12 April 2018 EMA/227889/2018 Human Medicines Evaluation Division Active substance(s): typhoid polysaccharide vaccine Procedure No.: PSUSA/00003065/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact An agency of the European Union European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Typherix 25 míkróg/0,5 ml, stungulyf, lausn Bóluefni gegn taugaveiki (Vi fjölsykrungur) Typherix 25 mikrogram/0,5 ml, injeksjonsvæske, oppløsning Vaksine mot tyfoidfeber (Vi polysakkarid) Typherix 25 mikrogramai/0,5 ml injekcinis tirpalas užpildytame švirkšte Polisacharidine vakcina nuo viduriu šiltines Typherix 25 mikrogramai/0,5 ml injekcinis tirpalas užpildytame švirkšte Polisacharidinė vakcina nuo vidurių šiltinės Typherix 25 mikrogramai/0,5 ml injekcinis tirpalas užpildytame švirkšte Polisacharidine vakcina nuo viduriu šiltines Typherix 25 mikrogramai/0,5 ml injekcinis tirpalas užpildytame švirkšte Polisacharidine vakcina nuo viduriu šiltines Typherix 25 mikrogrami / 0,5 ml škidums injekcijam pilnšlirce Vi polisaharida vakcina pret vedertifu Vaccinum febris typhoidis polysaccharidicum not available 990215(IS) GLAXOSMITHKLINE PHARMA A/S not available 99-620 GLAXOSMITHKLINE AS NO not available LT/1/2000/2581/002 GLAXOSMITHKLINE LIETUVA UAB not available LT/1/2000/2581/003 GLAXOSMITHKLINE LIETUVA UAB not available LT/1/2000/2581/004 GLAXOSMITHKLINE LIETUVA UAB not available LT/1/2000/2581/001 GLAXOSMITHKLINE LIETUVA UAB not available 01-0022 GLAXOSMITHKLINE IS LT LT LT LT LV EMA/227889/2018 Page 2/12
Typherix 25 Mikrogramm/0,5 ml Injektionslösung Typhus- Polysaccharid-Impfstoff Typherix injektioneste, liuos, esitäytetyssä ruiskussa Polysakkaridirokote lavantautia vastaan Typherix oldat injekcióhoz előretöltött fecskendőben Hastífusz elleni poliszacharid vakcina Typherix solução injetável em seringa pré-cheia Vacina de polissacárido tifoide Typherix solução injetável em seringa pré-cheia Vacina de polissacárido tifoide Typherix solução injetável em seringa pré-cheia Vacina de polissacárido tifoide Typherix solução injetável em seringa pré-cheia Vacina de polissacárido tifoide Typherix, 25 µg/0,5 ml süstelahus süstlis Typherix, injekcní roztok v predplnené injekcní stríkacce Polysacharidová vakcína proti tyfu Typherix, injektioneste, liuos esitäytetyssä ruiskussa Polysakkaridirokote lavantautia vastaan Typherix, injektionsvæske, opløsning UK/H/0289/001 2-00237 GLAXOSMITHKLINE PHARMA GMBH. UK/H/0289/001 13888 GLAXOSMITHKLINE not available OGYI-T-8726/01 GLAXOSMITHKLINE KFT. HU UK/H/0289/001 2894582 SMITH KLINE & FRENCH PORTUGUESA-PDUTOS FARMACEUTICOS LDA UK/H/0289/001 2894681 SMITH KLINE & FRENCH PORTUGUESA-PDUTOS FARMACEUTICOS LDA UK/H/0289/001 2894780 SMITH KLINE & FRENCH PORTUGUESA-PDUTOS FARMACEUTICOS LDA UK/H/0289/001 2894889 SMITH KLINE & FRENCH PORTUGUESA-PDUTOS FARMACEUTICOS LDA not available 330000 GLAXOSMITHKLINE not available 59/520/00-C GLAXOSMITHKLINE UK/H/0289/001 13888 GLAXOSMITHKLINE UK/H/0289/001 30510 GLAXOSMITHKLINE PHARMA A/S AT FI PT PT PT PT EE CZ FI DK EMA/227889/2018 Page 3/12
Typherix, injektionsvätska, lösning, förfylld spruta Polysackaridvaccin mot tyfoidfeber Typherix, oplossing voor injectie in een voorgevulde spuit Tyfus polysaccharidevaccin TYPHERIX, Oplossing voor injectie in voorgevulde spuit.polysaccharide Buiktyfusvaccin Typherix, solución inyectable en jeringa precargada Vacuna de polisacárido antitifoideo UK/H/0289/001 15145 GLAXOSMITHKLINE AB SE UK/H/0289/001 RVG 23842 GLAXOSMITHKLINE B.V. NL UK/H/0289/001 BE202851 GLAXOSMITHKLINE UK/H/0289/001 62.710 GLAXOSMITHKLINE, S.A. ES not available 5126/2012/01 GLAXOSMITHKLINE not available 5126/2012/03 GLAXOSMITHKLINE not available 5126/2012/04 GLAXOSMITHKLINE not available 5126/2012/05 GLAXOSMITHKLINE not available 5126/2012/06 GLAXOSMITHKLINE not available 5126/2012/07 GLAXOSMITHKLINE not available 5126/2012/08 GLAXOSMITHKLINE BE EMA/227889/2018 Page 4/12
