Sweden· SE-20000922000038
Gadovist 1,0 mmol/ml Injektionsvätska, lösning
A medicinal product containing gadobutrol, registered in Sweden by Bayer AB.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Gadobutrol
- Manufacturer
- Bayer AB
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20000922000038
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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.
- CzechiaGADOBUTROL FMKFARMAK INTERNATIONAL Sp.z.o.o., Varšava
- BelgiumGadovist 1 mmol/mlBayer
- SwitzerlandGadovist 1,0 mmol/ml, InjektionslösungBayer (Schweiz) AG
- SpainGADOBUTROL FARMAK 1 MMOL/ML SOLUCION INYECTABLE EFGIcm Farmak S.L.
- NorwayGadovistBayer AB - Solna
- PolandGadobutrol FarmakFarmak International Sp. z o.o.
- United StatesGadavistBayer HealthCare Pharmaceuticals Inc.
- United KingdomGadobutrol 1mmol/ml solution for injection 10ml pre-filled syringesBayer Plc
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
- 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
- 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 Swedish Medical Products Agency (Sweden). 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/323cb8d7-1f8a-4ba8-9599-2199529c2ad8 GET /v1/drugs/323cb8d7-1f8a-4ba8-9599-2199529c2ad8?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.
{
"source": "lakemedelsverket",
"doc_types": [
"SmPC",
"PL"
],
"se_npl_id": "20000922000038",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20000922000038",
"product_doc_link": "https://docetp.mpa.se/LMF/Gadovist%20solution%20for%20injection%20SmPC_09001bee807a3218.pdf"
}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.