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

bayer australia ltd - damoctocog alfa pegol, quantity: 250 iu - injection, powder for - excipient ingredients: polysorbate 80; sucrose; glycine; calcium chloride dihydrate; histidine; sodium chloride - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 3000 iu - injection, powder for - excipient ingredients: calcium chloride dihydrate; sucrose; sodium chloride; glycine; histidine; polysorbate 80 - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 500 iu - injection, powder for - excipient ingredients: sucrose; calcium chloride dihydrate; polysorbate 80; glycine; sodium chloride; histidine - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

viatris pty ltd - fluticasone propionate, quantity: 50 microgram/actuation; azelastine hydrochloride, quantity: 137 microgram/actuation (equivalent: azelastine, qty 125 microgram/actuation) - spray, nasal - excipient ingredients: phenethyl alcohol; benzalkonium chloride; purified water; microcrystalline cellulose; polysorbate 80; carmellose sodium; glycerol; disodium edetate - symptomatic treatment of moderate to severe allergic rhinitis for up to 6 months.

Namibia - English - Namibia Medicines Regulatory Council

adcock ingram ltd - ammonium chloride 34 mg; ; polysorbate 20 36, mg - syrup - in each 10ml:; ammonium chloride 34 mg; ; polysorbate 20 36.0 mg

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

specialised therapeutics alim pty ltd - tafasitamab, quantity: 200 mg - injection, powder for - excipient ingredients: polysorbate 20; citric acid monohydrate; trehalose dihydrate; sodium citrate dihydrate - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).,this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.

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

janssen-cilag pty ltd - teclistamab, quantity: 30 mg - injection, solution - excipient ingredients: glacial acetic acid; sucrose; disodium edetate; sodium acetate trihydrate; polysorbate 20; water for injections - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

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

janssen-cilag pty ltd - teclistamab, quantity: 153 mg - injection, solution - excipient ingredients: polysorbate 20; sodium acetate trihydrate; glacial acetic acid; sucrose; water for injections; disodium edetate - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

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

pharmacor pty ltd - omeprazole, quantity: 20 mg - capsule - excipient ingredients: quinoline yellow; purified water; gelatin; titanium dioxide; sodium lauryl sulfate; dibasic sodium phosphate; mannitol; hypromellose; macrogol 6000; purified talc; polysorbate 80; methacrylic acid copolymer; maize starch; sucrose - the relief of heartburn and other symptoms associated with gord. the treatment and prevention of relapse in erosive oesophagitis. the treatment of duodenal and gastric ulcer. combination therapy for the treatment of peptic ulcer disease associated with h. pylori infection. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs.the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be h. pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. the treatment of zollinger-ellison syndrome.

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

pharmacor pty ltd - omeprazole, quantity: 20 mg - capsule - excipient ingredients: quinoline yellow; purified water; gelatin; titanium dioxide; sodium lauryl sulfate; dibasic sodium phosphate; mannitol; hypromellose; macrogol 6000; purified talc; polysorbate 80; methacrylic acid copolymer; maize starch; sucrose - the relief of heartburn and other symptoms associated with gord. the treatment and prevention of relapse in erosive oesophagitis. the treatment of duodenal and gastric ulcer. combination therapy for the treatment of peptic ulcer disease associated with h. pylori infection. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs.the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be h. pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. the treatment of zollinger-ellison syndrome.