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

pfizer australia pty ltd - raltitrexed, quantity: 2 mg - injection, powder for - excipient ingredients: sodium hydroxide; mannitol; dibasic sodium phosphate dodecahydrate - for use as a single agent in the palliative treatment of advanced colorectal cancer (distant metastases or unresectable local disease).

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

aspen pharmacare australia pty ltd - estriol, quantity: 0.5 mg - pessary, moulded - excipient ingredients: hard fat; cetomacrogol 1000; glyceryl ricinoleate - vulvo-vaginal complaints due to oestrogen deficiency associated with the climacteric and the postmenopause or after ovariectomy - atrophic vaginitis; - pruritus vulvae; - dyspareunia due to vulvo-vaginal atrophy; - as auxillary therapy in the treatment of vaginal infections - as pre-operative therapy for vulvo-vaginal surgery and during subsequent convalescence; - ulcers in cases of prolapse of the uterus or vagina; - to avoid misinterpretation of a cytological smear.

Den europeiske union - engelsk - EMA (European Medicines Agency)

takeda pharmaceuticals international ag - icatibant - angioedemas, hereditary - cardiac therapy - firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults (with c1-esterase-inhibitor deficiency).

Den europeiske union - engelsk - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - idebenone - optic atrophy, hereditary, leber - other psychostimulants and nootropics, psychoanaleptics, - raxone is indicated for the treatment of visual impairment in adolescent and adult patients with leber’s hereditary optic neuropathy (lhon).

Den europeiske union - engelsk - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedemas, hereditary - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Den europeiske union - engelsk - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedemas, hereditary - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Den europeiske union - engelsk - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioedemas, hereditary - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

Den europeiske union - engelsk - EMA (European Medicines Agency)

almirall, s.a. - eflornithine - hirsutism - other dermatological preparations - treatment of facial hirsutism in women.

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

aspen pharmacare australia pty ltd - iron polymaltose, quantity: 185 mg/ml (equivalent: iron, qty 50 mg/ml) - oral liquid - excipient ingredients: sodium propyl hydroxybenzoate; sodium methyl hydroxybenzoate; purified water; sucrose; sodium hydroxide; flavour - treatment of iron deficiency in adults and adolescents where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.,prevention of iron deficiency in adults and adolescents at high risk where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.

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

aspen pharmacare australia pty ltd - iron polymaltose, quantity: 37 mg/ml (equivalent: iron, qty 10 mg/ml) - oral liquid - excipient ingredients: propyl hydroxybenzoate; purified water; sorbitol solution (70 per cent) (non-crystallising); ethanol; sucrose; sodium hydroxide; methyl hydroxybenzoate; flavour - treatment of iron deficiency in adults and adolescents where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate. prevention of iron deficiency in adults and adolescents at high risk where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.