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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

12 July 2018 EMA/495687/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: diphtheria / tetanus / pertussis (acellular, component) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed)

Procedure no.: PSUSA/00001124/201711

List of nationally authorised medicinal products EMA/495687/2018 Page 2/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac Pulver und Suspension zur Herstellung einer Injektionslösung Diphtherie-, Tetanus-, Pertussis-(azelluläre Bestandteile), Poliomyelitis-(inaktiviert), und konjugierte Haemophilus influenzae Typ b-Vakzine (adsorbiert)

SE/H/0153/001 2-00227 SANOFI PASTEUR EUROPE AT

Infanrix®-IPV+Hib Pulver und Suspension zur Herstellung einer Injektionssuspension Diphtherie-, Tetanus- (azellulärer) Pertussis-, Poliomyelitis (inaktiviert)- und Haemophilus-influenzae-Typ b-Konjugatimpfstoff (adsorbiert)

DE/H/0145/002 2-00370 GLAXOSMITHKLINE PHARMA GMBH.

AT

Pentavac, poudre et suspension injectable Vaccin diphtérique, tétanique, coquelucheux (acellulaire, composant) et poliomyélitique (inactivé), et vaccin Haemophilus influenzae type b conjugué (adsorbé)

SE/H/0153/001 BE196131 SANOFI PASTEUR EUROPE BE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac, poeder en suspensie voor injectie Difterie-, tetanus-, kinkhoest-(acellulaire, component), poliomyelitisvaccin (geïnactiveerd), en geconjugeerd Haemophilus influenzae type b-vaccin (geadsorbeerd).

SE/H/0153/001 BE196131 SANOFI PASTEUR EUROPE BE

Pentavac, Pulver und Injektionssuspension Diphtherie-, Tetanus-, Pertussis-(azellulär), Poliomyelitis-(inaktiviert), und konjugierte Haemophilus influenzae Typ b - Impfstoff (adsorbiert)

SE/H/0153/001 BE196131 SANOFI PASTEUR EUROPE BE

ПЕНТАКСИМ Прах и суспензия за инжекционна суспензия, Адсорбирана ваксина срещу дифтерия, тетанус, коклюш (безклетъчна, компонентна), полиомиелит (инактивирана) и Haemophilus тип b (конюгатна)

not available 20050449 SANOFI PASTEUR SA BG

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Инфанрикс-IPV+Hib прах и суспензия за инжекционна суспензия [Адсорбирана ваксина срещу дифтерия, тетанус, коклюш (безклетъчна, компонентна), полиомиелит (инактивирана) и Haemophilus influenzae тип b (конюгатна)]

DE/H/0145/002 20090475 GLAXOSMITHKLINE EOOD BG

PENTAXIM, powder and suspension for suspension for injection in prefilled syringe, Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine and Haemophilus type b conjugate vaccine, adsorbed

not available 19523 SANOFI PASTEUR SA CY

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

INFANRIX-IPV+Hib, prášek a suspenze pro injekcní suspenzi Vakcína proti difterii, tetanu, pertusi (acelulární komponenta), poliomyelitide (inaktivovaná vakcína) a konjugovaná vakcína proti Haemophilus influenzae typu b (adsorbovaná)

DE/H/0145/002 59/101/05-C GLAXOSMITHKLINE BIOLOGICALS S.A.

CZ

PENTAVAC Pulver und Suspension zur Herstellung einer Injektionssuspension Diphtherie-Tetanus-Pertussis (azellulär)-Poliomyelitis (inaktiviert)-Adsorbat-Impfstoff und Haemophilus influenzae Typ b-Konjugat-Impfstoff

not available 11A/97 SANOFI PASTEUR EUROPE DE

Infanrix®-IPV+Hib – Pulver und Suspension zur Herstellung einer Injektionssuspension Diphtherie-Tetanus- (azellulärer) Pertussis-, Poliomyelitis (inaktiviert)- und Haemophilus-influenzae-Typ b-Konjugatimpfstoff (adsorbiert)

