New Zealand - English - Medsafe (Medicines Safety Authority)

celgene limited, a bristol myers squibb company - azacitidine 100mg;   - powder for injection - 100 mg - active: azacitidine 100mg   excipient: mannitol - · intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss) in whom allogenic stem cell transplantation is not indicated.

Singapore - English - HSA (Health Sciences Authority)

nagase singapore (pte) ltd - 13c urea - tablet - 100mg - 13c urea 100mg

Singapore - English - HSA (Health Sciences Authority)

abbvie pte. ltd. - ritonavir - tablet, film coated - 100.0 mg - ritonavir 100.0 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - levetiracetam 1000mg - film coated tablet - 1000 mg - active: levetiracetam 1000mg excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate maize starch opadry white 04f58804 povidone purified water - everet tablets are indicated for: · use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. · monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. · add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme). · add-on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - canagliflozin hemihydrate 102mg equivalent to canagliflozin 100 mg - film coated tablet - 100 mg - active: canagliflozin hemihydrate 102mg equivalent to canagliflozin 100 mg excipient: croscarmellose sodium hyprolose lactose magnesium stearate microcrystalline cellulose opadry ii yellow 85f92209 - invokana is indicated in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise, to improve glycaemic control as: monotherapy: when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. add-on combination therapy: combination therapy with other anti-hyperglycaemic agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

New Zealand - English - Medsafe (Medicines Safety Authority)

psm healthcare ltd trading as api consumer brands - levetiracetam 1000mg - film coated tablet - 1000 mg - active: levetiracetam 1000mg excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate maize starch opadry white 85f18422 povidone purified talc - use in epileptic patients aged 6 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation. monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme). add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 6 years of age with idiopathic generalized epilepsy (ige).

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - cyproterone acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; maize starch; pregelatinised maize starch; lactose monohydrate; magnesium stearate; povidone - inoperable prostatic carcinoma. to suppress 'flare' with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - cyproterone acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; maize starch; pregelatinised maize starch; lactose monohydrate; magnesium stearate; povidone - inoperable prostatic carcinoma. to suppress 'flare' with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - capsule, hard - excipient ingredients: crospovidone; sodium stearylfumarate; gelatin; titanium dioxide; purified water; iron oxide yellow; sodium lauryl sulfate; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? 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). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - capsule, hard - excipient ingredients: purified water; gelatin; crospovidone; titanium dioxide; iron oxide yellow; sodium lauryl sulfate; sodium stearylfumarate; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? 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). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)