United States· US:64406-109_cd6631f3-a134-4743-81b1-ede10394e394
QALSODY
A tofersen product containing tofersen, registered in United States by Biogen Inc.. The same ATC class is registered in 11 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Tofersen is registered in 11 of 19 countries.
Countries holding a registration under ATC N07XX22 (tofersen), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 7 of them publish a price we can compare per daily dose
Tofersen · ATC N07XX22
11 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- TOFERSEN
- Manufacturer
- Biogen Inc.
- Country
- United States (US)
- ATC code
- N07XX22
- ATC class
- Tofersen
- Defined daily dose
- 3.57 mg, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1164406109011 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USE
- ndc1164406-109-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tofersen in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumQalsody 100 mgBiogen Netherlands
- SwitzerlandQalsody, Injektionslösung zur intrathekalen AnwendungBiogen Switzerland AG
- CzechiaQALSODYBiogen Netherlands B.V., Badhoevedorp
- SpainQALSODY 100 MG SOLUCIÓN INYECTABLEBiogen Netherlands B.V.
- FinlandQalsodyBiogen Netherlands B.V.
- United KingdomQalsody 100mg/15ml solution for injection vialsBiogen Idec Ltd
- IrelandQalsody 100 mg solution for injectionBiogen Netherlands B.V.
- IcelandQalsodyBiogen Netherlands B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Qalsody
- Liechtenstein · Qalsody
- Norway · Qalsody
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/dd86670e-ddc6-43c0-8404-1eb9f1707f21 GET /v1/drugs/dd86670e-ddc6-43c0-8404-1eb9f1707f21?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRATHECAL",
"source": "ndc",
"strength": "100",
"substance": "TOFERSEN",
"productndc": "64406-109",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/15mL",
"application_number": "NDA215887",
"marketing_category": "NDA"
}See everything about tofersen.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.