P/0451/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for trilaciclib (dihydrochloride) (EMEA-002534-PIP03-22) - paediatric investigation plan

trilaciclib (dihydrochloride)

Key facts

• Active substance:
  trilaciclib (dihydrochloride)
• Therapeutic area:
  Oncology
• Decision number:
  P/0451/2022
• PIP number:
  P/0451/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for trilaciclib (dihydrochloride) (EMEA-002534-PIP03-22)
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of breast cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0451/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for trilaciclib (dihydrochloride) (EMEA-002534-PIP03-22)

Adopted Reference Number: EMA/834732/2022