Typherix, solution for injection in a pre-filled syringe Typhoid Polysaccharide vaccine Typherix, solution for injection in a pre-filled syringe Typhoid Polysaccharide vaccine Typherix, solution for injection in a pre-filled syringe. Typhoid Polysaccharide vaccine. TYPHERIX, solution injectable dans une seringue preremplie Vaccin typhoidique polysaccharidique TYPHERIX, solution injectable dans une seringue préremplie Vaccin typhoïdique polysaccharidique Typherix, solution injectable en seringue préremplie Vaccin typhoïdique polyosidique not available 5126/2012/02 GLAXOSMITHKLINE UK/H/0289/001 PA 1077/38/1 GLAXOSMITHKLINE (IRELAND) LIMITED not available MA 172/00701 SMITHKLINE BEECHAM PLC MT UK/H/0289/001 PL 10592/0126 SMITHKLINE BEECHAM LTD UK UK/H/0289/001 BE202851 GLAXOSMITHKLINE UK/H/0289/001 BE202851 GLAXOSMITHKLINE UK/H/0289/001 NL24338 LABORATOIRE GLAXOSMITHKLINE UK/H/0289/001 034461057 GLAXOSMITHKLINE S.P.A. IT UK/H/0289/001 034461069 GLAXOSMITHKLINE S.P.A. IT IE BE BE FR EMA/227889/2018 Page 5/12
Typherix, Injektionslösung in einer Fertigspritze Typhus- Polysaccharid-Impfstoff UK/H/0289/001 034461071 GLAXOSMITHKLINE S.P.A. IT UK/H/0289/001 034461083 GLAXOSMITHKLINE S.P.A. IT UK/H/0289/001 034461095 GLAXOSMITHKLINE S.P.A. IT UK/H/0289/001 034461107 GLAXOSMITHKLINE S.P.A. IT UK/H/0289/001 034461018 GLAXOSMITHKLINE S.P.A. IT UK/H/0289/001 034461044 GLAXOSMITHKLINE S.P.A. IT UK/H/0289/001 034461032 GLAXOSMITHKLINE S.P.A. IT UK/H/0289/001 034461020 GLAXOSMITHKLINE S.P.A. IT UK/H/0289/001 PEI.H.00644.01.1 GLAXOSMITHKLINE GMBH & CO. KG DE EMA/227889/2018 Page 6/12
not available 5006101 SANOFI PASTEUR EUPE PT not available 5006119 SANOFI PASTEUR EUPE PT not available 3323680 SANOFI PASTEUR EUPE PT not available 5006143 SANOFI PASTEUR EUPE PT not available 3323581 SANOFI PASTEUR EUPE PT not available 5006127 SANOFI PASTEUR EUPE PT not available 5006150 SANOFI PASTEUR EUPE PT EMA/227889/2018 Page 7/12
mikrog/0,5 ml injektioneste, liuos, esitäytetty ruisku Polysakkaridilavantautirokot e. mikrogram/ 0,5 ml injektionsvätska, lösning. Polysackaridvaccin mot tyfoidfeber mikrogram/0,5 ml injektionsvätska, lösning i förfylld spruta polysackaridvaccin mot tyfoidfeber Mikrogramm Injektionslösung in einer Fertigspritze Typhus- Polysaccharid-Impfstoff TYPHIM Vi injekcinis tirpalas Polisacharidinė vakcina nuo vidurių šiltinės Typhim Vi Injektionslösung in einer Fertigspritze Typhim Vi oldatos injekció előretöltött fecskendőben poliszacharid hastífusz vakcina Typhim Vi oldatos injekció előretöltött fecskendőben poliszacharid hastífusz vakcina not available 5006135 SANOFI PASTEUR EUPE PT not available 11693 SANOFI PASTEUR EUPE FI not available 11757 SANOFI PASTEUR EUPE SE not available 11693 SANOFI PASTEUR EUPE FI not available 521A/91 SANOFI PASTEUR EUPE DE not available LT/1/95/1149/001 SANOFI PASTEUR SA LT not available 2-00093 SANOFI PASTEUR EUPE AT not available OGYI-T-9175/01 SANOFI PASTEUR SA HU not available OGYI-T-9175/02 SANOFI PASTEUR SA HU EMA/227889/2018 Page 8/12
