EMEA-002818-PIP01-20 - paediatric investigation plan

Human plasma derived C1-inhibitor (OCTA-C1-INH)

Key facts

• Active Substance:
  Human plasma derived C1-inhibitor (OCTA-C1-INH)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0225/2021
• PIP number:
  EMEA-002818-PIP01-20
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary angioedema
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Octapharma Pharmazeutika Produktionsges.m.b.H

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/06/2021

Decision

P/0225/2021 : EMA decision of 9 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human plasma derived C1-inhibitor (OCTA-C1-INH) (EMEA-002818-PIP01-20)

AdoptedReference Number: EMA/300928/2021