List of nationally authorised medicinal products

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1 11 October 2017 EMA/691535/2017 Human Medicines Evaluation Division Active substance: Haemophilus type b conjugate vaccines 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 VAXEM Hib sospensione iniettabile in siringa preriempita Vaccino coniugato anti-haemophilus influenzae tipo b Хиберикс прах и разтворител за инжекционен разтвор Конюгатна ваксина срещу Haemophilus тип b Hiberix Polvere e solvente per soluzione iniettabile per uso intramuscolare Vaccino Haemophilus influenzae di tipo b coniugato al tossoide tetanico HIBERIX 10 μg/0,5 ml Pó e solvente para solução injetável. Vacina contra Haemophilus influenzae tipo b (Hib) HIBERIX - 10 microgrammes/0,5 ml Poudre et solvant pour solution injectable HIBERIX - 10 microgrammes/0,5 ml Poudre pour solution injectable Hiberix Wirkstoff: Haemophilusinfluenzae-b-Konjugat-Impfstoff HIBERIX Εμβόλιο Αιμόφιλου της ινφλουέντζας τύπου b (Hib) Hiberix. Haemophilus Type b (Hib) vaccine Powder and Solvent for Solution for Injection IT/H/0122/ GSK VACCINES S.R.L. IT not available GLAXOSMITHKLINE EOOD BG not available GLAXOSMITHKLINE S.P.A. IT not available BEECHAM PORTUGUESA- PT PRODUTOS FARMACEUTICOS E QUIMICOS, LDA not available BE GLAXOSMITHKLINE BE not available BE GLAXOSMITHKLINE BE not available 100A/95 GLAXOSMITHKLINE GMBH & CO. KG DE not available 40487/ GLAXOSMITHKLINE AEBE GR not available PA1077/027/001 GLAXOSMITHKLINE IE (IRELAND) LIMITED EMA/691535/2017 Page 2/8

3 Hiberix Vakcína proti Haemophilus influenzae typu b Prášek a rozpouštedlo pro injekcní roztok VAXEM Hib sospensione iniettabile in siringa preriempita Vaccino coniugato anti-haemophilus influenzae tipo b VAXEM Hib sospensione iniettabile Vaccino coniugato anti- Haemophilus influenzae tipo b HIBERIX Εμβόλιο Αιμόφιλου της ινφλουέντζας τύπου b (Hib) HIBERIX - 10 microgrammes/0.5ml Poudre et solvant pour solution injectable Hiberix, polvo y disolvente para solución inyectable. Vacuna conjugada Haemophilus influenzae tipo b Hiberix Polvere e solvente per soluzione iniettabile per uso intramuscolare Vaccino Haemophilus influenzae di tipo b coniugato al tossoide tetanico Hiberix Vaccine Haemophilus influenzae type b (Hib) vaccine Hiberix Vaccine Haemophilus influenzae type b (Hib) vaccine not available 59/1287/97-C GLAXOSMITHKLINE CZ IT/H/0122/ GSK VACCINES S.R.L. IT not available GSK VACCINES S.R.L. IT not available GLAXOSMITHKLINE CY not available GLAXOSMITHKLINE LU not available GLAXOSMITHKLINE, S.A. ES not available GLAXOSMITHKLINE S.P.A. IT not available PL 10592/0120 SMITHKLINE BEECHAM LTD UK not available MA 172/00401 SMITHKLINE BEECHAM PLC MT EMA/691535/2017 Page 3/8

4 Hiberix, poeder en oplosmiddel voor suspensie voor injectie Haemophilus Influenzae type b (Hib) vaccin HIBERIX 10 µg/0,5 ml Pó e solvente para solução injectável. Vacina contra Haemophilus influenzae tipo b (Hib) HIBERIX 10 µg/0,5 ml Pó e solvente para solução injectável Vacina contra Haemophilus influenzae tipo b (Hib) Hiberix, proszek i rozpuszczalnik do sporzadzania zawiesiny do wstrzykiwan. Vaccinum haemophili stirpe b coniugatum Szczepionka przeciwko zakazeniom haemophilus typ b, skoniugowana Act-HIB 10 microgrammes/0,5 ml, poudre et solvant pour solution injectable en seringue préremplie, Vaccin Haemophilus influenzae type b (conjugué) not available RVG GLAXOSMITHKLINE B.V. NL not available BEECHAM PORTUGUESA- PT PRODUTOS FARMACEUTICOS E QUIMICOS, LDA not available BEECHAM PORTUGUESA- PT PRODUTOS FARMACEUTICOS E QUIMICOS, LDA not available R/7048 GLAXOSMITHKLINE PL not available NL SANOFI PASTEUR SA FR EMA/691535/2017 Page 4/8

