SPINRAZA

This brand name is authorized in Austria, Australia, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States

Active ingredients

The drug SPINRAZA contains one active pharmaceutical ingredient (API):

1 Nusinersen UNII 4CHB7QQU1Q - NUSINERSEN SODIUM

Nusinersen is an antisense oligonucleotide (ASO) which increases the proportion of exon 7 inclusion in survival motor neuron 2 (SMN2) messenger ribonucleic acid (mRNA) transcripts by binding to an intronic splice silencing site (ISS-N1) found in intron 7 of the SMN2 pre-messenger ribonucleic acid (pre-mRNA) and hence when SMN2 mRNA is produced, it can be translated into the functional full length SMN protein. SMA is a progressive neuromuscular disease resulting from mutations in chromosome 5q in the SMN1 gene. Gene SMN2, located near SMN1, is responsible for a small amount of SMN protein production. Read about Nusinersen

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SPINRAZA Solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
M09AX07		M Musculo-skeletal system → M09 Other drugs for disorders of the musculo-skeletal system → M09A Other drugs for disorders of the musculo-skeletal system → M09AX Other drugs for disorders of the musculo-skeletal system
Discover more medicines within M09AX07

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11363C, 11378W, 11472T, 11476B, 12176W, 12177X
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 538317110002101
Country: CA	Health Products and Food Branch	Identifier(s): 02465663
Country: EE	Ravimiamet	Identifier(s): 1746536
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171188001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 103330
Country: FR	Base de données publique des médicaments	Identifier(s): 65599882
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 347228
Country: HK	Department of Health Drug Office	Identifier(s): 65896
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8467
Country: IT	Agenzia del Farmaco	Identifier(s): 045426018
Country: JP	医薬品医療機器総合機構	Identifier(s): 1190403A1022
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1083031
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 149055
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 19619
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100391500
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65220001
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699783770389
Country: US	FDA, National Drug Code	Identifier(s): 64406-058