EMEA-001212-PIP01-11 - paediatric investigation plan

anakinra

Key facts

• Invented name:
  • Kineret
  • Kineret
• Active Substance:
  anakinra
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0066/2012
• PIP number:
  EMEA-001212-PIP01-11
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing
  • Treatment of cryopyrin-associated periodic syndromes (CAPS)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Swedish Orphan Biovitrum AB

  [e-mail]; Country: Sweden; Phone: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  28/03/2012
• Compliance procedure number:
  EMEA-C-001212-PIP01-11
• Compliance opinion date:
  12/12/2014
• Compliance outcome:
  Positive

Decision

P/0066/2012: EMA decision of 28 March 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for anakinra (Kineret), (EMEA-001212-PIP01-11)

AdoptedReference Number: EMA/184118/2012