Engerix B 10 micrograms / 0.5 ml Suspension for injection in pre-filled syringe Hepatitis B (rDNA) vaccine (adsorbed) (HBV)
- Licence status
- Withdrawn: 02/12/2025
- Active substances
- Hepatitis b surface antigen, recominant
- Dosage Form
- Suspension for injection in pre-filled syringe
- Licence number
- PA1077/023/001
- Licence holder
- GlaxoSmithKline (Ireland) Limited
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- J07BC Hepatitis vaccines, J07BC01 hepatitis B, purified antigen
- Legal supply status
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.1 of Directive 2001/83/EC.
- Marketing availability
- Not marketed
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 26/06/1998