List of nationally authorised medicinal products · 21069 GLAXOSMITHKLINE AB SE Boostrix-IPV...
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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 17 March 2016 EMA/243503/2016 Procedure Management and Committees Support List of nationally authorised medicinal products Active substance: diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) reduce antigens content Procedure no.: PSUSA/00001126/201507
Transcript of List of nationally authorised medicinal products · 21069 GLAXOSMITHKLINE AB SE Boostrix-IPV...
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
17 March 2016 EMA/243503/2016 Procedure Management and Committees Support
List of nationally authorised medicinal products
Active substance: diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) reduce antigens content Procedure no.: PSUSA/00001126/201507
List of nationally authorised medicinal products EMA/243503/2016 Page 2/42
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 Booster, injektionsvæske, suspension, fyldt injektionssprøjte
35304 STATENS SERUM INSTITUT DK
Boostrix Polio, suspension injectable en seringue préremplie. Vaccin (adsorbé, contenu réduit en antigènes) diphtérique, tétanique, coquelucheux (composant acellulaire) et poliomyélitique (inactivé)
BE 270435 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
Boostrix Polio, suspension injectable en seringue préremplie. Vaccin (adsorbé, contenu réduit en antigènes) diphtérique, tétanique, coquelucheux (composant acellulaire) et poliomyélitique (inactivé)
BE 270426 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
Boostrix Polio - stungulyf, dreifa, í áfylltri sprautu Bóluefni gegn barnaveiki, stífkrampa, kíghósta (frumulaust, hlutar) og mænusótt (deyddar veirur), (aðsogað, skert mótefnavakainnihald)
IS/1/07/027/01 GLAXOSMITHKLINE EHF. IS
Boostrix Polio, suspensie voor injectie Vaccin (geadsorbeerd, antigengereduceerde inhoud) tegen difterie, tetanus, kinkhoest (acellulaire component)
BE270426 GLAXOSMITHKLINE BIOLOGICALS S.A.
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
en poliomyelitis (geïnactiveerd) Boostrix Polio, suspensie voor injectie in voorgevulde injectiespuit Vaccin (geadsorbeerd, antigengereduceerde inhoud) tegen difterie, tetanus, kinkhoest (acellulaire component) en poliomyelitis (geïnactiveerd)
BE 270435 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
Boostrix Polio injeksjonsvæske, suspensjon, i ferdigfylt sprøyte Vaksine mot difteri, tetanus, kikhoste (acellulær, komponent) og poliomyelitt (inaktivert), (adsorbert, redusert innhold av antigen(er))
04/2685 GLAXOSMITHKLINE AS NO
IPV-Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)
MA 170/00103 GLAXOSMITHKLINE BIOLOGICALS S.A.
MT
Boostrix-IPV suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis
PL 10592/0214 SMITHKLINE BEECHAM LTD GB
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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
(inactivated) vaccine (adsorbed, reduced antigen(s) content) IPV-Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)
MA 170/00104 GLAXOSMITHKLINE BIOLOGICALS S.A.
MT
Boostrix Polio, injektionsvätska, suspension i förfylld spruta. Vaccin mot difteri, stelkramp, kikhosta (acellulärt, komponent) och polio (inaktiverat), adsorberat, med reducerat antigeninnehåll
21069 GLAXOSMITHKLINE AB SE
Boostrix-IPV suspension for injection Diphtheria, tetanus, pertussis (acellular component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)
PL 10592/0215 SMITHKLINE BEECHAM LTD GB
Boostrix Polio injektioneste, suspensio esitäytetyssä ruiskussa Kurkkumätä, jäykkäkouristus ja hinkuyskä (soluton, komponentti) poliomyeliitti (inaktivoitu)
19479 GLAXOSMITHKLINE BIOLOGICALS S.A.
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
rokote (adsorboitu, matala antigeenipitoisuus) Boostrix Polio 23509/15/4/10 GLAXOSMITHKLINE AEBE GR
Boostrix®Polio - Injektionssuspension in einer Fertigspritze Diphtherie-, Tetanus-, Pertussis azellulär- und Poliomyelitis (inaktiviert) - Impfstoff (adsorbiert, verminderter Antigengehalt)
2-00302 GLAXOSMITHKLINE PHARMA GMBH.
