EMEA-001215-PIP01-11-M07

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
Compliance procedure number
EMEA-C-001215-PIP01-11-M07
Compliance opinion date
10/09/2021
Compliance outcome
positive

Decision

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