EMEA-002264-PIP01-17 - paediatric investigation plan

Voclosporin

Key facts

• Active Substance:
  Voclosporin
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0152/2019
• PIP number:
  EMEA-002264-PIP01-17
• Pharmaceutical form(s):
  Capsule (soft)
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  17/04/2019

Decision

P/0152/2019: EMA decision of 17 April 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for voclosporin (EMEA-002264-PIP01-17)

AdoptedReference Number: EMA/215117/2019