Malta - English - Malta Medicines Authority

tad pharma gmbh heinz-lohmann-strasse 5, 27472 cuxhaven, germany - rivaroxaban - film-coated tablet - rivaroxaban 20 mg - antithrombotic agents

European Union - English - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastic agents - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment.adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy.adult patients with relapsed or refractory ph+ all as monotherapy.adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements.adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatment.the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Malta - English - Malta Medicines Authority

tad pharma gmbh heinz-lohmann-strasse 5, 27472 cuxhaven, germany - film-coated tablet - imatinib mesilate 100 mg - antineoplastic agents

Malta - English - Malta Medicines Authority

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

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - imatinib mesilate - film-coated tablet - 100 milligram(s) - protein kinase inhibitors; imatinib

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - imatinib mesilate - film-coated tablet - 400 milligram(s) - protein kinase inhibitors; imatinib

Malta - English - Malta Medicines Authority

1 a pharma gmbh keltenring 1+3, 82041 oberhaching, germany - imatinib mesilate - film-coated tablet - imatinib mesilate 100 mg - antineoplastic agents

Malta - English - Malta Medicines Authority

1 a pharma gmbh keltenring 1+3, 82041 oberhaching, germany - imatinib mesilate - film-coated tablet - imatinib mesilate 400 mg - antineoplastic agents

Malta - English - Malta Medicines Authority

denk pharma gmbh & co. kg prinzregentenstrasse 79 81675 münchen , germany - rivaroxaban - film-coated tablet - rivaroxaban 15 mg - antithrombotic agents

Malta - English - Malta Medicines Authority

denk pharma gmbh & co. kg prinzregentenstrasse 79 81675 münchen , germany - rivaroxaban - film-coated tablet - rivaroxaban 20 mg - antithrombotic agents