EMEA-001064-PIP01-10-M03
Key facts
Invented name |
|
Active substance |
octocog alfa
|
Therapeutic area |
Haematology-Hemostaseology
|
Decision number |
P/0060/2018
|
PIP number |
EMEA-001064-PIP01-10-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
E-mail: clinical-trials-contact@bayer.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-001064-PIP01-10-M03
|
Compliance opinion date |
23/07/2021
|
Compliance outcome |
positive
|