EMEA-000463-PIP01-08-M03

Key facts

Invented name
Glivec
Active substance
imatinib mesilate
Therapeutic area
Oncology
Decision number
P/0028/2012
PIP number
EMEA-000463-PIP01-08-M03
Pharmaceutical form(s)
  • hard capsule
  • Film-coated tablet
Condition(s) / indication(s)
  • Dermatofibrosarcoma protuberans
  • Kit (CD 117)-positive gastrointestinal stromal tumours
  • Hypereosinophilic syndrome and/or chronic eosinophilic leukaemia with FIP1L1-platelet-derived growth factor receptor alpha gene re-arrangement
  • 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
paediatric.enquiries@novartis.com
Country: Switzerland
Phone: +41 61 324 6715
Fax: +41 61 324 2224
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000463-PIP01-08-M03
Compliance opinion date
09/03/2012
Compliance outcome
positive

Decision

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