France· FR:67926980
ZADITEN L.P. 2 mg, comprimé pelliculé à libération prolongée
A medicinal product containing fumarate de ketotifène, 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
- FUMARATE DE KETOTIFÈNE
- 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 · 1
1 priced- cip133400933692148plaquette(s) thermoformée(s) PVC PVDC aluminium de 30 comprimé(s)EUR 8.92
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fumarate de ketotifène in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesAlawayBausch & Lomb Incorporated
- CzechiaKETOFHexal AG, Holzkirchen
- United KingdomKetofall 0.25mg/ml eye drops 0.4ml unit doseScope Ophthalmics Ltd
- NetherlandsAltriabak 0,25 mg/ml, oogdruppels, oplossingEuro Registratie Collectief B.V.
- SpainBENTIFEN 0,25mg/ml COLIRIO EN SOLUCIONLaboratoires Thea
- FinlandBentifenNovartis Healthcare A/S
- NorwayKetazedHorus Pharma
- GermanyAllergo-Vision SineOmnivision Gmbh
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/95170098-e8d6-430c-aabe-7547d4e6e986 GET /v1/drugs/95170098-e8d6-430c-aabe-7547d4e6e986?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": "67926980",
"date_amm": "1993-12-24",
"type_amm": "Procédure nationale",
"numero_ue": null,
"substance": "FUMARATE DE KETOTIFÈNE",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "comprimé pelliculé à libération prolongée",
"voies_administration": "orale",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about fumarate de ketotifène.
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.