Израиль - английский - 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.

Сингапур - английский - HSA (Health Sciences Authority)

organon singapore pte. ltd. - finasteride - tablet, film coated - 1 mg - finasteride 1 mg

Израиль - английский - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - film coated tablets - ivacaftor 150 mg - ivacaftor - kalydeco tablets are indicated for the treatment of patients with cystic fibrosis (cf) aged 6 years and older and weighing 25 kg or more 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.

Израиль - английский - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - elexacaftor; ivacaftor; ivacaftor; tezacaftor - film coated tablets - ivacaftor 75 mg; tezacaftor 50 mg; elexacaftor 100 mg; ivacaftor 150 mg - ivacaftor, tezacaftor and elexacaftor - trikafta is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data.

Израиль - английский - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; ivacaftor; tezacaftor - film coated tablets - ivacaftor 75 mg; tezacaftor 50 mg; ivacaftor 75 mg - ivacaftor and tezacaftor - symdeko is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (cf) age 6 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.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 75 mg - granules - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; lactose monohydrate; mannitol; sucralose; croscarmellose sodium; silicon dioxide; magnesium stearate - kalydeco is indicated for the treatment of cystic fibrosis (cf) in patients aged 4 months and older who have at least one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data(see section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties).

Австралия - английский - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 50 mg - granules - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; lactose monohydrate; mannitol; sucralose; croscarmellose sodium; silicon dioxide; magnesium stearate - kalydeco is indicated for the treatment of cystic fibrosis (cf) in patients aged 4 months and older who have at least one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data(see section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties).

Австралия - английский - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 150 mg - tablet, film coated - excipient ingredients: carnauba wax; croscarmellose sodium; silicon dioxide; magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate; hypromellose acetate succinate; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - kalydeco is indicated for the treatment of cystic fibrosis (cf) in patients aged 4 months and older who have at least one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data(see section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties)

Австралия - английский - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 25 mg - granules - excipient ingredients: lactose monohydrate; hypromellose acetate succinate; croscarmellose sodium; sodium lauryl sulfate; silicon dioxide; magnesium stearate; mannitol; sucralose - kalydeco is indicated for the treatment of cystic fibrosis (cf) in patients aged 4 months and older who have at least one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data(see section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties).

Австралия - английский - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 75 mg - tablet, film coated - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; microcrystalline cellulose; lactose monohydrate; silicon dioxide; magnesium stearate; carnauba wax; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - trikafta is indicated for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.