List of nationally authorised medicinal products

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1 13 September 2017 EMA/695016/2017 Human Medicines Evaluation Division Active substance: roxithromycin Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom 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 where ASSORAL 150 mg compresse not available I.B.N. SAVIO S.R.L. IT ASSORAL 300 mg compresse not available I.B.N. SAVIO S.R.L. IT OVERAL ADULTI 150 mg compresse not available ISTITUTO LUSO FARMACO IT OVERAL ADULTI 300 mg compresse not available ISTITUTO LUSO FARMACO IT OVERAL Bambini 50 mg compresse not available ISTITUTO LUSO FARMACO IT dispersibili ROSSITROL not available SANOFI SPA IT ROSSITROL not available SANOFI SPA IT ROSSITROL not available SANOFI SPA IT Roximin επικαλυμμένα με λεπτό not available /14/ GALENICA SA GR υμένιο δισκία 150 mg/tab. Roximin επικαλυμμένα με λεπτό not available /14/ GALENICA SA GR υμένιο δισκία 300 mg/tab. ROXITHROMYCINE ZENTIVA 150 MG, not available SANOFI-AVENTIS FRANCE FR ROXITHROMYCINE ZENTIVA 150 MG, not available SANOFI-AVENTIS FRANCE FR ROXITHROMYCINE ZENTIVA 150 MG, not available SANOFI-AVENTIS FRANCE FR RULID not available SANOFI-AVENTIS CYPRUS CY LTD RULID not available SANOFI-AVENTIS RULID not available (1149/93) SANOFI-AVENTIS AEBE GR EMA/695016/2017 Page 2/5

3 where RULID not available SANOFI SPA IT RULID not available 082/02702 SANOFI MALTA LTD MT RULID not available R/0859 SANOFI-AVENTIS FRANCE PL RULID not available 7859 SANOFI-AVENTIS FRANCE PL RULID 150 MG not available SANOFI BULGARIA EOOD BG RULID 150 MG, COMPRIME ENROBE not available SANOFI-AVENTIS FRANCE FR RULID 150 MG, COMPRIME ENROBE not available SANOFI-AVENTIS FRANCE FR RULID 150 MG, COMPRIME ENROBE not available SANOFI-AVENTIS FRANCE FR RULID 300 not available SANOFI SPA IT RULID 300 MG not available SANOFI-AVENTIS RULID 300 MG not available SANOFI-AVENTIS RULID 50 MG, not available SANOFI-AVENTIS FRANCE FR RULID 50 MG, not available SANOFI-AVENTIS FRANCE FR RULID 50 MG, COMPRIME SECABLE not available SANOFI-AVENTIS FRANCE FR POUR SUSPENSION BUVABLE RULID 50 MG, COMPRIME SECABLE not available SANOFI-AVENTIS FRANCE FR POUR SUSPENSION BUVABLE RULID 50 MG, POUDRE POUR not available SANOFI-AVENTIS FRANCE FR SUSPENSION BUVABLE EN SACHET RULID 50 MG, POUDRE POUR not available SANOFI-AVENTIS FRANCE FR SUSPENSION BUVABLE EN SACHET RULID BAMBINI not available SANOFI SPA IT EMA/695016/2017 Page 3/5

4 where RULI 150 MG-FILMTABLETTEN not available SANOFI-AVENTIS GMBH AT OSTERREICH RULI 300 MG COMPRIMIDOS not available SANOFI-AVENTIS, S.A. ES RULI 300 MG-FILMTABLETTEN not available SANOFI-AVENTIS GMBH OSTERREICH SURLID not available SANOFI-AVENTIS NMARK A/S AT EMA/695016/2017 Page 4/5

5 where NMARK A/S NMARK A/S NMARK A/S SURLID not available SANOFI-AVENTIS NMARK A/S SURLID not available SANOFI AB SE EMA/695016/2017 Page 5/5

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