Infanrix Penta
Lapsed
This medicine's authorisation has lapsed
diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
MedicineHumanLapsed
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This marketing authorisation for Infanrix Penta has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
Infanrix Penta : EPAR - Summary for the public
English (EN) (518.03 KB - PDF)
First published: Last updated:
български (BG) (689.7 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
español (ES) (597.05 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
čeština (CS) (644.01 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
dansk (DA) (596.34 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
Deutsch (DE) (597.98 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
eesti keel (ET) (578.56 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
ελληνικά (EL) (679.41 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
français (FR) (597.86 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
italiano (IT) (521.12 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
latviešu valoda (LV) (648.38 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
lietuvių kalba (LT) (605.32 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
magyar (HU) (637.94 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
Malti (MT) (583.66 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
Nederlands (NL) (596.19 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
polski (PL) (645.51 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
português (PT) (579.68 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
română (RO) (605.29 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
slovenčina (SK) (644.26 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
slovenščina (SL) (638.78 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
Suomi (FI) (595.58 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
svenska (SV) (578.9 KB - PDF)
First published: 23/12/2008Last updated: 10/07/2013
Product information
Infanrix Penta : EPAR - Product Information
English (EN) (1.26 MB - PDF)
First published: Last updated:
български (BG) (1.31 MB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
español (ES) (767.19 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
čeština (CS) (1.08 MB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
dansk (DA) (759.78 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
Deutsch (DE) (769.29 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
eesti keel (ET) (752.28 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
ελληνικά (EL) (1.36 MB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
français (FR) (762.44 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
íslenska (IS) (893.94 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
italiano (IT) (770.15 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
latviešu valoda (LV) (1.15 MB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
lietuvių kalba (LT) (810.15 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
magyar (HU) (1.05 MB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
Malti (MT) (1.19 MB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
Nederlands (NL) (769.21 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
norsk (NO) (877.49 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
polski (PL) (1.13 MB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
português (PT) (762.73 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
română (RO) (814.88 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
slovenčina (SK) (1.07 MB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
slovenščina (SL) (1.08 MB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
Suomi (FI) (754.31 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
svenska (SV) (758.72 KB - PDF)
First published: 26/11/2008Last updated: 10/07/2013
Latest procedure affecting product information:
R/0067
31/08/2010
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Infanrix Penta : EPAR - All Authorised presentations
English (EN) (481.5 KB - PDF)
First published: Last updated:
български (BG) (607.88 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
español (ES) (516.39 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
čeština (CS) (565.7 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
dansk (DA) (519.02 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
Deutsch (DE) (522.73 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
eesti keel (ET) (522.84 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
ελληνικά (EL) (553.35 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
français (FR) (516.85 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
italiano (IT) (513.92 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
latviešu valoda (LV) (551.84 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
lietuvių kalba (LT) (538.02 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
magyar (HU) (550.29 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
Malti (MT) (558 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
Nederlands (NL) (518.86 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
polski (PL) (553.92 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
português (PT) (515.43 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
română (RO) (542.17 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
slovenčina (SK) (552.66 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
slovenščina (SL) (545.53 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
Suomi (FI) (513.65 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
svenska (SV) (517.41 KB - PDF)
First published: 21/10/2005Last updated: 10/07/2013
Product details
- Name of medicine
- Infanrix Penta
- Active substance
- Diphtheria toxoid
- tetanus toxoid
- Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin)
- poliovirus (inactivated) (type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain))
- hepatitis B surface antigen
- International non-proprietary name (INN) or common name
- diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
- Therapeutic area (MeSH)
- Hepatitis B
- Tetanus
- Immunization
- Whooping Cough
- Poliomyelitis
- Diphtheria
- Anatomical therapeutic chemical (ATC) code
- J07CA12
Pharmacotherapeutic group
VaccinesTherapeutic indication
Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Authorisation details
- EMA product number
- EMEA/H/C/000295
- Marketing authorisation holder
- GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
B-1330 Rixensart
Belgium - Marketing authorisation issued
- 23/10/2000
- Lapse of marketing authorisation
- 30/05/2013
- Revision
- 13
Assessment history
Infanrix Penta : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (289.47 KB - PDF)
First published: Last updated:
Infanrix Penta-H-C-295-P45-47 : EPAR - Assessment Report
AdoptedReference Number: EMA/378903/2013
English (EN) (543.19 KB - PDF)
First published: Last updated:
Infanrix Penta-H-C-295-P46-59 : EPAR - Assessment Report
AdoptedReference Number: EMA/379037/2013
English (EN) (2.57 MB - PDF)
First published: Last updated:
Infanrix Penta : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (987.25 KB - PDF)
First published: Last updated:
More information on Infanrix Penta
Public statement on Infanrix Penta: Cessation of validity of the marketing authorisation in the European Union
English (EN) (67.02 KB - PDF)
First published: Last updated:
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