AT
Boostrix Polio 07-0238 GLAXOSMITHKLINE LATVIA SIA
LV
Boostrix Polio OGYI-T-20497/04 GLAXOSMITHKLINE KFT. HU
Boostrix Polio, injektionsvätska, suspension i förfylld spruta. Vaccin mot difteri, stelkramp, kikhosta (acellulärt, komponent) och polio (inaktiverat), adsorberat, med reducerat antigeninnehåll
21068 GLAXOSMITHKLINE AB SE
Boostrix Polio injectieflacon suspensie voor injectie Difterie, tetanus, pertussis (acellulaire component) en poliomyelitis
RVG 35124 GLAXOSMITHKLINE B.V. NL
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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
(geïnactiveerd) vaccin (geadsorbeerd, verminderd aantal antigenen) Boostrix Polio, suspension injectable en seringue pré-remplie Vaccin (adsorbé, contenu réduit en antigènes) diphtérique, tétanique, coquelucheux (composant acellulaire) et poliomyélitique (inactivé)
2009020265 GLAXOSMITHKLINE BIOLOGICALS S.A.
LU
Boostrix Polio OGYI-T-20497/02 GLAXOSMITHKLINE KFT. HU
Boostrix Polio szuszpenziós injekció diphtheria, tetanus, pertussis (acelluláris összetevo) és (inaktivált) poliomyelitis vakcina (adszorbeált, csökkentett antigén tartalmú)
OGYI-T-20497/06 GLAXOSMITHKLINE KFT. HU
BOOSTRIX POLIO LT/1/08/0971/003 GLAXOSMITHKLINE LIETUVA UAB
LT
Boostrix Polio 59/0374/07-S GLAXOSMITHKLINE SLOVAKIA S.R.O.
SK
Boostrix Polio Suspensão injectável Vacina contra a difteria, tétano e tosse convulsa (componente acelular) e poliomielite
5212980 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
(inactivado) (adsorvida, com conteúdo reduzido de antigénio(s)) Boostrix Polio zawiesina do wstrzykiwan w ampulkostrzykawce Szczepionka przeciw blonicy, tezcowi, krztuscowi (bezkomórkowa, zlozona) i poliomyelitis (inaktywowana), adsorbowana, o zmniejszonej zawartosci antygenów
DE/H/0466/004/E01 14241 GLAXOSMITHKLINE BIOLOGICALS S.A.
PL
PolioBoostrix sospensione iniettabile Vaccino (adsorbito, a ridotto contenuto di antigeni) difterico, tetanico, pertossico (componente acellulare) e poliomielitico (inattivato)
36752071 GLAXOSMITHKLINE S.P.A. IT
PolioBoostrix sospensione iniettabile Vaccino (adsorbito, a ridotto contenuto di antigeni) difterico, tetanico, pertossico (componente acellulare) e poliomielitico (inattivato)
36752083 GLAXOSMITHKLINE S.P.A. IT
Boostrix-IPV 5073/2012/02 GLAXOSMITHKLINE (GSK) S.R.L.
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
BOOSTRIX POLIO LT/1/08/0971/006 GLAXOSMITHKLINE LIETUVA UAB
LT
BOOSTRIX POLIO LT/1/08/0971/002 GLAXOSMITHKLINE LIETUVA UAB
LT
PolioBoostrix sospensione iniettabile in siringa preriempita. Vaccino (adsorbito, a ridotto contenuto di antigeni) difterico, tetanico, pertossico (componente acellulare) e poliomielitico (inattivato)
36752044 GLAXOSMITHKLINE S.P.A. IT
PolioBoostrix sospensione iniettabile in siringa preriempita. Vaccino (adsorbito, a ridotto contenuto di antigeni) difterico, tetanico, pertossico (componente acellulare) e poliomielitico (inattivato)
36752069 GLAXOSMITHKLINE S.P.A. IT
PolioBoostrix sospensione iniettabile in siringa preriempita. Vaccino (adsorbito, a ridotto contenuto di antigeni) difterico, tetanico, pertossico (componente acellulare) e poliomielitico (inattivato)
36752020 GLAXOSMITHKLINE S.P.A. IT
Boostrix Polio Suspensão injectável Vacina contra a difteria, tétano e tosse
5212881 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
convulsa (componente acelular) e poliomielite (inactivado) (adsorvida, com conteúdo reduzido de antigénio(s)) PolioBoostrix sospensione iniettabile in siringa preriempita. Vaccino (adsorbito, a ridotto contenuto di antigeni) difterico, tetanico, pertossico (componente acellulare) e poliomielitico (inattivato)
36752018 GLAXOSMITHKLINE S.P.A. IT
Boostrix Polio Suspensão injectável em seringa pré-cheia Vacina contra a difteria, tétano e tosse convulsa (componente acelular) e poliomielite (inactivado) (adsorvida, com conteúdo reduzido de antigénio(s))
5271184 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS, LDA
PT
Boostrix Polio Suspensão injectável em seringa pré-cheia Vacina contra a difteria, tétano e tosse convulsa (componente acelular) e poliomielite (inactivado) (adsorvida, com conteúdo reduzido de antigénio(s))
5212782 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS, LDA
PT
Boostrix Polio Suspensão injectável em seringa pré-cheia Vacina contra a difteria, tétano e tosse convulsa (componente
5212683 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
acelular) e poliomielite (inactivado) (adsorvida, com conteúdo reduzido de antigénio(s)) Boostrix Polio Suspensão injectável em seringa pré-cheia Vacina contra a difteria, tétano e tosse convulsa (componente acelular) e poliomielite (inactivado) (adsorvida, com conteúdo reduzido de antigénio(s))
5270889 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS, LDA
PT
Boostrix Polio Suspensão injectável em seringa pré-cheia Vacina contra a difteria, tétano e tosse convulsa (componente acelular) e poliomielite (inactivado) (adsorvida, com conteúdo reduzido de antigénio(s))
5271085 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS, LDA
PT
PolioBoostrix sospensione iniettabile in siringa preriempita. Vaccino (adsorbito, a ridotto contenuto di antigeni) difterico, tetanico, pertossico (componente acellulare) e poliomielitico (inattivato)
36752032 GLAXOSMITHKLINE S.P.A. IT
PolioBoostrix sospensione iniettabile in siringa preriempita. Vaccino (adsorbito, a ridotto contenuto di antigeni) difterico, tetanico,
36752057 GLAXOSMITHKLINE S.P.A. 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
pertossico (componente acellulare) e poliomielitico (inattivato) Boostrix Polio suspensija injekcijai Difterijas, stingumkrampju, gara klepus (acelularais komponents) un poliomielita (inaktiveta) vakcina (adsorbeta, ar samazinatu antigenu saturu)
07-0239 GLAXOSMITHKLINE LATVIA SIA
LV
Boostrix-IPV 5074/2012/02 GLAXOSMITHKLINE (GSK) S.R.L.
