EMEA-002427-PIP01-18
Key facts
| Active substance |
Adeno-associated viral vector serotype 5 containing a B-domain deleted variant of human coagulation factor VIII gene
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0218/2019
|
| PIP number |
EMEA-002427-PIP01-18
|
| Pharmaceutical form(s) |
Solution for infusion
|
| Condition(s) / indication(s) |
Treatment of Haemophilia A
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
BioMarin International Limited
Tel. +44 2074200800 |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|