Qalsody
- Prescription status not stated
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Tofersen
- Made by
- Biogen Netherlands B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (QALSODY). It describes the substance, not this exact product.
Tofersen is an antisense oligonucleotide that causes degradation of SOD1 mRNA through binding to SOD1 mRNA, which results in a reduction of SOD1 protein synthesis.
Tofersen is expected to be metabolized through exonuclease (3'- and 5')-mediated hydrolysis and is not a substrate for, or inhibitor or inducer of CYP450 enzymes.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-11-13
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Biogen Netherlands B.V. |
|---|---|
| Active substance | Tofersen |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Classification | N07XX22 · Pain, sleep, mood, epilepsy and the brain |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2024-05-29 |
| Last updated by the regulator | 2026-06-23 |
| EMA product number | EMEA/H/C/005493 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).