EMEA-001710-PIP03-17-M03 - paediatric investigation plan

Ozanimod (hydrochloride)

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: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/06/2021

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)

AdoptedReference Number: EMA/308733/2021