EMA/PE/0000221389 - paediatric investigation plan

darovasertib

Key facts

• Active substance:
  darovasertib
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000221389
• PIP number:
  EMA/PE/0000221389
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of ocular melanoma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000221389 : EMA decision of 15 May 2025 on the granting of a product specific waiver for darovasertib

Adopted Reference Number: EMADOC-1700519818-2117907