Drug Database
Back to search

Ireland· IE-PA-EU/1/17/1262/001

CRYSVITA 10 mg solution for injection

A burosumab product containing recombinant human igg1 monoclonal antibody to fibroblast growth factor 23, registered in Ireland by Kyowa Kirin Holdings B.V.. The same ATC class is registered in 14 of our 19 countries.

ATC M05BX05

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedCRYSVITA 10 mg solution for injectionATCM05BX05REGISTER NO.IE-PA-EU/1/17/1262/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about recombinant human igg1 monoclonal antibody to fibroblast growth factor 23Answers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Burosumab is registered in 14 of 19 countries.

Countries holding a registration under ATC M05BX05 (burosumab), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 9 of them publish a price we can compare per daily dose
Search burosumab products by name

Burosumab · ATC M05BX05

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • 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

HPRA (Ireland)
Active substance
Recombinant human igg1 monoclonal antibody to fibroblast growth factor 23
Manufacturer
Kyowa Kirin Holdings B.V.
Country
Ireland (IE)
ATC code
M05BX05
ATC class
Burosumab
Defined daily dose
2.5 mg, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/17/1262/001

Regulatory notes

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

Interactions

11 interactions on record for burosumab.

Graded by severity as the source publishes them — 9 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check burosumab against other medicinesHow interaction checks work

Burosumab · interactions on record

11 records

  • 9 severe
  • 2 moderate

Most severe, free to view

  • DihydrotachysterolA11CC02severe
  • CalcitriolA11CC04severe
  • CalcifediolA11CC06severe
  • ParicalcitolA11CC07severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Burosumab in 15 other countries

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

All burosumab products

Authorised across Europe · EMA

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

  • Iceland · Crysvita
  • Liechtenstein · Crysvita
  • Norway · Crysvita

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 HPRA (Ireland). 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/91796f6a-669e-4ea2-ad64-c2daab21ed0e
GET /v1/drugs/91796f6a-669e-4ea2-ad64-c2daab21ed0e?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",
  "routes": [
    "Subcutaneous use"
  ],
  "source": "hpra",
  "atc_all": [
    "M05BX",
    "M05BX05"
  ],
  "strength": null,
  "pa_number": "EU/1/17/1262/001",
  "substances": [
    "Recombinant human igg1 monoclonal antibody to fibroblast growth factor 23"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": null,
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

See everything about burosumab.

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.

Try it freeOpen in the console