5 Act-HIB, 10 mikrogramów/0,5 ml, proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań Vaccinum haemophili stirpi b coniugatum Szczepionka przeciw haemophilus typ b, skoniugowana ACT-HIB 10 micrograms/0.5 ml, powder and solvent for solution for injection in a pre-filled syringe Haemophilus Influenzae type b vaccine (conjugated) ACT-HIB, 10 µg/0.5 ml, poudre et solvant pour solution injectable (IM, SC) en flacon multidose, Vaccin Haemophilus type b conjugué Act-HIB stungulyfsstofn og leysir, lausn Samtengt bóluefni gegn Haemophilus influenzae af stofni b Act-HIB 10 microgram/0,5 ml poeder en oplosmiddel voor oplossing voor injectie Geconjugeerd Haemophilus influenzae type b vaccin ACT-HIB Συνεζευγμένο εμβόλιο Haemophilus influenzae τύπου b not available R/3468 SANOFI PASTEUR SA PL not available SANOFI PASTEUR SA CY not available NL SANOFI PASTEUR SA FR not available SANOFI PASTEUR EUROPE IS not available RVG SANOFI PASTEUR EUROPE NL not available 60813/ & 63436/ SANOFI PASTEUR EUROPE GR 2016 EMA/691535/2017 Page 5/8

6 Act-HIB powder and solvent for solution for injection Haemophilus influenzae type b conjugate vaccine ACT-HIB Polvere e solvente per soluzione iniettabile Vaccino Haemophilus influenzae di tipo b coniugato al tossoide tetanico Act-HIB 10 µg/0,5 ml pó e solvente para solução injectável Vacina conjugada contra o Haemophilus influenzae tipo b (conjugada com proteína tetânica) Act-HIB powder and solvent for solution for injection Haemophilus influenzae type b conjugate vaccine ACT-HIB polvo y disolvente para solución inyectable. Vacuna de polisacárido de Haemophilus influenzae tipo b conjugado a proteína del tétanos Act-HIB 10 mikrogram/0,5 ml.pulver og væske til injeksjonsvæske, oppløsning Vaksine mot Haemophilus type b, konjugert Act-HIB, pulver og solvens til injektionsvæske, opløsning not available PL 46602/0011 SANOFI PASTEUR EUROPE UK not available SANOFI PASTEUR EUROPE IT not available SANOFI PASTEUR EUROPE PT not available PA 2131/001/001 SANOFI PASTEUR EUROPE IE not available SANOFI PASTEUR EUROPE ES not available 7985 SANOFI PASTEUR EUROPE NO not available SANOFI PASTEUR EUROPE DK EMA/691535/2017 Page 6/8

7 Act-HIB,10 mikrog/0,5 ml injektiokuiva-aine ja liuotin, liuosta varten Haemophilus influenzae tyyppi b (Hib) -rokote (konjugoitu) Act-HIB 10 mikrogram/0,5 ml pulver och vätska till injektionsvätska, lösning Haemophilus influenzae -vaccin, typ b (konjugerat) Act-HIB 10 µg/0,5 ml, Trockensubstanz und Lösungsmittel für Injektionslösungen Impfstoff Haemophilus influenzae Typ b (Konjugat) Act-HIB 10μg/0,5 ml, poudre et solvant pour solution injectable Vaccin Haemophilus influenzae type b (conjugué) Act-HIB Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension Act-HIB 10 microgram/0,5 ml, poeder en oplosmiddel voor oplossing voor injectie Geconjugeerd Haemophilus influenzae type b vaccin not available SANOFI PASTEUR EUROPE FI not available SANOFI PASTEUR EUROPE FI not available 0491/02/12/7082 SANOFI PASTEUR EUROPE LU not available 0491/02/12/7082 SANOFI PASTEUR EUROPE LU not available SANOFI PASTEUR EUROPE AT not available BE SANOFI PASTEUR EUROPE BE EMA/691535/2017 Page 7/8

8 Act-HIB 10 Mikrogramm/0,5 ml, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Konjugatimpfstoff gegen Haemophilus influenzae Typ b Act-HIB 10 microgrammes/0,5 ml, poudre et solvant pour solution injectable Vaccin conjugué de l' Haemophilus influenzae type b Act-HIB pulver och vätska till injektionsvätska, lösning Vaccin mot Haemophilus influenzae typ b, konjugerat Act-HiB Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension Haemophilus Typ b-impfstoff (konjugiert) not available BE SANOFI PASTEUR EUROPE BE not available BE SANOFI PASTEUR EUROPE BE not available SANOFI PASTEUR EUROPE SE not available 482A/91 SANOFI PASTEUR EUROPE DE EMA/691535/2017 Page 8/8