Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
Qalsody 100 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear and colourless to slightly yellow solution with a pH of 6.7 to 7.7. |
Each 15 ml vial contains 100 mg of tofersen.
Each ml contains 6.7 mg of tofersen.
Excipient with known effect: Each 15 ml vial contains 52 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tofersen |
SOD1-ALS is a primarily autosomal-dominant disorder affecting approximately 2% of the ALS population. Mutations in the SOD1 gene lead to accumulation of a toxic form of SOD1 protein. Tofersen is an antisense oligonucleotide (ASO) that is complementary to a portion of the 3′ untranslated region (3′UTR) of the mRNA for human SOD1 and binds to the mRNA by Watson-Crick base pairing (hybridisation). This hybridisation of tofersen to the cognate mRNA results in RNase-Hmediated degradation of the mRNA for SOD1, which reduces the amount of SOD1 protein synthesis. |
| List of Excipients |
|---|
|
Disodium phosphate |
20 ml clear Type I glass vial with chlorobutyl rubber stopper and an aluminium overseal with flip-off plastic button.
Qalsody is available in a pack of 1 vial.
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
EU/1/23/1783/001
| Drug | Countries | |
|---|---|---|
| QALSODY | United States |
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