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Ireland· IE-PA-PA1410/018/002

Gadovist 1.0 mmol/ml solution for injection in prefilled syringe

A gadobutrol product containing gadobutrol, registered in Ireland by Bayer Limited. The same ATC class is registered in 16 of our 19 countries.

ATC V08CA09

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedGadovist 1.0 mmol/ml solution for inj…ATCV08CA09REGISTER NO.IE-PA-PA1410/018/002PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Gadobutrol is registered in 16 of 19 countries.

Countries holding a registration under ATC V08CA09 (gadobutrol), 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

Gadobutrol · ATC V08CA09

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • 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
Gadobutrol
Manufacturer
Bayer Limited
Country
Ireland (IE)
ATC code
V08CA09
ATC class
Gadobutrol
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA1410/018/002

Regulatory notes

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

Interactions

22 interactions on record for gadobutrol.

Graded by severity as the source publishes them — 22 moderate. 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

Gadobutrol · interactions on record

22 records

  • 22 moderate

Most severe, free to view

  • PindololC07AA03moderate
  • PropranololC07AA05moderate
  • TimololC07AA06moderate
  • SotalolC07AA07moderate
  • 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

Gadobutrol in 15 other countries

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

All gadobutrol products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Gadovist, Pixxoscan
  • Belgium · Gadovist
  • Bulgaria · Гадовист
  • Cyprus · Gadovist
  • Czechia · Gadobutrol Fmk, Gadovist
  • Germany · Gadovist, Gadovistauto
  • Denmark · Gadovist
  • Estonia · Gadovist
  • Spain · Gadobutrol Farmak, Gadovist
  • Finland · Gadovist
  • France · Gadovist, Gadovistauto
  • United Kingdom (Northern Ireland) · Gadobutrol, Gadobutrol Farmak Pharmaceuticals Uk
  • Greece · Gadovist, Pixxoscan
  • Croatia · Gadovist
  • Hungary · Gadovist
  • Iceland · Gadovist
  • Italy · Gadovist, Pixxoscan
  • Lithuania · Gadovist
  • Luxembourg · Gadovist
  • Latvia · Gadovist
  • Malta · Gadovist
  • Netherlands · Gadovist
  • Norway · Gadovist, Pixxoscan
  • Poland · Gadobutrol Farmak, Gadovist
  • Portugal · Gadobutrol, Gadovist
  • Romania · Gadovist
  • Sweden · Gadovist, Pixxoscan
  • Slovenia · Gadovist
  • Slovakia · Gadobutrol Fmk, Gadovist

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/b9f55798-f2df-4d5f-9603-fa8528071f7b
GET /v1/drugs/b9f55798-f2df-4d5f-9603-fa8528071f7b?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 syringe",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "V08CA",
    "V08CA09"
  ],
  "strength": null,
  "pa_number": "PA1410/018/002",
  "substances": [
    "Gadobutrol"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "20/04/2001",
  "dispensing_status": "Product subject to Restricted Prescription (C)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about gadobutrol.

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.