Medicine
Qalsody 100 mg/15 mL injection
Qalsody 100 mg/15 mL injection is a prescription medicine containing Tofersen for intrathecal use, marketed by Biogen, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store refrigerated between 2°C to 8°C (36°F to 46°F) in the original carton to…
Key facts
- Active ingredient (INN)
- Tofersen
- Brand
- Qalsody
- Strength
- 100 mg/15 mL
- Dosage form
- Injection
- Route
- Intrathecal
- Packs
- 1 vial of 15 mL
- Marketing authorisation holder
- Biogen
- Manufacturer
- Biogen
- Origin register
- US FDA, United States
- Storage
- Store refrigerated between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. If no refrigeration is available, QALSODY may be stored in its original carton, protected from light at or below 30°C (86°F) for up to 14 days.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX22 Tofersen
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 April 2023
- Identifiers
- RxCUI 2634999, 2635005DailyMed set ID 81356b45-1cb7-4eef-88ea-e44cc18b47c5NDC 64406-109Application NDA215887
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-use in 1 carton / 15 mL in 1 vial, single-use | 64406-109-01 | Biogen | 25 April 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Tofersen is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 ( SOD1 ) gene. It is available as injection for intrathecal use. MedsAcross supplies Tofersen for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TofersenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- QALSODY prescribing information (Biogen) · U.S. National Library of Medicine, DailyMed
- Qalsody: European public assessment report (EPAR) · European Medicines Agency
Need Qalsody 100 mg/15 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.