RO
BOOSTRIX POLIO LT/1/08/0971/005 GLAXOSMITHKLINE LIETUVA UAB
LT
Boostrix Polio, Injektionssuspension Impfstoff (adsorbiert, Inhalt antigenreduziert) gegen Diphtherie, Tetanus, Pertussis (azellulär) und Poliomyelitis (inaktiv)
BE270426 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
Boostrix Polio OGYI-T20 497/01 GLAXOSMITHKLINE KFT. HU
Boostrix Polio, zawiesina do wstrzykiwan Szczepionka przeciw blonicy, tezcowi, krztuscowi (bezkomórkowa, zlozona) i poliomyelitis
DE/H/0466/003/E01 14240 GLAXOSMITHKLINE BIOLOGICALS S.A.
PL
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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
(inaktywowana), adsorbowana, o zmniejszonej zawartosci antygenów Boostrix Polio 59/0373/07-S GLAXOSMITHKLINE
SLOVAKIA S.R.O. SK
Boostrix Polio, suspension injectable en seringue pré-remplie Vaccin (adsorbé, contenu réduit en antigènes) diphtérique, tétanique, coquelucheux (composant cellulaire) et poliomyélitique (inactivé)
BE 270435 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
Boostrix Polio OGYI-T20 497/03 GLAXOSMITHKLINE KFT. HU
Boostrix Polio szuszpenziós injekció el?retöltött fecskend?ben diphtheria, tetanus, pertussis (acelluláris összetev?) és (inaktivált) poliomyelitis vakcina (adszorbeált, csökkentett antigén tartalmú)
OGYI-T-20497/07 GLAXOSMITHKLINE KFT. HU
Boostrix Polio OGYI-T-20497/05 GLAXOSMITHKLINE KFT. HU
Boostrix-IPV 5074/2012/05 GLAXOSMITHKLINE (GSK) S.R.L.
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
Boostrix Polio szuszpenziós injekció eloretöltött fecskendoben diphtheria, tetanus, pertussis (acelluláris összetevo) és (inaktivált) poliomyelitis vakcina (adszorbeált, csökkentett antigén tartalmú)
OGYI-T-20497/08 GLAXOSMITHKLINE KFT. HU
Boostrix Polio, suspension injectable Vaccin (adsorbé, contenu réduit en antigènes) diphtérique, tétanique, coquelucheux (composant cellulaire) et poliomyélitique (inactivé)
BE270426 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
Boostrix-IPV 5074/2012/06 GLAXOSMITHKLINE (GSK) S.R.L.
RO
BOOSTRIXTETRA, suspension injectable en seringue préremplie. Vaccin diphtérique, tétanique, coquelucheux (acellulaire multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigènes)
NL30351 LABORATOIRE GLAXOSMITHKLINE
FR
Boostrix-IPV suspensie 5074/2012/03 GLAXOSMITHKLINE (GSK) S.R.L.
RO
Boostrix-IPV 5074/2012/01 GLAXOSMITHKLINE (GSK) S.R.L.
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
Boostrix-IPV 5074/2012/04 GLAXOSMITHKLINE (GSK) S.R.L.
