Summary for ARTG Entry:
CHEMMART IMATINIB 400mg tablet blister pack
ARTG entry for
Apotex Pty Ltd
PO Box 280,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. CHEMMART IMATINIB
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
-treatment of patients with chronic myeloid leukaemia (CML)
-treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with
-treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy
-treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor
(PDGFR) gene re-arrangements, where conventional therapies have failed
-treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed
-treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL)
-adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
Additional Product information
Store below 25
Pack Size/Poison information
(S4) Prescription Only Medicine
1. CHEMMART IMATINIB
Tablet, film coated
Route of Administration
Brownish orange, capsule shaped biconvex, film-coated tablets. Engraved
"IMA" score "400" on one side, "APO" on the other side
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Produced at 28.11.2017 at 03:04:59 AEDT
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