Malta - anglès - Medicines Authority

tad pharma gmbh heinz-lohmann-strasse 5, 27472 cuxhaven, germany - film-coated tablet - imatinib mesilate 400 mg - antineoplastic agents

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

koanaa healthcare limited - imatinib mesylate - film-coated tablet - 100 milligram(s) - protein kinase inhibitors; imatinib

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

koanaa healthcare limited - imatinib mesylate - film-coated tablet - 400 milligram(s) - protein kinase inhibitors; imatinib

Israel - anglès - Ministry of Health

teva pharmaceutical industries ltd, israel - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. imatinib teva is also indicated for the treament of : adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph + all as monotherapy. adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr ( platelet - derived growth factor receptor ) gene re- arrangements. adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration fo chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-p

Israel - anglès - Ministry of Health

teva pharmaceutical industries ltd, israel - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. imatinib teva is also indicated for the treament of : adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph + all as monotherapy. adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr ( platelet - derived growth factor receptor ) gene re- arrangements. adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration fo chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-p

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - dasatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; hyprolose; titanium dioxide; hypromellose; triacetin - dasatinib is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - imatinib mesilate, quantity: 119.469 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatiqual (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatiqual (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatiqual (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatiqual (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatiqual (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatiqual (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatiqual (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatiqual (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatiqual (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - imatinib mesilate, quantity: 119.469 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) glibine (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) glibine (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) glibine (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) glibine (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) glibine (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) glibine (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) glibine (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) glibine (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) glibine (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - imatinib mesilate, quantity: 119.469 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatiqual (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatiqual (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatiqual (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatiqual (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatiqual (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatiqual (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatiqual (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatiqual (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatiqual (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - imatinib mesilate, quantity: 119.469 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) glibine (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) glibine (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) glibine (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) glibine (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) glibine (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) glibine (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) glibine (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) glibine (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) glibine (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).