DE/H/0145/002 76A/97 GLAXOSMITHKLINE GMBH & CO. KG

DE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

DiTeKiPol/Act-Hib, pulver og solvens til injektionsvæske, suspension

not available 32847 AJ VACCINES A/S DK

DiTeKiPol/Act-Hib, pulver og solvens til injektionsvæske, suspension

not available 32847 AJ VACCINES A/S DK

DiTeKiPol/Act-Hib, pulver og solvens til injektionsvæske, suspension

not available 32847 AJ VACCINES A/S DK

Pentavac Difteri, tetanus, pertussis (acellulær, komponent), polio (inaktiveret) og Haemophilus influenza type b konjugeret vaccine (adsorberet)

SE/H/0153/001 30187 SANOFI PASTEUR EUROPE DK

PENTAXIM, süstesuspensiooni pulber ja suspensioon süstlis, Difteeria, teetanuse, läkaköha (atsellulaarne komponent), poliomüeliidi (inaktiveeritud) vaktsiin ja Haemophilus influenzae tüüp b konjugeeritud vaktsiin (adsorbeeritud)

not available 430604 SANOFI PASTEUR SA EE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PEDIACEL, suspensión inyectable en jeringa precargada Vacuna de difteria, tétanos, tos ferina (componente acelular), poliomielitis (inactivada) y Haemophilus tipo b conjugada (adsorbida)

UK/H/2388/001 73.316 SANOFI PASTEUR EUROPE ES

Pentavac polvo y suspensión inyectable. Vacuna de difteria, tétanos, tos ferina (componente acelular), poliomielitis (inactivada) y Haemophilus influenzae tipo b conjugada (adsorbida)

SE/H/0153/001 62.483 SANOFI PASTEUR EUROPE ES

Pentavac Kurkkumätä-, jäykkäkouristus-, hinkuyskä- (soluton komponentti), polio- (inaktivoitu) ja Haemophilus influenzae tyyppi b -konjugaattirokote (adsorboitu)

SE/H/0153/001 13677 SANOFI PASTEUR EUROPE FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac pulver och suspension till injektionsvätska, suspension Difteri, stelkramp, kikhosta (acellulärt, komponent), polio (inaktiverat) och Hemofilus influensa typ b konjugerat vaccin (adsorberat)

SE/H/0153/001 13677 SANOFI PASTEUR EUROPE FI

Infanrix Polio+Hib, injektiokuiva-aine ja suspensio, suspensiota varten Kurkkumätä-, jäykkäkouristus-, hinkuyskä (soluton, komponentti)-, poliomyeliitti (inaktivoitu)- ja Haemophilus influenzae tyyppi b konjugoitu rokote (adsorboitu)

DE/H/0145/002 13043 GLAXOSMITHKLINE BIOLOGICALS S.A.

FI

PENTAXIM, poudre et suspension pour suspension injectable en seringue préremplie, Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé), poliomyélitique (inactivé) et conjugué de l’haemophilus type b, adsorbé

not available NL 22 418 SANOFI PASTEUR SA FR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PEDIACEL, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé), poliomyélitique (inactivé) et conjugué de l'Haemophilus type b (adsorbé)

UK/H/2388/001 34009 499 618 9 4 SANOFI PASTEUR EUROPE FR

PEDIACEL, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé), poliomyélitique (inactivé) et conjugué de l'Haemophilus type b (adsorbé)

UK/H/2388/001 34009 499 619 5 5 SANOFI PASTEUR EUROPE FR

PEDIACEL, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé), poliomyélitique (inactivé) et conjugué de l'Haemophilus type b (adsorbé)

UK/H/2388/001 34009 499 620 3 7 SANOFI PASTEUR EUROPE FR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PEDIACEL, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé), poliomyélitique (inactivé) et conjugué de l'Haemophilus type b (adsorbé)

UK/H/2388/001 34009 499 623 2 7 SANOFI PASTEUR EUROPE FR

PEDIACEL, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé), poliomyélitique (inactivé) et conjugué de l'Haemophilus type b (adsorbé)

UK/H/2388/001 34009 499 622 6 6 SANOFI PASTEUR EUROPE FR

IΝFΑΝRΙΧ IPV Hib κόνις και εναιώρημα για ενέσιμο εναιώρημα. Συζευγμένο εμβόλιο διφθερίτιδας, τετάνου, κοκκύτου (ακκυταρικό συστατικό), πολιομυελίτιδας (αδρανοποιημένο) και αιμόφιλου τύπου β (προσροφημένο)

