EMEA-002587-PIP01-19 - paediatric investigation plan

duvelisib

Key facts

• Active Substance:
  duvelisib
• Therapeutic area:
  Oncology
• Decision number:
  P/0428/2019
• PIP number:
  EMEA-002587-PIP01-19
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of mature B cell malignancies
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Verastem, Inc.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/12/2019

Decision

P/0428/2019: EMA decision of 6 December 2019 on the granting of a product specific waiver for duvelisib (EMEA-002587-PIP01-19)

AdoptedReference Number: EMA/633947/2019