FENDRIX Suspension for injection Ref.[28269] Active ingredients: Hepatitis B, purified antigen

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: GlaxoSmithKline Biologicals s.a., Rue de lInstitut 89, B-1330 Rixensart, Belgium

Product name and form

Fendrix suspension for injection.

Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).

Pharmaceutical Form

Suspension for injection.

Turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be observed.

Qualitative and quantitative composition

1 dose (0.5 ml) contains:

Hepatitis B surface antigen1,2,3: 20 micrograms.

1 adjuvanted by AS04C containing: -3-O-desacyl-4'-monophosphoryl lipid A (MPL)2; 50 micrograms
2 adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total)
3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology

For the full list of excipients, see section 6.1.

Active Ingredient Description
Hepatitis B, purified antigen

Hepatitis B vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.
List of Excipients

Sodium chloride
Water for injections

For adjuvants, see section 2.

Pack sizes and marketing

0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without separate needle in a pack size of 1, or without needles in a pack size of 10.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Biologicals s.a., Rue de l’Institut 89, B-1330 Rixensart, Belgium

Marketing authorization dates and numbers

EU/1/04/0299/001
EU/1/04/0299/002
EU/1/04/0299/003

Date of first authorisation: 02 February 2005
Date of latest renewal: 10 December 2009

Drugs

Drug Countries
FENDRIX Austria, Estonia, Spain, Croatia, Ireland, Lithuania, Netherlands, Poland, United Kingdom
 
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