan


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Penilan DT


875/125 mg


Film-coated tablet


Oral use


 




Penilan Forte


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Romania







Beecham Group PLC




980 Great West Road, Brentford, Middlesex TW8 9GS




United Kingdom






Augmentin
intravenos 1,2 g


1 000/200 mg


Powder for injection/infusion


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin
Intravenos 2,2 g


2 000/200 mg


Powder for infusion


Intravenous use


2 000 mg: 200 mg/120 ml




Augmentin 625 mg


500/125 mg


Film-coated tablet


Oral use


 




Augmentin 1 g


875/125 mg


Film-coated tablet


Oral use


 




Augmentin BIS


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml




Augmentin SR


1 000/62,5 mg


Prolonged release film-coated tablet


Oral use


 




Slovak Republic


GlaxoSmithKline Slovakia sro., Galvaniho7/A, 82104 Bratislava, Slovakia


Augmentin 375 mg


250/125 mg


Film-coated tablet


Oral use


 




Augmentin 625 mg


500/125 mg


Film-coated tablet


Oral use


 




Augmentin 1 g


875/125 mg


Film-coated tablet


Oral use


 




Augmentin DUO


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin ES


600/42,9 mg/5 ml


Powder for oral suspension


Oral use


600 mg: 42,9 mg/5 ml




Augmentin SR


1 000/62,5 mg


Prolonged-release tablet


Oral use


 




Slovenia







GSK d.o.o., Ljubljana




Knezov štradon 90




SI-1000 Ljubljana




Slovenija






Augmentin Augmentin 0,6 g prašek za raztopino za injiciranje ali infundiranje


500/100 mg


Powder for injection


Intravenous use


500 mg: 100 mg/10,5 ml




Augmentin 1,2 g prašek za raztopino za injiciranje ali infundiranje


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin 625 mg filmsko obložene tablete


500/125 mg


Film-coated tablet


Oral use


 




Augmentin 1 000 mg filmsko obložene tablete


875/125 mg


Film-coated tablet


Oral use


 




Augmentin 457 mg/5 ml prašek za peroralno suspenzijo


400/57 mg/5 ml


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




Augmentin SR 1 000 mg/62,5 mg filmsko obložene tablete s podaljšanim sproščanjem


1 000/62,5 mg


Film-coated tablet


Oral use


 




Spain







GlaxoSmithKline, S.A.




P.T.M.- C/Severo Ochoa, 2




28760 Tres Cantos (Madrid).






Augmentine Intravenoso


500/50 mg


Powder for injection


Intravenous use


500 mg: 50 mg/10,5 ml




Augmentine Intravenoso


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentine Intravenoso


2 000/200 mg


Powder for infusion


Intravenous use


2 000 mg: 200 mg/120 ml




Augmentine


500/125 mg


Film-coated tablet


Oral use


 




Augmentine


875/125 mg


Film-coated tablet


Oral use


 




Augmentine


100/12,5 mg/ml


Powder for oral suspension


Oral use


100 mg: 12,5 mg/ml




Augmentine


500/125 mg


Powder for oral suspension


Oral use


 




Augmentine


875/125 mg


Powder for oral suspension


Oral use


 




Augmentine Plus


1 000/62,5 mg


Film-coated tablet


Oral use


 









Laboratorios Beecham, S.A.




P.T.M.- C/Severo Ochoa, 2




28760 Tres Cantos (Madrid).






Pangamox


250/62,5 mg


Powder for oral suspension


Oral use


 




Pangamox


500/125 mg


Powder for oral suspension


Oral use


 




Pangamox


875/125 mg


Powder for oral suspension


Oral use


 









Allen Farmacéutica, S.A.P.T.M.- C/Severo Ochoa, 2




28760 Tres Cantos (Madrid).






Clavepen


500/125 mg


Film-coated tablet


Oral use


 




Clavumox


500/125 mg


Film-coated tablet


Oral use


 




Clavumox


875/125 mg


Film-coated tablet


Oral use


 




Clavumox


125/31,25 mg/5 ml


Oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Clavumox


250/62,5 mg


Powder for oral suspension


Oral use


 




Clavepen


500/125 mg


Powder for oral suspension


Oral use


 




Clavumox


500/125 mg


Powder for oral suspension


Oral use


 




Clavumox


875/125 mg


Powder for oral suspension


Oral use


 




Amoxicilina/Ác. Clavulanico ALLEN


875/125 mg


Powder for oral suspension


Oral use


 




Sweden







Meda AB




Box 906




170 09 Sverige (SWE)




Sweden






Spektramox


250/125 mg
(Amoxicillin: 250 mg)


Film-coated tablet


Oral use


 




Spektramox


500/125 mg
(Amoxicillin: 500 mg)


Film-coated tablet


Oral use


 




Spektramox


875/125 mg
(Amoxicillin 875 mg)


Film-coated tablet


Oral use


 




Spektramox


125/31,25 mg/5 ml
(Amoxicillin 25 mg/ml)


