EMEA-002307-PIP01-17-M02
Key facts
| Invented name |
Zabdeno
|
| Active substance |
Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV]
|
| Therapeutic area |
|
| Decision number |
P/0307/2021
|
| PIP number |
EMEA-002307-PIP01-17-M02
|
| Pharmaceutical form(s) |
Suspension for injection
|
| Condition(s) / indication(s) |
Prevention of Ebola virus disease
|
| Route(s) of administration |
Intramuscular use
|
| Contact for public enquiries |
Janssen Cilag International NV
Tel. +3214602111 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-002307-PIP01-17-M02
|
| Compliance opinion date |
24/06/2022
|
| Compliance outcome |
positive
|