RO
Boostrix Polio 59/498/07-C GLAXOSMITHKLINE S.R.O. CZ
Boostrix Polio LT/1/08/0971/001 GLAXOSMITHKLINE LIETUVA UAB
LT
Boostrix Polio- injektioneste, suspensio Kurkkumätä-, jäykkäkouristus-, hinkuyskä (soluton, komponentti), poliomyeliitti (inaktivoitu) rokote, (adsorboitu, matala antigeenipitoisuus)
19480 GLAXOSMITHKLINE BIOLOGICALS S.A.
FI
Boostrix Polio suspensión inyectable en jeringa precargada Vacuna combinada antidiftérica, antitetánica, antitos ferina (componente acelular), antipoliomielitis (inactivada) (adsorbida, contenido antigénico reducido)
66.462 GLAXOSMITHKLINE S.A. ES
Boostrix Polio 59/497/07-C GLAXOSMITHKLINE S.R.O. CZ
Boostrix® Polio Injektionssuspension in einer Fertigspritze Diphtherie-, Tetanus-,
PEI.H.02950.01.1 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
Pertussis (azellulär, aus Komponenten)- und Poliomyelitis (inaktiviert)-Adsorbatimpfstoff (mit reduziertem Antigengehalt) ab dem vollendeten 4. Lebensjahr Boostrix Polio suspenzija za injiciranje v napolnjeni injekcijski brizgi. cepivo proti davici, tetanusu, oslovskemu kašlju – acelularno in otroški paralizi - inaktivirano (adsorbirano, z zmanjšano vsebnostjo antigenov)
DE/H/0466 H/10/00651/001 GLAXOSMITHKLINE D.O.O. SI
Boostrix Polio suspensie voor injectie in voorgevulde spuit Difterie, tetanus, pertussis (acellulaire component) en poliomyelitis (geïnactiveerd) vaccin (geadsorbeerd, verminderd aantal antigenen)
RVG 35123 GLAXOSMITHKLINE B.V. NL
IPV-Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content
PA 1077/101/001 GLAXOSMITHKLINE (IRELAND) LIMITED
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
BOOSTRIX POLIO LT/1/08/0971/004 GLAXOSMITHKLINE LIETUVA UAB
LT
Boostrix Polio suspenzija za injiciranje cepivo proti davici, tetanusu, oslovskemu kašlju – acelularno in otroški paralizi - inaktivirano (adsorbirano, z zmanjšano vsebnostjo antigenov)
DE/H/0466 H/10/00651/005 GLAXOSMITHKLINE D.O.O. SI
Boostrix Polio Suspensão injectável em seringa pré-cheia Vacina contra a difteria, tétano e tosse convulsa (componente acelular) e poliomielite (inactivado) (adsorvida, com conteúdo reduzido de antigénio(s)
5270988 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS, LDA
PT
Boostrix-IPV 5073/2012/01 GLAXOSMITHKLINE (GSK) S.R.L.
RO
DiTeKiPol, injektionsvätska, suspension, förfylld spruta
14398 STATENS SERUM INSTITUT SE
DiTeKiPol, injektioneste suspensio, esitäytetyssä ruiskussa
13440 STATENS SERUM INSTITUT FI
DiTeKiPol, injektionsvæske, suspension i fyldt engangssprøjte
17843 STATENS SERUM INSTITUT DK
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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 Injektionsvätska, suspension i förfylld spruta
13440 STATENS SERUM INSTITUT FI
INFANRIX-IPV, 0,5 ml/dosis, suspensie voor injectie in een voorgevulde spuit
BE212152 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
Infanrix Polio injeksjonsvæske, suspensjon i ferdigfylt sprøyte. Vaksine mot difteri, tetanus, kikhoste (acellulær, komponent) og poliomyelitt (inaktivert), (adsorbert).
05/3312 GLAXOSMITHKLINE AS NO
INFANRIXTETRA, suspension injectable en seringue préremplie. Vaccin diphtérique, tétanique, coquelucheux acellulaire, poliomyélitique inactivé, adsorbé
NL21433 LABORATOIRE GLAXOSMITHKLINE
FR
INFANRIX TETRA 20232 GLAXOSMITHKLINE (CYPRUS) LIMITED
CY
IPV Infanrix, suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)
192/01701 GLAXOSMITHKLINE (IRELAND) LIMITED
MT
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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 Polio suspensija injekcijam pilnšlirce Difterijas, tetanusa, gara klepus (acelulars komponents) un poliomielita (inaktiveta) vakcina (adsorbeta) Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementis preparatum et poliomyelitidis inactivatum adsorbatum
05-0635 GLAXOSMITHKLINE BIOLOGICALS S.A.
