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
|