EMEA-003495-PIP02-24 - paediatric investigation plan

3,3-Dimethyl-N-(6-methyl-5-{[2-(1-methyl-1H-pyrazol-4-yl)pyridine-4-yl]oxy}pyridine-2-yl)-2-oxopyrrolidine-1-carboxamide hydrochloride hydrate

Key facts

• Active substance:
  3,3-Dimethyl-N-(6-methyl-5-{[2-(1-methyl-1H-pyrazol-4-yl)pyridine-4-yl]oxy}pyridine-2-yl)-2-oxopyrrolidine-1-carboxamide hydrochloride hydrate
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0373/2024
• PIP number:
  EMEA-003495-PIP02-24
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of tenosynovial giant cell tumours
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0373/2024 : EMA decision of 25 October 2024 on agreement of a PIP and on granting of deferral and waiver for 3,3-Dimethyl-N-(6-methyl-5-{[2-(1-methyl-1H-pyrazol-4-yl)pyridine-4- yl]oxy}pyridine-2-yl)-2-oxopyrrolidine-1-carboxamide hydrochloride hydrate

Adopted Reference Number: EMA/480695/2024