Belgium· BE-AMP-SAM665745-00

Dawnzera 80 mg

A donidalorsen product containing donidalorsen sodium, registered in Belgium by Otsuka Pharmaceutical Netherlands. The same ATC class is registered in 10 of our 19 countries.

ATC B06AC09

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedDawnzera 80 mgATCB06AC09REGISTER NO.BE-AMP-SAM665745-00PACKS LISTED0CHECKEDSeptember 26, 2026

Where it is registered

Donidalorsen is registered in 10 of 19 countries.

Countries holding a registration under ATC B06AC09 (donidalorsen), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 8 of them publish a price we can compare per daily dose

Donidalorsen · ATC B06AC09

10 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Norwayprice
  • Spainprice
  • Switzerlandprice
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Donidalorsen Sodium
Manufacturer
Otsuka Pharmaceutical Netherlands
Country
Belgium (BE)
ATC code
B06AC09
ATC class
Donidalorsen
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FAMHP / AFMPS (Belgium). 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/98e0b17d-8772-445f-b869-8f2e9d97efac
GET /v1/drugs/98e0b17d-8772-445f-b869-8f2e9d97efac?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": "Solution for injection in pre-filled pen",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Dawnzera 80 mg",
  "name_fr": "Dawnzera 80 mg",
  "name_nl": "Dawnzera 80 mg",
  "amp_code": "SAM665745-00",
  "strengths": [
    "80.0000",
    "80.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Donidalorsen Sodium",
    "Donidalorsen",
    "Disodium Hydrogen Phosphate",
    "Sodium Dihydrogen Phosphate Anhydrous",
    "Sodium Chloride",
    "Sodium Hydroxide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Donidalorsen",
  "authorisation_numbers": [
    "EU/1/25/2001/002",
    "EU/1/25/2001/001"
  ]
}

See everything about donidalorsen.

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.