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

bayer australia ltd - regorafenib, quantity: 40 mg - tablet - excipient ingredients: polyvinyl alcohol; croscarmellose sodium; iron oxide red; microcrystalline cellulose; povidone; purified talc; magnesium stearate; titanium dioxide; macrogol 3350; colloidal anhydrous silica; iron oxide yellow; lecithin - stivarga is indicated for the treatment of patients with metastatic colorectal cancer (crc) who have been previously treated with fluoropyrimidine,- oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf therapy, and, if ras wild type, an anti-egfr therapy.,stivarga is indicated for the treatment of patients with unresectable or metastatic gastrointestinal stromal tumours (gist) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.,stivarga is indicated for the treatment of patients with hepatocellular carcinoma (hcc) who have been previously treated with sorafenib.

Israel - English - Ministry of Health

bayer israel ltd - regorafenib - film coated tablets - regorafenib 40 mg - regorafenib - regorafenib - stivarga is indicated as monotherapy for the treatment of adults patients:- with metastatic colorectal cancer (crc) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf therapy,and if kras wild- type, an anti-egfr therapy.- with locally advanced, unresectable or metastatic gastrointestinal stromal tumors (gist) who have been previously treated with imatinib mesylate and sunitinib malate.- hepatocellular carcinoma (hcc) who have been previously treated with sorafenib.

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesothelioma pemetrexed sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer pemetrexed sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,

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

alembic pharmaceuticals australia pty ltd - venlafaxine hydrochloride, quantity: 169.8 mg (equivalent: venlafaxine, qty 150 mg) - capsule, modified release - excipient ingredients: gelatin; ethylcellulose; sunset yellow fcf; povidone; magnesium stearate; microcrystalline cellulose; brilliant blue fcf; copovidone; allura red ac; purified talc; colloidal anhydrous silica; titanium dioxide; propylene glycol; ethanol; isopropyl alcohol; shellac; tert-butyl alcohol; sodium hydroxide - sandoz venlafaxine xr is indicated for the treatment of: - major depression, including prevention of relapse and recurrence where appropriate; - generalised anxiety disorder; - social anxiety disorder; panic disorder, including prevention of relapse.

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

alembic pharmaceuticals australia pty ltd - venlafaxine hydrochloride, quantity: 84.9 mg (equivalent: venlafaxine, qty 75 mg) - capsule, modified release - excipient ingredients: iron oxide black; colloidal anhydrous silica; ethylcellulose; iron oxide red; magnesium stearate; microcrystalline cellulose; povidone; purified talc; titanium dioxide; gelatin; copovidone; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia - sandoz venlafaxine xr is indicated for the treatment of: - major depression, including prevention of relapse and recurrence where appropriate; - generalised anxiety disorder; - social anxiety disorder; panic disorder, including prevention of relapse.

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

arrotex pharmaceuticals pty ltd - enalapril maleate, quantity: 5 mg - tablet - excipient ingredients: maleic acid; lactose monohydrate; hypromellose; sodium stearylfumarate; croscarmellose sodium - hypertension ,enalapril is indicated in the treatment of all grades of essential hypertension and renovascular hypertension. ,congestive heart failure ,enalapril is indicated for the treatment of all degrees of symptomatic heart failure. in such patients, it is recommended that enalapril be administered together with a diuretic. ,left ventricular dysfunction ,all degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35 percent, irrespective of the presence or severity of obvious symptoms of heart failure.

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

arrotex pharmaceuticals pty ltd - enalapril maleate, quantity: 20 mg - tablet - excipient ingredients: maleic acid; hypromellose; sodium stearylfumarate; lactose monohydrate; croscarmellose sodium - hypertension ,enalapril is indicated in the treatment of all grades of essential hypertension and renovascular hypertension. ,congestive heart failure ,enalapril is indicated for the treatment of all degrees of symptomatic heart failure. in such patients, it is recommended that enalapril be administered together with a diuretic. ,left ventricular dysfunction ,all degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35 percent, irrespective of the presence or severity of obvious symptoms of heart failure.

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

arrotex pharmaceuticals pty ltd - enalapril maleate, quantity: 10 mg - tablet - excipient ingredients: sodium stearylfumarate; lactose monohydrate; hypromellose; croscarmellose sodium; maleic acid - hypertension ,enalapril is indicated in the treatment of all grades of essential hypertension and renovascular hypertension. ,congestive heart failure ,enalapril is indicated for the treatment of all degrees of symptomatic heart failure. in such patients, it is recommended that enalapril be administered together with a diuretic. ,left ventricular dysfunction ,all degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35 percent, irrespective of the presence or severity of obvious symptoms of heart failure.

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

sandoz pty ltd - codeine phosphate hemihydrate, quantity: 12.8 mg; ibuprofen, quantity: 200 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400 - for the temporary relief of acute moderate pain and inflammation in patients over the age of 12 years (see also contraindications and paediatric use)

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

sandoz pty ltd - quetiapine fumarate, quantity: 115.13 mg (equivalent: quetiapine, qty 100 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; calcium hydrogen phosphate dihydrate; iron oxide yellow; sodium starch glycollate type a; silicon dioxide; povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 4000 - quetiapine sandoz is indicated for:,bipolar disorder adults ? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder (see dose and method of administration) ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years ? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years) ? treatment of schizophrenia