Израел - английски - 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.

Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - ivacaftor 150mg;  ;  ; tezacaftor 100mg;  ;  ; ivacaftor 150mg - film coated tablet - active: ivacaftor 150mg     tezacaftor 100mg     excipient: croscarmellose sodium hypromellose hypromellose acetate succinate magnesium stearate microcrystalline cellulose opadry yellow 20a120010 sodium laurilsulfate active: ivacaftor 150mg excipient: carnauba wax colloidal silicon dioxide croscarmellose sodium hypromellose acetate succinate lactose monohydrate magnesium stearate microcrystalline cellulose opacode black s-1-17823 opadry blue 85f90614 sodium laurilsulfate - symdeko is 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.

Малта - английски - Medicines Authority

meda pharma 25 boulevard de l'amiral bruix, 75016 paris, france - glycerol - rectal gel - glycerol 3.9 g - drugs for constipation

Малта - английски - Medicines Authority

lcm limited linthwaite laboratories, huddersfield, hd7 5qh, united kingdom - glycerol - suppository - glycerol - drugs for constipation

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

petrus pharmaceuticals pty ltd - glycerol, quantity: 100 mg/g; cetylpyridinium chloride, quantity: 100 microgram/g; ethanol, quantity: 374 mg/g; benzocaine, quantity: 30 mg/g - gel - excipient ingredients: white soft paraffin; vitamin a; hypromellose; dl-alpha-tocopheryl acetate; zinc amino acid chelate; peppermint oil - this product accepted for registration/listing as 'currently supplied' at the time of commencement of the act. indications held in artg paper records. (old code) for the temporary relief of transient, recurrent mouth ulcers, abrasions of the gums, tongue and palate, denture discomfort. a soothing, pain relieving, antibacterial, adhesive gel for use as an aid in the treatment of inflammed gums and oral tissue.

Ирландия - английски - HPRA (Health Products Regulatory Authority)

laneshealth (ireland) limited - choline salicylate; glycerol - ear drops, solution - 20 %w/v +12.6 percent weight/volume - analgesics and anesthetics

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

fresenius kabi australia pty ltd - sodium glycerophosphate hydrate, quantity: 6.122 g (equivalent: sodium glycerophosphate, qty 4.32 g) - injection, concentrated - excipient ingredients: hydrochloric acid; water for injections - glycophos? is indicated in adult and paediatric patients as a supplement to parenteral nutrition to meet the daily requirements of phosphate.

Израел - английски - Ministry of Health

medison pharma ltd - glycerol phenylbutyrate - liquid - glycerol phenylbutyrate 1.1 g / 1 ml - glycerol phenylbutyrate - ravicti is indicated for use as adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age with urea cycle disorders (ucds) including deficiencies of carbamoyl phosphate-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginase i (arg) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (hhh) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Израел - английски - Ministry of Health

medison pharma ltd - glycerol phenylbutyrate - liquid - glycerol phenylbutyrate 1.1 g / 1 ml - glycerol phenylbutyrate - ravicti is indicated for use as adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age with urea cycle disorders (ucds) including deficiencies of carbamoyl phosphate-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginase i (arg) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (hhh) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Израел - английски - Ministry of Health

medison pharma ltd - glycerol phenylbutyrate - liquid - glycerol phenylbutyrate 1.1 g / 1 ml - glycerol phenylbutyrate - ravicti is indicated for use as adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age with urea cycle disorders (ucds) including deficiencies of carbamoyl phosphate-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginase i (arg) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (hhh) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).