EMEA-000311-PIP05-17

Key facts

Invented name
Stelara
Active substance
Ustekinumab
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0190/2018
PIP number
EMEA-000311-PIP05-17
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
  • Solution for injection in pre-filled syringe
Condition(s) / indication(s)
Treatment of ulcerative colitis
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries
Janssen Cilag International NV

Tel. +3214602111
E-mail: contact@Janssen-emea.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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