My HPRA: Register

The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Hexyon



Sanofi PasteurEU/1/13/829/001-007

Main Information

Trade NameHexyon
Active Substances(polyribosylribitol phosphate) conjugated to tetanous protein
Type 1 (mahoney)
Haemophilus influenzae type b polysaccharide
Diphtheria toxoid
Type 2 (mef-1)
Filamentous haemagglutinin
Tetanus toxoid
Pertussis toxoid
Type 3 (saukett)
Hepatitis b surface antigen
Dosage FormSuspension for injection
Licence HolderSanofi Pasteur
Licence NumberEU/1/13/829/001-007

Group Information

ATC CodeJ07CA Bacterial and viral vaccines, combined
J07CA09 diphtheria-hemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B

Status

License statusAuthorised
Licence Issued17/04/2013
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back
Follow medicine

Print