EMEA-001523-PIP04-19

Table of contents

Key facts

Invented name
Tremfya
Active substance
guselkumab
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0461/2020
PIP number
EMEA-001523-PIP04-19
Pharmaceutical form(s)
  • Solution for injection
  • Solution for injection in pre-filled syringe
  • Solution for injection in pre-filled pen
Condition(s) / indication(s)
Treatment of ulcerative colitis
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries
Janssen-Cilag International N.V.

Tel. +32 14602111
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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