EMEA-003436-PIP01-23 - paediatric investigation plan

lerociclib (dihydrochloride)

Key facts

• Active substance:
  lerociclib (dihydrochloride)
• Therapeutic area:
  Oncology
• Decision number:
  P/0374/2023
• PIP number:
  EMEA-003436-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of endometrial carcinoma
• 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:
  08/09/2023
• Compliance check done:
  No

Decision

P/0374/2023: EMA decision of 8 September 2023 on the granting of a product specific waiver for lerociclib (dihydrochloride) (EMEA-003436-PIP01-23)

Adopted Reference Number: EMA/351239/2023