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Netherlands· NL-86733d2a5be7

Dawnzera 80 mg oplossing voor injectie in een voorgevulde pen

A medicinal product containing donidalorsen natrium, registered in Netherlands by Otsuka Pharmaceutical Netherlands B.V..

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedDawnzera 80 mg oplossing voor injecti…ATC—REGISTER NO.NL-86733d2a5be7PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about donidalorsen natriumAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

CBG-MEB (Netherlands)
Active substance
DONIDALORSEN NATRIUM
Manufacturer
Otsuka Pharmaceutical Netherlands B.V.
Country
Netherlands (NL)
ATC code
—
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/25/2001

Regulatory notes

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

Same medicine, other countries

Donidalorsen natrium in 5 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All donidalorsen natrium products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Dawnzera
  • Liechtenstein · Dawnzera
  • Norway · Dawnzera

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/a46d2786-904f-4320-9059-e3a68219bd84
GET /v1/drugs/a46d2786-904f-4320-9059-e3a68219bd84?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": "Subcutaan gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/dawnzera-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": null,
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp134384",
  "excipients": [
    "DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339)",
    "NATRIUMCHLORIDE",
    "NATRIUMDIWATERSTOFFOSFAAT 2-WATER (E 339)",
    "NATRIUMHYDROXIDE (E 524)",
    "WATER VOOR INJECTIE",
    "ZOUTZUUR (E 507)"
  ],
  "substances": [
    "DONIDALORSEN NATRIUM"
  ],
  "leaflet_url": null,
  "authorised_at": "2026/01/19",
  "procedure_number": "EMEA/H/C/006554",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/25/2001",
  "additional_monitoring": "Y"
}
API referenceMCP serverPlans

See everything about donidalorsen natrium.

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.

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