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

accelagen pty ltd - erlotinib hydrochloride, quantity: 163.9 mg (equivalent: erlotinib, qty 150 mg) - tablet, film coated - excipient ingredients: titanium dioxide; sodium starch glycollate; lactose monohydrate; magnesium stearate; hyprolose; propylene glycol; microcrystalline cellulose; hypromellose; sodium lauryl sulfate - non-small cell lung cancer,erlotinib arx is indicated for the first-line treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations.,erlotinib arx is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy.,erlotinib arx is also indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of prior chemotherapy.,pancreatic cancer,erlotinib arx in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

accelagen pty ltd - erlotinib hydrochloride, quantity: 27.317 mg (equivalent: erlotinib, qty 25 mg) - tablet, film coated - excipient ingredients: propylene glycol; magnesium stearate; lactose monohydrate; sodium lauryl sulfate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; hyprolose - non-small cell lung cancer,erlotinib arx is indicated for the first-line treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations.,erlotinib arx is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy.,erlotinib arx is also indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of prior chemotherapy.,pancreatic cancer,erlotinib arx in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

arrotex pharmaceuticals pty ltd - plerixafor, quantity: 24 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - plerixafor arx is indicated in combination with granulocyte-colony stimulating factor (g-csf) to mobilise haematopoietic stem cells (hscs) to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma (mm).

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

accelagen pty ltd - solifenacin succinate, quantity: 10 mg (equivalent: solifenacin, qty 7.5 mg) - tablet, film coated - excipient ingredients: titanium dioxide; lactose monohydrate; triacetin; hypromellose; purified talc; magnesium stearate; iron oxide red - solifenacin dr.reddy's is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

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

accelagen pty ltd - solifenacin succinate, quantity: 5 mg (equivalent: solifenacin, qty 3.75 mg) - tablet, film coated - excipient ingredients: magnesium stearate; purified talc; iron oxide yellow; hypromellose; triacetin; titanium dioxide; lactose monohydrate - solifenacin dr.reddy's is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

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

accelagen pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - resolute 2.0 is a real-time rt-pcr test intended for the qualitative detection of nucleic acid from the sars-cov-2 virus in nasopharyngeal swabs specimen from individuals with signs and symptoms of infection who are suspected of covid-19.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 400 mg - tablet, film coated - excipient ingredients: sodium chloride; hyprolose; macrogol 4000; titanium dioxide; crospovidone; polacrilin potassium; iron oxide red; colloidal anhydrous silica; iron oxide yellow; purified talc; silicified microcrystalline cellulose; polyvinyl alcohol; magnesium stearate - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

arrotex pharmaceuticals pty ltd - moxifloxacin hydrochloride monohydrate, quantity: 436.33 mg (equivalent: moxifloxacin, qty mg) - tablet, film coated - excipient ingredients: lactose; povidone; lactose monohydrate; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - moxifloxacin apo (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions:,- acute bacterial sinusitis,- community acquired pneumonia,- acute exacerbations of chronic bronchitis,appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin apo may be initiated, in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.,consideration should be given to available official guidance on the appropriate use of antibacterial agents.

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

sandoz pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine is indicated for the treatment of patients with: ? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ? chronic myelomonocytic leukemia [cmmol (10%-29% marrow blasts without myeloproliferative disorder)], ? acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

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

juno pharmaceuticals pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine is indicated for the treatment of patients with: ? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ? chronic myelomonocytic leukemia [cmmol (10%-29% marrow blasts without myeloproliferative disorder)], ? acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.