EMEA-002901-PIP01-20 - paediatric investigation plan

thienopyrimidine derivative

Key facts

• Active substance:
  thienopyrimidine derivative
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0459/2021
• PIP number:
  EMEA-002901-PIP01-20
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of fibrosing Interstitial Lung Diseases (ILD)
• Route(s) of administration:
  • Gastric use
  • Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/10/2021
• Compliance check done:
  No

Decision

P/0459/2021 EMA decision of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Thienopyrimidine Derivative (EMEA-002901-PIP01-20)

Adopted Reference Number: EMA/510195/2021