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

hospira australia pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection - excipient ingredients: water for injections; mannitol; sodium hydroxide; sulfuric acid - vincristine sulfate injection is indicated in acute leukemia. vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in hodgkin's disease, non-hodgkin's malignant lymphomas (lymphocytic, mixed cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, and wilm's tumor.

Israel - English - Ministry of Health

j-c health care ltd - oxybutynin chloride - tablets prolonged release - oxybutynin chloride 5 mg - oxybutynin - oxybutynin - once daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Israel - English - Ministry of Health

j-c health care ltd - oxybutynin chloride - tablets prolonged release - oxybutynin chloride 10 mg - oxybutynin - oxybutynin - once daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - clonazepam - drops - clonazepam 2.5 mg/ml - clonazepam - clonazepam - anti-epileptic. panic disorder.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - cabergoline - tablets - cabergoline 0.5 mg - cabergoline - cabergoline - treatment of hyperprolactinemic disorders.dostinex is indicated for the treatment of dysfunctions associated with hyperprolactinemia, including amenorrhea, oligomenorrhea, anovulation and galactorrhea. dostinex is indicated in patients with prolactin-secreting pituitary adenomas (micro-and macroprolactinomas), idiopathic hyperprolactinemia, or empty sella syndrome with associated hyperprolactinemia. inhibition and supression of lactation .

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - posaconazole 100mg - modified release tablet - 100 mg - active: posaconazole 100mg excipient: colloidal silicon dioxide croscarmellose sodium hyprolose hypromellose acetate succinate magnesium stearate microcrystalline cellulose opadry ii yellow 85f92209 - indicated for use in the treatment of the following invasive fungal infections in patients 18 years of age or older: - invasive aspergillosis in patients with disease that is refractory to, or are intolerant of, amphotericin b, itraconazole or voriconazole. - oesophageal candidiasis or candidemia in patients with disease that is refractory to, or who are intolerant of, amphotericin b, fluconazole, or itraconazole. - fusariosis, zygomycosis, cryptococcosis, chromoblastomycosis, and mycetoma in patients with disease refractory to other therapy, or patients who are intolerant of other therapy. - coccidioidomycosis noxafil tablets are also indicated for use as: - prophylaxis of invasive fungal infections, including both yeasts and moulds, in patients 13 years of age and older who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards.,psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

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: 59.735 mg (equivalent: imatinib, qty 50 mg) - capsule, hard - excipient ingredients: sodium stearylfumarate; gelatin; sodium lauryl sulfate; titanium dioxide; purified water; iron oxide yellow; crospovidone; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; iron oxide red; 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: 477.88 mg - capsule, hard - excipient ingredients: crospovidone; purified water; titanium dioxide; sodium stearylfumarate; sodium lauryl sulfate; gelatin; iron oxide yellow; iron oxide black; 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)