Key facts

Invented name
Alprolix
Active Substance
eftrenonacog alfa
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0071/2020
PIP number
EMEA-000914-PIP01-10-M05
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

Swedish Orphan Biovitrum AB (publ)

E-mail: medical.info@sobi.com
Tel. +46 8697 2000

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000914-PIP01-10-M05
Compliance opinion date
Compliance outcome
Positive

Decision

P/0071/2020: EMA decision of 18 March 2020 on the acceptance of a modification of an agreed paediatric investigation plan for Eftrenonacog alfa (Alprolix) (EMEA-000914-PIP01-10-M05)

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