Singapore - English - HSA (Health Sciences Authority)

zuellig pharma pte. ltd. - alfacalcidol - capsule, liquid filled - 0.5 mcg - alfacalcidol 0.5 mcg

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

sandoz pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: mannitol; iron oxide yellow; magnesium stearate; gelatin; titanium dioxide - fingolimod sandoz is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

aspen pharmacare australia pty ltd - amoxicillin trihydrate, quantity: 573.9 mg (equivalent: amoxicillin, qty 500 mg) - capsule, hard - excipient ingredients: iron oxide yellow; erythrosine; titanium dioxide; indigo carmine; magnesium stearate; gelatin; purified talc; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - indications as at 14th february 2005: it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: note; therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. skin and skin structure: staphylococcus, non-penicillinase producing; streptococcus; e.coli (see microbiology). respiratory (acute and chronic): h.influenzae, streptococcus; s.pneumoniae; staphylococcus, non-penicillinase-producing; e.coli (see microbiology). genitourinary tract (complicated and uncomplicated, acute and chronic): e.coli (see microbiology), p.mirabilis and s.faecalis. gonorrhoea: n.gonorrhoeae (non-penicillinase producing). prophylaxis of endocarditis: amoxil may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

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

aspen pharmacare australia pty ltd - amoxicillin trihydrate, quantity: 286.95 mg (equivalent: amoxicillin, qty 250 mg) - capsule, hard - excipient ingredients: erythrosine; iron oxide yellow; titanium dioxide; magnesium stearate; gelatin; indigo carmine; purified talc; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - indications as at 14th february 2005: it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: note; therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. skin and skin structure: staphylococcus, non-penicillinase producing; streptococcus; e.coli (see microbiology). respiratory (acute and chronic): h.influenzae, streptococcus; s.pneumoniae; staphylococcus, non-penicillinase-producing; e.coli (see microbiology). genitourinary tract (complicated and uncomplicated, acute and chronic): e.coli (see microbiology), p.mirabilis and s.faecalis. gonorrhoea: n.gonorrhoeae (non-penicillinase producing). prophylaxis of endocarditis: amoxil may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

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

roche products pty ltd - pralsetinib, quantity: 100 mg - capsule, hard - excipient ingredients: sodium bicarbonate; microcrystalline cellulose; magnesium stearate; citric acid; pregelatinised starch; hypromellose; titanium dioxide; brilliant blue fcf; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - non-small cell lung cancer (nsclc),gavreto has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (ret) fusion-positive non-small cell lung cancer (nsclc). the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor) in single-arm trials. continued approval of this indication depends on verification and description of benefit in confirmatory trials. ret-fusion positive thyroid cancer,gavreto has provisional approval in australia for the treatment of adult patients with advanced or metastatic ret-fusion positive thyroid cancer that is refractory to (or unsuitable for) radioactive iodine and who have progressed on or are unable to tolerate lenvatinib or sorafenib. the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Israel - English - Ministry of Health

merck sharp & dohme israel ltd - aprepitant - capsules - aprepitant 80 mg - aprepitant - aprepitant - emend in combination with other antiemetic agents is indicated for the: - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin. - prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Israel - English - Ministry of Health

merck sharp & dohme israel ltd - aprepitant - capsules - aprepitant 80 mg - aprepitant - aprepitant - emend in combination with other antiemetic agents is indicated for the: - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin. - prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Israel - English - Ministry of Health

merck sharp & dohme israel ltd - aprepitant - capsules - aprepitant 125 mg - aprepitant - aprepitant - emend in combination with other antiemetic agents is indicated for the: - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin. - prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

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

eisai australia pty ltd - lenvatinib mesilate, quantity: 12.25 mg (equivalent: lenvatinib, qty 10 mg) - capsule, hard - excipient ingredients: microcrystalline cellulose; iron oxide yellow; purified talc; iron oxide red; calcium carbonate; propylene glycol; hyprolose; mannitol; potassium hydroxide; titanium dioxide; hypromellose; iron oxide black; shellac - endometrial carcinoma lenvima, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation., differentiated thyroid cancer (dtc) lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine (rai) refractory differentiated thyroid cancer (dtc).,renal cell carcinoma (rcc) lenvima, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,lenvima, in combination with everolimus, is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.,hepatocellular carcinoma (hcc) lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc).

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

eisai australia pty ltd - lenvatinib mesilate, quantity: 4.9 mg (equivalent: lenvatinib, qty 4 mg) - capsule, hard - excipient ingredients: iron oxide yellow; propylene glycol; potassium hydroxide; mannitol; iron oxide black; titanium dioxide; hypromellose; purified talc; iron oxide red; calcium carbonate; microcrystalline cellulose; hyprolose; shellac - endometrial carcinoma lenvima, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.,differentiated thyroid cancer (dtc) lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine (rai) refractory differentiated thyroid cancer (dtc).,renal cell carcinoma (rcc) lenvima, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,lenvima, in combination with everolimus, is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.,hepatocellular carcinoma (hcc) lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc).