EMEA-000457-PIP02-10-M02
Key facts
| Active substance |
Fibrinogen (human plasma-derived)
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0136/2014
|
| PIP number |
EMEA-000457-PIP02-10-M02
|
| Pharmaceutical form(s) |
Powder and solvent for infusion
|
| Condition(s) / indication(s) |
Treatment of congenital fibrinogen deficiency
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
LFB Biotechnologies
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000457-PIP02-10-M02
|
| Compliance opinion date |
16/12/2016
|
| Compliance outcome |
positive
|