Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2012-03-16
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012078EN.01001001.xml










16.3.2012   


EN


Official Journal of the European Union


C 78/10





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 2012

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

2012/C 78/02
—   Issuing, maintenance or modification 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




13.1.2012


Cephalosporins


See Annex I


See Annex I


18.1.2012




20.1.2012


Nimesulide


See Annex II


See Annex II


23.1.2012






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, ACTIVE SUBSTANCE, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, APPLICANTS/ MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Applicant/Marketing Authorisation Holder


Name


Active substance


Strength


Pharmaceutical form


Animal species




Austria







Intervet GmbH




Siemensstraße 107




1210 Wien




AUSTRIA






Cobactan 2,5 % w/v Injektionssuspension für Rinder und Schweine


Cefquinome


25 mg/ml


Suspension for injection


Cattle, pigs




Austria







Intervet GmbH




Siemensstraße 107




1210 Wien




AUSTRIA






COBACTAN LA 7,5 % - Injektionssupension für Rinder


Cefquinome


75 mg/ml


Suspension for injection


Cattle




Austria







Intervet GmbH




Siemensstraße 107




1210 Wien




AUSTRIA






Cobactan 4,5 % Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Pferde und Rinder


Cefquinome


45 mg/ml


Powder and solvent for solution for injection


Cattle, horses




Austria







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil 50 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Rinder und Schweine


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Austria







Vetoquinol Österreich GmbH




Zehetnergasse 24




1140 Wien




AUSTRIA






Ceftiocyl 50 mg/ml, Injektionssuspension für Rinder und Schweine


Ceftiofur as hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




Austria







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL 50 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Rinder und Schweine


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Austria







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL RTU 50 mg/ml Injektionssuspensiuon für Rinder und Schweine


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Austria







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR 50 mg/ml Injektionssuspension für Schweine und Rinder


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Austria







Pfizer Corporation Austria GmbH




Floridsdorfer Hauptstraße 1




1210 Wien




AUSTRIA






Excenel - Pulver zur Herstellung einer Injektionslösung für Tiere


Ceftiofur


50 mg/ml


Powder for solution for injection


Cattle, pigs




Austria







Pfizer Corporation Austria GmbH




Floridsdorfer Hauptstraße 1




1210 Wien




AUSTRIA






Excenel RTU 50 mg/ml Injektionssuspension für Schweine und Rinder


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Austria







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






READYCEF 50 mg/ml Injektionssuspension für Schweine und Rinder


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Austria







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






Virbacef Pulver zur Herstellung einer Injektionslösung für Rinder und Schweine


Ceftiofur


50 mg/ml


Powder for solution for injection


Cattle, pigs




Belgium







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN 2,5 %


Cefquinome (as sulfate)


25 mg/ml


Suspension for injection


Cattle, pigs




Belgium







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN 4,5 %


Cefquinome (as sulfate)


45 mg/ml


Powder and solvent for solution for injection


Cattle, Horses (adult and foal) and (adult and calf)




Belgium







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN LA 7,5 %


Cefquinome (as sulfate)


75 mg/ml


Suspension for injection


Cattle




Belgium







Laboratorios SYVA S.A.U.




Avda. Párroco Pablo Díez 49-57




24010 León




SPAIN






ACTIONIS 50 MG/ML


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Belgium







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






CEFENIL 50 MG/ML


Ceftiofur (as sodium)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Belgium







VETOQUINOL N.V./S.A.




Kontichsesteenweg 42




2630 Aartselaar




BELGIUM






CEFTIOCYL 50 MG/ML


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Belgium







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






CEFTIOSAN


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Pigs weighing up to 125 kg.
Cattle




Belgium







CEVA Santé Animale NV/SA




Metrologielaan 6




1130 Brussel




BELGIUM






CEVAXEL 50MG/ML


Ceftiofur (as sodium)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Belgium







CEVA Santé Animale NV/SA




Metrologielaan 6




1130 Brussel




BELGIUM






CEVAXEL-RTU 50 MG/ML


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Belgium







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR 50 MG/ML


Ceftiofur (as sodium)


50 mg/ml


Suspension for injection


Cattle, pigs




Belgium







Pfizer Animal Health s.a.




Rue Laid Burniat 1




B-1348 Louvain La Neuve




BELGIUM






EXCENEL


Ceftiofur (as sodium)


50 mg/ml


Powder for Solution for Injection


Cattle, pigs




Belgium







Pfizer Animal Health s.a.




Rue Laid Burniat 1




B-1348 Louvain La Neuve




BELGIUM






EXCENEL RTU


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Belgium







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






READYCEF 50 MG/ML


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Belgium







Continental Farmaceutica, S.L.




Parque Empresarial La Moraleja




Avenida de Europa 20-B




E-28108 Madrid, Alcobendas




SPAIN






TRULEVA RTU


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Belgium







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






VIRBACEF Poudre pour solution injectable pour bovins et porcins


Ceftiofur (as sodium)


50 mg/ml


Powder for Solution for Injection


Cattle, pigs




Bulgaria







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






Цефтиомакс 50 mg/ml инжекционна суспензия за едри преживни животни и свине


Ceftiofur


50mg/ml


Suspension for injection


Cattle, pigs




Bulgaria







Ceva Animal Health Bulgaria EOOD




26 Elemag Str., ent. B, app. 1




1113 Sofia




BULGARIA






Севаксел-РТУ 50 мг/мл, суспенсия за инжектиране при говеда и свине


Ceftiofur


50mg/ml


Suspension for injection


Cattle, pigs




Bulgaria







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






Ефикур 50 мг/мл инжекционна суспензия за свине и говеда


Ceftiofur


50mg/ml


Suspension for injection


Cattle, pigs




Bulgaria







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Цефтиозан 50 мг/мл инжекционна суспензия за свине и говеда


Ceftiofur


50mg/ml


Suspension for injection


Cattle, pigs




Bulgaria







Interchemie werken "De Adelaar" BV




Horsterweg 26A




5811 AC Castenray




THE NETHERLANDS






Цефтионел-50-ceftiofur base(50mg/ml), инжекционна суспензия за говеда и свине


Ceftiofur


50mg/kg


Suspension for injection


Cattle, pigs




Bulgaria







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Кобактан ЛА 7,5 % инжективна суспензия за говеда


Cefquinome


75mg/ml


Suspension for injection


Cattle




Bulgaria







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Кобактан 2,5 %


Cefquinome


25 mg/ml


Suspension for injection


Cattle, pigs




Cyprus







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil 50mg/ml Σκόνη και διαλύτης για ενέσιμο διάλυμα για βοοειδή και χοίρους


Ceftiofur (as ceftiofur sodium)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Cyprus







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






Eficur 50mg/ml ενέσιμο διάλυμα για χοίρους και βοοειδή


Ceftiofur (as hydrochloride)


50 mg/ml


Injectable suspension


Cattle, pigs




Cyprus







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan 2,5 %


Cefquinome (as sulfate)


25 mg/ml


Injectable suspension


Cattle




Cyprus







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan LA 7,5 %


Cefquinome (as sulfate)


75 mg/ml


Suspension for injection


Cattle




Czech Republic







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil 50 mg/ml powder and solvent for solution for njection for cattle and pigs.


Ceftiofurum (ut Ceftiofurum natricum)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Czech Republic







Vetoquinol s.r.o.




Zámečnická 411




CZ - 288 02 Nymburk




CZECH REPUBLIC






Ceftiocyl 50 mg/ml suspension for injection for cattle and pigs


Ceftiofurum (ut hydrochloridum)


50 mg/ml


Suspension for injection


Cattle, pigs




Czech Republic







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






Ceftiomax 50 mg/ml suspension for injection for pigs and cattle


Ceftiofurum (ut Ceftiofuri hydrochloridum)


50 mg/ml


Suspension for injection


Cattle, pigs




Czech Republic







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL 50 mg/ml powder and solvent for solution for njection for cattle and pigs.


Ceftiofurum (ut natricum)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Czech Republic







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR
50 mg/ml suspension for injection for pigs and cattle


Ceftiofurum (ut hydrochloridum)


50 mg/ml


Suspension for injection


Cattle, pigs




Czech Republic







Pfizer s.r.o.




Stroupežnického 17




150 00 Praha 5




CZECH REPUBLIC






Excenel 50 mg/ml freeze-dried powder for solution for injection


Ceftiofurum (ut natricum)


50 mg/ml


Freeze-dried powder for solution for injection


Cattle, pigs, horses




Czech Republic







Pfizer s.r.o.




Stroupežnického 17




150 00 Praha 5




CZECH REPUBLIC






EXCENEL RTU inj


Ceftiofurum (ut hydrochloridum)


50 mg/ml


Suspension for injection


Cattle, pigs




Czech Republic







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






Virbacef powder for solution for injection for cattle and pigs


Ceftiofurum (ut Ceftiofurum natricum)


50 mg/ml


Powder for solution for injection


Cattle, pigs




Czech Republic







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan 2,5 % inj


Cefquinomum (ut sulfas)


25 mg/ml


Injection


Cattle, pigs




Czech Republic







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan LA 7,5 % suspension for injection for cattle


Cefquinomum (ut sulfas)


75 mg/ml


Suspension for injection


Cattle




Denmark







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan Vet.


cefquinome


75 mg/ml


Solution for injection, suspension


Cattle




Denmark







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan Vet.


cefquinome


25mg/ml


Solution for injection, suspension


Cattle, pigs




Denmark







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan Vet.


cefquinome


45 mg/ml


Powder and solvent for injections for solution


Horses




Denmark







Vetoquinol scandinavia AB




Torggatan 2




Box 9




SE-26521 Åstorp




SWEDEN






Ceftiocyl


Ceftiofur as hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




Denmark







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






Eficur Vet.


ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Denmark







Pfizer Oy, Animal Health




Tietokuja 4




FI-00330 Helsinki




FINLAND






Excenel Vet.


ceftiofur


50 mg/ml


Solution for injection, suspension


Cattle, pigs




Denmark







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Ceftiosan


Ceftiofur


50 mg/ml


Solution for injection, suspension


Cattle, pigs




Denmark







Pfizer Oy, Animal Health




Tietokuja 4




FI-00330 Helsinki




FINLAND






Excenel Vet.


Ceftiofur


50 mg/ml


Powder for solution for injection


Cattle, pigs




Denmark







Pfizer Oy, Animal Health




Tietokuja 4




FI-00330 Helsinki




FINLAND






Excenel Vet.


Ceftiofur


50 mg/ml


Powder for solution for injection


Cattle, pigs




Estonia







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Ceftiosan 50mg/ml


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Estonia







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






Cevaxel


Ceftiofur (as sodium)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Estonia







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






Cevaxel-RTU


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Estonia







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan 2,5 %


Cefquinome (as sulfate)


25 mg/ml


Suspension for injection


Cattle, pigs




Estonia







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan LA 7,5 %


Cefquinome (as sulfate)


75 mg/ml


Suspension for injection


Cattle




Estonia







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






Ceftiomax


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Estonia







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






Eficur


Ceftiofur (as Ceftiofur Hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Estonia







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil


Ceftiofur (as ceftiofur sodium)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Estonia







Pfizer Manufacturing Belgium N,V./S.A.




Rijksweg 12




B-2870 Puurs




BELGIUM






Excenel RTU


Ceftiofur (as Ceftiofur Hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Estonia







Vetoquinol S.A.




Magny-Vernois




70200 Lure




FRANCE






Ceftiocyl


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Finland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






CEFENIL VET 50 mg/ml


Ceftiofurum natricum


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




France







PFIZER HOLDING France




23/25 Avenue du Docteur Lannelongue




75014 Paris




FRANCE






EXCENEL 1 G


Ceftiofur (sous forme de sel de sodium)


50 mg/ml


Powder for solution for injection.


Cattle, horses, pigs




France







PFIZER HOLDING France




23/25 Avenue du Docteur Lannelongue




75014 Paris




FRANCE






EXCENEL 4 G


Ceftiofur (sous forme de sel de sodium)


50 mg/ml


Powder for solution for injection.


Cattle, horses, pigs




France







INTERVET




Rue Olivier De Serres




Angers Technopole




49070 Beaucouze




FRANCE






COBACTAN 2,5 %


Cefquinome (sous forme de sulfate)


25 mg/ml


Suspension for injection


Cattle, pigs, calves




France







PFIZER HOLDING France




23/25 Avenue du Docteur Lannelongue




75014 Paris




FRANCE






EXCENEL RTU


Ceftiofur (sous forme de chlorhydrate)


50 mg/ml


Suspension for injection


Cattle, pigs




France







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN LA 7,5 %


Cefquinome (sous forme de sulfate)


75 mg/ml


Suspension for injection


Cattle




France







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN IV IM 4,5 %


Cefquinome (sous forme de sulfate)


45 mg/ml


Powder and solvent for solution for injection.


