EMEA-001521-PIP02-18 - paediatric investigation plan

Luspatercept

Key facts

• Active Substance:
  Luspatercept
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0254/2018
• PIP number:
  EMEA-001521-PIP02-18
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of myelofibrosis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/08/2018

Decision

P/0254/2018: EMA decision of 15 August 2018 on the granting of a product specific waiver for luspatercept (EMEA-001521-PIP02-18)

AdoptedReference Number: EMA/471686/2018