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Belgium· BE-AMP-SAM429161-00

Gadovist 1 mmol/ml

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

ATC V08CA09

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedGadovist 1 mmol/mlATCV08CA09REGISTER NO.BE-AMP-SAM429161-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about gadobutrolAnswers 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Gadobutrol
Manufacturer
Bayer
Country
Belgium (BE)
ATC code
V08CA09
ATC class
Gadobutrol
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    7713472
  • be_apb
    3262912

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
  • 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
  • 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 FAMHP / AFMPS (Belgium). 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/e5545d1b-9882-461d-9ee9-8eb6371e9fa4
GET /v1/drugs/e5545d1b-9882-461d-9ee9-8eb6371e9fa4?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Gadovist 1 mmol/ml",
  "name_fr": "Gadovist 1 mmol/ml",
  "name_nl": "Gadovist 1 mmol/ml",
  "amp_code": "SAM429161-00",
  "strengths": [
    "9.0708",
    "0.0024"
  ],
  "pack_count": 2,
  "substances": [
    "Gadobutrol",
    "Sodium Hydroxide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Gadobutrol",
  "authorisation_numbers": [
    "BE429161"
  ]
}
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