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
|