LV
InfanrixTetra, injektionsvæske, suspension i fyldt injektionssprøjte
37854 GLAXOSMITHKLINE PHARMA A/S
DK
Infanrix-Polio injektioneste, suspensio esitäytetyssä ruiskussa Kurkkumätä-, jäykkäkouristus-, hinkuyskä (soluton, komponentti), poliomyeliitti (inaktivoitu) rokote (adsorboitu)
20846 GLAXOSMITHKLINE BIOLOGICALS S.A.
FI
Infanrix Polio LT/1/05/0301/001 GLAXOSMITHKLINE LIETUVA UAB
LT
Infanrix Polio LT/1/05/0301/003 GLAXOSMITHKLINE LIETUVA UAB
LT
Infanrix-IPV, suspensie voor injectie Difterie-(D), tetanus-(T), pertussis-(acellulair, component)
RVG 34568 GLAXOSMITHKLINE B.V. NL
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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
(Pa) en poliomyelitis-(geïnactiveerd) (IPV) vaccin Infanrix IPV szuszpenziós injekció eloretöltött fecskendoben Kombinált diphtheria, tetanus, acellularis pertussis, inaktivált poliomyelitis adszorbeált vakcina
OGYI-T-20352/03 GLAXOSMITHKLINE KFT. HU
Infanrix IPV szuszpenziós injekció eloretöltött fecskendoben Kombinált diphtheria, tetanus, acellularis pertussis, inaktivált poliomyelitis adszorbeált vakcina
OGYI-T-20352/04 GLAXOSMITHKLINE KFT. HU
Infanrix IPV szuszpenziós injekció eloretöltött fecskendoben Kombinált diphtheria, tetanus, acellularis pertussis, inaktivált poliomyelitis adszorbeált vakcina
OGYI-T-20352/02 GLAXOSMITHKLINE KFT. HU
Infanrix IPV szuszpenziós injekció eloretöltött fecskendoben Kombinált diphtheria, tetanus, acellularis pertussis, inaktivált poliomyelitis adszorbeált vakcina
OGYI-T-20352/05 GLAXOSMITHKLINE KFT. HU
Infanrix IPV szuszpenziós injekció eloretöltött fecskendoben Kombinált diphtheria, tetanus, acellularis pertussis,
OGYI-T-20352/06 GLAXOSMITHKLINE KFT. HU
List of nationally authorised medicinal products EMA/243503/2016 Page 20/42
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
inaktivált poliomyelitis adszorbeált vakcina
Infanrix IPV szuszpenziós injekció eloretöltött fecskendoben Kombinált diphtheria, tetanus, acellularis pertussis, inaktivált poliomyelitis adszorbeált vakcina
OGYI-T-20352/01 GLAXOSMITHKLINE KFT. HU
INFANRIX-IPV, 0,5 ml/dose, suspension injectable
BE212152 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
Infanrix-IPV, suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)
PL 10592/0209 SMITHKLINE BEECHAM LTD GB
Infanrix-IPV, 0,5 ml/dose, suspension injectable
BE212152 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
Infanrix Polio 59/0417/08-S GLAXOSMITHKLINE BIOLOGICALS S.A.
SK
Infanrix Polio LT/1/05/0301/002 GLAXOSMITHKLINE LIETUVA UAB
LT
Infanrix Tetra, suspensão injetável em seringa pré-cheia Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular) e
5621180 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
poliomielite (inativado)
Infanrix Tetra, suspensão injetável em seringa pré-cheia Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativado)
5621081 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS, LDA
PT
Infanrix Tetra, suspensão injetável em seringa pré-cheia Vacina (adsorvida) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativado)
5267356 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS, LDA
PT
Infanrix-IPV FR/H/251/01/E01 11884 GLAXOSMITHKLINE BIOLOGICALS S.A.
PL
Infanrix-IPV, 0,5 ml/dosis, suspensie voor injectie
BE212152 GLAXOSMITHKLINE BIOLOGICALS S.A.
BE
IPV Infanrix, suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)
PA 1077/108/001 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Infanrix Polio (adsorbeeritud)
FR/H/0251/002/DC 483205 GLAXOSMITHKLINE BIOLOGICALS S.A.
EE
List of nationally authorised medicinal products EMA/243503/2016 Page 22/42
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, 0,5 ml/dose, suspension injectable
2007069308 GLAXOSMITHKLINE BIOLOGICALS S.A.
LU
Infanrix Tetra 48464/11 GLAXOSMITHKLINE AEBE GR
Infanrix-Polio injektioneste, suspensio esitäytetyssä ruiskussa. Kurkkumätä-, jäykkäkouristus-, hinkuyskä (soluton, komponentti), poliomyeliitti (inaktivoitu) rokote (adsorboitu)
20846 GLAXOSMITHKLINE BIOLOGICALS S.A.
FI
Infanrix Polio, injektionsvätska, suspension i förfylld spruta Vaccin mot difteri, stelkramp och kikhosta, acellulärt, komponent samt mot polio, inaktiverat, adsorberat
22287 GLAXOSMITHKLINE AB SE
Infanrix Polio 59/268/05-C GLAXOSMITHKLINE BIOLOGICALS S.A.
CZ
PolioInfanrix – sospensione iniettabile in siringa preriempita Vaccino (adsorbito) anti difterico, tetanico, pertossico (componente acellulare) e anti-poliomielite (inattivato).
