EMEA-000715-PIP02-11-M06 - paediatric investigation plan

apremilast

Key facts

• Invented name:
  Otezla
• Active Substance:
  apremilast
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0352/2022
• PIP number:
  EMEA-000715-PIP02-11-M06
• Pharmaceutical form(s):
  • Tablet
  • Oral liquid
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Amgen Europe B.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2022

Decision

P/0352/2022 : EMA decision of 11 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla), (EMEA-000715-PIP02-11-M06)

AdoptedReference Number: EMA/675392/2022