Horses




France







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL 50 MG/ML


Ceftiofur (sous forme de sel de sodium)


50 mg/ml


Powder and solvent for solution for injection.


Cattle, pigs




France







INTERVET




Rue Olivier De Serres




Angers Technopole




49070 Beaucouze




FRANCE






COBACTAN 4,5 % PS


Cefquinome (sous forme de sulfate)


45 mg/ml


Powder and solvent for solution for injection.


Cattle, horses




France







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






CEFENIL 50 MG/ML


Ceftiofur (sous forme de sel de sodium)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




France







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS


Ceftiofur (sous forme de chlorhydrate)


50 mg/ml


Suspension for injection


Cattle, pigs




France







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






VIRBACEF POUDRE POUR SOLUTION INJECTABLE POUR BOVINS ET PORCINS


Ceftiofur (sous forme de sel de sodium)


50 mg/ml


Powder for solution for injection.


Cattle, pigs




France







Vetoquinol S.A.




Magny-Vernois




70200 Lure




FRANCE






CEFTIOCYL 50 MG/ML SUSPENSION INJECTABLE POUR BOVINS ET PORCINS


Ceftiofur (sous forme de chlorhydrate)


50 mg/ml


Suspension for injection


Cattle, pigs




France







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






READYCEF 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS


Ceftiofur (sous forme de chlorhydrate)


50 mg/ml


Suspension for injection


Cattle, pigs




France







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL-RTU 50 MG/ML SUSPENSION INJECTABLE POUR BOVINS ET PORCINS


Ceftiofur (sous forme de chlorhydrate)


50 mg/ml


Suspension for injection


Cattle, pigs




France







Continental Farmaceutica, S.L.




Parque Empresarial La Moraleja




Avenida de Europa 20-B




E-28108 Madrid, Alcobendas




SPAIN






TRULEVA RTU 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS


Ceftiofur (sous forme de chlorhydrate)


50 mg/ml


Suspension for injection.


Cattle, pigs




France







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






CEFTIOSAN 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS


Ceftiofur (sous forme de chlorhydrate)


50 mg/ml


Suspension for injection


Cattle, pigs




France







Laboratorios SYVA S.A.U.




Avda. Párroco Pablo Díez 49-57




24010 León




SPAIN






ACTIONIS 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS


Ceftiofur (sous forme de chlorhydrate)


50 mg/ml


Suspension for injection


Cattle, pigs




France







Laboratorios Maymó, S.A.




Vía Augusta, 302




08017. Barcelona




SPAIN






CEMAY 50 MG/ML SUSPENSION INJECTABLE POUR PORCS


Ceftiofur (sous forme de chlorhydrate)


50 mg/ml


Suspension for injection


Pigs




Germany







Laboratorios SYVA S.A.U.




Avda. Párroco Pablo Díez 49-57




24010 León




SPAIN






Actionis 50 mg/ml Injektionssuspension


ceftiofur HCl


50 mg/ml


Suspension for injection


Cattle, pigs




Germany







CEVA Tiergesundheit GmbH




Kanzlerstr. 4




D-40472 Düsseldorf




GERMANY






CEVAXEL-RTU


ceftiofur HCl


50 mg/ml


Suspension for injection


Cattle, pigs




Germany







Intervet Deutschland GmbH




Feldstr. 1a




D-85716 Unterschleißheim




GERMANY






Cobactan LA 7,5 %


cefquinome sulfate


75 mg/ml


Suspension for injection


Cattle




Germany







Laboratorios Maymó S.A.




Calle Ferro 9, Poligono Industrial Can Pelegri




E-08755 Castellbisbal (Barcelona)




SPAIN






CEMAY 50 mg/ml


ceftiofur HCl


50 mg/ml


Suspension for injection


Pigs




Germany







Intervet Deutschland GmbH




Feldstr. 1a




D-85716 Unterschleißheim




GERMANY






Cobactan 2,5 %


cefquinome sulfate


25 mg/ml


Suspension for injection


Cattle, pigs




Germany







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Ceftiosan, 50 mg/ml, injectable suspension for cattle and pigs


ceftiofur HCl


50 mg/ml


Suspension for injection


Cattle, pigs




Germany







Vetoquinol GmbH




Parkstr. 10




D-88212 Ravensburg




GERMANY






CEFTIOCYL


ceftiofur HCl


50 mg/ml


Suspension for injection


Cattle, pigs




Germany







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil 50 mg/ml


ceftiofur sodium


50 mg/ml


Powder and solvent for reconstitution


Cattle, pigs




Germany







Intervet Deutschland GmbH




Feldstr. 1a




D-85716 Unterschleißheim




GERMANY






Cobactan 4,5 %


cefquinome sulfate


45 mg/ml


Powder and solvent for reconstitution


Cattle, horses




Germany







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






Readycef 50 mg/ml Injektionssuspension für Schweine und Rinder


ceftiofur HCl


50 mg/ml


Suspension for injection


Cattle, pigs




Germany







CEVA Tiergesundheit GmbH




Kanzlerstr. 4




D-40472 Düsseldorf




GERMANY






CEVAXEL 50 mg/ml


ceftiofur sodium


50 mg/ml


Powder and solvent for reconstitution


Cattle, pigs




Germany







Intervet Deutschland GmbH




Feldstr. 1a




D-85716 Unterschleißheim




GERMANY






Cobactan IV 4,5 % Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Pferde


cefquinome sulfate


45 mg/ml


Powder and solvent for reconstitution


Horses




Germany







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR


ceftiofur HCl


50 mg/ml


Suspension for injection


Cattle, pigs




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




GERMANY






Excenel 1g Pulver zur Herstellung einer Injektionslösung für Schweine und Rinder


ceftiofur sodium


50 mg/ml


Powder


Cattle, pigs




Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin




GERMANY






Excenel 4g


ceftiofur sodium


50 mg/ml


Powder


Cattle, pigs




Germany







Pfizer GmbH




Linkstr. 10




D-10785 Berlin




GERMANY






Excenel RTU


ceftiofur HCl


50 mg/ml


Suspension for injection


Cattle, pigs




Germany







Continental Farmaceutica, S.L.




Parque Empresarial La Moraleja




Avenida de Europa 20-B




E-28108 Madrid, Alcobendas




SPAIN






Truleva RTU


ceftiofur HCl


50 mg/ml


Suspension for injection


Cattle, pigs




Greece







INTERVET HELLAS AE




Ag Dimitriou Str 63, Alimos




174 55 Athens




GREECE






COBACTAN


Cefquinome sulphate


25 mg/ml


Inj.sol.


Cattle, pigs




Greece







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN 4,5 %


Cefquinome sulphate


45 mg/ml


Powder and solvent for solution for injection


Horses, foals, cattle, calves




Greece







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN LA


Cefquinome sulphate


75 mg/ml


Suspension for injection


Cattle




Greece







CEVA HELLAS




Ag. Nikolaou 15




17455 Alimos




GREECE






CEVAXEL


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Greece







CEVA HELLAS




Ag. Nikolaou 15




17455 Alimos




GREECE






CEVAXEL-RTU, for cattle and pigs


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Greece







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






CEFENIL


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Greece







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






VIRBACEF σκόνη για ενέσιμο διάλυμα για βοοειδή και χοίρους


Ceftiofur


50 mg/ml


Powder for Solution for Injection


Cattle, pigs




Greece







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






READYCEF


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Greece







PFIZER HELLAS AE




Messogeion Ave 243.




Neo Psychiko




GR-154 51




GREECE






EXCENEL


CEFTIOFUR


50 mg/ml


Ppowder for injection


Cattle, pigs




Greece







PFIZER HELLAS AE




Messogeion Ave 243.




Neo Psychiko




GR-154 51




GREECE






EXCENEL PTU


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Greece







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR


Ceftiofur (as Ceftiofur Hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Hungary







Pfizer Co. Ltd.




Budapest




Alkotás u. 54.




H-1123




HUNGARY






Excenel SP injekció


Ceftiofur Sodium


50 mg/ml


Sterile powder for injection
Water for parenteral use


Cattle, pigs




Hungary







Pfizer Co. Ltd.




Budapest




Alkotás u. 54.




H-1123




HUNGARY






Excenel RTU injekció


Ceftiofur Hydrochloride


50 mg/ml


Injection


Cattle, pigs




Hungary







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan 2,5 % injekció


Cefquinom sulphate


25 mg/ml


Injection


Cattle, pigs




Hungary







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan IV 4,5 % injekció


Cefquinom sulphate


45 mg/ml


Injection


Cattle, horses




Hungary







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan LA 7,5 % injekció


Cefquinom sulphate


75 mg/ml


Injection


Cattle




Hungary







Ceva Phylaxia Co. Ltd.




Budapest




Szállás u. 5.




H-1107




HUNGARY






Cevaxel RTU 50 mg/ml szuszpenziós injekció szarvasmarha és sertés részére


Ceftiofur Hydrochloride


50 mg/ml


Injection


Cattle, pigs




Hungary







Ceva Phylaxia Co. Ltd.




Budapest




Szállás u. 5.




H-1107




HUNGARY






Cevaxel 50 mg/ml por és oldószer injekcióhoz szarvasmarha és sertés részére


Ceftiofur Sodium


50 mg/ml


Sterile powder for injection
Water for parenteral use


Cattle, pigs




Hungary







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






Ceftiomax 50 mg/ml injekció sertés és szarvasmarha részére


Ceftiofur Hydrochloride


50 mg/ml


Injection


Cattle, pigs




Hungary







Vetoquinol S.A.




Magny-Vernois




70200 Lure




FRANCE






Ceftiocyl 50 mg/ml injekció szarvasmarhák és sertések részére


Ceftiofur Hydrochloride


50 mg/ml


Injection


Cattle, pigs




Hungary







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






Eficur 50 mg/ml injekció szarvasmarhák és sertések részére


Ceftiofur Hydrochloride


50 mg/ml


Injection


Cattle, pigs




Iceland







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






Eficur vet.


Ceftiofurum INN


50 mg/ml


Suspension for injection


Cattle, pigs




Ireland







Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)




Ringaskiddy Co. Cork




IRELAND






Excenel RTU, 50 mg/ml, suspension for injection for pigs and cattle


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for Injection


Cattle, pigs




Ireland







Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)




Ringaskiddy Co. Cork




IRELAND






Excenel 1 g Sterile Powder for Solution for Injection


Ceftiofur (as ceftiofur sodium)


50 mg/ml


Powder for solution for injection


Cattle, pigs




Ireland







Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)




Ringaskiddy Co. Cork




IRELAND






Excenel 4 g Sterile Powder for Solution for Injection


Ceftiofur (as ceftiofur sodium)


50 mg/ml


Powder for solution for injection


Cattle, pigs




Ireland







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR 50 mg/ml suspension for injection for pigs and cattle


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Pigs, cattle




Ireland







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






Virbacef Powder for Solution for Injection for cattle and pigs.


Ceftiofur (as ceftiofur sodium)


50 mg/ml


Powder for solution for injection


Cattle, pigs




Ireland







Vetoquinol UK Limited




Vetoquinol House




Great Slade




Buckingham Industrial Park




Buckingham




MK18 1PA




UNITED KINGDOM






Ceftiocyl 50 mg/ml, suspension for injection for cattle and pigs.


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Ireland







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL-RTU 50 mg/ml, suspension for injection for cattle and pigs


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Ireland







Intervet Ireland Ltd.




Magna Drive




Magna Business Park




Citywest Road




Dublin 24




IRELAND






Cobactan 2,5 % w/v Suspension for Injection


Cefquinome sulfate


25 mg/ml


Suspension for injection


Cattle, pigs




Ireland







Intervet Ireland Ltd.




Magna Drive




Magna Business Park




Citywest Road




Dublin 24




IRELAND






Cobactan LA 7,5 % suspension for injection for cattle


Cefquinome (as sulfate)


75 mg/ml


Suspension for injection


Cattle




Ireland







Intervet Ireland Ltd.




Magna Drive




Magna Business Park




Citywest Road




Dublin 24




IRELAND






Cobactan 4,5 % powder and solvent for solution for injection for horse and cattle


Cefquinome (as sulfate)


45 mg/ml


Powder and solvent for solution for injection.


