France· FR:68070293
ZADITEN 1 mg, gélule
A medicinal product containing ketotifène (fumarate de), registered in France by ALFASIGMA (ITALIE), 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
- KETOTIFÈNE (FUMARATE DE)
- Manufacturer
- ALFASIGMA (ITALIE)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 2
2 priced- cip133400932303502plaquette(s) thermoformée(s) PVC-aluminium de 60 gélule(s)EUR 7.84
- cip1334009351585121 flacon(s) en verre brun de 60 gélule(s)EUR 7.84
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ketotifène (fumarate de) in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaKETOTIFEN ALSTADA Arzneimittel AG, Bad Vilbel
- United KingdomKetotifen 1mg capsulesSpecial Order
- BelgiumZaditen 1 mgAlfasigma
- NorwayKetotifen stadaStada
- United StatesAlawayBausch & Lomb Incorporated
- NetherlandsAltriabak 0,25 mg/ml, oogdruppels, oplossingEuro Registratie Collectief B.V.
- SpainBENTIFEN 0,25mg/ml COLIRIO EN SOLUCIONLaboratoires Thea
- FinlandBentifenNovartis Healthcare A/S
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Ketotifen Stulln, Ketotifen Stulln 0,25 Mg/Ml Augentropfen Pharma Stulln
- Belgium · Altriabak, Ketazed
- Bulgaria · Ketotifen Sopharma, Забак
- Cyprus · Meni-Drops, Tenerel
- Czechia · Ketof, Ketotifen Al
- Germany · Allergo-Vision Sine, Ketazed
- Denmark · Ketazed, Zaditen
- Spain · Bentifen, Ketisal
- Finland · Ketazed, Ketotifen Stulln 0,25 Mg/Ml Silmätipat, Liuos
- United Kingdom (Northern Ireland) · Ketazed, Ketofall
- Greece · Cleroptic, K-Drops
- Ireland · Ketofall, Zaditen
- Iceland · Zaditen
- Italy · Brunistill, Chetotifene Mylan Generics
- Luxembourg · Altriabak, Ketazed
- Latvia · Ketotifen
- Netherlands · Altriabak, Ketazed
- Norway · Ketazed, Zaditen
- Poland · Ketotifen Hasco, Ketotifen Stulln
- Portugal · Lidina, Lidinafree
- Romania · Ketazed, Ketof
- Sweden · Bentifen, Ketazed
- Slovenia · Zaditen, Zaditen Sdu
- Slovakia · Denerel, Zaditen
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/3f636334-ec2b-4a92-afd6-c4ff8170545b GET /v1/drugs/3f636334-ec2b-4a92-afd6-c4ff8170545b?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": "68070293",
"date_amm": "1979-07-26",
"type_amm": "Procédure nationale",
"numero_ue": null,
"substance": "KETOTIFÈNE (FUMARATE DE)",
"statut_amm": "Autorisation abrogée",
"statut_bdm": "Warning disponibilité",
"forme_pharmaceutique": "gélule",
"voies_administration": "orale",
"etat_commercialisation": "Non commercialisée",
"surveillance_renforcee": "Non"
}See everything about ketotifène (fumarate de).
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.