DE/H/0145/002 2402001 GLAXOSMITHKLINE AEBE GR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac Προσροφημένο εμβόλιο διφθερίτιδας, τετάνου, κοκκύτη (ακυτταρικό, συστατικό) και πολιομυελίτιδας (αδρανοποιημένο) και εμβόλιο Haemophilus influenzae τύπου b συζευγμένο

SE/H/153/01 30984/6-5-2015 & 63436/21-09-2016 & 56885/22-06-2017

SANOFI PASTEUR EUROPE GR

IΝFΑΝRΙΧ IPV Hib κόνις και εναιώρημα για ενέσιμο εναιώρημα. Συζευγμένο εμβόλιο διφθερίτιδας, τετάνου, κοκκύτου (ακκυταρικό συστατικό), πολιομυελίτιδας (αδρανοποιημένο) και αιμόφιλου τύπου β (προσροφημένο)

DE/H/0145/002 2402001 GLAXOSMITHKLINE AEBE GR

PENTAXIM, prašak i suspenzija za suspenziju za injekciju u napunjenoj štrcaljki, cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno), poliomijelitisa (inaktivirano) i hemofilusa tip b (konjugirano), adsorbirano

not available HR-H-854134391 SANOFI PASTEUR SA HR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

INFANRIX-IPV+Hib prašak i suspenzija za suspenziju za injekciju cjepivo protiv difterije (D), tetanusa (T), pertusisa (nestanično, komponentno) (Pa), poliomijelitisa (inaktivirano) (IPV) i hemofilusa tipa b (Hib) (konjugirano), adsorbirano

DE/H/0145/002 HR-H-255493749 GLAXOSMITHKLINE D.O.O. HR

Infanrix-IPV+Hib por szuszpenziós injekcióhoz és szuszpenziós injekció előretöltött fecskendőben Adszorbeált kombinált, diphtheria, tetanus, acellularis pertussis, inaktivált poliomyelitis és konjugált b-típusú Haemophilus influenzae (Hib) szuszpenziós injekció

not available OGYI-T-9521/01 GLAXOSMITHKLINE KFT. HU

Pentaxim por és szuszpenzió szuszpenziós injekcióhoz, előretöltött fecskendőben Diftéria tetanusz, pertusszisz (acelluláris, komponens), poliomielitisz (inaktivált) és konjugált b típusú hemofilusz vakcina (adszorbeált)

not available OGYI-T-9414/01 SANOFI PASTEUR SA HU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentaxim por és szuszpenzió szuszpenziós injekcióhoz, előretöltött fecskendőben Diftéria tetanusz, pertusszisz (acelluláris, komponens), poliomielitisz (inaktivált) és konjugált b típusú hemofilusz vakcina (adszorbeált)

not available OGYI-T-9414/02 SANOFI PASTEUR SA HU

Pentaxim por és szuszpenzió szuszpenziós injekcióhoz, előretöltött fecskendőben Diftéria tetanusz, pertusszisz (acelluláris, komponens), poliomielitisz (inaktivált) és konjugált b típusú hemofilusz vakcina (adszorbeált)

not available OGYI-T-9414/03 SANOFI PASTEUR SA HU

Pentaxim por és szuszpenzió szuszpenziós injekcióhoz, előretöltött fecskendőben Diftéria tetanusz, pertusszisz (acelluláris, komponens), poliomielitisz (inaktivált) és konjugált b típusú hemofilusz vakcina (adszorbeált)

not available OGYI-T-9414/04 SANOFI PASTEUR SA HU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentaxim por és szuszpenzió szuszpenziós injekcióhoz, előretöltött fecskendőben Diftéria tetanusz, pertusszisz (acelluláris, komponens), poliomielitisz (inaktivált) és konjugált b típusú hemofilusz vakcina (adszorbeált)

not available OGYI-T-9414/05 SANOFI PASTEUR SA HU

Pentaxim por és szuszpenzió szuszpenziós injekcióhoz, előretöltött fecskendőben Diftéria tetanusz, pertusszisz (acelluláris, komponens), poliomielitisz (inaktivált) és konjugált b típusú hemofilusz vakcina (adszorbeált)

not available OGYI-T-9414/06 SANOFI PASTEUR SA HU

Pentavac Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

SE/H/0153/001 PA 2131/005/001 SANOFI PASTEUR EUROPE IE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac Barnaveiki-, stífkrampa-, kíghósta (frumulaus þáttur), mænusóttarveirubóluefni (dautt), og samtengt Haemophilus influenzae bóluefni af b stofni (aðsogað)

