EMEA-001064-PIP01-10-M03 - paediatric investigation plan

Octocog alfa
PIPHuman

Key facts

Invented name
    • Iblias
    • Kovaltry
    • Iblias
    • Kovaltry
Active Substance
Octocog alfa
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0060/2018
PIP number
EMEA-001064-PIP01-10-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

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

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001064-PIP01-10-M03
Compliance opinion date
Compliance outcome
Positive

Decision

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