22 July 2016 EMA/499815/2016 Procedure Management and Business Support authorisations which are recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established as adopted by the CHMP on 21 July 2016 Article 31 of Directive 2001/83/EC Procedure number: EMEA/H/A-31/1443 30 Churchill Place Canary Wharf London E14 5EU Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
Austria Abacavir/Lamivudin Aristo 600 mg/300 mg Filmten Austria Abacavir/Lamivudin 600 mg/300 mg - Filmten Belgium Abacavir/Lamivudin Belgium bvba Abacavir/Lamivudin Bulgaria d.d. Abacavir/Lamivudin Croatia Abakavir/Lamivudin 600 mg/300 mg filmom obložene e Cyprus Denmark Denmark AB Abacavir /Lamivudine Estonia ABACAVIR/LAMIVUDINE SANDOZ Finland Finland AB EMA/499815/2016 Page 2/6
France Venipharm BAMIVENI France Venipharm BAMIVUDINE France Venipharm VIRAMUDINE Abacavir/Lamivudin 600 mg / 300 mg Filmten Hormosan 600 mg/300 mg Filmten Abacavir/Lamivudin HEXAL 600 mg/300 mg Filmten Abacavir/Lamivudin Aristo 600 mg/300 mg Filmten Abacavir/Lamivudin Klinge 600 mg/300 mg Filmten Ireland Generics (UK) Abacavir / Lamivudine Limited Ireland Rowex ABACAVIR E LAMIVUDINA LUPIN EMA/499815/2016 Page 3/6
ABACAVIR E LAMIVUDINA SANDOZ ABACAVIR E LAMIVUDINA MYLAN ABACAVIR E LAMIVUDINA ARISTO Lithuania 600mg/300 mg plėvele dengtos ės Norway AB Abacavir/Lamivudin Poland Abacavir+Lamivudine Poland Abacavir + Lamivudine Portugal Abacavir + Lamivudina Lupin Portugal Abacavir + Lamivudina Portugal, Lda. Abacavir + Lamivudina Romania Abacavir/lamivudină 600 mg/300 mg, film-coated s EMA/499815/2016 Page 4/6
Slovenia Abakavir/lamivudin 600 mg/300 mg filmsko obložene e Spain Abacavir/Lamivudina Amneal 600 mg/300 mg comprimidos Spain Abacavir/Lamivudina Aristo 600 mg/300 mg comprimidos Spain B.V. Abacavir/Lamivudina 600 mg/300 mg comprimimidos Spain s, S.L. Abacavir/Lamivudina 600 mg/300 mg comprimidos Sweden EMA/499815/2016 Page 5/6
Sweden AB Abacavir /Lamivudine The Netherlands Aristo The Netherlands Lupin The Netherlands Lupin Aristo Pharma Abacavir/ GmbH coated s Abacavir/ coated s Abacavir/ coated s Generics (UK) Abacavir/ Limited coated s 600 mg/ 300 mg Tablet EMA/499815/2016 Page 6/6