EMEA-000971-PIP01-10-M03
Key facts
| Invented name |
Coagadex
|
| Active substance |
Human coagulation factor X
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0389/2017
|
| PIP number |
EMEA-000971-PIP01-10-M03
|
| Pharmaceutical form(s) |
Powder for solution for injection or infusion
|
| Condition(s) / indication(s) |
Treatment of hereditary factor X deficiency
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Bio Products Laboratory Limited
Tel. +44 2089572200
E-mail: medinfo@bpl.co.uk |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000971-PIP01-10-M03
|
| Compliance opinion date |
26/01/2018
|
| Compliance outcome |
positive
|