List of nationally authorised medicinal products

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1 14 June 2018 EMA/418958/2018 Human Medicines Evaluation Division Active substance: atovaquone / proguanil 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 National Number Malarone, 250 mg/100 mg õhukese mg, comprime pellicule MALARONE 62,5 mg/25 mg ENFANTS, comprimé IL ZENTIVA 62,5 mg/25 mg ENFANTS, comprimé ILBIOGARAN 250 mg / 100 mg, comprimé ILBIOGARAN 62,5 mg / 25 mg ENFANTS, comprimé IL ZENTIVA 250 mg/100 mg, comprimé mg/25 mg comprimés s not available GLAXO GROUP EE not available PHARMA not available PHARMA not available NL22479 LABORATOIRE not available NL27585 LABORATOIRE not available NL42884 LABORATOIRE not available NL42822 LABORATOIRE not available NL42821 LABORATOIRE not available NL42885 LABORATOIRE UK/H/170/ EMA/418958/2018 Page 2/7

3 National Number Malarone? Junior Filmtabletten 62,5 mg/25 mg Filmtabletten Malarone Παιδιατρικό Δισκίο MALARONE Bambini 62,5 mg/25 mg compresse rivestite con film mg/25 mg comprimés s /25 mg filmomhulde tabletten mg/25 mg filmdrasjerte Malarone Pediátrico 62,5 mg/25 mg comprimidos recubiertos con película /25 mg filmdragerade Malarone paediatric 62.5mg/25 mg filmcoated tablets mg filmdragerade UK/H/0170/ GMBH & CO. KG UK/H/170/ AE GR UK/H/170/ S.P.A. IT UK/H/170/ / UK/H/170/002 RVG B.V. NL UK/H/0170/ AS NO UK/H/170/ S.A. ES UK/H/0170/ AB SE UK/H/0170/002 PL 10949/0363 GLAXO WELLCOME UK LTD TRADING AS UK UK UK/H/170/ OY FI DE EMA/418958/2018 Page 3/7

4 National Number mg filmomhulde tabletten mg Filmtabletten mg/25 mg filmomhulde tabletten mg/25 mg Filmtabletten mg/25 mg Filmtabletten mg Filmtabletten mg filmsko obložene tablete mg Filmtabletten mg comprimés s Malarone, potahované tablety 250 mg/100 mg mg tabletti, kalvopäällysteinen Malarone Filmtabletten 250 mg/100 mg Filmtabletten UK/H/0170/ UK/H/170/ UK/H/170/ UK/H/0170/ UK/H/170/ / UK/H/170/ /09/04/0394 UK/H/170/001 H/06/00962/001 D.O.O. SI UK/H/170/ PHARMA GMBH. AT UK/H/170/ UK/H/0170/001 25/547/05-C GLAXO WELLCOME UK LTD CZ UK/H/170/ OY FI UK/H/170/ GMBH & CO. KG DE EMA/418958/2018 Page 4/7

5 National Number Malarone επικαλυμμένα με λεπτό υμένιο δισκία 250 mg/100 mg mg filmtabletta mg filmuhúðaðar töflur mg compresse rivestite con film mg apvalkotās tabletes mg plėvele dengtos tabletės mg comprimés s Malarone 250/100 mg filmomhulde tabletten mg filmdrasjerte Malarone, 250 mg mg, tabletki powlekane mg comprimidos revestidos por película UK/H/170/ AE GR UK/H/170/001 OGYI-T-20107/01 KFT. HU UK/H/0170/001 IS/1/05/054/01 PHARMA IS UK/H/0170/001 PA 1077/111/1 IE (IRELAND) UK/H/170/ S.P.A. IT UK/H/170/ LATVIA SIA UK/H/170/001 LT/1/06/0441/001 LIETUVA UAB UK/H/170/ UK/H/170/001 RVG B.V. NL UK/H/170/ AS NO UK/H/0170/ EXPORT LTD UK/H/0170/ PRODUTOS FARMACEUTICOS, LDA LV LT PL PT EMA/418958/2018 Page 5/7

6 National Number mg filmom obalené tablety mg comprimidos recubiertos con película mg filmdragerade Malarone, 250 mg/100 mg õhukese mg, comprime pellicule UK/H/0170/001 25/0127/06-S GLAXO GROUP SK UK/H/170/ S.A. ES UK/H/0170/ AB SE UK/H/0170/001 PL 10949/0258 GLAXO WELLCOME UK LTD TRADING AS UK UK not available GLAXO GROUP EE not available PHARMA not available PHARMA not available NL22479 LABORATOIRE EMA/418958/2018 Page 6/7

7 National Number MALARONE 62,5 mg/25 mg ENFANTS, comprimé not available NL27585 LABORATOIRE EMA/418958/2018 Page 7/7

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