EMEA-001710-PIP02-14-M07 - paediatric investigation plan

Ozanimod (hydrochloride)

Key facts

• Invented name:
  Zeposia
• Active Substance:
  Ozanimod (hydrochloride)
• Therapeutic area:
  Neurology
• Decision number:
  P/0392/2022
• PIP number:
  EMEA-001710-PIP02-14-M07
• Pharmaceutical form(s):
  • Capsule (hard)
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Celgene Europe B.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022

Decision

P/0392/2022: EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ozanimod (hydrochloride) (Zeposia), (EMEA-001710-PIP02-14-M07)

Reference Number: EMA/677609/2022