EMEA-003406-PIP01-23 - paediatric investigation plan

opicapone
PIPHuman

Key facts

Invented name
  • Ongentys
  • Ontilyv
Active Substance
opicapone
Therapeutic area
Neurology
Decision number
P/0260/2023
PIP number
EMEA-003406-PIP01-23
Pharmaceutical form(s)
Capsule, hard
Condition(s) / indication(s)
Treatment of Parkinson's disease
Route(s) of administration
Oral use
Contact for public enquiries

BIAL - Portela & Ca, SA

E-mail: info@bial.com
Tel. +351 229866100

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date

Decision

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