EMEA-002937-PIP01-20 - paediatric investigation plan

ensartinib

Key facts

• Active Substance:
  ensartinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0165/2021
• PIP number:
  EMEA-002937-PIP01-20
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of non-small cell lung cancer
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Xcovery Holdings, 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:
  14/04/2021

Decision

P/0165/2021 : EMA decision of 14 April 2021 on the granting of a product specific waiver for ensartinib (EMEA-002937-PIP01-20)

Reference Number: EMA/192354/2021