EMEA-001107-PIP01-10-M04

Key facts

Invented name
Idelvion
Active substance
albutrepenonacog alfa
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0031/2020
PIP number
EMEA-001107-PIP01-10-M04
Pharmaceutical form(s)
  • Powder and solvent for solution for infusion
  • 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
CSL Behring GmbH

Tel.: +49 6421393304
E-mail: rix-fp@cslbehring.com

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001107-PIP01-10-M04
Compliance opinion date
21/01/2022
Compliance outcome
negative

Decision

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