Horses (adult and foal), cattle (adult and calf)




Ireland







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Ceftiosan 50 mg/ml suspension for injection for pigs and cattle


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Pigs weighing up to 125 kg.
Cattle




Ireland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs.


Ceftiofur (as ceftiofur sodium)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Italy







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






CEFENIL


Ceftiofur chlorhidrate


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







Vetoquinol S.A.




Magny-Vernois




70200 Lure




FRANCE






CEFTIOCYL


Ceftiofur as hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






CEFTIOMAX


Ceftiofur chlorhidrate


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






CEFTIOSAN


Ceftiofur chlorhidrate


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







Laboratorios Maymó, S.A.




Vía Augusta, 302




08017. Barcelona




SPAIN






CEMAY


Ceftiofur chlorhidrate


50 mg/ml


Suspension for injection


Pigs




Italy







Laboratorios SYVA S.A.U.




Avda. Párroco Pablo Díez 49-57




24010 León




SPAIN






ACTIONIS


Ceftiofur as hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







Ceva Vetem SpA




Via Colleoni 15




20041 Agrate Brianza (MB)




ITALY






CEVAXEL


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL RTU


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







PFIZER ITALIA SRL




Via Valbondione, 113




00188 Roma




ITALY






EXCENEL


Sodium ceftiofur


50 mg/ml


Powder for injection


Cattle, pigs, horses




Italy







PFIZER ITALIA SRL




Via Valbondione, 113




00188 Roma




ITALY






EXCENEL RTU


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







Fatro Spa




Via Emilia 285




40064 Ozzano Dell'Emilia (BO)




ITALY






WONDERCEF


Ceftiofur sodium


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Italy







Continental Farmaceutica, S.L.




Parque Empresarial La Moraleja




Avenida de Europa 20-B




E-28108 Madrid, Alcobendas




SPAIN






TRULEVA


Ceftiofur chlorhidrate


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







Continental Farmaceutica, S.L.




Parque Empresarial La Moraleja




Avenida de Europa 20-B




E-28108 Madrid, Alcobendas




SPAIN






TRULEVA


Ceftiofur chlorhidrate


50 mg/ml


Suspension for injection


Cattle, pigs




Italy







INTERVET ITALIA SRL




Via Nettunense Km 20,300.




04011 Aprilia (LT)




ITALY






COBACTAN


Cefquinome sulphate


25 mg/ml


Suspension for injection


Cattle, pigs




Italy







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN IV IM 4,5 %


Cefquinome sulphate


No information available


Suspension for injection


Cattle, horses




Italy







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN LA 7,5 %


Cefquinome sulphate


No information available


Suspension for injection


Cattle




Latvia







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil


ceftiofur sodium


50 mg/ml


Powder for solution for injection


Cattle, pigs




Latvia







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL


ceftiofur sodium


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Latvia







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






Ceftiomax


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Latvia







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






Cevaxel-RTU


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Latvia







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan 2,5 %


cefquinome


25 mg/ml


Suspension for injection


Cattle, pigs




Latvia







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan LA 7,5 %


cefquinome


75 mg/ml


Suspension for injection


Cattle




Latvia







Pfizer Animal Health




Boulevard de la Paine 17




B-1050 Brussels




BELGIUM






Excenel RTU


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Latvia







Pfizer Animal Health




Boulevard de la Paine 17




B-1050 Brussels




BELGIUM






Excenel Sterile Powder


ceftiofur sodium


50 mg/ml


Powder for solution for injection


Cattle, pigs




Latvia







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Latvia







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Ceftiosan


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Lithuania







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN 2,5 %, injekcinė suspensija


Cefquinome (as sulphate)


25 mg/ml


Suspension for injection


Cattle, pigs




Lithuania







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN LA 7,5 %, injekcinė suspensija


Cefquinome (as sulphate)


75 mg/ml


Suspension for injection


Cattle




Lithuania







Pfizer Manufacturing Belgium N,V./S.A.




Rijksweg 12




B-2870 Puurs




BELGIUM






EXCENEL, milteliai injekciniam tirpalui ruošti


Ceftiofur (as sodium)


50 mg/ml


Powder for solution for injection


Cattle, pigs, one-day-old chickens




Lithuania







Pfizer Manufacturing Belgium N,V./S.A.




Rijksweg 12




B-2870 Puurs




BELGIUM






EXCENEL RTU, injekcinė suspensija


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Lithuania







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR 50 mg/ml injekcinė ceftiofuro suspensija kiaulėms ir galvijams


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Lithuania







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL 50 mg/ml, milteliai ir tirpiklis injekciniam tirpalui ruošti


Ceftiofur (as sodium)


50 mg/ml


Powder for solution for injection


Cattle, pigs




Lithuania







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL RTU, injekcinė suspensija


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Lithuania







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






CEFENIL 50 mg/ml, milteliai ir tirpiklis injekciniam tirpalui ruošti


Ceftiofur (as sodium)


50 mg/ml


Powder for solution for injection


Cattle, pigs




Lithuania







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






Ceftiomax 50 mg/ml injekcinė suspensija kiaulėms ir galvijams


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Lithuania







Interchemie werken "De Adelaar" BV




Horsterweg 26A




5811 AC Castenray




THE NETHERLANDS






CEFTIONEL-50, injekcinė suspensija galvijams ir kiaulėms


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Lithuania







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Pigs weighing up to 125 kg, cattle




Poland







Pfizer Trading Polska Sp. z o.o.




ul. Rzymowskiego 34




02-697 Warszawa




POLAND






Excenel Ceftiofur (w postaci Ceftiofuru sodowego) 50 mg/ml, proszek do sporządzania roztworu do wstrzykiwań


Ceftiofurum


50 mg/ml


Powder for solution for injection


Cattle, horses, pigs




Poland







Pfizer Trading Polska Sp. z o.o.




ul. Rzymowskiego 34




02-697 Warszawa




POLAND






Excenel RTU


Ceftiofurum


50 mg/ml


Suspention for injection


Cattle, pigs




Poland







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






Ceftiomax 50 mg/ml zawiesina do wstrzykiwań dla świń i bydła


Ceftiofuri hydrochloridum


50 mg/ml


Suspention for injection


Cattle, pigs




Poland







Ceva Animal Health Polska Sp. z o.o.




ul. Okrzei 1A




03-715 Warszawa




POLAND






Cevaxel 50 mg/ml proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań dla bydła i świń


Ceftiofurum


50 mg/ml


Powder and solution for solution for injection


Cattle, pigs




Poland







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






Eficur 50 mg/ml zawiesina do wstrzykiwań dla świń i bydła


Ceftiofurum


50 mg/ml


Suspention for injection


Cattle, pigs




Poland







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefur 50 mg/ml proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań dla bydła i świń


Ceftiofurum natricum


50 mg/ml


Powder and solution for solution for injection


Cattle, pigs




Poland







Vetoquinol Biowet Sp. z o.o




ul. Kosynierów Gdyńskich 13-14




66-400 Gorzów Wielkopolski




POLAND






Ceftiocyl 50 mg/ml, zawiesina do wstrzykiwań dla bydła i świń


Ceftiofur as hydrochloride


50 mg/ml


Suspention for injection


Cattle, pigs




Poland







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan, 25 mg/ml, zawiesina do wstrzykiwań dla bydła i świń


Cefquinomum


25 mg/ml


Suspention for injection


Cattle, pigs




Poland







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan 4,5 % proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań dla koni i bydła


Cefquinomum


45 mg/ml


Powder and solution for solution for injection


Cattle, horses




Poland







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan LA 7,5 % zawiesina do wstrzykiwań dla bydła


Cefquinomum


75 mg/ml


Suspention for injection


Cattle




Portugal







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil 50 mg/ml pó e solvente para solução injectável para bovinos e suínos


Ceftiofur (as ceftiofur sodium)


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Portugal







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






Virbacef Pó para solução injectável para bovinos e suínos


Ceftiofur (as ceftiofur sodium)


50 mg/ml


Powder for solution for injection.


Cattle, pigs




Portugal







Intervet Portugal – Saúde Animal, Lda




Rua Agualva dos Açores n.o 16




2735-557 Agualva-Cacém




PORTUGAL






COBACTAN 2,5 % p/v suspensão injectável para bovinos e suínos


Cefquinome (as sulfate)


25 mg/ml


Suspension for injection


Cattle, pigs




Portugal







Laboratórios Pfizer, Lda




Lagoas Park – Edifício 10




2740-244 Porto Salvo




PORTUGAL






EXCENEL RTU


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection.


Cattle, pigs




Portugal







CALIER PORTUGAL, S.A.




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




Estrada de Albarraque




2710 - 335 Sintra




PORTUGAL






CEFTIOMAX 50 mg/ml suspensão injectável para bovinos e suínos


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Portugal







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR 50 mg/ml suspensão injectável para suínos e bovinos


Ceftiofur (as Ceftiofur Hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Portugal







Intervet Portugal – Saúde Animal, Lda




Rua Agualva dos Açores n.o 16




2735-557 Agualva-Cacém




PORTUGAL






COBACTAN LA 7,5 %, suspensão injectável para bovinos


Cefquinome (as sulfate)


75 mg/ml


Suspension for injection


Cattle




Portugal







Intervet Portugal – Saúde Animal, Lda




Rua Agualva dos Açores n.o 16




2735-557 Agualva-Cacém




PORTUGAL






Cobactan 4,5 % pó e solvente para solução injectável para equinos e bovinos


cefquinome (as sulphate)


45 mg/ml


Powder and solvent for solution for injection


Horses (adult and foal), cattle (adult and calf)




Portugal







Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.




Rua Doutor António Loureiro Borges, no 9/9A, 9oA




Miraflores- 1495-131 Algés




PORTUGAL






CEVAXEL 50 mg/ml pó e solvente para solução injectável para bovinos e suínos


Ceftiofur (as sodium)


50 mg/ml


Powder and solvent for solution for injection.


Cattle, pigs




Portugal







VÉTOQUINOL, Lda




Rua Consiglieri Pedroso, no 123, Edifício H




Queluz de Baixo




2730-056 BARCARENA




PORTUGAL






Ceftiocyl 50 mg/ml, suspensão injectável para Bovinos e Suínos


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Portugal







Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.




Rua Doutor António Loureiro Borges, no 9/9A, 9oA




Miraflores- 1495-131 Algés




PORTUGAL






CEVAXEL -RTU 50 mg/ml, suspensão injectável para bovinos e suínos


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Portugal







Laboratorios SYVA S.A.U.




Avda. Párroco Pablo Díez 49-57




24010 León




SPAIN






Actionis 50 mg/ml, suspensão injectável para suínos e bovinos


Ceftiofur (as ceftiofur hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Portugal







Laboratorios Maymó, S.A.




Vía Augusta, 302




08017. Barcelona




SPAIN






CEMAY 50 mg/ml, suspension for injection for pigs


Ceftiofur (as hydrochloride)


50 mg/ml


Supension for injection


Pigs




Portugal







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle


Ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Pigs weighing up to 125 kg. Cattle.




Romania







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN 2,5 %


Cefquinome


25 mg/ml


Injectable suspension


Cattle, dairy cows, calves, pigs, piglets




Romania







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN 7,5 % L.A.


Cefquinome


75 mg/ml


Injectable suspension


Cattle




Romania







Pfizer Ltd




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






EXCENEL RTU


Ceftiofur


50 mg/ml


Injectable suspension


Cattle, pigs




Romania







Pfizer Animal Health




Boulevard de la Paine 17




B-1050 Brussels




BELGIUM






EXCENEL


Ceftiofur


50 mg/ml.


Sterile powder


Cattle, pigs




Romania







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR 50mg/ml


Ceftiofur


50 mg/ml


Oily suspension


Cattle, pigs




Romania







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






CEFENIL 50 m


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Romania







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






CEVAXEL 50mg/ml


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection


Cattle, horses, pigs




Romania







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






CEFTIOMAX 50mg/ml


Ceftiofur


50 mg/ml


Injectable suspension


Cattle, pigs




Slovakia







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6J




UNITED KINGDOM






Cefenil 50 mg/ml prášok a riedidlo na prípravu injekčného roztoku pre hovädzí dobytok a ošípané


ceftiofurum


50 mg/ml


powder+ diluent


Cattle, pigs




Slovakia







Vetoquinol s.r.o.




