Poland· PL-100532530

Dawnzera

A drugs used in hereditary angioedema product containing donidalorsen, registered in Poland by Otsuka Pharmaceutical Netherlands B.V.. The same ATC class is registered in 2 of our 19 countries.

ATC B06AC

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedDawnzeraATCB06ACREGISTER NO.PL-100532530PACKS LISTED1CHECKEDSeptember 27, 2026

Where it is registered

Donidalorsen is registered in 2 of 19 countries.

Countries holding a registration under ATC B06AC (drugs used in hereditary angioedema), each read from that country’s own register.

  • This record: Poland, from URPL (Poland)
  • 1 of them publish a price we can compare per daily dose

Donidalorsen · ATC B06AC

2 / 19 countries

  • Denmark
  • Polandprice
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

URPL (Poland)
Active substance
Donidalorsen
Manufacturer
Otsuka Pharmaceutical Netherlands B.V.
Country
Poland (PL)
ATC code
B06AC
ATC class
Drugs used in hereditary angioedema
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 1

  • gtin
    05038256003587

Regulatory notes

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

Same medicine, other countries

Donidalorsen in 5 other countries

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

All donidalorsen 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 URPL (Poland). 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/ad5a1521-d51b-485c-9d57-59445b0fcb6c
GET /v1/drugs/ad5a1521-d51b-485c-9d57-59445b0fcb6c?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": "Roztwór do wstrzykiwań we wstrzykiwaczu",
  "source": "urpl",
  "strength": "80 mg",
  "packaging": "05038256003587 ¦ Rpz ¦ EU/1/25/2001/001 ¦ 165687\n1 wstrzyk. 0,8 ml\nRpz ¦ EU/1/25/2001/002 ¦ 165688\n3 wstrzyk. 0,8 ml",
  "substance": "Donidalorsen 80 mg",
  "common_name": "Donidalorsen",
  "pl_product_id": "100532530",
  "pozwolenie_nr": null,
  "auth_procedure": "CEN",
  "authorisation_validity": null
}

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.