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Engerix B 10 micrograms/0.5 ml Suspension for injection in pre-filled syringe Hepatitis B (rDNA) vaccine (adsorbed) (HBV)



GlaxoSmithKline (Ireland) LimitedPA1077/023/001

Main Information

Trade NameEngerix B 10 micrograms/0.5 ml Suspension for injection in pre-filled syringe Hepatitis B (rDNA) vaccine (adsorbed) (HBV)
Active SubstancesHepatitis b surface antigen, recominant
Dosage FormSuspension for injection in pre-filled syringe
Licence HolderGlaxoSmithKline (Ireland) Limited
Licence NumberPA1077/023/001

Group Information

ATC CodeJ07BC Hepatitis vaccines
J07BC01 hepatitis B, purified antigen

Status

License statusAuthorised
Licence Issued26/06/1998
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.
Marketing StatusNot marketed

Documents

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