SE/H/0153/001 970044 SANOFI PASTEUR EUROPE IS

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126058 SANOFI PASTEUR EUROPE IT

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126060 SANOFI PASTEUR EUROPE IT

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126019 SANOFI PASTEUR EUROPE IT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126021 SANOFI PASTEUR EUROPE IT

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126033 SANOFI PASTEUR EUROPE IT

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126045 SANOFI PASTEUR EUROPE IT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126072 SANOFI PASTEUR EUROPE IT

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126096 SANOFI PASTEUR EUROPE IT

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126108 SANOFI PASTEUR EUROPE IT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac Vaccino antidifterico, antitetanico, antipertossico (componente acellulare), antipolio (inattivato) ed anti-Haemophilus influenzae di tipo b coniugato (adsorbito)

SE/H/0153/001 034126084 SANOFI PASTEUR EUROPE IT

PENTAXIM milteliai ir suspensija injekcinei suspensijai užpildytame švirkšte, Vakcina nuo difterijos, stabliges, kokliušo (nelasteline, komponentine), nuo poliomielito (inaktyvuota) ir nuo b tipo Haemophilus, konjuguota, (adsorbuota)

not available LT/1/99/3124/001 SANOFI PASTEUR SA LT

PENTAXIM milteliai ir suspensija injekcinei suspensijai užpildytame švirkšte Vakcina nuo difterijos, stabligės, kokliušo (neląstelinė, komponentinė), nuo poliomielito (inaktyvuota) ir nuo b tipo Haemophilus, konjuguota, (adsorbuota)

not available LT/1/99/3124/002 SANOFI PASTEUR SA LT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PENTAXIM milteliai ir suspensija injekcinei suspensijai užpildytame švirkšte Vakcina nuo difterijos, stabligės, kokliušo (neląstelinė, komponentinė), nuo poliomielito (inaktyvuota) ir nuo b tipo Haemophilus, konjuguota, (adsorbuota)

not available LT/1/99/3124/003 SANOFI PASTEUR SA LT

PENTAXIM milteliai ir suspensija injekcinei suspensijai užpildytame švirkšte Vakcina nuo difterijos, stabligės, kokliušo (neląstelinė, komponentinė), nuo poliomielito (inaktyvuota) ir nuo b tipo Haemophilus, konjuguota, (adsorbuota)

not available LT/1/99/3124/004 SANOFI PASTEUR SA LT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PENTAXIM milteliai ir suspensija injekcinei suspensijai užpildytame švirkšte Vakcina nuo difterijos, stabligės, kokliušo (neląstelinė, komponentinė), nuo poliomielito (inaktyvuota) ir nuo b tipo Haemophilus, konjuguota, (adsorbuota)

not available LT/1/99/3124/005 SANOFI PASTEUR SA LT

PENTAXIM milteliai ir suspensija injekcinei suspensijai užpildytame švirkšte Vakcina nuo difterijos, stabligės, kokliušo (neląstelinė, komponentinė), nuo poliomielito (inaktyvuota) ir nuo b tipo Haemophilus, konjuguota, (adsorbuota)

not available LT/1/99/3124/006 SANOFI PASTEUR SA LT

Pentavac Vaccin diphtérique, tétanique, coquelucheux (acellulaire, composant) et poliomyélitique (inactivé), et vaccin Haemophilus influenzae type b conjugué (adsorbé)

SE/H/0153/001 2009020171 SANOFI PASTEUR EUROPE LU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac, Pulver und Injektionssuspension Diphtherie-, Tetanus-, Pertussis-(azellulär), Poliomyelitis-(inaktiviert), und konjugierte Haemophilus influenzae Typ b - Impfstoff (adsorbiert)

SE/H/0153/001 2009020171 SANOFI PASTEUR EUROPE LU

PENTAXIM pulveris un suspensija injekciju suspensijas pagatavošanai pilnšlirce, Difterijas, stingumkrampju, acelulara gara klepus, poliomielita (inaktiveta) un b tipa Haemophilus influenzae konjugata vakcina (adsorbeta), Vaccinum diphtheriae, tetani, pertussis, poliomyelitidis inactivatum et haemophili stirpe b coniugatum adsorbatum

not available 02-0311 SANOFI PASTEUR SA LV

Product full name (in authorisation country as per Art. 57 data)

