EMEA-001114-PIP01-10-M03
Key facts
| Invented name |
Elocta
|
| Active substance |
Efmorocotocog alfa
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0149/2016
|
| PIP number |
EMEA-001114-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 |
Biogen Idec Ltd
United Kingdom
Tel. +44 (0) 16285 12609 / 44 (0)7557057823 Fax +44 (0) 16285 12696 E-mail: amit.patel@biogen.cpm |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001114-PIP01-10-M03
|
| Compliance opinion date |
29/05/2019
|
| Compliance outcome |
positive
|