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. +80066838470
E-mail: medinfoeuceemea@shire.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000568-PIP01-09-M06
Compliance opinion date
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)

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