MRP/DCP or CP Authorisation number (if not available then insert not available)

National Authorisation Number of product in the member state

MAH of product in the member state

Member State where product is authorised

List of nationally authorised medicinal products EMA/495687/2018 Page 22/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PEDIACEL®, suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)

UK/H/2388/001 MA573/01601 SANOFI PASTEUR SA MT

PEDIACEL, suspensie voor injectie in injectieflaconDifterie, tetanus, kinkhoest (acellulair, componenten), poliomyelitis (geïnactiveerd) en Haemophilus influenzae type b conjugaatvaccin (geadsorbeerd)

UK/H/0775/001 RVG 32118 SANOFI PASTEUR EUROPE NL

Pentavac Vaksine mot difteri, tetanus, kikhoste (acellulær, komponent), poliomyelitt (inaktivert) og Haemophilus influenzae type b konjugert, (adsorbert)

not available 97-710 SANOFI PASTEUR EUROPE NO

List of nationally authorised medicinal products EMA/495687/2018 Page 23/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PENTAXIM, proszek i zawiesina do sporzadzania zawiesiny do wstrzykiwan, Vaccinum diphteriae, tetani, pertussis sine cellulis ex elementis praeparatum, poliomyelitidis inactivatum et haemophili stirpe b coniugatum adsorbatum, Szczepionka przeciw blonnicy, tezcowi, krztuscowi (bezkomórkowa, zlozona), poliomyelitis (inaktywowana) i haemophilus typ b (skoniugowana), adsorbowana

not available 10130 SANOFI PASTEUR SA PL

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 2856482 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

List of nationally authorised medicinal products EMA/495687/2018 Page 24/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular), a poliomielite (inativada) e conjugada contra o Haemophilus influenzae tipo b

SE/H/0153/001 2782282 SANOFI PASTEUR EUROPE PT

Pentavac Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular), a poliomielite (inativada) e conjugada contra o Haemophilus influenzae tipo b

SE/H/0153/001 2782381 SANOFI PASTEUR EUROPE PT

Pentavac Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular), a poliomielite (inativada) e conjugada contra o Haemophilus influenzae tipo b

SE/H/0153/001 5458989 SANOFI PASTEUR EUROPE PT

Pentavac Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular), a poliomielite (inativada) e conjugada contra o Haemophilus influenzae tipo b

SE/H/0153/001 5459086 SANOFI PASTEUR EUROPE PT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Pentavac Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular), a poliomielite (inativada) e conjugada contra o Haemophilus influenzae tipo b

SE/H/0153/001 5459185 SANOFI PASTEUR EUROPE PT

Pentavac Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular), a poliomielite (inativada) e conjugada contra o Haemophilus influenzae tipo b

SE/H/0153/001 5459284 SANOFI PASTEUR EUROPE PT

Pentavac Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular), a poliomielite (inativada) e conjugada contra o Haemophilus influenzae tipo b

SE/H/0153/001 5459383 SANOFI PASTEUR EUROPE PT

Pentavac Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular), a poliomielite (inativada) e conjugada contra o Haemophilus influenzae tipo b

SE/H/0153/001 5458880 SANOFI PASTEUR EUROPE PT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 2856482 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4059382 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 2856383 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

List of nationally authorised medicinal products EMA/495687/2018 Page 27/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4059986 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4059580 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4059283 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

List of nationally authorised medicinal products EMA/495687/2018 Page 28/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 2856581 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 2858082 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4068789 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4059481 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4060083 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 2858181 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

List of nationally authorised medicinal products EMA/495687/2018 Page 30/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4068680 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4060182 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 2857688 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

List of nationally authorised medicinal products EMA/495687/2018 Page 31/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 2857787 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4059788 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4059689 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

List of nationally authorised medicinal products EMA/495687/2018 Page 32/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 2857886 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

INFANRIX–IPV+Hib Pó e suspensão para suspensão injetável Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular), poliomielite (inativado) e Haemophilus influenzae do tipo b conjugado

