EMEA-000715-PIP05-13-M05 - paediatric investigation plan

apremilast

Key facts

• Invented name:
  • Otezla
  • Otezla
• Active Substance:
  apremilast
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0353/2022
• PIP number:
  EMEA-000715-PIP05-13-M05
• Pharmaceutical form(s):
  • Tablet
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of Behcet disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2022

Decision

P/0353/2022 : EMA decision of 11 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla), (EMEA-000715-PIP05-13-M05)

AdoptedReference Number: EMA/675386/2022