Malta - inglise - Malta Medicines Authority

pharmsol europe limited the victoria centre unit 2, lower ground floor, valletta road, mosta mst 9012 , malta - cefazolin sodium - powder for solution for injection/infusion - cefazolin sodium 1 g - antibacterials for systemic use

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - mecasermin, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium chloride; benzyl alcohol; polysorbate 20; glacial acetic acid; sodium acetate trihydrate; water for injections - for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor 1 deficiency (primary igfd).,severe primary igfd is defined by:,? height standard deviation score less than or equal to ?3.0 and,? baseline height velocity less than the 25th percentile for bone age, based on two measurements over 12 months and,? basal igf-1 levels below the 2.5th percentile for age and gender and,? gh sufficiency.,? exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.,igf-1 and gh levels must be performed using validated assays with paediatric normal ranges.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - cemiplimab, quantity: 350 mg - injection, intravenous infusion - excipient ingredients: sucrose; histidine; histidine hydrochloride monohydrate; water for injections; proline; polysorbate 80 - cutaneous squamous cell carcinoma,libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. non-small cell lung cancer,libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 tumour proportion score (tps) greater than and equal to 50% as determined by a validated test, with no egfr, alk or ros1 aberrations, who have:,? locally advanced nsclc and who are not candidates for surgical resection or definitive chemoradiation, or ? metastatic nsclc.,libtayo in combination with platinum-based chemotherapy is indicated for the first-line treatment of patients with nsclc whose tumours have no egfr, alk or ros1 aberrations and is:,? locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or,? metastatic. basal cell carcinoma,libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (bcc) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - alpelisib, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide - piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, her2-negative, advanced or metastatic breast cancer with a pik3ca mutation as detected by a validated test following progression on or after an endocrine-based regimen

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - alpelisib, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide - piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, her2-negative, advanced or metastatic breast cancer with a pik3ca mutation as detected by a validated test following progression on or after an endocrine-based regimen

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - alpelisib, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide - piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, her2-negative, advanced or metastatic breast cancer with a pik3ca mutation as detected by a validated test following progression on or after an endocrine-based regimen

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

abacus dx pty ltd - ct1236 - clinical chemistry biological screening ivds - validate urine chemistry kits are designed to assist in the documentation of linearity, calibration verification, and verification of linear range or provide assistance when troubleshooting instrument systems, reagent problems, and calibration anomalies.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

abacus dx pty ltd - ct847 - clinical chemistry vitamin and mineral ivds - validate vitamin and/or mineral kits (such as for vitamin d) are designed to assist in the documentation of linearity, calibration verification, and verification of linear range or provide assistance when troubleshooting instrument systems, reagent problems, and calibration anomalies.

Iirimaa - inglise - HMA (Heads of Medicines Agencies)

merial - infectious bronchitis virus 3.7 log10 eid50 - aqueous suspension - chicken - avian infectious bronchitis virus vaccine

Austria - inglise - HMA (Heads of Medicines Agencies)

merial - infectious bronchitis virus 3.7 log10 eid50 - aqueous suspension - chicken - avian infectious bronchitis virus vaccine