EMEA-001127-PIP02-11-M02

Table of contents

Key facts

Invented name
Heplisav B
Active substance
Hepatitis B (rDNA) surface antigen adjuvanted
Therapeutic area
Vaccines
Decision number
P/0245/2022
PIP number
EMEA-001127-PIP02-11-M02
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Prevention of hepatitis B virus infection
Route(s) of administration
Intramuscular use
Contact for public enquiries
Dynavax GmbH

E-mail: dynavaxmedinfo@lashgroup.com

Tel. +49 21175845126

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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