EMEA-000463-PIP01-08-M03 - paediatric investigation plan

imatinib mesilate

Key facts

• Invented name:
  • Glivec
  • Glivec
• Active Substance:
  imatinib mesilate
• Therapeutic area:
  Oncology
• Decision number:
  P/0028/2012
• PIP number:
  EMEA-000463-PIP01-08-M03
• Pharmaceutical form(s):
  • Capsule (hard)
  • Film-coated tablet
• Condition(s) / indication(s):
  • Dermatofibrosarcoma protuberans
  • Hypereosinophilic syndrome and/or chronic eosinophilic leukaemia with FIP1L1-platelet-derived growth factor receptor alpha gene re-arrangement
  • Kit (CD 117)-positive gastrointestinal stromal tumours
  • Myelodysplastic / myeloproliferative diseases associated with platelet-derived growth factor receptor gene re-arrangements
  • Philadelphia chromosome (BCR-ABL translocation)-positive acute lymphoblastic leukaemia
  • Philadelphia chromosome (BCR-ABL translocation)-positive chronic myeloid leukaemia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2012
• Compliance procedure number:
  EMEA-C-000463-PIP01-08-M03
• Compliance opinion date:
  09/03/2012
• Compliance outcome:
  Positive

Decision

P/0028/2012: EMA decision of 27 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for imatinib mesilate (Glivec) (EMEA-000463-PIP01-08-M03)

AdoptedReference Number: EMA/36974/2012