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

astrazeneca pty ltd - palivizumab, quantity: 100 mg - injection, solution - excipient ingredients: histidine; glycine; water for injections - synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age less than or equal to 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd). (see clinical trials).

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

astrazeneca pty ltd - palivizumab, quantity: 50 mg - injection, solution - excipient ingredients: histidine; glycine; water for injections - synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age less than or equal to 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd). (see clinical trials).

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

aft pharmaceuticals pty ltd - dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml); timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml) - eye drops, solution - excipient ingredients: sodium hydroxide; hyetellose; mannitol; water for injections; sodium citrate - vizo-pf dorzolatim is indicated in the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

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

aft pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); bimatoprost, quantity: 300 microgram/ml - eye drops, solution - excipient ingredients: sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; citric acid monohydrate; hydrochloric acid; sodium hydroxide - vizo-pf bimatotim 0.3/5 eye drops are indicated for the reduction of intraocular pressure (iop) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy

United States - English - NLM (National Library of Medicine)

medi-physics, inc. dba ge healthcare - flutemetamol f-18 (unii: l49m066s0o) (flutemetamol f-18 - unii:l49m066s0o) - flutemetamol f-18 4.05 mci in 1 ml - vizamyl is indicated for positron emission tomography (pet) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for alzheimer's disease (ad) and other causes of cognitive decline. a negative vizamyl scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of ad at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to ad. a positive vizamyl scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with ad, but may also be present in patients with other types of neurologic conditions as well as in older people with normal cognition. vizamyl is an adjunct to other diagnostic evaluations. limitations of use: - a positive vizamyl scan does not establish a diagnosis of ad or other cognitive disorder. - safety and effe

United States - English - NLM (National Library of Medicine)

medimmune, llc - palivizumab (unii: dq448mw7ks) (palivizumab - unii:dq448mw7ks) - palivizumab 100 mg in 1 ml - 1 indications and usage synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in pediatric patients: limitations of use: the safety and efficacy of synagis have not been established for treatment of rsv disease [see warnings and precautions (5.4)] . synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to synagis [see warnings and precautions (5.1)] . risk summary synagis is not indicated for use in females of reproductive potential. risk summary synagis is not indicated for use in females of reproductive potential. the safety and effectiveness of synagis in children older than 24 months of age at the start of dosing have not been established [see clinical studies (14) ] .

European Union - English - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - ophthalmologicals - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv)

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - dacomitinib (unii: 5092u85g58) (dacomitinib anhydrous - unii:2xjx250c20) - vizimpro is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 19 deletion or exon 21 l858r substitution mutations as detected by an fda-approved test [see dosage and administration (2.1)] . none. risk summary based on findings from animal studies and its mechanism of action, vizimpro can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on vizimpro use in pregnant women. in animal reproduction studies, oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss and reduced fetal body weight at doses resulting in exposures near the exposure at the 45 mg human dose (see data) . the absence of egfr signaling has been shown to result in embryolethality as well as post-natal death in animals (see data) . advise pregnant women of the potential risk to a fetus

United States - English - NLM (National Library of Medicine)

u.s. pharmaceuticals - dacomitinib (unii: 5092u85g58) (dacomitinib anhydrous - unii:2xjx250c20) - vizimpro is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 19 deletion or exon 21 l858r substitution mutations as detected by an fda-approved test [see dosage and administration (2.1)] . none. risk summary based on findings from animal studies and its mechanism of action, vizimpro can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on vizimpro use in pregnant women. in animal reproduction studies, oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss and reduced fetal body weight at doses resulting in exposures near the exposure at the 45 mg human dose (see data) . the absence of egfr signaling has been shown to result in embryolethality as well as post-natal death in animals (see data) . advise pregnant women of the potential risk to a fetus