EMA/PE/0000228081 - paediatric investigation plan

voclosporin

Key facts

• Invented name:
  Lupkynis
• Active substance:
  voclosporin
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0152/2019
• PIP number:
  EMA/PE/0000228081
• Pharmaceutical form(s):
  Capsule, soft
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/03/2025
• Compliance check done:
  Níl

Decision

EMA/PE/0000228081: EMA decision of 19 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for voclosporin (Lupkynis)

Adopted Reference Number: EMADOC-1700519818-1976753 Corr1