EMEA-001710-PIP04-17-M03 - paediatric investigation plan

Ozanimod (hydrochloride)
PIPHuman

Key facts

Invented name
Zeposia
Active Substance
Ozanimod (hydrochloride)
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0131/2022
PIP number
EMEA-001710-PIP04-17-M03
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate oral liquid dosage form
Condition(s) / indication(s)
Treatment of Crohn's disease
Route(s) of administration
Oral use
Contact for public enquiries

Bristol-Myers Squibb Pharma EEIG

E-mail: medical.information@bms.com
Tel. +44 1423 533 610

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

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