Zámečnícka 411




CZ-288 02 Nymburk




CZECH REPUBLIC






Ceftiocyl 50 mg/ml injekčná suspenzia


Ceftiofur as hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




Slovakia







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






Cevaxel 50 mg/ml prášok a riedidlo na prípravu injekčného roztoku pre hovädzí dobytok a ošípané


ceftiofurum


50 mg/ml


powder+ diluent


Cattle, pigs




Slovakia







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






Efficur 50 mg/ml injekčná suspenzia pre ošípané a hovädzí dobytok


ceftiofurum


50 mg/ml


Suspension for injection


Cattle, pigs




Slovakia







Pfizer Manufacturing Belgium N,V./S.A.




Rijksweg 12




B-2870 Puurs




BELGIUM






Excenel 50 mg/ml lyofilizát na prípravu injekčného roztoku


ceftiofurum


50 mg/ml


lyophilisate


Cattle, pigs, one day old chicken, horses.




Slovakia







Pfizer Manufacturing Belgium N,V./S.A.




Rijksweg 12




B-2870 Puurs




BELGIUM






Excenel RTU 50 mg/ml injekčná suspenzia


ceftiofurum


50 mg/ml


Suspension for injection


Cattle, pigs




Slovakia







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan 25 mg/ ml injekčná suspenzia


cefquinomum


25 mg/ml


Suspension for injection


Cattle, pigs




Slovakia







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan LA 7,5 % inj.susp. pre hovädzí dobytok


cefquinomum


75 mg/ml


Suspension for injection


Cattle




Slovakia







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






Virbacef prášok na prípravu injekčného roztoku pre hovädzí dobytok a ošípané


Ceftiofurum (ut natricum)


50 mg/ml


Powder for solution for injection


Cattle, pigs




Slovakia







Ceva Sante Animale




10 avenue de la Ballastiere




33500 Libourne




FRANCE






Cevaxel RTU 50 mg/ml injekčná suspnzia pre hovädzí dobytok a ošípané


ceftiofurum


50 mg/ml


Suspension for injection


Cattle, pigs




Slovenia







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN 2,5 %


cefquinome (as sulfate)


25 mg/ml


Suspension for injection


Cattle, pigs




Slovenia







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN LA 7,5 % suspenzija za injiciranje za govedo


cefquinome (as sulfate)


75 mg/ml


Suspension for injection


Cattle




Slovenia







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR 50 mg/ml suspenzija za injiciranje za prašiče in govedo


ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Slovenia







Pfizer Luxembourg SARL




51 Avenue J.F.Kennedy




L-1855 Luxembourg




LUXEMBOURG






EXCENEL 50 mg/ml prašek za raztopino za injiciranje za govedo in prašiče


ceftiofur


50 mg/ml


Powder for solution for injection


Cattle, pigs




Slovenia







Pfizer Luxembourg SARL




51 Avenue J.F.Kennedy




L-1855 Luxembourg




LUXEMBOURG






EXCENEL RTU suspenzija za injiciranje za prašiče in govedo


ceftiofur (as hydrochloride)


50 mg/ml


Suspension for injection


Cattle, pigs




Spain


PFIZER, S.A.
Avda. de Europa, 20 B.
Parque Empresarial
28108 La Moraleja
SPAIN


EXCENEL


Ceftiofur


50 mg/ml


Sterile powder to dissolve into sterile bacteriostatic water


Cattle, pigs




Spain







CEVA SALUD ANIMAL, S.A.




Carabela La Niña no 12




5a planta




08017 Barcelona




SPAIN






CEVAXEL 50 mg/ml


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Spain







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






CEFENIL 50 mg/ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE PARA BOVINO Y PORCINO


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Spain


PFIZER, S.A.
Avda. de Europa, 20 B.
Parque Empresarial
28108 La Moraleja
SPAIN


EXCENEL RTU


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Spain







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






CEFTIOMAX 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO


ceftiofur


50 mg/ml


Suspension for injection


Pigs




Spain







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR


ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Spain







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






CEFTIOMAX 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO Y VACUNO


ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Spain







Vetoquinol Especialidades Veterinarias, S.A.




Autovia Fuencarral-Alcobendas km 15




700-Edificio Europa I, Portal 3, 2o5




28108 Alcobendas.




SPAIN






CEFTIOCYL 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO Y BOVINO


ceftiofur as hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




Spain







CEVA SALUD ANIMAL, S.A.




Carabela La Niña no 12




5a planta




08017 Barcelona




SPAIN






CEVAXEL RTU 50 MG/ML SUSPENSIÓN INYECTABLE PARA BOVINO Y PORCINO


ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Spain







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil HCL Injection for Cattle and Swine (Name proposed in ES: Cefenil RTU)
Procedure curretly ongoing


ceftiofur


50 mg/ml


Solution for injection


Cattle, pigs




Spain







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle


ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




Spain







Laboratorios SYVA S.A.U.




Avda. Párroco Pablo Díez 49-57




24010 León




SPAIN






ACTIONIS 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO Y BOVINO


ceftiofur as hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




Spain







Laboratorios Maymó, S.A.




Vía Augusta, 302




08017. Barcelona




SPAIN






CEMAY 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO


ceftiofur


50 mg/ml


Suspension for injection


Pigs




Spain







Laboratorios E Industrias Iven, S.A.




Luis I, 56.




Polígono Industrial Vallecas




28031 Madrid




SPAIN






CEFTIONIL 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO


ceftiofur


50 mg/ml


Suspension for injection


Pigs




Spain







Laboratorios Intervet, S.A.




Polígono Industrial El Montalvo I




C/ Zeppelín no 6, parcela 39




37188- Carbajosa de la Sagrada (Salamanca)




SPAIN






COBACTAN 2,5 % P/V SUSPENSIÓN INYECTABLE PARA BOVINO Y PORCINO


cefquinoma


25 mg/ml


Suspension for injection


Cattle, pigs




Spain







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN LA 7,5 %


cefquinoma


75 mg/ml


Suspension for injection


Cattle




Spain







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






COBACTAN 4,5 % INYECTABLE PARA EQUINO Y BOVINO


Cefquinoma


45 mg/ml


Powder and solvent for solution for injection


Cattle, horses




Sweden







Pfizer Oy, Animal Health




Tietokuja 4




FI-00330 Helsinki




FINLAND






Excenel vet.®


ceftiofur sodium


1g and 4g


Powder for injection


Cattle




Sweden







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Ceftiofur N-vet


ceftiofur sodium


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




Sweden







Vetoquinol scandinavia AB




Box 9




SE-26521 Åstorp




SWEDEN






Ceftiocyl


ceftiofur hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




The Netherlands







Ceva Santé Animale B.V.




Tiendweg 8c




2671 SB Naaldwijk




THE NETHERLANDS






CEVAXEL 50 mg/ml poeder en oplosmiddel voor oplossing voor injectie voor runderen en varkens


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




The Netherlands


Vétoquinol BV
Postbus 3191
NL-5203 DD
’s-Hertogenbosch
THE NETHERLANDS


CEFTIOCYL 50 mg/ml, suspensie voor injectie voor runderen en varkens


Ceftiofur as hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




The Netherlands







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






READYCEF 50 mg/ml suspensie voor injectie voor varkens en runderen


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




The Netherlands







Ceva Santé Animale B.V.




Tiendweg 8c




2671 SB Naaldwijk




THE NETHERLANDS






CEVAXEL-RTU 50 mg/ml, suspensie voor injectie voor runderen en varkens


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




The Netherlands







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




THE NETHERLANDS






Ceftiosan, 50 mg/ml, suspensie voor injectie voor runderen en varkens


Ceftiofur


50 mg/ml


Suspension for injection


Pigs weighing up to 125 kg.
Cattle




The Netherlands







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






EFICUR 50 mg/ml suspensie voor injectie voor runderen en varkens


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




The Netherlands







Pfizer Animal Health B.V.




Rivium Westlaan 142




2909 Ld Capelle a/d Ijssel




THE NETHERLANDS






EXCENEL RTU


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




The Netherlands







D-Vett. B.V.




Gebroek 37




6043 GP Roermond




THE NETHERLANDS






EXCENEL RTU


Ceftiofur


50 mg/ml


Suspension for injection


Cattle, pigs




The Netherlands







Intervet Nederland B.V.




Postbus 50




5830 AB Boxmeer




THE NETHERLANDS






Cobactan LA 7,5 %


Cefquinome


75 mg/ml


Suspension for injection


Cattle




The Netherlands







Intervet Nederland B.V.




Postbus 50




5830 AB Boxmeer




THE NETHERLANDS






Cobactan 4,5 %, poeder en oplosmiddel voor oplssing voor injectie.


Cefquinome


45 mg/ml


Powder and solvent for solution for injection.


Horses (adult and foal) and cattle (adult and calf)




The Netherlands







Intervet Nederland B.V.




Postbus 50




5830 AB Boxmeer




THE NETHERLANDS






Cobactan IV 4,5 %


Cefquinome


45 mg/ml


Powder and solvent for solution for injection.


Horses (adult and foal)




The Netherlands







Intervet Nederland B.V.




Postbus 50




5830 AB Boxmeer




THE NETHERLANDS






Cobactan 2,5 % suspensie voor injectie voor rund en varken


Cefquinome


25 mg/ml


Suspension for injection


Cattle, pigs




The Netherlands







D-Vett. B.V.




Gebroek 37




6043 GP Roermond




THE NETHERLANDS






Cobactan 2,5 % suspensie voor injectie voor rund en varken


Cefquinome


26 mg/ml


Suspension for injection


Cattle, pigs




The Netherlands







Pfizer Animal Health B.V.




Rivium Westlaan 142




2909 LD Capelle a/d Ijssel




THE NETHERLANDS






Excenel


Ceftiofur


50 mg/ml


Powder for solution for injection.


Cattle, pigs




The Netherlands







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil 50 mg/ml, poeder en oplosmiddel voor oplossing voor injectie voor runderen en varkens


Ceftiofur


50 mg/ml


Powder and solvent for solution for injection.


Cattle, pigs




United Kingdom







Intervet UK




Walton Manor, Walton




Milton Keynes




Buckinghamshire




MK7 7AJ




UNITED KINGDOM






Cobactan 2,5 % w/v suspension for injection for cattle and pigs


Cefquinome (as sulfate)


25 mg/ml


Suspension for injection


Cattle, pigs




United Kingdom







Intervet UK




Walton Manor, Walton




Milton Keynes




Buckinghamshire




MK7 7AJ




UNITED KINGDOM






Cobactan 25 mg/ml Suspension for Injection


Cefquinome (as sulfate)


25 mg/ml


Suspension for injection


Cattle, pigs




United Kingdom







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




THE NETHERLANDS






Cobactan 4,5 % Powder and Solvent for Solution for Injection for Horse and Cattle


Cefquinome (as sulfate)


45 mg/ml


Powder and solvent for solution for injection


Cattle, horses




United Kingdom







Intervet UK




Walton Manor, Walton




Milton Keynes




Buckinghamshire




MK7 7AJ




UNITED KINGDOM






Cobactan LA 7,5 % Suspension for Injection for Cattle


Cefquinome (as sulfate)


75 mg/ml


Suspension for injection


Cattle




United Kingdom







Laboratorios SYVA S.A.U.




Avda. Párroco Pablo Díez 49-57




24010 León




SPAIN






Actionis 50 mg/ml Suspension for Injection for Cattle and Pigs


Ceftiofur Hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs


Ceftiofur Sodium


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




United Kingdom







Norbrook Laboratories Limited




Station Works




Camlough Road




Newry




Co Down,




BT35 6JP




UNITED KINGDOM






Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle, Pigs and Horses


Ceftiofur Sodium


50 mg/ml


Powder and solvent for solution for injection


Cattle, horses, pigs




United Kingdom







Vetoquinol UK Limited




Vetoquinol House




Great Slade




Buckingham Industrial Park




Buckingham




MK18 1PA




UNITED KINGDOM






Ceftiocyl 50 mg/ml Suspension for Injection for Cattle and Pigs


Ceftiofur Hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




United Kingdom







Alfasan Nederland BV




Kuipersweg 9




3449 JA Woerden




The Netherlands






Ceftiosan 50 mg/ml Injectable Suspension for Cattle and Pigs


Ceftiofur Hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




United Kingdom







Ceva Animal Health Ltd




90 The Broadway




Chesham




Buckinghamshire




HP5 1EG




UNITED KINGDOM






Cevaxel 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs


Ceftiofur Sodium


50 mg/ml


Powder and solvent for solution for injection


Cattle, pigs




United Kingdom







Ceva Animal Health Ltd




90 The Broadway




Chesham




Buckinghamshire




HP5 1EG




UNITED KINGDOM






Cevaxel - RTU


Ceftiofur Hydrochloride


No information provided


Suspension for injection


Cattle, pigs




United Kingdom







Laboratorios Hipra S.A.




Avenida la Selva 135




17 170, Amer (Girona)




SPAIN






Eficur 50 mg/ml Suspension for Injection for Pigs and Cattle


Ceftiofur Hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




United Kingdom







Pfizer Ltd




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






Excenel 1 g Sterile Powder for Solution for Injection


Ceftiofur


50 mg/ml


Powder for solution for injection


Cattle, horses, pigs




United Kingdom







Pfizer Ltd




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






Excenel 4 g Sterile Powder for Solution for Injection


Ceftiofur


50 mg/ml


Powder for solution for injection


Cattle, horses, pigs




United Kingdom







Pfizer Ltd




Ramsgate Road




Sandwich, Kent




CT13 9NJ




UNITED KINGDOM






Excenel RTU 50 mg/ml Suspension for Injection for Pigs and Cattle


Ceftiofur Hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




United Kingdom







Laboratorios Calier S.A.




Barcelones 26 (Pla del Ramassa)




ES 08520, Les Franqueses del Valles




SPAIN






Readycef 50 mg/ml Suspension for Injection for Swine and Cattle


Ceftiofur Hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




United Kingdom







Continental Farmaceutica, S.L.




Parque Empresarial La Moraleja




Avenida de Europa 20-B




E-28108 Madrid, Alcobendas




SPAIN






Truleva RTU 50 mg/ml Suspension for Injection for Pigs and Cattle


Ceftiofur Hydrochloride


50 mg/ml


Suspension for injection


Cattle, pigs




United Kingdom







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






Virbacef Powder for Solution for Injection for Cattle and Pigs


Ceftiofur as Ceftiofur Sodium


50 mg/ml


Powder for solution for injection


Cattle, pigs




United Kingdom







Virbac S.A.




1ère avenue 2065 m L.I.D




FR 06 516 Carros cedex




FRANCE






Virbacef Sterile Powder for Cattle, Pigs and Horses


Ceftiofur as Ceftiofur Sodium


50 mg/ml


Powder for solution for injection


Cattle, horses, pigs







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




AT - Austria







CSC Pharmaceuticals Handels GmbH




Gewerbestraße 18-20




A-2102 Bisamberg




Austria






Aulin 100 mg - Granulat


100 mg


Granules for oral suspension


Oral use




AT - Austria







CSC Pharmaceuticals Handels GmbH




Gewerbestraße 18-20




A-2102 Bisamberg




Austria






Aulin 100 mg - Suppositorien


100 mg


Suppository


Rectal use




AT - Austria







CSC Pharmaceuticals Handels GmbH




Gewerbestraße 18-20




A-2102 Bisamberg




Austria






Aulin 200 mg - Suppositorien


200 mg


Suppository


Rectal use




AT - Austria







CSC Pharmaceuticals Handels GmbH




Gewerbestraße 18-20




A-2102 Bisamberg




Austria






Aulin 100 mg - Tabletten


100 mg


Tablet


Oral use




AT - Austria







CSC Pharmaceuticals Handels GmbH




Heiligenstädter Straße 395 b




A-1190 Wien




Austria






Mesulid 100 mg - Granulat


100 mg


Granules for oral suspension


Oral use




AT - Austria







CSC Pharmaceuticals Handels GmbH




Gewerbestraße 18-20




A-2102 Bisamberg




Austria






Mesulid 100 mg - Suppositorien


100 mg


Suppository


Rectal use




AT - Austria







CSC Pharmaceuticals Handels GmbH




Heiligenstädter Straße 395 b




A-1190 Wien




Austria






Mesulid 200 mg - Suppositorien


200 mg


Suppository


Rectal use




AT - Austria







CSC Pharmaceuticals Handels GmbH




Heiligenstädter Straße 395 b




A-1190 Wien




Austria






Mesulid 100 mg - Tabletten


100 mg


Tablet


Oral use




BG - Bulgaria







Laboratori Guidotti S.p.A.




Via Livornese, 897




56010 PISA La Vettola




Italy






Nimesil


100 mg


Granules for oral suspension


Oral use




BG - Bulgaria







Zentiva k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Coxtral


100 mg


Tablet


Oral use




BG - Bulgaria







Actavis EAD




29 Atanas Dukov str.




1407 Sofia




Bulgaria






Enetra


100 mg


Tablet


Oral use




BG - Bulgaria







Inbiotech Ltd




5A Triaditza str.




1000 Sofia




Bulgaria






Biolin


100 mg


Tablet


Oral use




BG - Bulgaria







Sopharma AD




16 Iliensko shosse str.




1220 Sofia




Bulgaria






Ameolin


100 mg


Tablet


Oral use




BG - Bulgaria







CSC Pharmaceuticals Ltd-Bulgaria EOOD,




10 Assen Jordanov str.,




1592 Sofia,




Bulgaria






Aulin


100 mg


Tablet


Oral use




BG - Bulgaria







CSC Pharmaceuticals Ltd-Bulgaria EOOD,




10 Assen Jordanov str.,




1592 Sofia,




Bulgaria






Aulin


100 mg


Granules for oral suspension


Oral use




BG - Bulgaria







CSC Pharmaceuticals Ltd-Bulgaria EOOD,




10 Assen Jordanov str.,




1592 Sofia,




Bulgaria






Nimed


100 mg


Tablet


Oral use




BG - Bulgaria







Chaikapharma – Highquality medicines AD,




1 G.M.Dimitrov Blvd




1172 Sofia,




Bulgaria






AllGone


100 mg


Effervescent tablet


Oral use




CY - Cyprus







CDL PHARMACEUTICAL LTD




5 Diomedous str.




P.O.Box 40981




6308 Larnaca




Cyprus






ELINAP TABLETS 100 mg


100 mg


Tablet


Oral use




CY - Cyprus







CHR. K. UNIMED LTD




21 Davlou




2114 Aglantzia




Lefkosia




Cyprus






FLOGOSTOP TABLETS 100 mg


100 mg


Tablet


Oral use




CY - Cyprus







CODAL SYNTO LTD




33 Thekla Lysioti str.




Dorothea Building, 6th floor




P.O.Box 51785




3508 Lemessos




Cyprus






NIMM TABLETS 100 mg


100 mg


Tablet


Oral use




CY - Cyprus







MEDOCHEMIE LTD




1-10 Constantinoupoleos str.




P.O.Box 51409




3505 Lemessos




Cyprus






APONIL TABLETS 100 mg


100 mg


Tablet


Oral use




CZ - Czech Republic







Laboratori Guidotti S.p.A (Menarini Group).




Via Livornese 897




560 10 San Piero a Grado Pisa




Italy






Nimesil


100 mg


Granules for oral suspension


Oral use




CZ - Czech Republic







Medicom International, s.r.o.




Páteřní 1216/7




635 00 Brno




Czech Republic






Aulin


100 mg


Granules for oral solution


Oral use




CZ - Czech Republic







Medicom International, s.r.o.




Páteřní 1216/7




635 00 Brno




Czech Republic






Aulin


100 mg


Tablet


Oral use




CZ - Czech Republic







Zentiva k.s.




Evropská 846/176a




160 00 Prague




Czech Republic






COXTRAL 100 MG TABLETY


100 mg


Tablet


Oral use




CZ - Czech Republic







Medicom International, s.r.o.




Páteřní 1216/7




635 00 Brno




Czech Republic






MESULID


100 mg


Granules for oral solution


Oral use




CZ - Czech Republic







Medicom International, s.r.o.




Páteřní 1216/7




635 00 Brno




Czech Republic






MESULID


100 mg


Tablet


Oral use




CZ - Czech Republic







Medicom International, s.r.o.




Páteřní 1216/7




635 00 Brno




Czech Republic






Nimed


100 mg


Tablet


Oral use




EL - Greece







ALET PHARMACEUTICALS




M. Alexander 121




Agia Varvara 12351




Greece






SPECILID


100 MG/TAB


Tablet


Oral use




EL - Greece







ANFARM HELLAS S.A.




Perikleous 53-57




Gerakas Attikis 153 44




Greece






LEMESILIN


100 MG/TAB


Tablet


Oral use




EL - Greece







ANTONIOS POLYCHRONIS OF MARINOU




Ethnikis Antistaseos 6A




Holargos 15562




Greece






OMNIBUS


100 MG/TAB


Tablet


Oral use




EL - Greece







ANTOR EPE




P. Mavromihali 1




Vrilissia 15235




Greece






MELIMONT


100 MG/TAB


Tablet


Oral use




EL - Greece







ARMEDICA A.E.




Agias Markellis 17




Athens 11855




Greece






ALENCAST


100 MG/TAB


Tablet


Oral use




EL - Greece







B.I. FARMA A.E.




Aristotelous 73




Athens 10434




Greece






NIMESULIDE / B.I. FARMA


100 MG/TAB


Tablet


Oral use




EL - Greece







BALU EPE




30 Km Athens-Lavrion




Markopoulo 19003




Greece






NIBERAN


100 MG/TAB


Tablet


Oral use




EL - Greece







BIOMEDICA-CHEMICA A.E.




G. Lyra 25




Kato Kifissia 14564




Greece






NIMESULIDE / BIOMEDICA CHEMICA


100 MG/TAB


Tablet


Oral use




EL - Greece







BIOSPRAY ABEE




18TH Km Marathonos Avenue




Pallini 15344




Greece






FLOGOSTOP


100 MG/TAB


Tablet


Oral use




EL - Greece







BOEHRINGER INGELHEIM HELLAS S.A.




Ellinikou 2




167 77 Elliniko




Greece






MESULID


100 MG/TAB


Tablet


Oral use




EL - Greece







BOEHRINGER INGELHEIM HELLAS S.A.




Ellinikou 2




167 77 Elliniko




Greece






MESULID


200 MG/SUPP


Suppository


Rectal use




EL - Greece







BOEHRINGER INGELHEIM HELLAS S.A.




Ellinikou 2




167 77 Elliniko




Greece






MESULID


100 MG/SACHET


Granules for oral solution


Oral use




EL - Greece







BROS EPE




Avgis & Gallinis 15




N. Kifissia 14564




Greece






DISCORID


100 MG/TAB


Tablet


Oral use




EL - Greece







COUP ABEE




Agias Varvaras 53-55




Dafni, Athens 17235




Greece






MELICAT


100 MG/TAB


Tablet


Oral use




EL - Greece







DEMO ABEE




21ST Km National Highway Athens-Lamia 14565




Greece






RITAMINE


100 MG/TAB


Tablet


Oral use




EL - Greece







ELPEN A.E. PHARMACEUTICAL INDUSTRY,




Marathonos Avenue 95




Pikermi 19009




Greece






ROLAKET


100 MG/TAB


Tablet


Oral use




EL - Greece







ELPEN A.E. PHARMACEUTICAL INDUSTRY,




Marathonos Avenue 95




Pikermi 19009




Greece






ROLAKET


200 MG/SUPP


Suppository


Rectal use




EL - Greece







EVAGGELOS KALOFOLIAS & SIA O.E.




Menandrou 54




Athens 10431




Greece






ALGOVER


100 MG/TAB


Tablet


Oral use




EL - Greece







FARMANIC CHEMIPHARMA S.A.




Fylis 137




Kamatero Attikis 13451




Greece






CHEMISULIDE


100 MG/TAB


Tablet


Oral use




EL - Greece







FARMEDIA A.E.




Athinas 22 & Apollonos




Gerakas Attikis 15344




Greece






MULTIFORMIL


100 MG/TAB


Tablet


Oral use




EL - Greece







FARMILIA E.E.




Favierou 48




Athens 10438




Greece






AUROMELID


100 MG/TAB


Tablet


Oral use




EL - Greece







FINIXFARM EPE




Dervenakion 38 & Sahini




Gerakas 15344




Greece






KARTAL


100 MG/TAB


Tablet


Oral use




EL - Greece







GENEPHARM A.E.




