Izrael - angielski - Ministry of Health

merck sharp & dohme israel ltd - pembrolizumab - powder for solution for infusion - pembrolizumab 50 mg/vial - pembrolizumab - - melanoma:keytruda (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma.- non-small cell lung cancer:• keytruda, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (nsclc) negative for egfr or alk genomic tumor aberrations.• keytruda, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous nsclc. • keytruda, as a single agent, is indicated for the treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors express pd-l1 [tumor proportion score (tps) ≥50%)] as determined by a validated test. patients with egfr or alk genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving keytruda.• keytruda, as a single agent, is indic

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

pfizer australia pty ltd - lorlatinib, quantity: 25 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; sodium starch glycollate; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350; iron oxide black - lorviqua is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by a validated test.

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

pfizer australia pty ltd - lorlatinib, quantity: 25 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350; iron oxide black - lorviqua is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by a validated test.

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

pfizer australia pty ltd - lorlatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; magnesium stearate; microcrystalline cellulose; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350; iron oxide black - lorviqua is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by a validated test.

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

pfizer australia pty ltd - lorlatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; calcium hydrogen phosphate; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350; iron oxide black - lorviqua is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by a validated test.

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

pierre fabre australia pty ltd - binimetinib, quantity: 15 mg - tablet, film coated - excipient ingredients: iron oxide black; macrogol 3350; colloidal anhydrous silica; purified talc; iron oxide yellow; microcrystalline cellulose; polyvinyl alcohol; magnesium stearate; titanium dioxide; croscarmellose sodium; lactose monohydrate - binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600e or v600k mutation, as detected by a validated test.

Izrael - angielski - Ministry of Health

remedix care ltd - ascorbic acid; biotin; cocarboxylase tetrahydrate; colecalciferol; cyanocobalamin; dexpanthenol; folic acid; nicotinamide; pyridoxine (vit b6) hydrochloride; retinol palmitate; riboflavine; tocopherol - powder for solution for injection - retinol palmitate 3500 iu/vial; colecalciferol 220 iu/vial; tocopherol 10.2 mg/vial; ascorbic acid 125 mg/vial; riboflavine 5.67 mg/vial; pyridoxine (vit b6) hydrochloride 5.5 mg/vial; cyanocobalamin 0.006 mg/vial; folic acid 0.414 mg/vial; dexpanthenol 16.15 mg/vial; biotin 0.069 mg/vial; nicotinamide 46 mg/vial; cocarboxylase tetrahydrate 5.8 mg/vial - combinations - combinations - vitamin supplementation in patients receiving parenteral nutrition. only for adults and children over 11 years of age.

Unia Europejska - angielski - EMA (European Medicines Agency)

merial - bluetongue virus serotype 8 antigen - immunologicals for ovidae, immunologicals for bovidae - sheep; cattle - active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.*(below the level of detection by the validated rt-pcr method at 3.14log10 rna copies/ml, indicating no infectious virus transmission).onset of immunity has been demonstrated 3 weeks after the primary vaccination course.the duration of immunity for cattle and sheep is 1 year after the primary vaccination course.the duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.

Unia Europejska - angielski - EMA (European Medicines Agency)

zoetis belgium sa - inactivated bluetongue virus, serotype 1, strain btv-1/alg2006/01 e1 rp, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02 - bluetongue virus, immunologicals, immunologicals for bovidae, cattle, inactivated viral vaccines - cattle - active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus (btv), serotypes 1 and 8.*(cycling value (ct) ≥ 36 by a validated rt-pcr method, indicating no presence of viral genome).

Izrael - angielski - Ministry of Health

kamada ltd, israel - conestat alfa - powder for solution for injection - conestat alfa 2100 u/vial - conestat alfa - ruconest is indicated for treatment of acute angioedema attacks in adults and adolescents aged 12 years and above with hereditary angioedema (hae) due to c1 esterase inhibitor deficiency.