Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

coherus biosciences inc - ranibizumab (unii: zl1r02vt79) (ranibizumab - unii:zl1r02vt79) - cimerli is indicated for the treatment of patients with:           cimerli is contraindicated in patients with ocular or periocular infections. cimerli is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in cimerli. hypersensitivity reactions may manifest as severe intraocular inflammation. risk summary there are no adequate and well-controlled studies of ranibizumab products administered in pregnant women. administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [c max ]) after a single eye treatment at the recommended clinical dose. no skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose [see animal data]

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

biogen inc. - ranibizumab (unii: zl1r02vt79) (ranibizumab - unii:zl1r02vt79) - byooviz is indicated for the treatment of patients with: byooviz is contraindicated in patients with ocular or periocular infections. byooviz is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in byooviz. hypersensitivity reactions may manifest as severe intraocular inflammation. risk summary there are no adequate and well-controlled studies of ranibizumab products administered in pregnant women. administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [cmax ]) after a single eye treatment at the recommended clinical dose. no skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose [see animal data ]. animal reproduction studies are not always predictive of human re

Kanāda - angļu - Health Canada

hoffmann-la roche limited - ranibizumab - solution - 100mg - ranibizumab 100mg

Izraēla - angļu - Ministry of Health

astrazeneca (israel) ltd - palivizumab - solution for injection - palivizumab 100 mg/ml - palivizumab - abbosynagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (rsv) in children at high risk for rsv disease: • children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the rsv season.• children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.• children less than 2 years of age and with haemodynamically significant congenital heart disease.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

samsung bioepis au pty ltd - ranibizumab, quantity: 2.3 mg - injection, solution - excipient ingredients: water for injections; polysorbate 20; trehalose dihydrate; histidine hydrochloride monohydrate; histidine - byooviz (ranibizumab) 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),,- treatment of proliferative diabetic retinopathy (pdr),,- the treatment of visual impairment due to choroidal neovascularisation (cnv),,- the treatment of visual impairment due to choroidal neovascularisation (cnv) secondary to pathologic myopia (pm),,- the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (rvo).

Lielbritānija - angļu - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - ranibizumab - solution for injection - 10mg/1ml

Lielbritānija - angļu - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - ranibizumab - solution for injection - 10mg/1ml

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

abbvie limited - palivizumab 100mg (;+overage = 122mg/vial) - injection with diluent - 100 mg - active: palivizumab 100mg (;+overage = 122mg/vial) excipient: glycine histidine mannitol nitrogen transferrin water for injection - synagis 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 < 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd).

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

abbvie limited - palivizumab 50mg (;+ overage = 73mg/vial) - injection with diluent - 50 mg - active: palivizumab 50mg (;+ overage = 73mg/vial) excipient: glycine histidine mannitol nitrogen water for injection - synagis 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 < 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd).

Eiropas Savienība - angļu - EMA (European Medicines Agency)

novartis europharm limited - ranibizumab - wet macular degeneration; macular edema; diabetes complications; myopia, degenerative; choroidal neovascularization - ophthalmologicals - lucentis is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to choroidal neovascularisation (cnv)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)