EMEA-000311-PIP01-08-M04 - paediatric investigation plan

Ustekinumab

Key facts

• Invented name:
  • Stelara
  • Stelara
• Active Substance:
  Ustekinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0003/2016
• PIP number:
  EMEA-000311-PIP01-08-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic plaque psoriasis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Janssen-Cilag International NV

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/01/2016
• Compliance procedure number:
  EMEA-C-000311-PIP01-08-M04
• Compliance opinion date:
  29/05/2019
• Compliance outcome:
  Positive

Decision

P/0003/2016: EMA decision of 15 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara) (EMEA-000311-PIP01-08-M04)

AdoptedReference Number: EMA/3164/2016