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Spektramox


125/31,25 mg
(Amoxicillin: 125 mg)


Powder for oral suspension


Oral use


 




Spektramox


250/62,5 mg/5 ml
(Amoxicillin: 50 mg/ml)


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Spektramox


400/57 mg/5 ml
(Amoxicillin: 80 mg/ml)


Powder for oral suspension


Oral use


400 mg: 57 mg/5 ml




United Kingdom







Beecham Group PLC




SB House




Great West Road




Brentford




Middlesex TW8 9GS




United Kingdom






Augmentin Intravenous 600 mg & 1,2 gm


500/100 mg


Powder for injection


Intravenous use


500 mg: 100 mg/10,5 ml




Augmentin Intravenous 600 mg & 1,2 gm


1 000/200 mg


Powder for injection


Intravenous use


1 000 mg: 200 mg/20,9 ml




Augmentin 375 mg Tablets


250/125 mg


Film-coated tablet


Oral use


 




Augmentin 375 mg dispersible tablets


250/125 mg


Dispersible tablets


Oral use


 




Augmentin 1 g Tablets


875/125 mg


Film-coated tablet


Oral use


 




Augmentin 625 mg Tablets


500/125 mg


Film-coated tablet


Oral use


 




Augmentin 250/62 SF Suspension


250/62,5 mg/5 ml


Powder for oral suspension


Oral use


250 mg: 62,5 mg/5 ml




Augmentin 125/31 SF Sachet


125/31,25 mg


Powder for oral suspension


Oral use


 




Augmentin 125/31 SF Suspension


125/31,25 mg/5 ml


Powder for oral suspension


Oral use


125 mg: 31,25 mg/5 ml




Augmentin Duo


200/28,5 mg/5 ml


Powder for oral suspension


Oral use


200 mg: 28,5 mg/5 ml







ANNEX XI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES












Member State


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Denmark







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel,




Germany






 


Fentrans Depotplaster


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Germany


 







STADA Arzneimittel AG




Stadastrasse 2-18,




61118 Bad Vilbel,




Germany






Fentanyl-GRY


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h







ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES












Member State


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Denmark







STADA Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






 


Matripain Depotplaster


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Germany


 







STADA Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentanyl AL


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h







ANNEX XIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES












Member State


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Austria


 







Teva Pharma B.V.




3640 AE Mijdrecht, Industrieweg 23, P.O. Box 217




The Netherlands






Fentanyl TEVA transdermales Pflaster


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Belgium


 







TEVA Pharma Belgium N.V




B-2610 Wilrijk; Laarstraat 16,




Belgium






Fentanyl TEVA Pleister voor transdermaal gebruik


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Czech Republic


 







Teva Pharmaceuticals CR, s.r.o.




Radlická 3185/1C




Praha 5




Czech Republic






Fentanyl - TEVA
25 μg/h


25 μg/h


Transdermal patch


Transdermal use




Fentanyl - TEVA
50 μg/h


50 μg/h




Fentanyl - TEVA
75 μg/h


75 μg/h




Fentanyl - TEVA
100 μg/h


100 μg/h




Denmark







STADA Arzneimittel AG




Stadastrasse 2-18,




61118 Bad Vilbel




Germany






 


Matrigesic Depotplaster


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Estonia


 







Teva Pharmaceuticals Europe B.V.




3641 RK Mijdrecht, Indrustrieweg 23




The Netherlands






Fentanyl - TEVA transdermalpatch


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Finland


 







TEVA Sweden AB




PO Box 1070;




251 10 Helsingborg,




Sweden






Fentanyl TEVA


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




France


 







Société TEVA CLASSICS Immeuble Le Palatin 1;




1, Cours du Triangle; 92936 Paris La Défense Cedex,




France






Fentanyl TEVA dispositif transdermique


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Hungary


 







TEVA Magyarország Rt. Rákóczi út. 70- 72, H-1074 Budapest




Hungary






Fentanyl – Teva tapasz


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Italy


 







TEVA Pharma Italia S.r.l.




Via Giulio Richard, 7 20143 Milan




Italy






Fentanil Teva cerotti transdermici


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Latvia


 







Teva Pharmaceuticals Europe B.V.




3641 RK Mijdrecht, Indrustrieweg 23




The Netherlands






Fentanyl - TEVA transdermālie plāksteri


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Lithuania


 







Teva Pharmaceuticals Europe B.V.




Industrieweg 23, 3641 RK Mijdrecht




The Netherlands






Fentanyl - TEVA


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Luxembourg


 







TEVA Pharma Belgium N.V




B-2610 Wilrijk; Laarstraat 16,




Belgium






Fentanyl TEVA Dispositif transdermique


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




The Netherlands


 







STADA Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentanyl 25 microgram/uur PCH, pleister voor transdermaal gebruik


25 μg/h


Transdermal patch


Transdermal use




Fentanyl 50 microgram/uur PCH, pleister voor transdermaal gebruik


50 μg/h




Fentanyl 75 microgram/uur PCH, pleister voor transdermaal gebruik


75 μg/h




Fentanyl 100 microgram/uur PCH, pleister voor transdermaal gebruik


100 μg/h




Norway


 







TEVA Sweden AB




PO Box 1070;




251 10 Helsingborg




Sweden






Fentanyl TEVA


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Poland


 







TEVA PHARMACEUTICALS Polska Sp. Z.o.o.




