EMA/PE/0000237724 - paediatric investigation plan

pimicotinib hydrochloride hydrate

Key facts

• Active substance:
  pimicotinib hydrochloride hydrate
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000237724
• PIP number:
  EMA/PE/0000237724
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of tenosynovial giant cell tumours
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  Nee

Decision

EMA/PE/0000237724 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for pimicotinib hydrochloride hydrate

Adopted Reference Number: EMADOC-1700519818-2035407