European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate mbh - treosulfan - powder for solution for injection/infusion - 5 gram(s) - alkyl sulfonates; treosulfan

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - zoledronic acid monohydrate - fractures, bone; cancer - drugs for treatment of bone diseases - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.treatment of adult patients with tumour-induced hypercalcaemia (tih).

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - antineoplastic agents - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft für klinische spezialpräparate mbh - bacillus calmette guérin (bcg) - powder and solvent for intravesical suspension - unknown - other immunostimulants; bcg vaccine

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate mbh - methotrexate - solution for injection - 10 mg/ml - folic acid analogues

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft für klinische spezialpräparate mbh - oxaliplatin - powder for solution for infusion - 5 milligram(s)/millilitre - platinum compounds; oxaliplatin

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft für klinische spezialpräparate mbh - bortezomib - powder for solution for injection - 3.5 milligram(s) - other antineoplastic agents; bortezomib

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft für klinische spezialpräparate mbh - melphalan - powder and solvent for solution for injection/infusion - 50 milligram(s) - melphalan

Israel - English - Ministry of Health

tzamal bio-pharma ltd - hydroxycarbamide - capsules - hydroxycarbamide 500 mg - hydroxycarbamide - treatment of patient with chronic myeloid leukaemia (cml) in the chronic or accelerated phase of the disease.treatment of patients with essential thrombocytaemia or polycythaemia vera with a high risk for thrmboembolic complications.