18th Km Marathonos Avenue




Pallini Attikis 15351




Greece






NIMELIDE


100 MG/TAB


Tablet


Oral use




EL - Greece







HELP ABEE




Valaoritou 10




Metamorfosi Attikis 14452




Greece






MOSUOLIT


100 MG/TAB


Tablet


Oral use




EL - Greece







INTERMED ABEE




Kalyftaki 27




Athens 14564




Greece






DOLOSTOP


100 MG/TAB


Tablet


Oral use




EL - Greece







INTERMED ABEE




Kalyftaki 27




Athens 14564




Greece






DOLOSTOP


100 MG/TAB


Effervescent tablet


Oral use




EL - Greece







INTERMED ABEE




Kalyftaki 27




Athens 14564




Greece






DOLOSTOP


100 MG/SACHET


Granules for oral solution


Oral use




EL - Greece







INTERMED ABEE




Kalyftaki 27




Athens 14564




Greece






DOLOSTOP


200 MG/SUPP


Suppository


Rectal use




EL - Greece







KLEVA EPE




Parnithos Avenue 189




Aharnai Attikis 13671




Greece






ELINAP


100 MG/TAB


Tablet


Oral use




EL - Greece







LAVIPHARM HELLAS A.E.




Agias Marinas




Paiania Attikis 19002




Greece






AULIN


100 MG/TAB


Tablet


Oral use




EL - Greece







LEOVAN, M. LEWN & SIA EE




Argonafton 22




Argyroupoli 16452




Greece






RISTOLZIT


100 MG/TAB


Tablet


Oral use




EL - Greece







MEDARTE PHARMACEUTICLS ABEE




Spyrou Vretou 10




Metamorfosi 14452




Greece






MESILEX


100 MG/TAB


Tablet


Oral use




EL - Greece







MEDICHROM A.E.




6 Km Markopoulou-Koropi Avenue




Markopoulo Mesogeion 19003




Greece






NIMESUL


100 MG/TAB


Tablet


Oral use




EL - Greece







MED-ONE S.A., HELLAS




Parnithos Avenue 211




Aharnai 13671




Greece






ALGOSULID


100 MG/TAB


Tablet


Oral use




EL - Greece







MINERVA PHARMAKEFTIKI A.E.




Kifissou Avenue 132




Peristeri 12131




Greece






MIN-A-PON


100 MG/TAB


Tablet


Oral use




EL - Greece







NORMA HELLAS A.E.




Menandrou 54




Athens 10431




Greece






MYXINA


100 MG/TAB


Tablet


Oral use




EL - Greece







PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS




Dilou 9




Peristeri Attikis 12134




Greece






FLADALGIN


100 MG/TAB


Tablet


Oral use




EL - Greece







PHARMACYPRIA HELLAS A.E.




Paster 6




Ampelokipoi 11521




Greece






LALIDE


100 MG/TAB


Tablet


Oral use




EL - Greece







PHARMACYPRIA HELLAS A.E.




Paster 6




Ampelokipoi 11521




Greece






LALIDE


50 MG/5ML


Oral suspension


Oral use




EL - Greece







PHARMATHEN INTERNATIONAL S.A. GREECE,




Dervenakion 4




Pallini Attikis 15351




Greece






BIOXIDOL


100 MG/TAB


Tablet


Oral use




EL - Greece







RAFARM AEBE




Korintou 12




N. Psychiko 15451




Greece






VENTOR


100 MG/TAB


Tablet


Oral use




EL - Greece







RAFARM AEBE




Korintou 12




N. Psychiko 15451




Greece






VENTOR


100 MG/SACHET


Granules for oral solution


Oral use




EL - Greece







REMEDINA ABEE




Gounari 25 & Areos




Kamatero Attikis 13451




Greece






AMOCETIN


100 MG/TAB


Tablet


Oral use




EL - Greece







REMEK PHARMACEUTICALS ABEE




Pentelis 34




Palaio Faliro Attikis 17564




Greece






MESUPON


100 MG/TAB


Tablet


Oral use




EL - Greece







S.J.A. PHARM O.E.




Arkoleon 11




Kato Patissia 10445




Greece






CLIOVYL


100 MG/TAB


Tablet


Oral use




EL - Greece







VELKA HELLAS AEBE




Kapodistriou & Korinthou 12




Neo Psychiko 15451




Greece






NAOFID


100 MG/TAB


Tablet


Oral use




EL - Greece







VIOFAR EPE




Ethnikis Antistaseos & Trifyllias




Aharnai 13671




Greece






VOLONTEN


100 MG/TAB


Tablet


Oral use




EL - Greece







VOCATE PHARMAKEFTIKI A.E.




Gounari 150




Glyfada 16674




Greece






TRANZICALM


100 MG/TAB


Tablet


Oral use




ES - Spain







HELSINN BIREX PHARMACEUTICALS LTD.




Damastown Mulhuddart




County Dublin 15




Ireland






GUAXAN 100 mg comprimidos


100 mg


Tablet


Oral use




FR - France







CLL PHARMA




Nice Premier - Arenas




455, promenade des Anglais




06299 NICE Cedex 03




France






NIMESULIDE CEHEL PHARMA


100 mg


Tablet


Oral use




FR - France







EG LABO - Laboratoires EuroGenerics




"Le Quintet" - Bâtiment A




12, rue Danjou




92517 BOULOGNE BILLANCOURT Cedex




France






NIMESULIDE EG


100 mg


Tablet


Oral use




FR - France







HELSINN BIREX PHARMACEUTICALS Ltd




Damastown Mulhuddart




Dublin 15




Ireland






OXETIAN


100 mg


Tablet


Oral use




FR - France







HELSINN BIREX PHARMACEUTICALS Ltd




Damastown Mulhuddart




Dublin 15




Ireland






OXETIAN


100 mg


Granules for oral solution in sachet


Oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 PARIS LA DEFENSE Cedex




France






NIMESULIDE TEVA


100 mg


Tablet


Oral use




FR - France







THERABEL LUCIEN PHARMA




19 rue Alphonse de Neuville




75017 PARIS




France






NEXEN


100 mg


Tablet


Oral use




FR - France







THERABEL LUCIEN PHARMA




19 rue Alphonse de Neuville




75017 PARIS




France






NEXEN


100 mg


Granules for oral solution in sachet


Oral use




HU - Hungary







Eurodrug Lab. BV




Laan Copes van Cattenbruch 74.




2585 GD, The Hague,




The Netherlands






Nidol


100mg


Tablet


Oral use




HU - Hungary







Lab. Guidotti S.p.A.




Via Livornese 897




56010 San Piero a Grado, PISA




Italy






Xilox


50 mg/g


Granules for oral suspension


Oral use




HU - Hungary







PannonPharma Kft.




Pannonpharma út 1.




7720, Pécsvárad




Hungary






Nimelid


100 mg


Tablet


Oral use




HU - Hungary







sanofi-aventis zrt.




Tó u. 1-5.




1045 Budapest




Hungary






Mesulid


100 mg


Tablet


Oral use




HU - Hungary







sanofi-aventis zrt.




Tó u. 1-5.




1045 Budapest




Hungary






Mesulid


50 mg/g


Granules


Oral use




IT - Italy







Actavis Group PTC EHF




Reykjavikurvegi 76-78




Hafnarf Joerdur




Iceland






NIMESULIDE ACTAVIS


100 mg


Granules


Oral use




IT - Italy







Actavis Group PTC EHF




Reykjavikurvegi 76-78




Hafnarf Joerdur




Iceland






NIMESULIDE ACTAVIS


100 mg


Tablet


Oral use




IT - Italy







Aesculapius Farmaceutici Srl




Via Cozzaglio, 24




25125 Brescia




Italy






EFRIDOL


100 mg


Tablet


Oral use




IT - Italy







Aesculapius Farmaceutici Srl




Via Cozzaglio, 24




25125 Brescia




Italy






EFRIDOL


100 mg


Granules for oral suspension


Oral use




IT - Italy







Agips Farmaceutici Srl




Via Amendola, 4




16035 Rapallo (GE)




Italy






DELFOS


100 mg


Granules for oral suspension


Oral use




IT - Italy







Agips Farmaceutici Srl




Via Amendola, 4




16035 Rapallo (GE)




Italy






DELFOS


100 mg


Tablet


Oral use




IT - Italy







Almus Srl




Via Cesarea, 11/10




16121 Genova




Italy






NIMESULIDE ALMUS


100 mg


Tablet


Oral use




IT - Italy







Almus Srl




Via Cesarea, 11/10




16121 Genova




Italy






NIMESULIDE ALMUS


100 mg


Granules for oral suspension


Oral use




IT - Italy







Angenerico Spa




Via Nocera Umbra, 75




00181 Roma




Italy






NIMESULIDE ANGENERICO


100 mg


Granules for oral suspension


Oral use




IT - Italy







Angenerico Spa




Via Nocera Umbra, 75




00181 Roma




Italy






NIMESULIDE ANGENERICO


200 mg


Suppository


Rectal use




IT - Italy







Aurobindo Pharma Italia Srl




Vicolo San Giovanni sul Muro, 9




20121 Milano




Italy






ORONIME


100 mg


Orodispersible tablet


Oral use




IT - Italy







C.T.Laboratorio Farmaceutico Srl




Villa Sayonara - Strada Solaro, 75/77




18038 Sanremo (IM)




Italy






FLOLID


100 mg


Tablet


Oral use




IT - Italy







C.T.Laboratorio Farmaceutico Srl




Villa Sayonara - Strada Solaro, 75/77




18038 Sanremo (IM)




Italy






FLOLID


100 mg


Granules for oral suspension


Oral use




IT - Italy







Doc Generici Srl




Via Manuzio, 7




20124 Milano




Italy






NIMESULIDE DOC GENERICI


100 mg


Granules for oral suspension


Oral use




IT - Italy







Doc Generici Srl




Via Manuzio, 7




20124 Milano




Italy






NIMESULIDE DOC GENERICI


100 mg


Tablet


Oral use




IT - Italy







Dorom Srl




Via Messina, 38




20154 Milano




Italy






NIMESULIDE DOROM


100 mg


Powder for oral solution


Oral use




IT - Italy







Dr Reddy's Srl




Via Fernanda Wittengs, 3




20123 Milano




Italy






NIMESULIDE DR REDDY'S


100 mg


Granules for oral suspension


Oral use




IT - Italy







Ecobi Farmaceutici sas




Via E. Bazzano, 26




16019 Ronco Scrivia (GE)




Italy






AREUMA


100 mg


Granules for oral suspension


Oral use




IT - Italy







Ecobi Farmaceutici sas




Via E. Bazzano, 26




16019 Ronco Scrivia (GE)




Italy






AREUMA


100 mg


Tablet


Oral use




IT - Italy







Ecobi Farmaceutici sas




Via E. Bazzano, 26




16019 Ronco Scrivia (GE)




Italy






AREUMA


200 mg


Suppository


Rectal use




IT - Italy







Eg S.p.A.




Via Domenico Scarlatti, 31




20124 Milano




Italy






NIMESULIDE EG


100 mg


Tablet


Oral use




IT - Italy







Eg S.p.A.




Via Domenico Scarlatti, 31




20124 Milano




Italy






NIMESULIDE EG


100 mg


Granules for oral suspension


Oral use




IT - Italy







Farmac.Caber Spa




Viale Città D'Europa, 681




00144 Roma




Italy






NIMS


100 mg


Granules


Oral use




IT - Italy







Farmac.Damor Spa




Via Emilio Scaglione, 27




80145 Napoli




Italy






SULIDAMOR


100 mg


Powder for oral suspension


Oral use




IT - Italy







Farmac.Damor Spa




Via Emilio Scaglione, 27




80145 Napoli




Italy






SULIDAMOR


100 mg


Tablet


Oral use




IT - Italy







Benedetti & Co spa




Via Bolognese, 250




51020 Pistoia




Italy






NIMESULIDE Benedetti & Co


100 mg


Granules for oral suspension


Oral use




IT - Italy







Francia Farmac.Ind.Far.Bio.Srl




Via dei Pestagalli, 7




20138 Milano




Italy






ALGIMESIL


100 mg


Tablet


Oral use




IT - Italy







Francia Farmac.Ind.Far.Bio.Srl




Via dei Pestagalli, 7




20138 Milano




Italy






ALGIMESIL


100 mg


Granules


Oral use




IT - Italy







Germed Pharma Spa




Via Cesare Cantù, 11




20092 Cinisello Balsamo (Milano)




Italy






NIMESULIDE GERMED


100 mg


Tablet


Oral use




IT - Italy







Germed Pharma Spa




Via Cesare Cantù, 11




20092 Cinisello Balsamo (Milano)




Italy






NIMESULIDE GERMED


100 mg


Granules


Oral use




IT - Italy







Helsinn Birex Pharmac.Ltd




Mulhuddart, 15




Damastown - Dublin




Ireland






AULIN


100 mg


Tablet


Oral use




IT - Italy







Helsinn Birex Pharmac.Ltd




Mulhuddart, 15




Damastown - Dublin




Ireland






AULIN


100 mg


Granules for oral suspension


Oral use




IT - Italy







Helsinn Birex Pharmac.Ltd




Mulhuddart, 15




Damastown - Dublin




Ireland






AULIN


200 mg


Suppository


Rectal use




IT - Italy







Helsinn Birex Pharmac.Ltd




Mulhuddart, 15




Damastown - Dublin




Ireland






MESULID FAST


400 mg


Granules


Oral use




IT - Italy







Helsinn Birex Pharmac.Ltd




Mulhuddart, 15




Damastown - Dublin




Ireland






MESULID


100 mg


Granules for oral suspension


Oral use




IT - Italy







Helsinn Birex Pharmac.Ltd




Mulhuddart, 15




Damastown - Dublin




Ireland






MESULID


100 mg


Tablet


Oral use




IT - Italy







Helsinn Birex Pharmac.Ltd




Mulhuddart, 15




Damastown - Dublin




Ireland






MESULID


200 mg


Suppository


Rectal use




IT - Italy







Hexal Spa




Largo Boccioni 1




21040 Origgio Varese




Italy






NIMESULIDE HEXAL


100 mg


Tablet


Oral use




IT - Italy







I.B.N. Savio Srl




Via E. Bazzano, 14




16019 Ronco Scrivia (GE)




Italy






EUDOLENE


100 mg


Granules


Oral use




IT - Italy







Italfarmaco S.p.A.




