21 October 2015 EMA/827738/2015 Procedure Management and Committees Support Active substance: ondansetron Procedure no.: PSUSA/00002217/201502 30 Churchill Place Canary Wharf London E14 5EU United Kingdom 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, 2015. Reproduction is authorised provided the source is acknowledged.
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 BE150236 $ BE150263 Glaxosmithkline Pharmaceuticals Sa Belgium Cellondan Lingual 59771.00.00 $ 59771.01.00 Cell Pharm Gmbh Germany Ondansetrom B. DE/H/0805/001 5042775 $ 5042809 $ 5042817 $ 5042825 $ 5442850 B. Melsungen Ag Art 57 Portugal DE/H/0805/001 038128017 $ 038128029 $ 038128031 $ B. Melsungen Ag Art 57 Italy 038128043 $ 038128056 DE/H/0805/001 0667/08120021 $ 2012050043 $ B. Melsungen Ag Art 57 Luxembourg 2012050044 DE/H/0805/001 15717 B. Melsungen Ag Art 57 Poland DE/H/0805/001 20/0255/07-S B. Melsungen Ag Art 57 Slovakia DE/H/0805/001 23137 B. Melsungen Ag Art 57 Finland DE/H/0805/001 24997 B. Melsungen Ag Art 57 Sweden DE/H/0805/001 40588 B. Melsungen Ag Art 57 Denmark DE/H/0805/001 59057.00.00 $ 66115.00.00 $ B. Melsungen Ag Art 57 Germany 66118.00.00 DE/H/0805/001 BE316881 $ BE316897 $ BE421644 B. Melsungen Ag Art 57 Belgium DE/H/0805/001 RVG 34936 B. Melsungen Ag Art 57 Netherlands
DE/H/0805/001 2806/15-1-2008 $ 2807/15-1-2008 B. Melsungen Ag Art 57 Greece B. DE/H/0805/001 BE316881 $ BE316897 $ BE421644 B. Melsungen Ag Art 57 Belgium B. Ondansetrón B. DE/H/0805/001 69905 B. Melsungen Ag Art 57 Spain 027612074 $ 027612098 $ 027612112 Glaxosmithkline S.P.A. Italy 10792 $ 10793 $ 10794 Glaxo Operations Uk Ltd Finland 11272 $ 11493 $ 11494 $ 13433 $ 14651 Glaxosmithkline Ab Sweden 12319 Glaxosmithkline Oy Finland 13586 $ 13587 $ 13588 $ 17600 $ 17601 Glaxosmithkline Pharma A/S Denmark $ 18515 $ 18516 16848 $ 16849 Glaxo Group Limited Cyprus 20/0165/91-C/S Glaxosmithkline Slovakia S.R.O. Slovakia 20/433/99-C Glaxo Group Limited Czech Republic 215498 $ 215698 Glaxosmithkline Export Ltd Estonia 2504280 $ 2504389 $ 2504488 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
5363-I-194/13 $ 5363-I-195/13 $ 5363-I- Glaxosmithkline D.O.O. Slovenia 196/13 $ 5363-I-197/13 59.069 $ 59.070 Glaxosmithkline S.A. Spain 59.072 Glaxosmithkline S.A. Spain 7699 $ 7700 $ 7758 $ 95-2484 $ 95-2485 Glaxosmithkline As Norway $ 96-3183 $ 96-3184 8105 $ 8106 $ R/0018 $ R/0019 $ R/0020 Glaxosmithkline Export Ltd Poland 890110 $ 890111 $ IS/1/13/004/01 Glaxosmithkline Ehf. Iceland 890112 Glaxosmithkline Ehf. Iceland 98-0617 $ 98-0741 Glaxosmithkline Latvia Sia Latvia AA167/01502 $ MA 167/01501 Glaxo Wellcome Ltd Malta BE150272 $ BE150297 $ BE179417 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
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 14292 $ RVG 14293 $ RVG 19252 $ Glaxosmithkline B.V. Netherlands RVG 19922 UP/I-530-09/12-02/325 Glaxosmithkline D.O.O. Croatia Ireland UP/I-530-09/12-02/327 $ UP/I-530- Glaxosmithkline D.O.O. Croatia 09/12-02/328 Konserveret 18966 Glaxosmithkline Pharma A/S Denmark Munlöslig 13585 $ 13586 Glaxosmithkline Ab Sweden Zydis 12874 $ 12875 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 41349.00.00 $ 41349.01.00 Glaxosmithkline Gmbh & Co. Kg Germany Zydis 62.944 $ 62.945 Glaxosmithkline S.A. Spain EMA/827738/2015 Page 4
Zydis 8879 $ 8880 Glaxosmithkline Export Ltd Poland Zydis BE199193 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 21471 $ RVG 21472 Glaxosmithkline B.V. Netherlands Zofron 38976/10/18-4-11 $ 38980/10/18-4-11 Glaxosmithkline Aebe Greece Zofron 38978/10/18-4-11 $ 38981/10/18-4-11 $ Glaxosmithkline Aebe Greece 38983/10/18-4-11 $ 38987/10/18-4-11 $ 70468/13/30-7-2014 Zophren NL21260 $ NL22622 $ NL22623 Laboratoire Glaxosmithkline S.A.S. France Zophren NL21803 Laboratoire Glaxosmithkline S.A.S. France Зофран 20011016 $ 20011017 $ 20011018 Glaxosmithkline Eood Bulgaria Zydis 1-22512 Novartis Pharma GmbH Austria 1-22412 Novartis Pharma GmbH Austria Supporitories Zydis 1-22513 Novartis Pharma GmbH Austria Injection 1-19340 Novartis Pharma GmbH Austria EMA/827738/2015 Page 5
Oral 1-22404 Novartis Pharma GmbH Austria Injection 1-19342 Novartis Pharma GmbH Austria Tablets 1-19341 Novartis Pharma GmbH Austria Tablets 1-19343 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 382 836-6 Sanofi-Aventis France 382 837-2 Sanofi-Aventis France EMA/827738/2015 Page 6
ZOFRAN MELT 8MG 382 838-9 Sanofi-A France 382 839-5 Sanofi-Aventis France 382 840-3 Sanofi-Aventis France 382 842-6 Sanofi-Aventis France 382 843-2 Sanofi-Aventis France 382 844-9 Sanofi-Aventis France PL 10949/0264 GLAXO WELLCOME UK LIMITED United Kingdom EMA/827738/2015 Page 7