EMEA-003480-PIP01-23 - paediatric investigation plan

Derivative of pyrindin-2-yl)cyclopropanecarboxamide hydrochloride

Key facts

• Active Substance:
  Derivative of pyrindin-2-yl)cyclopropanecarboxamide hydrochloride
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0204/2024
• PIP number:
  EMEA-003480-PIP01-23
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of psoriasis
• 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

Decision

P/0204/2024: EMA decision of 14 June 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for derivative of pyrindin-2-yl)cyclopropanecarboxamide hydrochloride (EMEA-003480-PIP01-23)

Adopted