Article 31 of Directive 2001/83/EC. Procedure number: EMEA/H/A-31/ July 2016 EMA/499815/2016 Procedure Management and Business Support
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1 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/ Churchill Place Canary Wharf London E14 5EU Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 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
3 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
4 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
5 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
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
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