Poland· PL-100491562
Gadobutrol Farmak
A gadobutrol product containing gadobutrolum, registered in Poland by Farmak International Sp. z o.o.. The same ATC class is registered in 16 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
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: Poland, from URPL (Poland)
- 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
The record
At a glance
URPL (Poland)- Active substance
- Gadobutrolum
- Manufacturer
- Farmak International Sp. z o.o.
- Country
- Poland (PL)
- ATC code
- V08CA09
- ATC class
- Gadobutrol
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 12
- gtin05907637916573
- gtin05907637916580
- gtin05907637916597
- gtin05907637916603
- gtin05907637916610
- gtin05907637916627
- gtin05907637916634
- gtin05907637916641
- gtin05907637916658
- gtin05907637916665
- gtin05907637916672
- gtin05907637916689
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.
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
- SwedenGadovist 1,0 mmol/ml Injektionsvätska, lösningBayer AB
- United StatesGadavistBayer HealthCare Pharmaceuticals Inc.
- United KingdomGadobutrol 1mmol/ml solution for injection 10ml pre-filled syringesGE Healthcare Ltd
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
- 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 URPL (Poland). 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/cbb8d781-b0dd-46c9-b794-150b0f12604f GET /v1/drugs/cbb8d781-b0dd-46c9-b794-150b0f12604f?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": "Roztwór do wstrzykiwań",
"source": "urpl",
"strength": "1 mmol/ml",
"packaging": "05907637916573 ¦ Rpz ¦ 164363\n1 fiol. 2 ml\n05907637916580 ¦ Rpz ¦ 164364\n10 fiol. 2 ml\n05907637916597 ¦ Rpz ¦ 164365\n1 fiol. 7,5 ml\n05907637916603 ¦ Rpz ¦ 164366\n10 fiol. 7,5 ml\n05907637916610 ¦ Rpz ¦ 164367\n1 fiol. 10 ml\n05907637916627 ¦ Rpz ¦ 164368\n10 fiol. 10 ml\n05907637916634 ¦ Rpz ¦ 164369\n1 fiol. 15 ml\n05907637916641 ¦ Rpz ¦ 164370\n10 fiol. 15 ml\n05907637916658 ¦ Rpz ¦ 164371\n1 fiol. 30 ml\n05907637916665 ¦ Rpz ¦ 164372\n10 fiol. 30 ml\n05907637916672 ¦ Rpz ¦ 164373\n1 fiol. 65 ml\n05907637916689 ¦ Rpz ¦ 164374\n10 fiol. 65 ml",
"substance": "Gadobutrolum 604.72 mg/ml",
"common_name": "Gadobutrolum",
"pl_product_id": "100491562",
"pozwolenie_nr": "29352",
"auth_procedure": "DCP",
"authorisation_validity": "2030-10-24"
}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.