DE/H/0145/002 4059887 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA

PT

PENTAXIM, pulbere si suspensie pentru suspensie injectabila, în seringa preumpluta, vaccin diftero-tetano-pertussis (componenta acelulara)-poliomielitic inactivat, adsorbit si vaccin Haemophilus tip b, conjugat, adsorbit

not available 4956/2012/01 SANOFI PASTEUR SA RO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PENTAXIM, pulbere şi suspensie pentru suspensie injectabilă, în seringă preumplută, vaccin diftero-tetano-pertussis (componenta acelulară)-poliomielitic inactivat, adsorbit şi vaccin Haemophilus tip b, conjugat, adsorbit

not available 4956/2012/02 SANOFI PASTEUR SA RO

PENTAXIM, pulbere şi suspensie pentru suspensie injectabilă, în seringă preumplută, vaccin diftero-tetano-pertussis (componenta acelulară)-poliomielitic inactivat, adsorbit şi vaccin Haemophilus tip b, conjugat, adsorbit

not available 4956/2012/03 SANOFI PASTEUR SA RO

PENTAXIM, pulbere şi suspensie pentru suspensie injectabilă, în seringă preumplută, vaccin diftero-tetano-pertussis (componenta acelulară)-poliomielitic inactivat, adsorbit şi vaccin Haemophilus tip b, conjugat, adsorbit

not available 4956/2012/04 SANOFI PASTEUR SA RO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PENTAXIM, pulbere şi suspensie pentru suspensie injectabilă, în seringă preumplută, vaccin diftero-tetano-pertussis (componenta acelulară)-poliomielitic inactivat, adsorbit şi vaccin Haemophilus tip b, conjugat, adsorbit

not available 4956/2012/05 SANOFI PASTEUR SA RO

Pentavac Difteri-, tetanus-, pertussis- (acellulärt, komponent), poliomyelitis- (inaktiverat) och Haemophilus influenzae typ b konjugerat vaccin (adsorberat)

SE/H/0153/001 13523 SANOFI PASTEUR EUROPE SE

PENTAXIM prašek in suspenzija za suspenzijo za injiciranje v napolnjeni injekcijski brizgi, cepivo proti davici, tetanusu, oslovskemu kašlju - acelularno, otroški paralizi - inaktivirano in hemofilusu tipa b - konjugirano (adsorbirano)

not available H/04/01237/001 SANOFI PASTEUR SA SI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PENTAXIM prašek in suspenzija za suspenzijo za injiciranje v napolnjeni injekcijski brizgi, cepivo proti davici, tetanusu, oslovskemu kašlju - acelularno, otroški paralizi - inaktivirano in hemofilusu tipa b - konjugirano (adsorbirano)

not available H/04/01237/002 SANOFI PASTEUR SA SI

PENTAXIM prašek in suspenzija za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti davici, tetanusu, oslovskemu kašlju - acelularno, otroški paralizi - inaktivirano in hemofilusu tipa b – konjugirano (adsorbirano)

not available H/04/01237/003 SANOFI PASTEUR SA SI

List of nationally authorised medicinal products EMA/495687/2018 Page 36/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PENTAXIM prašek in suspenzija za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti davici, tetanusu, oslovskemu kašlju - acelularno, otroški paralizi - inaktivirano in hemofilusu tipa b – konjugirano (adsorbirano)

not available H/04/01237/004 SANOFI PASTEUR SA SI

Infanrix-IPV+Hib Prášok a suspenzia na injekcnú suspenziu Ockovacia látka proti diftérii, tetanu, pertussis (acelulárna zložka), poliomyelitíde (inaktivovaná) a Haemophilus influenzae typ b (konjugovaná, adsorbovaná)

DE/H/0145/002 59/0416/08-S GLAXOSMITHKLINE BIOLOGICALS S.A.

SK

PEDIACEL, suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)

UK/H/2388/001 PL 46602/0003 SANOFI PASTEUR EUROPE UK

List of nationally authorised medicinal products EMA/495687/2018 Page 37/37

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

PEDIACEL, suspension for injection in a vial Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)

UK/H/0775/001 PL 46602/0016 SANOFI PASTEUR EUROPE UK

Pentavac Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

SE/H/0153/001 PL 46602/0015 SANOFI PASTEUR EUROPE UK

INFANRIX-IPV+Hib powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (acellular component), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

DE/H/0145/002 PL10592/0216 SMITHKLINE BEECHAM LTD UK