Canada - English - Health Canada

biogen canada inc - nusinersen (nusinersen sodium) - solution - 2.4mg - nusinersen (nusinersen sodium) 2.4mg - antisense oligonucleotides

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

biogen idec ltd - nusinersen sodium - solution for injection - 2.4mg/1ml

European Union - English - EMA (European Medicines Agency)

biogen netherlands b.v. - nusinersen sodium - muscular atrophy, spinal - other nervous system drugs - spinraza is indicated for the treatment of 5q spinal muscular atrophy.

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

zuellig pharma sdn bhd - nusinersen sodium -

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

biogen - nusinersen (unii: 5z9sp3x666) (nusinersen - unii:5z9sp3x666) - nusinersen 2.4 mg in 1 ml - spinraza is indicated for the treatment of spinal muscular atrophy (sma) in pediatric and adult patients. none. risk summary there are no adequate data on the developmental risk associated with the use of spinraza in pregnant women. when nusinersen was administered by subcutaneous injection to mice throughout pregnancy and lactation, developmental toxicity (long-term neurobehavioral impairment) was observed at all doses tested (see data) . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when nusinersen (0, 3, 10, or 25 mg/kg) was administered subcutaneously to male and female mice every other day prior to and during mating and continuing in females throughout organogenesis, no adverse effects on embryofetal development were observed. subcutaneous administration of nu

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

biogen australia pty ltd - nusinersen heptadecasodium, quantity: 12.6 mg (equivalent: nusinersen, qty 12 mg) - injection, solution - excipient ingredients: calcium chloride dihydrate; sodium hydroxide; water for injections; potassium chloride; sodium chloride; monobasic sodium phosphate dihydrate; hydrochloric acid; dibasic sodium phosphate; magnesium chloride hexahydrate - spinraza is indicated for the treatment of 5q spinal muscular atrophy (sma).

Singapore - English - HSA (Health Sciences Authority)

zuellig pharma pte. ltd. - nusinersen sodium eqv nusinersen - injection, solution - nusinersen sodium eqv nusinersen 12mg/5ml

New Zealand - English - Medsafe (Medicines Safety Authority)

biogen nz biopharma ltd - nusinersen 12mg equivalent to equivalent to 12.6 mg nusinersen heptadecasodium - solution for injection - 12 mg/5ml - active: nusinersen 12mg equivalent to equivalent to 12.6 mg nusinersen heptadecasodium excipient: calcium chloride dihydrate dibasic sodium phosphate hydrochloric acid magnesium chloride hexahydrate monobasic sodium phosphate dihydrate potassium chloride sodium chloride sodium hydroxide water for injection - spinraza is indicated for the treatment of 5q spinal muscular atrophy

Israel - English - Ministry of Health

medison pharma ltd - nusinersen - solution for injection - nusinersen 2.4 mg / 1 ml - spinraza is indicated for the treatment of 5q spinal muscular atrophy except type 0 and type iv.

Israel - English - Ministry of Health

medison pharma ltd - nusinersen - solution for injection - nusinersen 2.4 mg / 1 ml - spinraza is indicated for the treatment of 5q spinal muscular atrophy except type 0 and type iv.