EMEA-003055-PIP02-23 - paediatric investigation plan

Tazemetostat

Key facts

• Active Substance:
  Tazemetostat
• Therapeutic area:
  Oncology
• Decision number:
  P/0286/2023
• PIP number:
  EMEA-003055-PIP02-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of follicular lymphoma
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Ipsen Pharma

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  25/07/2023

Decision

P/0286/2023 : EMA decision of 25 July 2023 on the granting of a product specific waiver for tazemetostat (EMEA-003055-PIP02-23)

Reference Number: EMA/33781/2023