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

merck healthcare pty ltd - somatropin -

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

merck healthcare pty ltd - progesterone, quantity: 90 mg - gel - excipient ingredients: purified water; polycarbophil; carbomer 934p; sodium hydroxide; sorbic acid; light liquid paraffin; hydrogenated palm glycerides; glycerol - for ivf and (art) where luteal phase support is indicated.

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

merck healthcare pty ltd - cetrorelix, quantity: 0.25 mg - injection, powder for - excipient ingredients: mannitol - indications: prevention of premature luteinization and ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques. in clinical trials cetrotide was used with human menopausal gonadotrophin (hmg), however limited experience with recombinant fsh suggested similar efficacy.

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

merck healthcare pty ltd - avelumab, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: polysorbate 20; mannitol; glacial acetic acid; sodium hydroxide; water for injections - bavencio is indicated for the treatment of adults and paediatric patients 12 years and older with metastatic merkel cell carcinoma (mmcc). this indication is approved based on tumour response rate, duration of response in a single arm study.,bavencio is indicated for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (uc) whose disease has not progressed with first-line platinum-based induction chemotherapy.,bavencio in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (rcc).

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

merck healthcare pty ltd - interferon beta-1a, quantity: 88 microgram/ml - injection, solution - excipient ingredients: methionine; acetic acid; mannitol; poloxamer; water for injections; benzyl alcohol; sodium hydroxide - rebif is indicated for the treatment of: ? patients with a single demyelinating event in the central nervous system with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis. high risk can be inferred from cerebral mri with 2 or more lesions suggestive of demyelination.,? ambulatory patients with multiple sclerosis who have experienced two or more relapses within the last 2 years. rebif therapy should not be initiated in secondary progressive ms patients who no longer experience relapses.?

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

merck healthcare pty ltd - interferon beta-1a, quantity: 88 microgram/ml - injection, solution - excipient ingredients: benzyl alcohol; water for injections; sodium hydroxide; acetic acid; methionine; poloxamer; mannitol - rebif is indicated for the treatment of: ? patients with a single demyelinating event in the central nervous system with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis. high risk can be inferred from cerebral mri with 2 or more lesions suggestive of demyelination.,? ambulatory patients with multiple sclerosis who have experienced two or more relapses within the last 2 years. rebif therapy should not be initiated in secondary progressive ms patients who no longer experience relapses.?

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

merck healthcare pty ltd - interferon beta-1a, quantity: 88 microgram/ml - injection, solution - excipient ingredients: benzyl alcohol; water for injections; sodium hydroxide; acetic acid; methionine; poloxamer; mannitol - rebif is indicated for the treatment of: ? patients with a single demyelinating event in the central nervous system with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis. high risk can be inferred from cerebral mri with 2 or more lesions suggestive of demyelination.,? ambulatory patients with multiple sclerosis who have experienced two or more relapses within the last 2 years. rebif therapy should not be initiated in secondary progressive ms patients who no longer experience relapses.?

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

merck healthcare pty ltd - cetuximab, quantity: 5 mg/ml - injection, intravenous infusion - excipient ingredients: citric acid monohydrate; water for injections; sodium chloride; sodium hydroxide; glycine; polysorbate 80 - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer. in combination with infusional 5-fluorouracil/folinic acid plus irinotecan. in combination with irinotecan in patients who are refractory to first-line chemotherapy. in first-line in combination with folfox. as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (see clinical trials) erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck. in combination with radiation therapy for locally advanced disease. in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

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

merck healthcare pty ltd - cetuximab, quantity: 5 mg/ml - injection, intravenous infusion - excipient ingredients: water for injections; citric acid monohydrate; polysorbate 80; sodium chloride; sodium hydroxide; glycine - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer. in combination with infusional 5-fluorouracil/folinic acid plus irinotecan. in combination with irinotecan in patients who are refractory to first-line chemotherapy. in first-line in combination with folfox. as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (see clinical trials) erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck. in combination with radiation therapy for locally advanced disease. in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

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

merck healthcare pty ltd - lutropin alfa, quantity: 75 iu - injection, powder for - excipient ingredients: methionine; sodium hydroxide; phosphoric acid; sucrose; polysorbate 20; dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate - luveris in association with a recombinant follicle stimulating hormone (fsh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. in clinical trials, these patients were defined by an endogenous serum lh of less than 1.2 iu/l.