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

spark therapeutics, inc. - voretigene neparvovec (unii: 2spi046ikd) (voretigene neparvovec - unii:2spi046ikd) - voretigene neparvovec 0.05 mg - luxturna (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic rpe65 mutation-associated retinal dystrophy. patients must have viable retinal cells as determined by the treating physician(s). none. risk summary adequate and well-controlled studies with luxturna have not been conducted in pregnant women. animal reproductive studies have not been conducted with luxturna. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of luxturna in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for luxturna and any potential adverse effects on the breastfed infant from luxturna. no nonclinical or clinica

Israel - English - Ministry of Health

novartis israel ltd - voretigene neparvovec - concentrate and solvent for solution for injection - voretigene neparvovec 5x10^12 vector genomes/ml - luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic rpe65 mutations and who have sufficient viable retinal cells.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic rpe65 mutations and who have sufficient viable retinal cells.

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

novartis pharmaceuticals australia pty ltd - voretigene neparvovec, quantity: 1 dna - injection, concentrated - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; sodium chloride; poloxalene - luxturna is indicated for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic rpe65 mutations and who have sufficient viable retinal cells as determined by the treating physician.,pathological mutations of rpe65 should be confirmed by a national association of testing authorities (nata) or international laboratory accreditation cooperation (ilac) accredited laboratory.

Canada - English - Health Canada

novartis pharmaceuticals canada inc - voretigene neparvovec - solution - 5000000000000vg - voretigene neparvovec 5000000000000vg - cellular and gene therapy

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

novartis europharm limited, ireland - voretigene neparvovec - concentrate and solvent for solution for injection - 5*10^12 vg/ml,

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - voretigene neparvovec 0.05 mg/ml equivalent to 5 x 10^12 vector genomes per ml - concentrate for injection with diluent - active: voretigene neparvovec 0.05 mg/ml equivalent to 5 x 10^12 vector genomes per ml excipient: dibasic sodium phosphate monobasic sodium phosphate poloxamer 188 sodium chloride water for injection dibasic sodium phosphate monobasic sodium phosphate poloxamer 188 sodium chloride water for injection - luxturna is indicated for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic rpe65 mutations and who have sufficient viable retinal cells as determined by the treating physician. pathological mutations of rpe65 should be confirmed by a national association of testing authorities (nata) laboratory, international laboratory accreditation cooperation (ilac) laboratory, or a laboratory demonstrating equivalent accreditation.

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

msn laboratories private limited - toremifene citrate (unii: 2498y783qt) (toremifene - unii:7nfe54o27t) - toremifene citrate tablets are estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. toremifene citrate is contraindicated in patients with known hypersensitivity to the drug. toremifene should not be prescribed to patients with congenital/acquired qt prolongation (long qt syndrome), uncorrected hypokalemia, or uncorrected hypomagnesemia. pregnancy category d [see warnings and precautions (5.6).] based on its mechanism of action in humans and findings of increased pregnancy loss and fetal malformation in animal studies, toremifene citrate can cause fetal harm when administered to a pregnant woman. toremifene caused embryo-fetal toxicities at maternal doses that were lower than the 60 mg daily recommended human dose on a mg/m2 basis. there are no adequate and well-controlled studies in pregnant women using toremifene citrate. if this drug is used during pregnancy, or if the patient becomes pregnant whi

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

novadoz pharmaceuticals llc - toremifene citrate (unii: 2498y783qt) (toremifene - unii:7nfe54o27t) - toremifene citrate tablets are estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. toremifene citrate is contraindicated in patients with known hypersensitivity to the drug. toremifene should not be prescribed to patients with congenital/acquired qt prolongation (long qt syndrome), uncorrected hypokalemia, or uncorrected hypomagnesemia. pregnancy category d [see warnings and precautions (5.6).] based on its mechanism of action in humans and findings of increased pregnancy loss and fetal malformation in animal studies, toremifene citrate can cause fetal harm when administered to a pregnant woman. toremifene caused embryo-fetal toxicities at maternal doses that were lower than the 60 mg daily recommended human dose on a mg/m2 basis. there are no adequate and well-controlled studies in pregnant women using toremifene citrate. if this drug is used during pregnancy, or if the patient becomes pregnant whi

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

rising pharmaceuticals, inc. - toremifene citrate (unii: 2498y783qt) (toremifene - unii:7nfe54o27t) - toremifene citrate tablets are an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. toremifene citrate tablets are contraindicated in patients with known hypersensitivity to the drug. toremifene should not be prescribed to patients with congenital/acquired qt prolongation (long qt syndrome), uncorrected hypokalemia, or uncorrected hypomagnesemia. pregnancy category d [see warnings and precautions (5.6)] based on its mechanism of action in humans and findings of increased pregnancy loss and fetal malformation in animal studies, toremifene citrate tablets can cause fetal harm when administered to a pregnant woman. toremifene caused embryo-fetal toxicities at maternal doses that were lower than the 60 mg daily recommended human dose on a mg/m2 basis. there are no adequate and well-controlled studies in pregnant women using toremifene citrate tablets. if this drug is used during pregnancy, or if the patie