EMEA-002387-PIP02-21 - paediatric investigation plan

Selinexor

Key facts

• Invented name:
  Nexpovio
• Active Substance:
  Selinexor
• Therapeutic area:
  Oncology
• Decision number:
  P/0364/2021
• PIP number:
  EMEA-002387-PIP02-21
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of endometrial carcinoma
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Karyopharm Europe GmbH

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2021

Decision

P/0364/2021 : EMA decision of 8 September 2021 on the granting of a product specific waiver for selinexor (Nexpovio), (EMEA-002387-PIP02-21)

AdoptedReference Number: EMA/440048/2021