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Czechia· CZ-0277984

GADOBUTROL FMK

A gadobutrol product containing gadobutrol monohydrate, registered in Czechia by FARMAK INTERNATIONAL Sp.z.o.o., Varšava. The same ATC class is registered in 16 of our 19 countries.

ATC V08CA09

Checked against SÚKL (Czech Republic) on

Informational only — not a medical device.

SOURCE REGISTER · CZSÚKL (Czech Republic)normalisedGADOBUTROL FMKATCV08CA09REGISTER NO.CZ-0277984PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about gadobutrol monohydrateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Czechia, from SÚKL (Czech Republic)
  • 9 of them publish a price we can compare per daily dose
Search gadobutrol products by name

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

SÚKL (Czech Republic)
Active substance
GADOBUTROL MONOHYDRATE
Manufacturer
FARMAK INTERNATIONAL Sp.z.o.o., Varšava
Country
Czechia (CZ)
ATC code
V08CA09
ATC class
Gadobutrol
Reimbursed
Not published by this register
Source register
SÚKL (Czech Republic)
Last checked
September 28, 2026

Packs & prices · 1

1 priced
  • cz_kod_sukl
    0277984
    1X30ML
    CZK 3688.8

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
Check gadobutrol against other medicinesHow interaction checks work

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
  • 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
  • Ireland · 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 SÚKL (Czech Republic). 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/060c30ee-8360-4eef-8a0b-9919d7bb5f80
GET /v1/drugs/060c30ee-8360-4eef-8a0b-9919d7bb5f80?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": "INJ SOL",
  "source": "sukl",
  "strength": "1MMOL/ML",
  "pack_size": "1X30ML",
  "substance": "GADOBUTROL MONOHYDRATE",
  "cz_kod_sukl": "0277984",
  "product_type": "CH",
  "substance_codes": "21267",
  "registration_state": "R",
  "registration_number": "48/523/23-C"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console