EMEA-003342-PIP01-22 - paediatric investigation plan

Enpatoran

Key facts

• Active Substance:
  Enpatoran
• Therapeutic area:
  • Dermatology
  • Immunology-Rheumatology-Transplantation
• Decision number:
  P/0081/2023
• PIP number:
  EMEA-003342-PIP01-22
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of cutaneous lupus erythemathosus
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Europe B.V.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/03/2023

Decision

P/0081/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for enpatoran (EMEA-003342-PIP01-22)

Reference Number: EMA/37968/2023