EMEA-001222-PIP01-11 - paediatric investigation plan

Olokizumab

Key facts

• Active Substance:
  Olokizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0189/2012
• PIP number:
  EMEA-001222-PIP01-11
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Accelsiors GmbH

  Russian Federation

  Email: [e-mail]

  Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  22/08/2012

Decision

P/0189/2012: EMA decision of 22 August 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for olokizumab (EMEA-001222-PIP01-11)

AdoptedReference Number: EMA/479559/2012