EMEA-001139-PIP01-11-M02

Key facts

Invented name
Rixubis
Active substance
Nonacog alfa
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0021/2016
PIP number
EMEA-001139-PIP01-11-M02
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Treatment of haemophilia B (congenital factor IX deficiency)
Route(s) of administration
Intravenous use
Contact for public enquiries
Baxalta Innovations GmbH
Austria 
Tel. + 431 201000
E-mail: EU.RA.Info@baxalta.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001139-PIP01-11-M02
Compliance opinion date
29/06/2018
Compliance outcome
positive

Decision

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