37157029 GLAXOSMITHKLINE S.P.A. IT
List of nationally authorised medicinal products EMA/243503/2016 Page 23/42
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
PolioInfanrix – sospensione iniettabile in siringa preriempita Vaccino (adsorbito) anti difterico, tetanico, pertossico (componente acellulare) e anti-poliomielite (inattivato).
037157031/M GLAXOSMITHKLINE S.P.A. IT
PolioInfanrix – sospensione iniettabile in siringa preriempita Vaccino (adsorbito) anti difterico, tetanico, pertossico (componente acellulare) e anti-poliomielite (inattivato)
037157017/M GLAXOSMITHKLINE S.P.A. IT
TETRAVAC Injektionssuspension Diphtherie-, Tetanus-, Pertussis- (azellulär, Komponenten) und Poliomyelitis-(inaktiviert) Impfstoff, adsorbiert
SE/H/154/01/000 2-00226 SANOFI PASTEUR MSD SNC AT
REPEVAX® Injektionssuspension in einer Fertigspritze Diphtherie-Tetanus-Pertussis(azellulär, aus Komponenten)-Poliomyelitis(inaktiviert)-Impfstoff (adsorbiert, mit reduziertem Antigengehalt)
DE/H/0215/001-002 2-00284 SANOFI PASTEUR MSD SNC AT
REPEVAX® Injektionssuspension in einer Durchstechflasche Diphtherie-Tetanus-
DE/H/0215/001-002 2-00285 SANOFI PASTEUR MSD SNC AT
List of nationally authorised medicinal products EMA/243503/2016 Page 24/42
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
Pertussis(azellulär, aus Komponenten)-Poliomyelitis(inaktiviert)-Impfstoff (adsorbiert, mit reduziertem Antigengehalt) Tetravac, suspensie voor injectie Geadsorbeerd difterie-, tetanus-, kinkhoest- (acellulair, component) en poliovaccin (geïnactiveerd)
SE/H/154/01/000 BE196122 SANOFI PASTEUR MSD BE
Tetravac, suspension injectable Vaccin diphtérique, tétanique, coquelucheux (acellulaire, composant) et poliomyélitique (inactivé), adsorbé
BE196122 SANOFI PASTEUR MSD BE
Tetravac, Suspension zur Injektion Impfstoff (adsorbiert) gegen Diphtherie, Tetanus, Pertussis (mit azellulärer Komponente) und Poliomyelitis (inaktiviert)
BE196122 SANOFI PASTEUR MSD BE
TETRAVAC® Injektionssuspension in einer Fertigspritze Diphtherie-Tetanus-Pertussis (azellulär)-Poliomyelitis (inaktiviert)-Adsorbat-Impfstoff
1A/97 SANOFI PASTEUR MSD GMBH DE
List of nationally authorised medicinal products EMA/243503/2016 Page 25/42
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
REPEVAX® Injektionssuspension Diphtherie-Tetanus-Pertussis(azellulär, aus Komponenten)-Poliomyelitis(inaktiviert)-Impfstoff (adsorbiert, mit reduziertem Antigengehalt)
DE/H/0215/001-002 PEI.H.02354.01.2 SANOFI PASTEUR MSD GMBH DE
REPEVAX® Injektionssuspension Injektionssuspension in einer Fertigspritze Diphtherie-Tetanus-Pertussis(azellulär, aus Komponenten)-Poliomyelitis(inaktiviert)-Impfstoff (adsorbiert, mit reduziertem Antigengehalt)
DE/H/0215/001-002 PEI.H.02354.01.1 SANOFI PASTEUR MSD GMBH DE
Tetravac, injektionsvæske, suspension
SE/H/154/01/000 30186 SANOFI PASTEUR MSD DK
REPEVAX, injektionsvæske, suspension i hætteglas Difteri, tetanus, pertussis (acellulær, komponent) og poliomyelitis (inaktiveret) vaccine (adsorberet, reduceret indhold af antigen(er))
DE/H/0215/001-002 33443 SANOFI PASTEUR MSD DK
REPEVAX, injektionsvæske, suspension i fyldt injektionssprøjte. Difteri, tetanus, pertussis
DE/H/0215/001-002 33442 SANOFI PASTEUR MSD DK
List of nationally authorised medicinal products EMA/243503/2016 Page 26/42
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
(acellulær, komponent) og poliomyelitis (inaktiveret) vaccine (adsorberet, reduceret indhold af antigen(er)) Tetravac, Injektioneste, suspensio Adsorboitu kurkkumätä-, jäykkäkouristus-, hinkuyskä- (soluton, komponentti) ja poliorokote (inaktivoitu) - rokote
13676 SANOFI PASTEUR MSD FI
Tetravac injektionsvätska, suspension Difteri, stelkramp, kikhosta (acellulärt, komponent) och poliomyelit (inaktiverat) vaccin, adsorberat
13676 SANOFI PASTEUR MSD FI
Repevax, injektioneste, suspensio, esitäytetyssä ruiskussa Kurkkumätä-, jäykkäkouristus-, hinkuyskä- (soluton komponentti) ja polio- (inaktivoitu) -rokote (adsorboitu, alhaisempi antigeenimäärä)
DE/H/0215/001-002 17190 SANOFI PASTEUR MSD FI
REPEVAX® Injektionsvätska, suspension Difteri-, tetanus-, pertussis- (acellulärt, komponent) och (inaktiverat) poliovaccin (adsorberat,
DE/H/0215/001-002 17191 SANOFI PASTEUR MSD FI
List of nationally authorised medicinal products EMA/243503/2016 Page 27/42
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
lägre antigenhalt)
REPEVAX® Injektionsvätska, suspension i förfylld spruta Difteri-, tetanus-, pertussis- (acellulärt, komponent) och (inaktiverat) poliovaccin (adsorberat, lägre antigenhalt)
17190 SANOFI PASTEUR MSD FI
REPEVAX, injektioneste, suspensio Kurkkumätä-, jäykkäkouristus-, hinkuyskä- (soluton komponentti) ja polio- (inaktivoitu) -rokote (adsorboitu, alhaisempi antigeenimäärä)
