EMEA-000715-PIP03-11-M06 - paediatric investigation plan

apremilast

Key facts

• Invented name:
  • Otezla
  • Otezla
• Active substance:
  apremilast
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0469/2020
• PIP number:
  EMEA-000715-PIP03-11-M06
• Pharmaceutical form(s):
  • Tablet
  • Oral liquid
• Condition(s) / indication(s):
  Treatment of psoriasis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2020
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000715-PIP03-11-M06
• Compliance opinion date:
  10/11/2023
• Compliance outcome:
  Positive

Decision

P/0469/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla) (EMEA-000715-PIP03-11-M06)

Adopted Reference Number: EMA/620964/2020