EMEA-001229-PIP01-11-M03
Key facts
Active substance |
Damoctocog alfa pegol
|
Therapeutic area |
Haematology-Hemostaseology
|
Decision number |
P/0195/2017
|
PIP number |
EMEA-001229-PIP01-11-M03
|
Pharmaceutical form(s) |
Powder and solvent for solution for injection
|
Condition(s) / indication(s) |
Treatment of hereditary factor VIII deficiency
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
Bayer AG
Tel. +49 30300139003 |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-001229-PIP01-11-M03
|
Compliance opinion date |
18/08/2017
|
Compliance outcome |
positive
|