EMA/PE/0000241250 - paediatric investigation plan

trilaciclib (dihydrochloride)

Key facts

• Active substance:
  trilaciclib (dihydrochloride)
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000241250
• PIP number:
  EMA/PE/0000241250
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Prevention of chemotherapy-induced myelosuppression in small-cell lung cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/05/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000241250 : EMA decision of 16 May 2025 on the granting of a product specific waiver for trilaciclib

Adopted Reference Number: EMADOC-1700519818-2114151