EMEA-002344-PIP02-18-M01 - paediatric investigation plan

liposomal ciclosporin A (L-CsA)

Key facts

• Active Substance:
  liposomal ciclosporin A (L-CsA)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0231/2022
• PIP number:
  EMEA-002344-PIP02-18-M01
• Pharmaceutical form(s):
  Powder for nebuliser solution
• Condition(s) / indication(s):
  Treatment of bronchiolitis obliterans syndrome
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Zambon S.p.A.

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/07/2022

Decision

P/0231/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for liposomal ciclosporin A (L-CsA) (EMEA-002344-PIP02-18-M01)

AdoptedReference Number: EMA/575636/2022