EMEA-003260-PIP03-23 - paediatric investigation plan

brigimadlin

Key facts

• Active substance:
  brigimadlin
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0199/2024
• PIP number:
  EMEA-003260-PIP03-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of soft tissue sarcoma excluding liposarcoma
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/06/2024
• Compliance check done:
  No

Decision

P/0199/2024: EMA decision of 14 June 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for brigimadlin (EMEA-003260-PIP03-23)

Adopted Reference Number: P/0199/2024