TYPHIM Vi Solution for Injection Typhoid Polysaccharide Vaccine TYPHIM Vi Solution for Injection Typhoid Polysaccharide Vaccine TYPHIM Vi Soluzione iniettabile per uso intramuscolare Vaccino antitifico da capsulare Vi TYPHIM Vi Soluzione iniettabile per uso intramuscolare Vaccino antitifico da capsulare Vi Typhim Vi Vi kapsulárna polysacharidová vakcína proti týfusu TYPHIM Vi, 25 microgram/dosis, oplossing voor injectie Polyoside buiktyfusvaccin TYPHIM Vi, 25 microgramm/ dosis, Injektionslösung Typhus-Polysaccharid- Impfstoff TYPHIM Vi, 25 microgramm/ dosis, Injektionslösung Typhus-Polysaccharid- Impfstoff TYPHIM Vi, 25 microgrammes/dose, solution injectable Vaccin typhoïdique polyosidique not available PA 2131/011/001 SANOFI PASTEUR EUPE IE not available PL 46602/0008 SANOFI PASTEUR EUPE UK not available 029153020 SANOFI PASTEUR EUPE IT not available 029153018 SANOFI PASTEUR EUPE IT not available 59/0257/96-S SANOFI PASTEUR SA SK not available BE160307 SANOFI PASTEUR EUPE BE not available BE160307 SANOFI PASTEUR EUPE BE not available 2009110626 SANOFI PASTEUR EUPE LU not available BE160307 SANOFI PASTEUR EUPE BE EMA/227889/2018 Page 9/12
TYPHIM Vi, 25 microgrammes/dose, solution injectable Vaccin typhoïdique polyosidique Typhim Vi, 25 mikrogram/dose, injeksjonsvæske, oppløsning Vaksine mot tyfoidfeber (polysakkarid) Typhim Vi, 25 mikrogrammi/0,5 ml süstelahus süstlis Kõhutüüfuse polüsahhariidvaktsiin Typhim Vi, 25 míkrógrömm/0,5 ml, stungulyf, lausn. Fjölsykrubóluefni við taugaveiki TYPHIM Vi, injekční roztok v předplněné injekční stříkačce Polysacharidová vakcína proti břišnímu tyfu Typhim Vi, injektionsvæske, opløsning TYPHIM Vi, oplossing voor injectie 0,025 mg/0,5 ml Polyoside buiktyfusvaccin Typhim Vi, otopina za injekciju u napunjenoj štrcaljki, cjepivo protiv tifusa, polisaharidno not available 2009110626 SANOFI PASTEUR EUPE LU not available 8115 SANOFI PASTEUR EUPE NO not available 247899 SANOFI PASTEUR SA EE not available 920065 SANOFI PASTEUR EUPE IS not available 59/109/01-C SANOFI PASTEUR SA CZ not available 14739 SANOFI PASTEUR EUPE DK not available RVG 17568 SANOFI PASTEUR EUPE NL not available UP/I-530-09/13-02/106 SANOFI PASTEUR SA HR EMA/227889/2018 Page 10/12
TYPHIM Vi, roztwór do not available 9523 SANOFI PASTEUR SA PL wstrzykiwań w ampułkostrzykawce Vaccinum febris typhoidis polysaccharidicum Szczepionka przeciw durowi brzusznemu, polisacharydowa TYPHIM Vi, roztwór do not available 9523 SANOFI PASTEUR SA PL wstrzykiwań w ampułkostrzykawce Vaccinum febris typhoidis polysaccharidicum Szczepionka przeciw durowi brzusznemu, polisacharydowa Typhim Vi, šķīdums not available 97-0552 SANOFI PASTEUR SA LV injekcijām pilnšļircē Vēdertīfa polisaharīda vakcīna Vaccinum febris typhoidis polysaccharidicum TYPHIM Vi, solución not available 61.509 SANOFI PASTEUR EUPE ES inyectable Vacuna antitifoidea de polisacáridos Typhim Vi, solutie injectabila not available 1346/2008/01 SANOFI PASTEUR SA Typhim Vi, solutie injectabila not available 1346/2008/02 SANOFI PASTEUR SA Typhim Vi, solutie injectabila not available 1346/2008/03 SANOFI PASTEUR SA Typhim Vi, solutie injectabila not available 1346/2008/04 SANOFI PASTEUR SA Typhim Vi, solutie injectabila not available 1346/2008/05 SANOFI PASTEUR SA Typhim Vi, solution for not available MA573/00701 SANOFI PASTEUR SA MT injection in a prefilled syringe Polysaccharide typhoid vaccine TYPHIM Vi, solution injectable en multidose Vaccin typhoïdique polyosidique not available NL 15 296-2 SANOFI PASTEUR SA FR EMA/227889/2018 Page 11/12
TYPHIM Vi, solution injectable en seringue préremplie Vaccin typhoïdique polyosidique ТАЙФИМ Vi Инжекционeн разтвор в предварително напълнена спринцовка Полизахаридна ваксина срещу коремен тиф Тиферикс инжекционен разтвор в предварително напълнена спринцовка Полизахаридна ваксина срещу коремен тиф not available NL 15 296-1 SANOFI PASTEUR SA FR not available 20021033 SANOFI PASTEUR SA BG not available 20021007 GLAXOSMITHKLINE EOOD BG EMA/227889/2018 Page 12/12