Infanrix Hexa
diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Infanrix hexa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Infanrix hexa.
For practical information about using Infanrix hexa, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
Product details | |
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Name |
Infanrix Hexa
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Agency product number |
EMEA/H/C/000296
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Active substance |
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International non-proprietary name (INN) or common name |
diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J07CA09
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Publication details | |
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Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
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Revision |
42
|
Date of issue of marketing authorisation valid throughout the European Union |
23/10/2000
|
Contact address |
Product information
03/09/2020 Infanrix Hexa - EMEA/H/C/000296 - II/0275
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Vaccines
Therapeutic indication
Infanrix Hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type-b.