EMEA-001839-PIP01-15
Key facts
| Active substance |
Emicizumab
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0196/2016
|
| PIP number |
EMEA-001839-PIP01-15
|
| Pharmaceutical form(s) |
Solution for injection
|
| Condition(s) / indication(s) |
Treatment of hereditary factor VIII deficiency
|
| Route(s) of administration |
Subcutaneous use
|
| Contact for public enquiries |
Roche Registration Limited
|
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
| Compliance procedure number |
EMEA-C-001839-PIP01-15
|
| Compliance opinion date |
26/04/2019
|
| Compliance outcome |
positive
|