EMEA-000463-PIP01-08-M03

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)	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 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

Add your rating

★ ★ ★ ★ ★