HEPLISAV B Solution for injection in pre-filled syringe Ref.[28057] Active ingredients: Hepatitis B, purified antigen

Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Dynavax GmbH, Eichsfelder Strasse 11, D-40595 Düsseldorf, Germany

Product name and form

HEPLISAV B 20 micrograms solution for injection in pre-filled syringe.

Hepatitis B vaccine (recombinant DNA, adjuvanted).

Pharmaceutical Form
Solution for injection in pre-filled syringe. Clear to slightly opalescent, colourless to slightly yellow solution.

Qualitative and quantitative composition

One dose (0.5 ml) contains:

Hepatitis B surface antigen (HBsAg)^1,2: 20 micrograms.

¹ Adjuvanted with 3000 micrograms CpG 1018 adjuvant, a 22-mer oligonucleotide comprising microbial DNA-like unmethylated CpG motifs
² Produced in yeast cells (Hansenula polymorpha) 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 Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Polysorbate 80 Water for injections For adjuvants, see Section 2.

Pack sizes and marketing

0.5 ml of solution in a pre-filled syringe (Type I glass) with tip cap (synthetic isoprene-bromobutyl rubber blend) and plunger stopper (chlorobutyl rubber). Syringes are provided without needles in packages of 5 syringes. The tip caps and stoppers of the prefilled syringes do not contain natural rubber latex.

Marketing authorization holder

Dynavax GmbH, Eichsfelder Strasse 11, D-40595 Düsseldorf, Germany

Marketing authorization dates and numbers

EU/1/20/1503/001

Drugs

Drug	Countries
HEPLISAV-B	Estonia, Croatia, Ireland, Lithuania, Poland, United States

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