France· FR:66743143
HELICOBACTER TEST INFAI pour les enfants agés de 3 à 11 ans, 45 mg, poudre pour solution buvable
A medicinal product containing urée [13c], registered in France by INFAI & NMR IMAGING (ALLEMAGNE), on the national reimbursement list.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- URÉE [13C]
- Manufacturer
- INFAI & NMR IMAGING (ALLEMAGNE)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cip1334009383086001 pot(s) polystyrène de 45 mg avec kit(s) de diagnostic(s)EUR 22.96
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Urée [13c] in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainHELICOBACTER TEST INFAI PARA LOS NIÑOS DE EDADES COMPRENDIDAS ENTRE 3 Y 11 AÑOS 45 MG POLVO PARA SOLUCION ORALInfai Gmbh
- 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
- SwedenCanoderm 5 % KrämACO Hud Nordic AB
- SwitzerlandCarbamid Crème Widmer
- NorwayCanodermAco Hud Nordic AB
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 Base de données publique des médicaments — BDPM (France). 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/31edebf2-ab53-4882-80de-eb7a3618e5d3 GET /v1/drugs/31edebf2-ab53-4882-80de-eb7a3618e5d3?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.
{
"cis": "66743143",
"date_amm": "2002-10-10",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/97/045",
"substance": "URÉE [13C]",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "poudre pour solution buvable",
"voies_administration": "orale",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about urée [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.