EMEA-000389-PIP01-08-M01 - paediatric investigation plan

N-[4-(3-amino-1H-indazol-4 yl)phenyl]-N1-(2-fluoro-5-methylphenyl) urea (ABT-869)

Key facts

• Active Substance:
  N-[4-(3-amino-1H-indazol-4 yl)phenyl]-N1-(2-fluoro-5-methylphenyl) urea (ABT-869)
• Therapeutic area:
  Oncology
• Decision number:
  P/290/2011
• PIP number:
  EMEA-000389-PIP01-08-M01
• Pharmaceutical form(s):
  • Liquid formulation
  • Age-appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of solid malignant tumours
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AbbVie Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/12/2011

Decision

P/290/2011: EMA decision of 2 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for N-[4-(3-amino-1Hindazol- 4 yl)phenyl]-N1-(2-fluoro-5-methylphenyl) urea (ABT-869) (EMEA-0003...

AdoptedReference Number: EMA/920517/2011