Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
Spinraza 12 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear and colourless solution with pH of approximately 7.2. |
Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Each ml contains 2.4 mg of nusinersen.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Nusinersen |
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. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate dihydrate |
5 ml in a Type I glass vial with bromobutyl rubber stopper and an aluminium over-seal and plastic cap.
Pack size of one vial per carton.
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
EU/1/17/1188/001
Date of first authorisation: 30 May 2017
| Drug | Countries | |
|---|---|---|
| SPINRAZA | 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 |
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