Key facts

Invented name
Zeposia
Active Substance
Ozanimod (hydrochloride)
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0233/2021
PIP number
EMEA-001710-PIP03-17-M03
Pharmaceutical form(s)
  • Capsule (hard)
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
Treatment of ulcerative colitis
Route(s) of administration
Oral use
Contact for public enquiries

Bristol-Myers Squibb Pharma EEIG

E-mail: medical.information@bms.com
Tel: +44 1423 53 3610

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

Decision

P/0233/2021 : EMA decision of 8 June 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ozanimod (hydrochloride) (Zeposia) (EMEA-001710-PIP03-17-M03)

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