EMEA-000367-PIP01-08-M08 - paediatric investigation plan

Conestat alfa

Key facts

• Invented name:
  • Ruconest
  • Ruconest
• Active substance:
  Conestat alfa
• Therapeutic area:
  Other
• Decision number:
  P/0343/2018
• PIP number:
  EMEA-000367-PIP01-08-M08
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary angioedema
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/11/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000367-PIP01-08-M08
• Compliance opinion date:
  01/03/2019
• Compliance outcome:
  Positive

Decision

P/0343/2018: EMA decision of 8 November 2018 on the acceptance of a modification of an agreed paediatric investigation plan for conestat alfa (Ruconest), (EMEA-000367-PIP01-08-M08)

Adopted Reference Number: EMA/768931/2018