Key facts

Invented name
Refixia
Active Substance
Nonacog beta pegol
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0139/2019
PIP number
EMEA-000731-PIP01-09-M03
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Treatment of hereditary factor IX deficiency
Route(s) of administration
Intravenous use
Contact for public enquiries

Novo Nordisk A/S

E-mail: paediatrics@novonordisk.com
Tel. +45 4444 8888

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000731-PIP01-09-M03
Compliance opinion date
Compliance outcome
Positive

Decision

P/0139/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for nonacog beta pegol (Refixia), (EMEA-000731-PIP01-09-M03)

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