BYOOVIZ ranibizumab 10 mg/mL solution for injection vial

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 公众评估报告 (PAR)
21-10-2022

有效成分:

Ranibizumab, Quantity: 2.3 mg

可用日期:

Samsung Bioepis AU Pty Ltd

药物剂型:

Injection, solution

组成:

Excipient Ingredients: water for injections; polysorbate 20; trehalose dihydrate; histidine hydrochloride monohydrate; histidine

给药途径:

Intravitreal-Within The Vitreous Cavity Of The Eye

每包单位数:

1

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

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).

產品總結:

Visual Identification: Vial: The solution is clear to slightly opalescent, colourless to pale yellow, sterile and preservative-free.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

授权状态:

Registered

授权日期:

2022-08-24