P/9/2010 - paediatric investigation plan

Givinostat

Key facts

• Active Substance:
  Givinostat
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/9/2010
• PIP number:
  P/9/2010
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Juvenile idiopathic arthritis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Italfarmaco SpA

  E-mail: [e-mail]; Country: Italy; Phone: [phone]; Fax: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/01/2010

Decision

P/9/2010: European Medicines Agency of 29 January 2010 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for Givinostat (EMEA-000551-PIP01-09) in accor...

AdoptedReference Number: EMA/35973/2010