Israel - English - Ministry of Health

novartis israel ltd - brolucizumab - solution for injection - brolucizumab 120 mg / 1 ml - brolucizumab - beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (amd).

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

novartis pharmaceuticals australia pty ltd - brolucizumab, quantity: 120 mg/ml - injection, solution - excipient ingredients: water for injections; polysorbate 80; sucrose; sodium citrate - beovu is indicated for the treatment of: ? neovascular (wet) age-related macular degeneration (amd). ? diabetic macular oedema (dme).

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

novartis pharmaceuticals corporation - brolucizumab (unii: xsz53g39h5) (brolucizumab - unii:xsz53g39h5) - beovu® is indicated for the treatment of: beovu is contraindicated in patients with ocular or periocular infections. beovu is contraindicated in patients with active intraocular inflammation. beovu is contraindicated in patients with known hypersensitivity to brolucizumab or any of the excipients in beovu. hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation. risk summary there are no adequate and well-controlled studies of beovu administration in pregnant women. in an animal reproduction study, intravitreal administration of brolucizumab to pregnant monkeys once every 4 weeks in one eye from organogenesis to birth did not indicate any harmful effects with respect to pre- or postnatal development at 10-fold the maximum recommended human dose (mrhd) on a mg/kg basis (see data ). based on the anti-vegf mechanism of action for brolucizumab [see clinical pharmacology (12.1)] , treatment with beovu may pose a risk to human embryo-fetal development. beovu should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. all pregnancies have a background risk of birth defect, loss, and other adverse outcomes. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in an enhanced pre- and postnatal development (eppnd) study in pregnant cynomolgus monkeys, brolucizumab was administered to all animals by intravitreal (ivt) injection to one eye at doses of 3 or 6 mg once every 4 weeks until delivery. there was no impact of ivt administration of brolucizumab on embryo-fetal development, pregnancy or parturition; or on the survival, growth, or postnatal development of offspring at 6 mg/eye (10-fold the mrhd on a mg/kg basis). vegf inhibition has been shown to cause malformations, embryo-fetal resorption, and decreased fetal weight. vegf also has been shown to affect follicular development, corpus luteum function, and fertility. risk summary there is no information regarding the presence of brolucizumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion. because many drugs are transferred in human milk and because of the potential for absorption and adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for at least one month after the last dose when stopping treatment with beovu. contraception females females of reproductive potential should use highly effective contraception (methods that result in less than 1% pregnancy rates) during treatment with beovu and for at least one month after the last dose when stopping treatment with beovu. infertility no studies on the effects of brolucizumab on fertility have been conducted. based on its anti-vegf mechanism of action, treatment with beovu may pose a risk to reproductive capacity. the safety and efficacy of beovu in pediatric patients has not been established. in the two phase 3 clinical studies in amd, approximately 90% (978/1089) of patients randomized to treatment with beovu were ≥ 65 years of age and approximately 60% (648/1089) were ≥ 75 years of age. in the two phase 3 clinical studies in dme, approximately 45% (164/368) of patients randomized to treatment with beovu were ≥ 65 years of age and approximately 10% (37/368) were ≥ 75 years of age. no significant differences in efficacy or safety were seen with increasing age in these studies. no dosage regimen adjustment is required in patients 65 years and above.

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

novartis pharmaceuticals australia pty ltd - brolucizumab, quantity: 120 mg/ml - injection, solution - excipient ingredients: sodium citrate; sucrose; polysorbate 80; water for injections - beovu is indicated for the treatment of: - neovascular (wet) age-related macular degeneration (amd). - diabetic macular oedema (dme)

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - brolucizumab -

European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - brolucizumab - wet macular degeneration - ophthalmologicals - beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (amd).

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

novartis pharma stein ag technical operations schweiz - brolucizumab - solution for injection - 120mg/ml

Canada - English - Health Canada

novartis pharmaceuticals canada inc - brolucizumab - solution - 6mg - brolucizumab 6mg - eent drugs, miscellaneous

Canada - English - Health Canada

novartis pharmaceuticals canada inc - brolucizumab - solution - 6mg - brolucizumab 6mg - eent drugs, miscellaneous

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

novartis pharmaceuticals australia pty ltd - brolucizumab, quantity: 120 mg/ml - injection, solution - excipient ingredients: sodium citrate; sucrose; polysorbate 80; water for injections - vsiqq is indicated for the treatment of: - neovascular (wet) age-related macular degeneration (amd). - diabetic macular oedema (dme).