List of nationally authorised medicinal products
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1 21 October 2015 EMA/827738/2015 Procedure Management and Committees Support Active substance: ondansetron 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 Avessaron 260/07/01/9174 $ 260/07/01/9175 Glaxosmithkline Pharmaceuticals Sa Luxembourg Avessaron 260/07/01/9174 $ 260/07/01/9175 Glaxosmithkline Pharmaceuticals Sa Luxembourg Avessaron BE $ BE Glaxosmithkline Pharmaceuticals Sa Belgium Cellondan Lingual $ Cell Pharm Gmbh Germany Ondansetrom B. DE/H/0805/ $ $ $ $ B. Melsungen Ag Art 57 Portugal DE/H/0805/ $ $ $ B. Melsungen Ag Art 57 Italy $ DE/H/0805/ / $ $ B. Melsungen Ag Art 57 Luxembourg DE/H/0805/ B. Melsungen Ag Art 57 Poland DE/H/0805/001 20/0255/07-S B. Melsungen Ag Art 57 Slovakia DE/H/0805/ B. Melsungen Ag Art 57 Finland DE/H/0805/ B. Melsungen Ag Art 57 Sweden DE/H/0805/ B. Melsungen Ag Art 57 Denmark DE/H/0805/ $ $ B. Melsungen Ag Art 57 Germany DE/H/0805/001 BE $ BE $ BE B. Melsungen Ag Art 57 Belgium DE/H/0805/001 RVG B. Melsungen Ag Art 57 Netherlands
3 DE/H/0805/ / $ 2807/ B. Melsungen Ag Art 57 Greece B. DE/H/0805/001 BE $ BE $ BE B. Melsungen Ag Art 57 Belgium B. Ondansetrón B. DE/H/0805/ B. Melsungen Ag Art 57 Spain $ $ Glaxosmithkline S.P.A. Italy $ $ Glaxo Operations Uk Ltd Finland $ $ $ $ Glaxosmithkline Ab Sweden Glaxosmithkline Oy Finland $ $ $ $ Glaxosmithkline Pharma A/S Denmark $ $ $ Glaxo Group Limited Cyprus 20/0165/91-C/S Glaxosmithkline Slovakia S.R.O. Slovakia 20/433/99-C Glaxo Group Limited Czech Republic $ Glaxosmithkline Export Ltd Estonia $ $ Glaxo Wellcome Farmacêutica, Lda Portugal 260/07/01/9167 $ 260/07/01/9168 $ 260/07/01/9170 Glaxosmithkline Pharmaceuticals Sa Luxembourg EMA/827738/2015 Page 2
4 5363-I-194/13 $ 5363-I-195/13 $ 5363-I- Glaxosmithkline D.O.O. Slovenia 196/13 $ 5363-I-197/ $ Glaxosmithkline S.A. Spain Glaxosmithkline S.A. Spain 7699 $ 7700 $ 7758 $ $ Glaxosmithkline As Norway $ $ $ 8106 $ R/0018 $ R/0019 $ R/0020 Glaxosmithkline Export Ltd Poland $ $ IS/1/13/004/01 Glaxosmithkline Ehf. Iceland Glaxosmithkline Ehf. Iceland $ Glaxosmithkline Latvia Sia Latvia AA167/01502 $ MA 167/01501 Glaxo Wellcome Ltd Malta BE $ BE $ BE Glaxosmithkline Pharmaceuticals Sa Belgium LT/1/94/1091/001 $ LT/1/94/1091/002 $ Uab Glaxosmithkline Lietuva Lithuania LT/1/94/1091/003 $ LT/1/94/1091/006 $ LT/1/94/1091/007 $ LT/1/94/1091/008 LT/1/94/1091/004 $ LT/1/94/1091/005 Glaxosmithkline Lietuva Uab Lithuania LT/1/94/1091/009 Glaxosmithkline Lietuva Uab Lithuania MA 192/01401 Glaxosmithkline (Ireland) Limited Malta EMA/827738/2015 Page 3
5 PA 1077/016/001 $ PA 1077/016/003 $ PA 1077/016/004 $ PA 1077/016/005 $ PA 1077/016/006 Glaxosmithkline (Ireland) Limited PL 10949/0263 $ PL 10949/0110 $ PL Glaxo Wellcome Ltd United Kingdom 10949/0111 $ PL 10949/0247 PL 00004/0375 Glaxo Operations Uk Ltd United Kingdom RVG $ RVG $ RVG $ Glaxosmithkline B.V. Netherlands RVG UP/I /12-02/325 Glaxosmithkline D.O.O. Croatia Ireland UP/I /12-02/327 $ UP/I-530- Glaxosmithkline D.O.O. Croatia 09/12-02/328 Konserveret Glaxosmithkline Pharma A/S Denmark Munlöslig $ Glaxosmithkline Ab Sweden Zydis $ Glaxosmithkline Oy Finland Zydis 20/0380/00-S Glaxosmithkline Slovakia S.R.O. Slovakia Zydis 20/474/99-C $ 20/475/99-C Glaxo Group Limited Czech Republic Zydis 260/07/01/9171 $ 260/07/01/9172 Glaxosmithkline Pharmaceuticals Sa Luxembourg Zydis $ Glaxosmithkline Gmbh & Co. Kg Germany Zydis $ Glaxosmithkline S.A. Spain EMA/827738/2015 Page 4
6 Zydis 8879 $ 8880 Glaxosmithkline Export Ltd Poland Zydis BE Glaxosmithkline Pharmaceuticals Sa Belgium Zydis LT/1/03/3250/001 $ LT/1/03/3250/002 Glaxo Wellcome Ltd Lithuania Zydis PA 1077/016/008 $ PA 1077/016/009 Glaxosmithkline (Ireland) Limited Ireland Zydis RVG $ RVG Glaxosmithkline B.V. Netherlands Zofron 38976/10/ $ 38980/10/ Glaxosmithkline Aebe Greece Zofron 38978/10/ $ 38981/10/ $ Glaxosmithkline Aebe Greece 38983/10/ $ 38987/10/ $ 70468/13/ Zophren NL21260 $ NL22622 $ NL22623 Laboratoire Glaxosmithkline S.A.S. France Zophren NL21803 Laboratoire Glaxosmithkline S.A.S. France Зофран $ $ Glaxosmithkline Eood Bulgaria Zydis Novartis Pharma GmbH Austria Novartis Pharma GmbH Austria Supporitories Zydis Novartis Pharma GmbH Austria Injection Novartis Pharma GmbH Austria EMA/827738/2015 Page 5
7 Oral Novartis Pharma GmbH Austria Injection Novartis Pharma GmbH Austria Tablets Novartis Pharma GmbH Austria Tablets Novartis Pharma GmbH Austria OGYI-T-6559/01 Novartis Kft Hungary Suppositories Injection OGYI-T-6559/04 Novartis Kft Hungary Tablets OGYI-T-6559/05 Novartis Kft Hungary Tablets OGYI-T-6559/06-07 Novartis Kft Hungary Injection OGYI-T-6559/03 Novartis Kft Hungary Sanofi-Aventis France Sanofi-Aventis France EMA/827738/2015 Page 6
8 ZOFRAN MELT 8MG Sanofi-A France Sanofi-Aventis France Sanofi-Aventis France Sanofi-Aventis France Sanofi-Aventis France Sanofi-Aventis France PL 10949/0264 GLAXO WELLCOME UK LIMITED United Kingdom EMA/827738/2015 Page 7
List of nationally authorised medicinal products
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