Canada - English - Health Canada

isologic innovative radiopharmaceuticals ltd. - florbetaben (18f) - solution - 5000mbq - florbetaben (18f) 5000mbq - radioactive agents

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

life molecular imaging, ltd - florbetaben f-18 (unii: tla7312toi) (florbetaben f-18 - unii:tla7312toi) - florbetaben f-18 135 mci in 1 ml - neuraceq 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 neuraceq scan indicates sparse to no amyloid 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 neuraceq 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 older people with normal cognition. neuraceq is an adjunct to other diagnostic evaluations. limitations of use • a positive neuraceq scan does not establish the diagnosis of ad or any other cognitive disorder. • safety and effectiveness of neuraceq have not been established for:    o predicting development of dementia or other neurologic conditions;    o monitoring responses to therapies. none risk summary there are no available data on neuraceq use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.  animal reproduction studies have not been conducted with neuraceq. all radiopharmaceuticals, including neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. if considering neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.  all pregnancies have a background risk of birth defect, loss, or other adverse outcomes.  in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data on the presence of florbetaben f 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben f 18 injection on milk production. exposure of neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding [see clinical considerations ]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for neuraceq and any potential adverse effects on the breastfed child from neuraceq or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of neuraceq. neuraceq is not indicated for use in pediatric patients. of the 872 subjects in clinical studies of neuraceq, 603 (69%) were 65 years or over, while 304 (35%) were 75 years or over. no overall differences in safety were observed between these subjects and younger subjects.

European Union - English - EMA (European Medicines Agency)

life molecular imaging gmbh - florbetaben (18f) - radionuclide imaging; alzheimer disease - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.neuraceq is a radiopharmaceutical indicated for positron emission tomography (pet) imaging of β amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for alzheimer’s disease (ad) and other causes of cognitive impairment. neuraceq should be used in conjunction with a clinical evaluation.a negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of ad.

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

eli lilly and company - florbetapir f-18 (unii: 6w15z5r0ru) (florbetapir f-18 - unii:6w15z5r0ru) - florbetapir f-18 51 mci in 1 ml - amyvid 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 amyvid 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 amyvid 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 older people with normal cognition. amyvid is an adjunct to other diagnostic evaluations. limitations of use: - a positive amyvid scan does not establish a diagnosis of ad or other cognitive disorder. - safety and effectivenes

European Union - English - EMA (European Medicines Agency)

eli lilly nederland b.v. - florbetapir (18f) - radionuclide imaging - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.amyvid is a radiopharmaceutical indicated for positron emission tomography (pet) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for alzheimer’s disease (ad) and other causes of cognitive impairment. amyvid should be used in conjunction with a clinical evaluation.a negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of ad.

India - English - Central Drugs Standard Control Organization

alkem(bergen) - clobetasol propionate,fusidic acid - crm - 0.05,2;%w/w - 10

India - English - Central Drugs Standard Control Organization

alkem - clobetasol propionate,miconazole nit. - crm - 0.05,2;%;w/w - 15g

Israel - English - Ministry of Health

m.p.vet ltd - florfenicol - solution for injection - florfenicol 300 mg/ml - cattle:treatment of bovine respiratory disease (brd) associated with pasteurella, haemolytica, paasteurella multocida and haemophilus somnus.sheep:treatment of ovine respiratory tract infections due to mannheimia haemolytica and pasteurella multocida susceptible to florfenicol.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

florfenicol - solution for injection - 300 mg/ml

India - English - Central Drugs Standard Control Organization

alkem - clobetasol propionate - crm - 0.05%w/w - 15g