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Netherlands· NL-fa60bf8d2bdb

Qalsody 100 mg oplossing voor injectie

A tofersen product containing tofersen, registered in Netherlands by Biogen Netherlands B.V.. The same ATC class is registered in 11 of our 19 countries.

ATC N07XX22

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedQalsody 100 mg oplossing voor injectieATCN07XX22REGISTER NO.NL-fa60bf8d2bdbPACKS LISTED1CHECKEDSeptember 29, 2026

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: Netherlands, from CBG-MEB (Netherlands)
  • 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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
TOFERSEN
Manufacturer
Biogen Netherlands B.V.
Country
Netherlands (NL)
ATC code
N07XX22
ATC class
Tofersen
Defined daily dose
3.57 mg, P
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/23/1783

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.

All tofersen products

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 CBG-MEB (Netherlands). 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/b91e39de-a1c7-492b-85f7-e788b275179b
GET /v1/drugs/b91e39de-a1c7-492b-85f7-e788b275179b?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.

{
  "form": "Oplossing voor injectie",
  "route": "Intrathecaal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/qalsody-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Tofersen",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp130725",
  "excipients": [
    "CALCIUMCHLORIDE 2-WATER (E 509)",
    "DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339)",
    "KALIUMCHLORIDE (E 508)",
    "MAGNESIUMCHLORIDE 6-WATER (E 511)",
    "NATRIUMCHLORIDE",
    "NATRIUMDIWATERSTOFFOSFAAT 2-WATER (E 339)",
    "WATER VOOR INJECTIE"
  ],
  "substances": [
    "TOFERSEN"
  ],
  "leaflet_url": null,
  "authorised_at": "2024/05/29",
  "procedure_number": "EMEA/H/C/005493",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/23/1783",
  "additional_monitoring": "Y"
}

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.