EMEA-001523-PIP03-18-M02 - paediatric investigation plan

Guselkumab

Key facts

• Invented name:
  Tremfya
• Active Substance:
  Guselkumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0435/2022
• PIP number:
  EMEA-001523-PIP03-18-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
• 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:
  28/10/2022

Decision

P/0435/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya) (EMEA-001523-PIP03-18-M02)

AdoptedReference Number: EMA/808374/2022