Belgium· BE-AMP-SAM475351-00
Dotagraph 0.5 mmol/ml
A gadotersäure product containing gadoterate meglumine, registered in Belgium by Bayer. The same ATC class is registered in 12 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Gadotersäure is registered in 12 of 19 countries.
Countries holding a registration under ATC V08CA02 (gadotersäure), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 7 of them publish a price we can compare per daily dose
Gadotersäure · ATC V08CA02
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Gadoterate Meglumine
- Manufacturer
- Bayer
- Country
- Belgium (BE)
- ATC code
- V08CA02
- ATC class
- Gadotersäure
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
31 interactions on record for gadotersäure.
Graded by severity as the source publishes them — 31 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
Gadotersäure · interactions on record
31 records
- 31 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
Gadotersäure in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaCLARISCANGE Healthcare AS, Oslo
- United StatesCLARISCANGE Healthcare
- FranceCLARISCAN 0,5 mmol/mL, solution injectableGE HEALTHCARE
- CanadaDOTAREMGUERBET
- GermanyArtiremGuerbet
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Germany · Artirem
- Spain · Dotarem
- Portugal · Dotarem
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/f916302a-36b2-452c-8c5d-4f4f043ca109 GET /v1/drugs/f916302a-36b2-452c-8c5d-4f4f043ca109?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": "Dotagraph 0.5 mmol/ml",
"name_fr": "Dotagraph 0.5 mmol/ml",
"name_nl": "Dotagraph 0.5 mmol/ml",
"amp_code": "SAM475351-00",
"strengths": [
"0.5000",
"279.3200"
],
"pack_count": 2,
"substances": [
"Gadoterate Meglumine",
"Gadoteric Acid"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Gadoteric Acid",
"authorisation_numbers": [
"BE475351"
]
}See everything about gadotersäure.
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.