Viale Fulvio Testi, 330




20126 Milano




Italy






NIMEDEX


400 mg


Granules for oral suspension


Oral use




IT - Italy







Italfarmaco S.p.A.




Viale Fulvio Testi, 330




20126 Milano




Italy






NIMEDEX


400 mg


Tablet


Oral use




IT - Italy







Lab.Guidotti Spa




Via Livornese, 897




56010 La Vettola - Pisa




Italy






NIMESULENE


200 mg


Suppository


Rectal use




IT - Italy







Lab.Guidotti Spa




Via Livornese, 897




56010 La Vettola - Pisa




Italy






NIMESULENE


100 mg


Granules for oral suspension


Oral use




IT - Italy







Lab.Guidotti Spa




Via Livornese, 897




56010 La Vettola - Pisa




Italy






NIMESULENE


100 mg


Tablet


Oral use




IT - Italy







Laboratori Alter Srl




Via Egadi, 7




20144 Milano




Italy






NIMESULIDE ALTER


100 mg


Granules


Oral use




IT - Italy







Crinos spa




Via Pavia, 6




20136 Milano




Italy






LEDOREN


100 mg


Tablet


Oral use




IT - Italy







Crinos spa




Via Pavia, 6




20136 Milano




Italy






LEDOREN


100 mg


Granules for oral suspension


Oral use




IT - Italy







Levofarma Srl




Via Conforti, 42




84083 Castel San Giorgio (Salerno)




Italy






NOALGOS


100 mg


Granules


Oral use




IT - Italy







Magis Farmaceutici Spa




Via Cacciamali, 34-36-38/B




25125 Brescia




Italy






ISODOL


100 mg


Tablet


Oral use




IT - Italy







Magis Farmaceutici Spa




Via Cacciamali, 34-36-38/B




25125 Brescia




Italy






ISODOL


100 mg


Granules for oral suspension


Oral use




IT - Italy







MDM Spa




Viale Papiniano, 22/B




20100 Milano




Italy






SOLVING


100 mg


Granules for oral suspension


Oral use




IT - Italy







MDM Spa




Viale Papiniano, 22/B




20100 Milano




Italy






SOLVING


100 mg


Tablet


Oral use




IT - Italy







Hexal AG




Industriestrasse, 25




D-83607 Holzkirchen –




Germany






NIMESULIDE HEXAL AG


100 mg


Granules for oral suspension


Oral use




IT - Italy







Hexal AG




Industriestrasse, 25




D-83607 Holzkirchen –




Germany






NIMESULIDE HEXAL AG


100 mg


Tablet


Oral use




IT - Italy







Mylan Spa




Via Vittor Pisani, 20




20124 Milano




Italy






NIMESULIDE MYLAN GENERICS


100 mg


Granules for oral suspension


Oral use




IT - Italy







Mylan Spa




Via Vittor Pisani, 20




20124 Milano




Italy






NIMESULIDE MYLAN GENERICS


100 mg


Tablet


Oral use




IT - Italy







New Research Srl




Via della Tenuta di Torrenova, 142




00133 Roma




Italy






NERELID


100 mg


Capsule


Oral use




IT - Italy







New Research Srl




Via della Tenuta di Torrenova, 142




00133 Roma




Italy






NERELID


100 mg


Granules


Oral use




IT - Italy







Pantafarm Srl




Via Palestro, 14




00185 Roma




Italy






PANTAMES


100 mg


Orodispersible tablet


Oral use




IT - Italy







Pensa Pharma Spa




Via Rosellini Ippolito, 12




20124 Milano




Italy






NIMESULIDE PENSA


100 mg


Granules for oral suspension


Oral use




IT - Italy







Pensa Pharma Spa




Via Rosellini Ippolito, 12




20124 Milano




Italy






NIMESULIDE PENSA


100 mg


Tablet


Oral use




IT - Italy







Ranbaxy Italia Spa




Piazza Filippo Meda, 3




20121 Milano




Italy






NIMESULIDE RANBAXY


100 mg


Granules for oral suspension


Oral use




IT - Italy







Ratiopharm GmbH




Graf-Arcostrasse, 2




ULM D-89070




Germany






NIMESULIDE RATIOPHARM


100 mg


Tablet


Oral use




IT - Italy







Ratiopharm GmbH




Graf-Arcostrasse, 2




ULM D-89070




Germany






NIMESULIDE RATIOPHARM


100 mg


Granules for oral suspension


Oral use




IT - Italy







Ratiopharm GmbH




Graf-Arcostrasse, 2




ULM D-89070




Germany






NIMESULIDE RATIOPHARM


100 mg


Effervescent tablet


Oral use




IT - Italy







Sandoz Spa




Largo U. Boccioni, 1




21040 Origgio (VA)




Italy






NIMESULIDE SANDOZ


100 mg


Capsule


Oral use




IT - Italy







Sandoz Spa




Largo U. Boccioni, 1




21040 Origgio (VA)




Italy






NIMESULIDE SANDOZ


100 mg


Granules


Oral use




IT - Italy







Sarda Pharmaceutica Srl




Via Castiglione, 92/B




09100 Cagliari




Italy






DIMESUL


100 mg


Granules for oral suspension


Oral use




IT - Italy







Selvi Laboratorio Bioterapico Spa




Via Procoio, 28




0065 Fiano Romano (Roma)




Italy






ANTALGO


100 mg


Granules


Oral use




IT - Italy







SIAR Pharma Srl




Via Verdi, 33




20060 Bussero (MI)




Italy






ALGOLIDER


100 mg


Granules for oral suspension


Oral use




IT - Italy







So.Se.Pharm Srl




Via dei Castelli Romani, 22




00040 Pomezia (Roma)




Italy






DOMES


100 mg


Granules for oral suspension


Oral use




IT - Italy







So.Se.Pharm Srl




Via dei Castelli Romani, 22




00040 Pomezia (Roma)




Italy






DOMES


100 mg


Orodispersible tablet


Oral use




IT - Italy







Sofar Spa




Via Isonzo, 8




20100 Milano




Italy






FANSULIDE


100 mg


Tablet


Oral use




IT - Italy







Sofar Spa




Via Isonzo, 8




20100 Milano




Italy






FANSULIDE


100 mg


Granules for oral suspension


Oral use




IT - Italy







Teva Italia Srl




Via Messina, 38




20154 Milano




Italy






NIMESULIDE TEVA


100 mg


Tablet


Oral use




IT - Italy







Teva Italia Srl




Via Messina, 38




20154 Milano




Italy






NIMESULIDE TEVA


100 mg


Granules for oral suspension


Oral use




IT - Italy







Union Health Srl




Via Roccamandolfi, 1




00156 Roma




Italy






NIMESULIDE UNION HEALTH


100 mg


Tablet


Oral use




IT - Italy







Union Health Srl




Via Roccamandolfi, 1




00156 Roma




Italy






NIMESULIDE UNION HEALTH


100 mg


Granules for oral suspension


Oral use




IT - Italy







Piam Farmaceutici Spa




Via Padre G. Semeria, 5




16131 Genova




Italy






REMOV


100 mg


Tablet


Oral use




IT - Italy







Piam Farmaceutici Spa




Via Padre G. Semeria, 5




16131 Genova




Italy






REMOV


100 mg


Granules


Oral use




LT - Lithuania







Helsinn Birex Pharmaceuticals Ltd.




Damastown Mulhuddart




Dublin 15




Ireland






Mesulid


100 mg


Tablet


Oral use




LT - Lithuania







Laboratori Guidotti S.p.A.




Via Livornese, 897




Pisa-La Vettola




Italy






Nimesil


100 mg


Granules for oral suspension


Oral use




LT - Lithuania







Medochemie Ltd.




P.O. Box 51409




Limassol, CY-3505




Cyprus






Apronil


100 mg


Tablet


Oral use




LT - Lithuania







Zentiva k.s.




U Kabelovny 130,




102 37, Prague 10,




Dolni Mecholupy




Czech Republic






Coxtral


100 mg


Tablet


Oral use




LV - Latvia







Helsinn Birex Pharmaceutical Ltd.




Damastown, Mulhuddart




Dublin-15




Ireland






Mesulid 100 mg tabletes


100 mg


Tablet


Oral use




LV - Latvia







Laboratori Guidotti S.p.A.




Via Livornese 897 –




56010 Pisa – La Vettola




Italy






Nimesil 100 mg granulas iekšķīgi lietojamās suspensijas pagatavošanai


100 mg


Granules for oral suspension


Oral use




LV - Latvia







Medochemie Ltd.




Constantinoupoleos Str. 1-10




Limassol, CY–3011




Cyprus






Aponil 100 mg tabletes


100 mg


Tablet


Oral use




LV - Latvia







Zentiva k.s.




U kabelovny 130




Dolni Mecholupy




Praha 10, CZ-10237




Czech Republic






Coxtral 100 mg tabletes


100 mg


Tablet


Oral use




MT - Malta







VECCHI & C. PIAM s.a.p.a.




Via Padre G. Semeria,




5 - 16131 Genova




Italy






Remov


100 mg


Tablet


Oral use




MT - Malta







VECCHI & C. PIAM s.a.p.a.




Via Padre G. Semeria,




5 - 16131 Genova




Italy






Remov


100 mg/sachet


Granules for oral suspension


Oral use




PL - Poland







Laboratori Guidotti S.p.A. (Menarini Group)




Via Livornese 897




I-56010, Piza




Italy






Nimesil


100 mg


Granules for oral suspension


Oral use




PL - Poland







Medicom International s.r.o.




Paterni 7




635 00, Brno




Czech Republic






Aulin


100 mg


Granules for oral suspension


Oral use




PL - Poland







Medicom International s.r.o.




Paterni 7




635 00, Brno




Czech Republic






Aulin


100 mg


Tablet


Oral use




PL - Poland







Pabianickie Zakłady Farmaceutyczne Polfa S.A.




Marszałka J. Piłsudskiego 5,




95-200 Pabianice




Poland






Minesulin


100 mg


Powder for oral suspension


Oral use




PL - Poland







Pabianickie Zakłady Farmaceutyczne Polfa S.A.




Marszałka J. Piłsudskiego 5,




95-200 Pabianice




Poland






Minesulin


100 mg


Tablet


Oral use




PL - Poland







Zentiva a.s.




U Kabelovny 130




102 37 Praha 10




Czech Republic






Coxtral


100 mg


Tablet


Oral use




PT - Portugal







Alter, S.A.




Estrada Marco do Grilo - Zemouto




2830-000 Coina




Portugal






Nimesulida Alter


100 mg


Tablet


Oral use




PT - Portugal







Angelini Farmacêutica, Lda.




Rua João Chagas, 53 - 3o





1499-040 Cruz Quebrada – Dafundo




Portugal






Aulin


100 mg


Granules for oral suspension


Oral use




PT - Portugal







Angelini Farmacêutica, Lda.




