Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; tezacaftor - film coated tablets - ivacaftor 150 mg; tezacaftor 100 mg - ivacaftor and tezacaftor - symdeko is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (cf) aged 12 years and older who are homozygous for the f508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.if the patient’s genotype is unknown, a health authority cleared cf mutation test should be used to detect the presence of a cftr mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; tezacaftor - film coated tablets - ivacaftor 150 mg; tezacaftor 100 mg - ivacaftor and tezacaftor - symdeko is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (cf) aged 12 years and older who are homozygous for the f508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.if the patient’s genotype is unknown, a health authority cleared cf mutation test should be used to detect the presence of a cftr mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - granules - ivacaftor 50 mg - ivacaftor - kalydeco granules are indicated for the treatment of children with cystic fibrosis (cf) aged 2 years and older and weighing less than 25 kg who have one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data. limitations of use:kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene.

Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - granules - ivacaftor 75 mg - ivacaftor - kalydeco granules are indicated for the treatment of children with cystic fibrosis (cf) aged 2 years and older and weighing less than 25 kg who have one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data. limitations of use:kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: silicified microcrystalline cellulose; macrogol 4000; sodium chloride; iron oxide red; purified talc; titanium dioxide; hyprolose; crospovidone; polacrilin potassium; magnesium stearate; colloidal anhydrous silica; polyvinyl alcohol - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; purified talc; polyvinyl alcohol; hyprolose; polacrilin potassium; macrogol 4000; sodium chloride; titanium dioxide; iron oxide red; silicified microcrystalline cellulose; colloidal anhydrous silica; iron oxide yellow - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 400 mg - tablet, film coated - excipient ingredients: sodium chloride; hyprolose; macrogol 4000; titanium dioxide; crospovidone; polacrilin potassium; iron oxide red; colloidal anhydrous silica; iron oxide yellow; purified talc; silicified microcrystalline cellulose; polyvinyl alcohol; magnesium stearate - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

Armenia - engelsk - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

one pharma industrial pharmaceutical company societe anonyme - memantine (memantine hydrochloride) - tablets film-coated - 10mg

Armenia - engelsk - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

one pharma industrial pharmaceutical company societe anonyme - memantine (memantine hydrochloride) - oral solution - 5mg/0.5ml

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

interpharma pty ltd - pemetrexed disodium hemipentahydrate, quantity: 604.1 mg (equivalent: pemetrexed, qty 500 mg) - injection, concentrated - excipient ingredients: trometamol; hydrochloric acid; sodium hydroxide; water for injections; monothioglycerol; citric acid - malignant pleural mesothelioma,pemetrexed ever pharma, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,non-small cell lung cancer,pemetrexed ever pharma in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,pemetrexed ever pharma as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.