EMEA-001229-PIP01-11-M03

Key facts

Active substance
Damoctocog alfa pegol
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0195/2017
PIP number
EMEA-001229-PIP01-11-M03
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Treatment of hereditary factor VIII deficiency
Route(s) of administration
Intravenous use
Contact for public enquiries
Bayer AG

Tel. +49 30300139003
E-mail: clinical-trials-contact@bayer.com

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001229-PIP01-11-M03
Compliance opinion date
18/08/2017
Compliance outcome
positive

Decision

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