EMEA-001127-PIP02-11-M02
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
|