EMEA-003109-PIP01-21 - paediatric investigation plan

derivative of pyrrolopyrimidine

Key facts

• Active substance:
  derivative of pyrrolopyrimidine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0012/2022
• PIP number:
  EMEA-003109-PIP01-21
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of cardiovascular events in patients with heart failure
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2022
• Compliance check done:
  No

Decision

P/0012/2022 : EMA decision of 31 January 2022 on the granting of a product-specific waiver for derivative of pyrrolopyrimidine (EMEA-003109- PIP01-21)

Adopted