Belgium· BE-AMP-SAM541724-00
Espikur 50 mg
A 13c-urea product containing urea (13c isotope), registered in Belgium by Laboratoires Mayoly Spindler. The same ATC class is registered in 8 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
13c-urea is registered in 8 of 19 countries.
Countries holding a registration under ATC V04CX05 (13c-urea), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 5 of them publish a price we can compare per daily dose
13c-urea · ATC V04CX05
8 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Netherlands
- Norwayprice
- Switzerlandprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Urea (13C Isotope)
- Manufacturer
- Laboratoires Mayoly Spindler
- Country
- Belgium (BE)
- ATC code
- V04CX05
- ATC class
- 13C-urea
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
- be_apb4967469
- be_apb4230066
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
59 interactions on record for 13c-urea.
Graded by severity as the source publishes them — 58 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
13c-urea · interactions on record
59 records
- 58 moderate
- 1 minor
Most severe, free to view
- Magnesium hydroxideA02AA04moderate
- Kombinationen von AluminiumsalzenA02AB10moderate
- Liquid paraffinA06AA01moderate
- BisacodylA06AB02moderate
- 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
13c-urea in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesAVENASTER FUNGAL NAIL CARE DUO SET (DAY)Jiangxi Yudexi Pharmaceutical Co., LTD
- United KingdomAAA 10% Urea creamTriOn Pharma Ltd
- GermanyBalisaAbanta Pharma Gmbh
- SwitzerlandCarbamid Crème Widmer
- SwedenCanoderm 5 % KrämACO Hud Nordic AB
- SpainESPIKUR 50 MG COMPRIMIDOSLaboratoires Mayoly Spindler
- NorwayCanodermAco Hud Nordic AB
- FranceHELICOBACTER TEST INFAI pour les enfants agés de 3 à 11 ans, 45 mg, poudre pour solution buvableINFAI & NMR IMAGING (ALLEMAGNE)
Authorised across Europe · EMA
The same active substance is authorised in 10 EEA countries. Names it is sold under:
- Austria · Keratosis
- Czechia · Excipial U Hydrolotio, Excipial U Lipolotio
- Germany · Balisa, Basodexan
- Denmark · Canoderm
- Estonia · Linola
- Spain · Urea Nm
- Norway · Canoderm, Curemid
- Sweden · Canoderm, Curemid
- Slovenia · Linola
- Slovakia · Excipial U Hydrolotio, Excipial U Lipolotio
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/17501f60-d7ae-4c82-9dbe-1cdd7e5d7adc GET /v1/drugs/17501f60-d7ae-4c82-9dbe-1cdd7e5d7adc?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": "Tablet",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Espikur 50 mg",
"name_fr": "Espikur 50 mg",
"name_nl": "Espikur 50 mg",
"amp_code": "SAM541724-00",
"strengths": [
"50.0000"
],
"pack_count": 2,
"substances": [
"Urea (13C Isotope)"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "13C-urea",
"authorisation_numbers": [
"BE541724"
]
}See everything about 13c-urea.
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.