EMEA-003045-PIP01-21 - paediatric investigation plan

rusfertide

Key facts

• Active substance:
  rusfertide
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0422/2021
• PIP number:
  EMEA-003045-PIP01-21
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of polycythaemia vera
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021
• Compliance check done:
  No

Decision

P/0422/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for rusfertide, (EMEA-003045-PIP01-21)

Adopted Reference Number: EMA/532881/2021