Європейський Союз - англійська - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - leflunomide - arthritis, rheumatoid - selective immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard).recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Європейський Союз - англійська - 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).

Європейський Союз - англійська - 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).

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

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

Ірландія - англійська - 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

Ірландія - англійська - 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

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

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

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

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

Ізраїль - англійська - 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.

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

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