Spain· ES:97045001
HELICOBACTER TEST INFAI 75 mg POLVO PARA SOLUCION ORAL
A medicinal product containing urea(13c), registered in Spain by Infai Gmbh.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- urea(13C)
- Manufacturer
- Infai Gmbh
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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.
Same medicine, other countries
Urea(13c) in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceHELICOBACTER TEST INFAI, 75 mg poudre pour solution buvableINFAI & NMR IMAGING (ALLEMAGNE)
- PolandHelicobacter Test INFAIINFAI GmbH
- 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
- NorwayCanodermAco Hud Nordic AB
Authorised across Europe · EMA
The same active substance is authorised in 9 EEA countries. Names it is sold under:
- Austria · Keratosis
- Czechia · Excipial U Hydrolotio, Excipial U Lipolotio
- Germany · Balisa, Basodexan
- Denmark · Canoderm
- Estonia · Linola
- 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 AEMPS CIMA (Spain). 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/b164f362-7ce7-486e-9247-2627630a3556 GET /v1/drugs/b164f362-7ce7-486e-9247-2627630a3556?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":886287600000}",
"nregistro": "97045001",
"substance": "urea(13C)"
}See everything about urea(13c).
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.