Hexacima
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Hexacima. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Hexacima.
For practical information about using Hexacima, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
Product details | |
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Name |
Hexacima
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Agency product number |
EMEA/H/C/002702
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Active substance |
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International non-proprietary name (INN) or common name |
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J07CA09
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Publication details | |
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Marketing-authorisation holder |
Sanofi Pasteur
|
Revision |
29
|
Date of issue of marketing authorisation valid throughout the European Union |
17/04/2013
|
Contact address |
14 Espace Henry Vallée |
Product information
22/06/2023 Hexacima - EMEA/H/C/002702 - WS2468/G
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
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Vaccines
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Bacterial and viral vaccines, combined
Therapeutic indication
Hexacima (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
The use of this vaccine should be in accordance with official recommendations.