EMEA-001523-PIP02-14-M02 - paediatric investigation plan

Guselkumab

Key facts

• Invented name:
  • Tremfya
  • Tremfya
• Active Substance:
  Guselkumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0129/2018
• PIP number:
  EMEA-001523-PIP02-14-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of psoriasis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Janssen Cilag International NV

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/04/2018

Decision

P/0129/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP02-14-M02)

AdoptedReference Number: EMA/201260/2018