EMEA-000311-PIP04-13

Key facts

Invented name
Stelara
Active substance
Ustekinumab
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0045/2014
PIP number
EMEA-000311-PIP04-13
Pharmaceutical form(s)
  • Solution for injection
  • Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of Crohn disease
Route(s) of administration
  • Subcutaneous use
  • Intravenous use
Contact for public enquiries
Janssen-Cilag International NV
Belgium
E-mail: ldobell@its.jnj.com
Tel. +44 1494 56 75 67
Fax +44 1494 65 80 84
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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