Emilii Plater 53, 00-113




Warsaw




Poland






Fentanyl TEVA system transdermalny


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Portugal


 







Teva Pharma - Produtos Farmaceuticos, Lda Lagoas Park, Edifício 1, Piso 3, 2740 - 264 Porto Salvo




Portugal






Fentanilo Teva


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Slovak Republic


 







Teva Pharmaceuticals CR, s.r.o




Drazni 7;




627 00 Brno




Czech Republic






Fentanyl – TEVA


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Slovenia


 







Teva Pharmaceuticals Europe B.V.




3641 RK Mijdrecht, Indrustrieweg 23




The Netherlands






Fentanil TEVA transdermalni obliž


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Spain


 







TEVA GENERICOS ESPAÑOLA, S.L.




Guzman el Bueno; 133. Edif. Britannia




28003 Madrid




Spain






Fentanilo TEVA parches transdermicos EFG


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Sweden


 







TEVA Sweden AB




PO Box 1070;




251 10 Helsingborg,




Sweden






Matrigesic transdermal patch


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




United Kingdom


 







TEVA UK Limited




Brampton Road; Hampden Park; Eastbourne; East Sussex




BN22 9AG




United Kingdom






Fentanyl Transdermal Patch


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h







ANNEX XIV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES












Member State


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Denmark







STADA Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






 


Fentador
Depotplaster


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Germany


 







STADA Arzneimittel AG




Stadastrasse 2-18,




61118 Bad Vilbel,




Germany






Fentador


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h







ANNEX XV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES












Member State


Marketing Authorisation Holder


Applicant/MAH


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Austria


 







STADA Arzneimittel GmbH




Muthgasse 36/2




1190 Wien




Austria






Fentanyl STADA Depotpflaster


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Belgium


 







Eurogenerics N.V., Heizel Esplanade Heysel b22




1020 Brussels




Belgium






Fentanyl EG Pleister voor transdermaal gebruik


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Czech Republic


 







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentanyl STADA
25 μg/h


25 μg/h


Transdermal patch


Transdermal use




Fentanyl STADA
50 μg/h


50 μg/h




Fentanyl STADA
75 μg/h


75 μg/h




Fentanyl STADA
100 μg/h


100 μg/h




Denmark







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






 


Fentastad depotplaster


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Estonia


 







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentaderm transdermal patch


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Finland


 







STADA Arzneimittel AG Stadastrasse 2-18,




61118 Bad Vilbel




Germany






Fentanyl STADA


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




France


 







EGLABO




Le Quintet-Bat A




12 rue Danjou




92517 Boulogne Billancourt Cedex




France






Fentanyl EG LABO, dispositif transdermique


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Hungary


 







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentanyl STADA tapasz


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Italy


 







EG S.p.A.




Via D. Scarlatti, 31




20124 Milano




Italy






Nilafen cerotti transdermici


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Latvia


 







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentastad transdermālie plāksteri


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Lithuania


 







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentaderm


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Luxembourg


 







Eurogenerics N.V., Heizel Esplanade Heysel b22,




1020 Brussels




Belgium






Fentanyl EG pleister voor transdermal gebruik


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




The Netherlands


 







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentanyl CF 25 microgram/uur, pleister voor transdermaal gebruik


25 μg/h


Transdermal patch


Transdermal use




Fentanyl CF50 microgram/uur, pleister voor transdermaal gebruik


50 μg/h




Fentanyl CF 75 microgram/uur, pleister voor transdermaal gebruik


75 μg/h




Fentanyl CF 100 microgram/uur, pleister voor transdermaal gebruik


100 μg/h




Poland


 







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentanyl STADA


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Portugal


 







Ciclum Farma Unipessoal, Lda.




Quinta da Fonte, Rua Vitor Câmara, no 2, Edifício D. Amélia - Piso 1, Ala B, 2770-229 Paço de Arcos




Portugal






Fentanilo Ciclum


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Slovak Republic


 







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentanyl STADA transdermálna náplasť


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Spain


 







Lab. STADA




Frederic Mompou,5




08960 Sant Just Desvern, Barcelona




Spain






Fentanilo STADA parches transdermicos EFG


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




Sweden


 







STADA Arzneimittel AG Stadastrasse 2-18




61118 Bad Vilbel




Germany






Fentanyl STADA transdermal patch


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h




United Kingdom


 







Genus Pharmaceuticals Ltd.




(trading as Genus Pharmaceuticals)




Benham, Valence, Newbury




Berkshire, RG20 8LU




United Kingdom






Fentanyl Transdermal Patch


25 μg/h


Transdermal patch


Transdermal use




50 μg/h




75 μg/h




100 μg/h