Rua João Chagas, 53 - 3o





1499-040 Cruz Quebrada – Dafundo




Portugal






Aulin


100 mg


Tablet


Oral use




PT - Portugal







Arrowblue Produtos Farmacêuticos S.A.




Av. D. João II,




10 Esqo - Torre Fernão de Magalhães




1998-025 Lisboa




Portugal






Nimesulida Arrowblue


100 mg


Tablet


Oral use




PT - Portugal







Baldacci - Portugal, S.A.




Rua Cândido de Figueiredo, 84-B




1549-005 Lisboa




Portugal






Nimesulida Baldacci


100 mg


Tablet


Oral use




PT - Portugal







Bluepharma Genéricos - Comércio de Medicamentos, S.A.




São Martinho do Bispo




3045-016 Coimbra




Portugal






Nimesulida Bluepharma


100 mg


Tablet


Oral use




PT - Portugal







Ciclum Farma Unipessoal, Lda. Quinta da Fonte,




Rua Vitor Câmara, 2 –




Edifício D. Amélia, Piso 1, Ala B




2770-229 Paço de Arcos




Portugal






Nimesulida Ciclum


100 mg


Tablet


Oral use




PT - Portugal







Cinfa Portugal, Lda.




Av. Tomás Ribeiro, 43 - Bloco 1, 4o B –




Edifício Neopark




2790-221 Carnaxide




Portugal






Nimesulida Cinfa


100 mg


Tablet


Oral use




PT - Portugal







Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2,




Abrunheira




2710-089 Sintra




Portugal






Nimesulida Farmoz


100 mg


Coated tablet


Oral use




PT - Portugal







Generis Farmacêutica, S.A.




Rua João de Deus, 19




2700-487 Amadora




PORTUGAL






Nimesulida Generis


100 mg


Tablet


Oral use




PT - Portugal







Generis Farmacêutica, S.A.




Rua João de Deus, 19




2700-487 Amadora




PORTUGAL






Nimesulida Generis


100 mg


Granules for oral solution


Oral use




PT - Portugal







Germed Farmacêutica, Lda.




Rua Alto do Montijo, 13 – 1o Dto –




Edifício Monsanto




2790-012 Portela de Carnaxide




Portugal






Nimesulida Germed


100 mg


Tablet


Oral use




PT - Portugal







Germed Farmacêutica, Lda.




Rua Alto do Montijo, 13 – 1o Dto –




Edifício Monsanto




2790-012 Portela de Carnaxide




Portugal






Nimesulida Germed


100 mg


Granules for oral suspension


Oral use




PT - Portugal







GP - genéricos portugueses, Lda.




Rua Henrique Paiva Couceiro, 29 –




Venda Nova




2700-451 Amadora




Portugal






Nimesulida GP


100 mg


Tablet


Oral use




PT - Portugal







Jaba Recordati, S. A.




Lagoas Park, Edificio 5, Torre C,




Piso 32




2740-298 Porto Salvo




Portugal






Nimesulida Jabasulide


100 mg


Tablet


Oral use




PT - Portugal







Jaba Recordati, S. A.




Lagoas Park, Edificio 5, Torre C,




Piso 32




2740-298 Porto Salvo




Portugal






Nimesulida Jabasulide


100 mg


Granules for oral solution


Oral use




PT - Portugal







Labesfal - Laboratórios Almiro, S.A.




Zona Industrial do Lagedo




3465-157 Santiago de Besteiros




Portugal






Nimesulida Labesfal


100 mg


Tablet


Oral use




PT - Portugal







Labesfal - Laboratórios Almiro, S.A.




Zona Industrial do Lagedo




3465-157 Santiago de Besteiros




Portugal






Nimesulida Labesfal


100 mg


Granules for oral suspension


Oral use




PT - Portugal







Laboratori Guidotti, S.p.A.




Via Livornese, 897




I-56010 La Vettola – Pisa




Italy






Nimesulene


100 mg


Granules for oral suspension


Oral use




PT - Portugal







Laboratórios Basi - Indústria Farmacêutica, S.A.




Rua do Padrão, 98




3000-312 Coimbra




Portugal






Nimesulida Basi


100 mg


Tablet


Oral use




PT - Portugal







Laboratórios Basi - Indústria Farmacêutica, S.A.




Rua do Padrão, 98




3000-312 Coimbra




Portugal






Nimesulida Basi


100 mg


Granules for oral suspension


Oral use




PT - Portugal







Laboratórios Inibsa, S.A.




Zona Industrial da Abrunheira –




Edifício 1 - 2o I - Sintra Business Park




2710-089 Sintra




Portugal






Nimesulida Inibsa


100 mg


Tablet


Oral use




PT - Portugal







Laboratórios Inibsa, S.A.




Zona Industrial da Abrunheira –




Edifício 1 - 2o I - Sintra Business Park




2710-089 Sintra




Portugal






Nimesulida Inibsa


100 mg


Granules for oral suspension


Oral use




PT - Portugal







Mer Medicamentos, Lda.




Rua João deDeus,19




Venda Nova




2700-487 Amadora




Portugal






Nimesulida Mer


100 mg


Tablet


Oral use




PT - Portugal







Mylan, Lda.




Rua Doutor António Loureiro Borges,




Edíficio Arquiparque 1, R/C Esqo





1499-016 Algés




Portugal






Nimesulida Mylan


100 mg


Tablet


Oral use




PT - Portugal







Mylan, Lda.




Rua Doutor António Loureiro Borges,




Edíficio Arquiparque 1, R/C Esqo





1499-016 Algés




Portugal






Nimesulida Mylan


100 mg


Granules for oral solution


Oral use




PT - Portugal







Almus,Lda.




Rua Engenheiro Ferreira Dias,




728, 3o Piso Sul




4149-014 Porto




Portugal






Nimesulida Almus


100 mg


Film-coated tablet


Oral use




PT - Portugal







Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.




Edifício Atlas II,




Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31




1495-139 Miraflores – Algés




Portugal






Nimesulida Pharmakern


100 mg


Tablet


Oral use




PT - Portugal







Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.




Edifício Botânico




Rua do Campo Alegre




1306-5o-sala 501




4150-174 Porto




Portugal






Nimesulida Ranbaxy


100 mg


Tablet


Oral use




PT - Portugal







Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.




Edifício Botânico




Rua do Campo Alegre




1306-5o-sala 501




4150-174 Porto




Portugal






Nimesulida Ranbaxy


100 mg


Granules for oral suspension


Oral use




PT - Portugal







Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.




Rua Quinta do Pinheiro –




Edifício Tejo - 6o Piso




2790-143 Carnaxide




Portugal






Nimesulida Ratiopharm


100 mg


Tablet


Oral use




PT - Portugal







Rega Farma - Promoção de Produtos Farmacêuticos,




S.A. Rua João Chagas, 53 - 3o





1495-764 Cruz Quebrada




Portugal






Donulide


100 mg


Tablet


Oral use




PT - Portugal







Rega Farma - Promoção de Produtos Farmacêuticos, S.A.




Rua João Chagas, 53 - 3o





1495-764 Cruz Quebrada




Portugal






Donulide


100 mg


Granules for oral suspension


Oral use




PT - Portugal







Sandoz Farmacêutica, Lda.




Alameda da Beloura, Edifício 1, 2o -




Escritório 15




2710-693 Sintra




Portugal






Nimesulida Sandoz


100 mg


Tablet


Oral use




PT - Portugal







Helsinn Birex Pharmaceuticals, Ltd




Damastown-Mulhuddart




15 Dublin




Republic of Ireland






Nimed


100 mg


Film-coated tablet


Oral use




PT - Portugal







Helsinn Birex Pharmaceuticals, Ltd




Damastown-Mulhuddart




15 Dublin




Republic of Ireland






Nimed


100 mg


Granules for oral solution


Oral use




PT - Portugal







APceuticals-Farmacêutica, Lda




Av Aida, Edif. Garden-Bloco 9, Lj 910




2765-187 Estoril




Portugal






Nimesulida APceuticals


100 mg


Film-coated tablet


Oral use




PT - Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2 – Abrunheira




2710-089 Sintra




Portugal






Nimesulida Neuride


100 mg


Film-coated tablet


Oral use




PT - Portugal







Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16o Piso,




Amoreiras




1070-274 Lisboa




Portugal






Nimesulida Wynn


100 mg


Tablet


Oral use




RO - Romania







ANFARM HELLAS S.A.




Perikleous 53-57




153 44 Gerakas Attikis




Greece






LEMESIL, comprimate, 100 mg


100 mg


Tablet


Oral use




RO - Romania







CSC PHARMACEUTICALS HANDELS GmbH




Gewerbestrasse 18-20




Gewerbegebiet Klein-Engersdorf




A-2102 Bisamberg




Austria






AULIN, granule pentru suspensie orală, 100 mg/plic


100 mg/sachet


Granules for oral suspension


oral use




RO - Romania







CSC PHARMACEUTICALS HANDELS GmbH




Gewerbestrasse 18-20




Gewerbegebiet Klein-Engersdorf




A-2102 Bisamberg




Austria






AULIN 100 mg,


100 mg


Tablet


Oral use




RO - Romania







Dr. REDDY’S LABORATORIES ROMÂNIA S.R.L,




Str. Nicolae Caramfil nr. 71-73, et. 5 spațiul 10, sector 1,




București




Romania






NISE 100 mg, comprimate


100 mg


Tablet


Oral use




RO - Romania







LABORATORI GUIDOTTI SpA




Via Livornese, 897




56010 Pisa-La Vettola




Italy






NIMESIL, granule pentru suspensie orală, 100 mg


100 mg/sachet


Granules for oral suspension


oral use




RO - Romania







MEDOCHEMIE LTD. - CYPRUS,




P.O. Box 51409




Limassol




Cyprus






APONIL, comprimate, 100 mg


100 mg


Tablet


Oral use




RO - Romania







S.C. ARENA GROUP S.A.




Str. Ștefan Mihăileanu, Nr. 31, Sector 2,




București,




Romania






NIMESULID ARENA 100 mg, comprimate


100 mg


Tablet


Oral use




RO - Romania







S.C. FARMEX COMPANY SRL




Str.Drumul Potcoavei nr. 30, Pipera




Voluntari, Jud. Ilfov,




Romania






NIMESULID FARMEX 100 mg, comprimate


100 mg


Tablet


Oral use




RO - Romania







S.C. LABORMED PHARMA S.A.




B-dul Theodor Pallady nr. 44B sector 3,




Bucuresti




Romania






NIMESULID LPH 100 mg, comprimate


100 mg


Tablet


Oral use




RO - Romania







S.C. MAGISTRA C&C S.R.L.




B-dul Aurel Vlaicu nr. 82 A,




Constanța




Romania






NIMESULID 100 mg, comprimate


100 mg


Tablet


Oral use




RO - Romania







S.C. SLAVIA PHARM SRL




Str. Știrbei Vodă nr. 53-55 sector 1,




București




Romania






NIMESULID SLAVIA, comprimate, 100 mg


100 mg


Tablet


Oral use




RO - Romania







Zentiva k.s.,




U kabelovny 130,




Dolní Měcholupy




102 37, Praha 10,




Czech Republic






COXTRAL, comprimate, 100 mg


100 mg


Tablet


Oral use




SI - Slovenia







CSC Pharma d.o.o.




Jana Husa 1a




SI-1000 Ljubljana




Slovenia






Aulin 100 mg tablete


100 mg


Tablet


Oral use




SI - Slovenia







CSC Pharma d.o.o.




Jana Husa 1a




SI-1000 Ljubljana




Slovenia






Aulin 100 mg zrnca za peroralno suspenzijo


100 mg


Granules for oral suspension


oral use




SK - Slovakia







Laboratori Guidotti S.p.A.




Via Livornese 897




56010 Pisa - La Vettola




Italy






Nimesil


100 mg


Granules for oral suspension


Oral use




SK - Slovakia







Medicom International s.r.o.




Páteřní 7




635 00, Brno




Czech Republic






AULIN 100 mg granulát


100 mg


Granules for oral solution


Oral use




SK - Slovakia







Medicom International s.r.o.




Páteřní 7




635 00, Brno




Czech Republic






AULIN 100 mg tablety


100 mg


Tablet


Oral use




SK - Slovakia







Medicom International s.r.o.




Páteřní 7




635 00, Brno




Czech Republic






NIMED


100 mg


Tablet


Oral use




SK - Slovakia







Zentiva k.s.,




Evropská 846/176a,




160 00, Praha




Czech Republic






COXTRAL


100 mg


Tablet


Oral use