EMEA-000311-PIP03-11-M06

Table of contents

Key facts

Invented name
Stelara
Active substance
Ustekinumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0467/2020
PIP number
EMEA-000311-PIP03-11-M06
Pharmaceutical form(s)
  • Solution for injection
  • Solution for injection (in pre-filled syringe)
  • Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis)
Route(s) of administration
  • Subcutaneous use
  • Intravenous use
Contact for public enquiries
Janssen-Cilag International NV

E-mail: contact@janssen-emea.com
Tel.: +32 14602111
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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