EMEA-003476-PIP01-23 - paediatric investigation plan

Fusion protein consisting of relaxin and Fc domain of IgG1

Key facts

• Active Substance:
  Fusion protein consisting of relaxin and Fc domain of IgG1
• Therapeutic area:
  Cardiac disorders
• Decision number:
  P/0473/2023
• PIP number:
  EMEA-003476-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of pulmonary hypertension due to left heart disease
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2023

Decision

P/0473/2023 : EMA decision of 1 December 2023 on the granting of a product-specific waiver for fusion protein consisting of relaxin and Fc domain of IgG1 (EMEA-003476-PIP01-23)

AdoptedReference Number: EMA/512500/2023