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


AVAXIM, suspension for injection in a pre-filled syringeHepatitis A vaccine (inactivated, adsorbed)

160 D-ant. percent volume/volume Suspension for injection in pre-filled syringe

Sanofi PasteurPA2131/002/001

Main Information

Trade NameAVAXIM, suspension for injection in a pre-filled syringeHepatitis A vaccine (inactivated, adsorbed)
Active SubstancesHepatitis a virus
Strength160 D-ant. percent volume/volume
Dosage FormSuspension for injection in pre-filled syringe
Licence HolderSanofi Pasteur
Licence NumberPA2131/002/001

Group Information

ATC CodeJ07BC Hepatitis vaccines
J07BC02 hepatitis A, inactivated, whole virus

Status

Authorised/WithdrawnAuthorised
Licence Issued21/02/1997
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceBatches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.1 of Directive 2001/83/EC as amended.
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back