EMEA-002387-PIP01-18 - paediatric investigation plan

selinexor

Key facts

• Active substance:
  selinexor
• Therapeutic area:
  Oncology
• Decision number:
  P/0384/2018
• PIP number:
  EMEA-002387-PIP01-18
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/12/2018
• Compliance check done:
  No

Decision

P/0384/2018: EMA decision of 6 December 2018 on the granting of a product specific waiver for selinexor (EMEA-002387-PIP01-18)

Adopted Reference Number: EMA/775712/2018