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

gedeon richter australia pty ltd - follitropin alfa, quantity: 150 iu - injection, solution - excipient ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; trypsin - in adult women:,- bemfola is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated,- controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies,- bemfola in association with a luteinising hormone (lh) 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 level <1.2 iu/l.,in adult men:,- bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

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

gedeon richter australia pty ltd - follitropin alfa, quantity: 75 iu - injection, solution - excipient ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; trypsin - in adult women:,- bemfola is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated,- controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies,- bemfola in association with a luteinising hormone (lh) 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 level <1.2 iu/l.,in adult men:,- bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

gedeon richter (uk) ltd - not applicable

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

gedeon richter australia pty ltd - teriparatide, quantity: 250 microgram/ml - injection, solution - excipient ingredients: metacresol; water for injections; sodium hydroxide; hydrochloric acid; glacial acetic acid; mannitol; sodium acetate trihydrate - terrosa is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.,terrosa is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

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

gedeon richter australia pty ltd - progesterone, quantity: 400 mg - pessary - excipient ingredients: hard fat - cyclogest is indicated for luteal phase support as part of an assisted reproductive technology (art) treatment for women.

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

gedeon richter australia pty ltd - cariprazine hydrochloride, quantity: 6.54 mg (equivalent: cariprazine, qty 6 mg) - capsule, hard - excipient ingredients: pregelatinised maize starch; magnesium stearate; titanium dioxide; brilliant blue fcf; allura red ac; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; iron oxide black; potassium hydroxide - reagila? is indicated for the treatment of schizophrenia in adult patients.

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

gedeon richter australia pty ltd - cariprazine hydrochloride, quantity: 4.905 mg (equivalent: cariprazine, qty 4.5 mg) - capsule, hard - excipient ingredients: pregelatinised maize starch; magnesium stearate; titanium dioxide; brilliant blue fcf; iron oxide yellow; allura red ac; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - reagila? is indicated for the treatment of schizophrenia in adult patients.

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

gedeon richter australia pty ltd - cariprazine hydrochloride, quantity: 3.27 mg (equivalent: cariprazine, qty 3 mg) - capsule, hard - excipient ingredients: pregelatinised maize starch; magnesium stearate; titanium dioxide; brilliant blue fcf; iron oxide yellow; allura red ac; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; iron oxide black; potassium hydroxide - reagila? is indicated for the treatment of schizophrenia in adult patients.

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

gedeon richter australia pty ltd - cariprazine hydrochloride, quantity: 1.635 mg (equivalent: cariprazine, qty 1.5 mg) - capsule, hard - excipient ingredients: magnesium stearate; pregelatinised maize starch; titanium dioxide; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; iron oxide black; potassium hydroxide - reagila? is indicated for the treatment of schizophrenia in adult patients.

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

gedeon richter australia pty ltd - ganirelix acetate, quantity: 0.27 mg (equivalent: ganirelix, qty 0.25 mg) - injection, solution - excipient ingredients: mannitol; glacial acetic acid; water for injections; sodium hydroxide - for the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques.