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


Ambirix



GlaxoSmithKline Biologicals S.A.EU/1/02/224/002

Main Information

Trade NameAmbirix
Active SubstancesHepatitis b surface antigen (hbs ag)
Hepatitis a virus
Dosage FormSuspension for injection in pre-filled syringe
Licence HolderGlaxoSmithKline Biologicals S.A.
Licence NumberEU/1/02/224/002

Group Information

ATC CodeJ07BC Hepatitis vaccines
J07BC20 combinations

Status

License statusAuthorised
Licence Issued30/08/2002
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