EMEA-000060-PIP04-14-M01 - paediatric investigation plan

Canakinumab
PIPHuman

Key facts

Invented name
  • Ilaris
  • Ilaris
Active Substance
Canakinumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0057/2015
PIP number
EMEA-000060-PIP04-14-M01
Pharmaceutical form(s)
  • Solution for injection
  • Powder for solution for injection
  • Powder and solvent for solution for injection
Condition(s) / indication(s)
  • Treatment of hyperimmunoglobulin D syndrome
  • Treatment of familial Mediterranean fever
Route(s) of administration
Subcutaneous use
Contact for public enquiries

Novartis Europharm Ltd

Switzerland
Tel. +41 613241111
E-mail: paediatric.enquiries@novartis.com
 

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000060-PIP04-14-M01
Compliance opinion date
Compliance outcome
Positive

Decision

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