Key facts

Invented name
Afstyla
Active Substance
lonoctocog alfa
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0329/2019
PIP number
EMEA-001215-PIP01-11-M07
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Haemophilia A (congenital Factor VIII deficiency)
Route(s) of administration
Intravenous use
Contact for public enquiries

CSL Behring GmbH

Tel. +49 6421393290
E-mail: marburg.rfVIII@cslbehring.com
 

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001215-PIP01-11-M07
Compliance opinion date
Compliance outcome
Positive

Decision

P/0329/2019: EMA decision of 10 September 2019 on the acceptance of a modification of an agreed paediatric investigation plan for lonoctocog alfa (Afstyla) (EMEA-001215-PIP01-11-M07)

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