EMEA-000093-PIP01-07-M01 - paediatric investigation plan

Sotrastaurin acetate

Key facts

• Active Substance:
  Sotrastaurin acetate
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/155/2011
• PIP number:
  EMEA-000093-PIP01-07-M01
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of chronic plaque psoriasis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/07/2011

Decision

P/155/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for sotrastaurin (acetate) (EMEA-000093-PIP01-07-M01)

AdoptedReference Number: EMA/485323/2011