Infanrix Penta
diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Table of contents
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.
Authorisation details
| Product details | |
|---|---|
| Name |
Infanrix Penta
|
| Agency product number |
EMEA/H/C/000295
|
| Active substance |
|
| 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) |
|
| Anatomical therapeutic chemical (ATC) code |
J07CA12
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
|
| Revision |
13
|
| Date of issue of marketing authorisation valid throughout the European Union |
23/10/2000
|
| Contact address |
Rue de l'Institut, 89
B-1330 Rixensart Belgium |
Product information
31/08/2010 Infanrix Penta - EMEA/H/C/000295 - R/0067
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Vaccines
Therapeutic indication
Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.