SPINRAZA Solution for injection Ref.[9367] Active ingredients: Nusinersen

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands

Product name and form

Spinraza 12 mg solution for injection.

Pharmaceutical Form

Solution for injection.

Clear and colourless solution with pH of approximately 7.2.

Qualitative and quantitative composition

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
Disodium phosphate
Sodium chloride
Potassium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands

Marketing authorization dates and numbers

EU/1/17/1188/001

Date of first authorisation: 30 May 2017

Drugs

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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