EMEA-000568-PIP01-09-M06 - paediatric investigation plan

C1 inhibitor (human)

Key facts

• Invented name:
  • Cinryze
  • Cinryze
• Active Substance:
  C1 inhibitor (human)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0299/2015
• PIP number:
  EMEA-000568-PIP01-09-M06
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of C1 inhibitor deficiency
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  NPS Pharma Holdings Limited

  United Kingdom; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/12/2015
• Compliance procedure number:
  EMEA-C-000568-PIP01-09-M06
• Compliance opinion date:
  26/02/2016
• Compliance outcome:
  Positive

Decision

P/0299/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for C1 inhibitor (human) (Cinryze) (EMEA-000568-PIP01-09-M06)

AdoptedReference Number: EMA/792884/2015