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

pharmacor pty ltd - ticagrelor, quantity: 90 mg - tablet, film coated - excipient ingredients: purified water; croscarmellose sodium; calcium hydrogen phosphate dihydrate; magnesium stearate; mannitol; hyprolose; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - ticagrelor, in combination with aspirin, is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) in adult patients with acute coronary syndromes (unstable angina [ua], non st elevation myocardial infarction [nstemi] or st elevation myocardial infarction [stemi]) including patients managed medically, and those who are managed with percutaneous coronary intervention (pci) or coronary artery by-pass grafting (cabg).

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

pharmacor pty ltd - ticagrelor, quantity: 90 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; mannitol; calcium hydrogen phosphate dihydrate; purified water; hyprolose; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - ticagrelor, in combination with aspirin, is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) in adult patients with acute coronary syndromes (unstable angina [ua], non st elevation myocardial infarction [nstemi] or st elevation myocardial infarction [stemi]) including patients managed medically, and those who are managed with percutaneous coronary intervention (pci) or coronary artery by-pass grafting (cabg).

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

chs healthcare pty ltd - 15555 - bath, - the avero premium plus lifting tub was developed in close cooperation with nursing staff and occupational therapists. their ergonomical interior tub body with the lowered foot area and the premium materials provide for a relaxing bathing on the highest level. the tub body and the foot area allow an application of all modern nursing lifts on the market. the seating area is equipped with a hygienic opening allowing an easy cleaning of an intimate area. due to its extraordinary stability the avero premium plus tub does not need any floor fixation and provides an unrestricted access from 3 sides. easy operational elements with symbols avoid operating errors and facilitate everyday work of the nursing staff.

Den europeiske union - tysk - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - nintedanib - karzinom, nicht kleinzellige lunge - antineoplastische mittel - vargatef wird in kombination mit docetaxel zur behandlung von erwachsenen patienten mit lokal fortgeschrittenem, metastasiertem oder lokal rezidivierende nicht-kleinzelligem lungenkrebs (nsclc) von adenokarzinom tumor histologie nach der ersten zeile chemotherapie angezeigt..

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

beigene aus pty ltd - zanubrutinib, quantity: 80 mg - capsule - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; sodium lauryl sulfate; magnesium stearate; gelatin; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - waldenstr?m?s macroglobulinaemia (wm),brukinsa is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll),brukinsa is indicated as monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll), including patients with deletion 17p and/or tp53 mutation. mantle cell lymphoma (mcl),brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.,this indication was approved via the provisional approval pathway, based on objective response rate. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.,marginal zone lymphoma (mzl),brukinsa is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one-prior anti-cd20-based therapy.,this indication was approved via the provisional approval pathway, based on objective response rate. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.

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

gilead sciences pty ltd - voxilaprevir, quantity: 100 mg; velpatasvir, quantity: 100 mg; sofosbuvir, quantity: 400 mg - tablet - excipient ingredients: lactose monohydrate; copovidone; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - vosevi (sofosbuvir/velpatasvir/voxilaprevir fixed-dose combination) is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have: - genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an ns5a inhibitor; - genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an ns5a inhibitor; (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties, clinical trials).

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

biomarin pharmaceutical australia pty ltd - vosoritide, quantity: 1.2 mg - injection, powder for - excipient ingredients: citric acid monohydrate; mannitol; methionine; polysorbate 80; sodium citrate dihydrate; trehalose dihydrate - voxzogo is indicated for the treatment of achondroplasia in paediatric patients whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

biomarin pharmaceutical australia pty ltd - vosoritide, quantity: 0.56 mg - injection, powder for - excipient ingredients: mannitol; sodium citrate dihydrate; citric acid monohydrate; polysorbate 80; trehalose dihydrate; methionine - voxzogo is indicated for the treatment of achondroplasia in paediatric patients whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

biomarin pharmaceutical australia pty ltd - vosoritide, quantity: 0.4 mg - injection, powder for - excipient ingredients: citric acid monohydrate; mannitol; polysorbate 80; methionine; trehalose dihydrate; sodium citrate dihydrate - voxzogo is indicated for the treatment of achondroplasia in paediatric patients whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

novartis pharmaceuticals australia pty ltd - voretigene neparvovec, quantity: 1 dna - injection, concentrated - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; sodium chloride; poloxalene - luxturna is indicated for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic rpe65 mutations and who have sufficient viable retinal cells as determined by the treating physician.,pathological mutations of rpe65 should be confirmed by a national association of testing authorities (nata) or international laboratory accreditation cooperation (ilac) accredited laboratory.