17191 SANOFI PASTEUR MSD FI
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigène(s))
359 647-6 SANOFI PASTEUR MSD SNC FR
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur
359 648-2 SANOFI PASTEUR MSD SNC FR
List of nationally authorised medicinal products EMA/243503/2016 Page 28/42
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
réduite en antigène(s))
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigène(s))
359 645-3 SANOFI PASTEUR MSD SNC FR
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigène(s))
368 737-4 SANOFI PASTEUR MSD SNC FR
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigène(s))
368 740-5 SANOFI PASTEUR MSD SNC FR
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé),
368 739-7 SANOFI PASTEUR MSD SNC FR
List of nationally authorised medicinal products EMA/243503/2016 Page 29/42
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
(adsorbé, à teneur réduite en antigène(s))
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigène(s))
368 738-0 SANOFI PASTEUR MSD SNC FR
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigène(s))
359 643-0 SANOFI PASTEUR MSD SNC FR
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigène(s))
359 642-4 SANOFI PASTEUR MSD SNC FR
REPEVAX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé),
359 644-7 SANOFI PASTEUR MSD SNC FR
List of nationally authorised medicinal products EMA/243503/2016 Page 30/42
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
(adsorbé, à teneur réduite en antigène(s))
Tetravac, suspension for injection Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine, adsorbed
SE/H/154/01/000 PL06745/0100 SANOFI PASTEUR MSD LIMITED (UK)
GB
REPEVAX®, suspension for injection, in pre-filled syringe Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)
DE/H/0215/001-002 PL06745/0121 SANOFI PASTEUR MSD LIMITED (UK)
GB
REPEVAX®, suspension for injection Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)
DE/H/0215/001-002 PL06745/0122 SANOFI PASTEUR MSD LIMITED (UK)
GB
TETRAVAC® 30983/6-5-2015 SANOFI PASTEUR MSD SNC GR
TETRAVAC® SE/H/154/01/000 66802/10/29-7-2011 SANOFI PASTEUR MSD SNC GR
REPEVAX 23897/3-4-2015 SANOFI PASTEUR MSD SNC GR
List of nationally authorised medicinal products EMA/243503/2016 Page 31/42
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
REPEVAX DE/H/0215/001-002 38751/31-5-2012 SANOFI PASTEUR MSD SNC GR
REPEVAX DE/H/0215/001-002 38750/31-5-2012 SANOFI PASTEUR MSD SNC GR
Tetravac, suspension for injection Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine, adsorbed
PA544/33/1 SANOFI PASTEUR MSD LIMITED
IE
REPEVAX®, suspension for injection Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)
PA 544/36/2 SANOFI PASTEUR MSD LIMITED
IE
REPEVAX®, suspension for injection, in pre-filled syringe Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)
PA 544/36/1 SANOFI PASTEUR MSD LIMITED
IE
Tetravac, stungulyf, dreifa. Barnaveiki-, stífkrampa-, kíghósta (frumulaus þáttur)- og aðsogað mænusóttarveirubóluefni
970045 SANOFI PASTEUR MSD IS
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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
(dautt)
REPEVAX, stungulyf, dreifa Barnaveiki, stífkrampa, kíghósta (frumulaust, samsett) og mænusóttarveiru (dautt) bóluefni (aðsogað, minnkað mótefnisvaka innihald)
IS/1/02/020/02 SANOFI PASTEUR MSD IS
REPEVAX, stungulyf, dreifa, í áfylltri sprautu Barnaveiki, stífkrampa, kíghósta (frumulaust, samsett) og mænusóttarveiru (dautt) bóluefni, (aðsogað, minnkað mótefnisvaka innihald)
IS/1/02/020/01 SANOFI PASTEUR MSD IS
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127100/M SANOFI PASTEUR MSD SNC IT
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127047/M SANOFI PASTEUR MSD SNC 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
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127086/M SANOFI PASTEUR MSD SNC IT
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127098/M SANOFI PASTEUR MSD SNC IT
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127011/M SANOFI PASTEUR MSD SNC IT
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127050/M SANOFI PASTEUR MSD SNC IT
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127023/M SANOFI PASTEUR MSD SNC 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
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127062/M SANOFI PASTEUR MSD SNC IT
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127074/M SANOFI PASTEUR MSD SNC IT
TETRAVAC sospensione iniettabile Vaccino adsorbito antidifterico, antitetanico, antipertossico (componente acellulare) e antipolio (inattivato)
034127035/M SANOFI PASTEUR MSD SNC IT
Tetravac, suspension injectable Vaccin diphtérique, tétanique, coquelucheux (acellulaire, composant) et poliomyélitique (inactivé), adsorbé.
