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
|