Annex I. List of nationally authorised medicinal products and marketing authorisation applications
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1 Annex I List of nationally authorised medicinal products and marketing authorisation applications 1
2 Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established Member State Austria Cefuroxim Krka 250mg Filmten Austria Cefuroxim Krka Cefuroxime 500 mg Film-coated 500mg Filmten Bulgaria Furocef 250 mg film-coated s Bulgaria Furocef 500 mg Cefuroxime 500 mg Film-coated film-coated s Croatia Krka - farma d.o.o. Furocef 250 mg film-coated s Croatia Krka - farma d.o.o. Furocef 500 mg Cefuroxime 500 mg Film-coated film- coated s Czech Republic Ricefan 250 mg Czech Republic Ricefan 500 mg Cefuroxime 500 mg Film-coated Estonia FUROCEF Estonia FUROCEF Cefuroxime 500 mg Film-coated 2
3 Member State France CEFUROXIME KRKA 250 mg, comprimé pelliculé France CEFUROXIME Cefuroxime 500 mg Film-coated KRKA 500 mg, comprimé pelliculé Germany Alkem Pharma Cefuroxim Alkem 250 mg Filmten Germany Alkem Pharma Cefuroxim Alkem Cefuroxime 500 mg Film-coated 500 mg Filmten Hungary Furocef Krka 250 Cefuroxime 250 mg Tablet mg s Hungary Furocef Krka 500 Cefuroxime 500 mg Tablet mg s Latvia Ricefan 250 mg film-coated s Latvia Ricefan 500 mg Cefuroxime 500 mg Film-coated film-coated s Lithuania Ricefan Lithuania Ricefan Cefuroxime 500 mg Film-coated Lithuania SIA Ingen Pharma Cefuroxime Ingen Pharma 3
4 Member State Lithuania SIA Ingen Pharma Cefuroxime Ingen Pharma Cefuroxime 500 mg Film-coated Poland Furocef Poland Furocef Cefuroxime 500 mg Film-coated Portugal Cefuroxima Krka Portugal Cefuroxima Krka Cefuroxime 500 mg Film-coated Romania CEFUROXIME KRKA 250 mg, comprimate Romania CEFUROXIME Cefuroxime 500 mg Film-coated KRKA 500 mg, comprimate Slovak Republic Furocef 250 mg filmom obalené y Slovak Republic Furocef 500 mg Cefuroxime 500 mg Film-coated filmom obalené y Slovenia Ricefan Slovenia Ricefan Cefuroxime 500 mg Film-coated 4
5 Member State Spain Alkem Pharma Cefuroxima 500 mg comprimidos Spain Alkem Pharma Cefuroxima Alkem 250 mg comprimidos Spain Cefuroxima KRKA 250 mg comprimidos Spain Cefuroxima KRKA 500 mg comprimidos United Kingdom Alkem Pharma Cefuroxime 250mg film-coated s United Kingdom Alkem Pharma Cefuroxime 500mg film-coated s Cefuroxime 500 mg Film-coated Cefuroxime 500 mg Film-coated Cefuroxime 500 mg Film-coated 5
6 Annex IB: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation Member State Authorisatio n Czech Republic Alkem Pharma Riluzole Alkem 50 mg potahované y Riluzole 50 mg Film-coated Denmark Orion Corporation Ibuprofen Orion Ibuprofen 200 mg Film-coated Denmark Orion Corporation Ibuprofen Orion Ibuprofen 400 mg Film-coated Denmark Orion Corporation Ibuprofen Orion Ibuprofen 600 mg Film-coated Germany Alkem Pharma Riluzol Alkem 50 mg Riluzole 50 mg Film-coated Filmten Spain Alkem Pharma Riluzole 50 mg comprimidos recubiertos con EFG Riluzole 50 mg Film-coated Sweden Orion Corporation Ibuprofen Orion Ibuprofen 200 mg Film-coated Sweden Orion Corporation Ibuprofen Orion Ibuprofen 400 mg Film-coated Sweden Orion Corporation Ibuprofen Orion Ibuprofen 600 mg Film-coated United Kingdom Alkem Pharma Riluzole alkem 50 mg film-coated s Riluzole 50 mg Film-coated 6
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