EMEA-003256-PIP02-23 - paediatric investigation plan

valemetostat tosilate

Key facts

• Active substance:
  valemetostat tosilate
• Therapeutic area:
  Oncology
• Decision number:
  P/0394/2023
• PIP number:
  EMEA-003256-PIP02-23
• Pharmaceutical form(s):
  • Film-coated tablet
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of mature T-cell neoplasms
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/09/2023
• Compliance check done:
  No

Decision

P/0394/2023 : EMA decision of 29 September 2023 on the granting of a product specific waiver for valemetostat tosilate (EMEA-003256-PIP02-23)