EMEA-000093-PIP02-10 - paediatric investigation plan

Sotrastaurin acetate

Key facts

• Active Substance:
  Sotrastaurin acetate
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/24/2011
• PIP number:
  EMEA-000093-PIP02-10
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate dosage form, other
• Condition(s) / indication(s):
  Prevention of rejection of transplanted kidney
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Ltd

  [e-mail]; Switzerland; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  26/01/2011

Decision

P/24/2011: EMA decision of 26 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sotrastaurin acetate (EMEA-000093-PIP02-10)

AdoptedReference Number: EMA/32854/2011