0491/08089883 SANOFI PASTEUR MSD LU
Tetravac, Suspension zur Injektion Impfstoff (adsorbiert) gegen Diphtherie, Tetanus, Pertussis (mit azellulärer Komponente) und Poliomyelitis (inaktiviert)
2008089883 SANOFI PASTEUR MSD 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
Tetravac, suspension injectable Vaccin diphtérique, tétanique, coquelucheux (acellulaire, composant) et poliomyélitique (inactivé), adsorbé
2008089883 SANOFI PASTEUR MSD LU
TETRAVAC, injeksjonsvæske, suspensjon Vaksine mot difteri, tetanus, kikhoste (acellulær, komponent) og poliomyelitt (inaktivert), (adsorbert)
97-704 SANOFI PASTEUR MSD NO
REPEVAX®, suspensjon for injeksjon Vaksine mot difteri, tetanus, pertussis (acellulær, komponent) og poliomyelitt (inaktivert) (adsorbert, redusert antigeninnhold)
02-1070 SANOFI PASTEUR MSD NO
REPEVAX®, suspensjon til injeksjon i en ferdigfylt sprøyte Vaksine mot difteri, tetanus, pertussis (acellulær, komponent) og poliomyelitt (inaktivert) (adsorbert, redusert antigeninnhold)
02-1069 SANOFI PASTEUR MSD NO
Tetravac, suspensão injetável Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular) e a poliomielite (inativada)
5458484 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
List of nationally authorised medicinal products EMA/243503/2016 Page 36/42
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
Tetravac, suspensão injetável Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular) e a poliomielite (inativada)
5376389 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
Tetravac, suspensão injetável Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular) e a poliomielite (inativada)
2782480 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
Tetravac, suspensão injetável Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular) e a poliomielite (inativada)
5458583 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
Tetravac, suspensão injetável Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular) e a poliomielite (inativada)
5458781 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
Tetravac, suspensão injetável Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular) e a poliomielite (inativada)
5376488 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
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
Tetravac, suspensão injetável Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular) e a poliomielite (inativada)
5458682 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
Tetravac, suspensão injetável Vacina adsorvida contra a difteria, o tétano, a tosse convulsa (componente acelular) e a poliomielite (inativada)
2782589 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX Suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inactivada)
4083580 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX Suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inactivada)
4083689 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX Suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a
4083481 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
List of nationally authorised medicinal products EMA/243503/2016 Page 38/42
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
difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inactivada) REPEVAX suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
5459581 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
5459680 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
5459789 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse
4083796 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
List of nationally authorised medicinal products EMA/243503/2016 Page 39/42
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
convulsa (componente acelular) e poliomielite (inativada) REPEVAX suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
4083887 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
4083986 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
4082681 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
4082780 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
List of nationally authorised medicinal products EMA/243503/2016 Page 40/42
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
REPEVAX suspensão injectável Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
4082889 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
4082988 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
4083184 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
4083283 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável em seringa pré-cheia Vacina
4083382 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
List of nationally authorised medicinal products EMA/243503/2016 Page 41/42
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
(adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada) REPEVAX suspensão injectável em seringa pré-cheia Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
5459482 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
REPEVAX suspensão injectável Vacina (adsorvida, teor reduzido de antigénio(s)) contra a difteria, tétano, tosse convulsa (componente acelular) e poliomielite (inativada)
4083085 SANOFI PASTEUR MSD, S.A. (PORTUGAL)
PT
Tetravac, injektionsvätska, suspension. Difteri-, tetanus-, pertussis-(acellulärt, komponent) och poliomyelitisvaccin (inaktiverat) adsorberat
13464 SANOFI PASTEUR MSD SE
DTaP-IPV Vakzine SSI 2-00232 STATENS SERUM INSTITUT AT
Tetraxim suspensija injekcijai pilnšļircē
02-0343 Sanofi Pasteur S.A. LV
List of nationally authorised medicinal products EMA/243503/2016 Page 42/42
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
Tetraxim 430704 Sanofi Pasteur S.A. EE
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