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Netherlands· NL-ae8e2573b636

Pyrukynd 100 mg, filmomhulde tabletten

A mitapivat product containing mitapivat 0,5-sulfaat 1,5-water, registered in Netherlands by Agios Netherlands B.V.. The same ATC class is registered in 11 of our 19 countries.

ATC B06AX04

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedPyrukynd 100 mg, filmomhulde tablettenATCB06AX04REGISTER NO.NL-ae8e2573b636PACKS LISTED1CHECKEDSeptember 29, 2026

Where it is registered

Mitapivat is registered in 11 of 19 countries.

Countries holding a registration under ATC B06AX04 (mitapivat), 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

Mitapivat · ATC B06AX04

11 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
  • Spainprice
  • 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
MITAPIVAT 0,5-SULFAAT 1,5-WATER
Manufacturer
Agios Netherlands B.V.
Country
Netherlands (NL)
ATC code
B06AX04
ATC class
Mitapivat
Defined daily dose
0.1 g, O
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/22/1662

Regulatory notes

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

Same medicine, other countries

Mitapivat in 10 other countries

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

All mitapivat products

Authorised across Europe · EMA

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

  • Iceland · Pyrukynd
  • Liechtenstein · Pyrukynd
  • Norway · Pyrukynd

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/8d43710d-8157-4d5f-b90d-4ada2e2d48ce
GET /v1/drugs/8d43710d-8157-4d5f-b90d-4ada2e2d48ce?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": "Filmomhulde tablet",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/pyrukynd-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Mitapivat",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp134350",
  "excipients": [
    "BLAUWE INKT",
    "BRILJANTBLAUW FCF ALUMINIUMLAK (E133)",
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "CROSCARMELLOSE  NATRIUM  (E 468)",
    "GLYCEROLTRIACETAAT (E 1518)",
    "HYPROMELLOSE (E 464)",
    "INDIGOKARMIJN ALUMINIUMLAK (E 132)",
    "LACTOSE 1-WATER",
    "MACROGOL",
    "MANNITOL (D-) (E 421)",
    "NATRIUMSTEARYLFUMARAAT",
    "SCHELLAK GLAZE, GEDEELTELIJK VERESTERD",
    "TITAANDIOXIDE (E 171)",
    "TITAANDIOXIDE (E 171)"
  ],
  "substances": [
    "MITAPIVAT 0,5-SULFAAT 1,5-WATER"
  ],
  "leaflet_url": null,
  "authorised_at": "2022/11/09",
  "procedure_number": "EMEA/H/C/005540",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/22/1662",
  "additional_monitoring": "Y"
}

See everything about mitapivat.

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.