EMEA-000380-PIP02-09-M04

Key facts

Invented name
Cosentyx
Active substance
Secukinumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0372/2018
PIP number
EMEA-000380-PIP02-09-M04
Pharmaceutical form(s)
  • Powder for solution for injection or infusion
  • Solution for injection
Condition(s) / indication(s)
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
Route(s) of administration
  • Subcutaneous use
  • Intravenous use
Contact for public enquiries
Novartis Europharm Limited
Switzerland
Tel. +41 613241111
Fax +41 613240811
E-mail: paediatric.enquiries@novartis.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000380-PIP02-09-M04
Compliance opinion date
25/06/2021
Compliance outcome
positive

Decision

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