SPINRAZA

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

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 more about Nusinersen

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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