Hexavac
Withdrawn
This medicine's authorisation has been withdrawn
diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Hexavac has been withdrawn at the request of the marketing-authorisation holder.
Hexavac : EPAR - Summary for the public
English (EN) (365 KB - PDF)
First published: Last updated:
español (ES) (358.48 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
čeština (CS) (403.97 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
dansk (DA) (359.42 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
Deutsch (DE) (363.1 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
eesti keel (ET) (356.92 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
ελληνικά (EL) (456.58 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
français (FR) (355.4 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
italiano (IT) (364.13 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
latviešu valoda (LV) (418.87 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
lietuvių kalba (LT) (385.33 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
magyar (HU) (402.12 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
Nederlands (NL) (360.61 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
polski (PL) (416.82 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
português (PT) (359.64 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
slovenčina (SK) (401.52 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
slovenščina (SL) (396.84 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
Suomi (FI) (357.88 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
svenska (SV) (366.79 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
Product information
Hexavac : EPAR - Product Information
English (EN) (703.43 KB - PDF)
First published: Last updated:
español (ES) (700.36 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
čeština (CS) (1.15 MB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
dansk (DA) (718.53 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
Deutsch (DE) (746.78 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
eesti keel (ET) (691.69 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
ελληνικά (EL) (1.64 MB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
français (FR) (719.7 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
italiano (IT) (737.69 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
latviešu valoda (LV) (1.19 MB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
lietuvių kalba (LT) (776.47 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
magyar (HU) (1.12 MB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
Nederlands (NL) (731.4 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
polski (PL) (1.21 MB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
português (PT) (720.19 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
slovenčina (SK) (1.15 MB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
slovenščina (SL) (1.11 MB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
Suomi (FI) (706.7 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
svenska (SV) (706.2 KB - PDF)
First published: 23/03/2006Last updated: 16/08/2012
28/06/2012
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).
Hexavac : EPAR - All Authorised presentations
English (EN) (291.54 KB - PDF)
First published: Last updated:
español (ES) (302.45 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
čeština (CS) (327.1 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
dansk (DA) (305.18 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
Deutsch (DE) (312.45 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
eesti keel (ET) (300.77 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
ελληνικά (EL) (362.27 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
français (FR) (291.81 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
italiano (IT) (300.44 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
latviešu valoda (LV) (347.82 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
lietuvių kalba (LT) (319.05 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
magyar (HU) (332 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
Nederlands (NL) (300.4 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
polski (PL) (351.99 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
português (PT) (303.02 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
slovenčina (SK) (337.08 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
slovenščina (SL) (341.45 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
Suomi (FI) (297.61 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
svenska (SV) (299.23 KB - PDF)
First published: 25/10/2005Last updated: 16/08/2012
Product details
- Name of medicine
- Hexavac
- Active substance
- purified diphtheria toxoid
- Purified Tetanus Toxoid
- purified pertussis toxoid
- purified pertussis filamentous haemagglutinin
- hepatitis B surface antigen
- Inactivated Type 1 Poliovirus (Mahoney)
- inactivated type 2 poliovirus (MEF 1)
- Inactivated Type 3 Poliovirus (Saukett)
- Haemophilus influenzae type b polysaccharide
- International non-proprietary name (INN) or common name
- diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted
- Therapeutic area (MeSH)
- Hepatitis B
- Tetanus
- Immunization
- Meningitis, Haemophilus
- Whooping Cough
- Poliomyelitis
- Diphtheria
- Anatomical therapeutic chemical (ATC) code
- J07CA
Pharmacotherapeutic group
VaccinesTherapeutic indication
This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
Authorisation details
- EMA product number
- EMEA/H/C/000298
- Marketing authorisation holder
- Sanofi Pasteur MSD, SNC
Sanofi Pasteur MSD SNC
8 rue Jonas Salk
F-69007 Lyon
FRANCE - Marketing authorisation issued
- 23/10/2000
Assessment history
Hexavac : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (332.29 KB - PDF)
First published: Last updated:
Hexavac : EPAR - Scientific Conclusion
English (EN) (338.13 KB - PDF)
First published: Last updated:
español (ES) (339.93 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
čeština (CS) (399.47 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
dansk (DA) (340.35 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
Deutsch (DE) (344.77 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
eesti keel (ET) (338.24 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
ελληνικά (EL) (455.47 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
français (FR) (332.24 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
italiano (IT) (336.92 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
latviešu valoda (LV) (415.3 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
lietuvių kalba (LT) (368.85 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
magyar (HU) (379.93 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
Nederlands (NL) (341.2 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
polski (PL) (405.81 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
português (PT) (344.21 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
slovenčina (SK) (370.99 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
slovenščina (SL) (375.36 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
Suomi (FI) (336.53 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
svenska (SV) (338.29 KB - PDF)
First published: 21/03/2006Last updated: 16/08/2012
Hexavac : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (295.68 KB - PDF)
First published: Last updated:
More information on Hexavac
Public statement on Hexavac: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/273279/2012
English (EN) (43.67 KB - PDF)
First published: Last updated:
This page was last updated on