Spain· ES:63618
BENTIFEN 0,25mg/ml COLIRIO EN SOLUCION
A medicinal product containing ketotifeno, registered in Spain by Laboratoires Thea.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- ketotifeno
- Manufacturer
- Laboratoires Thea
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo6533045EUR 3.51
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ketotifeno 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.
- GermanyAllergo-Vision SineOmnivision Gmbh
- FinlandBentifenNovartis Healthcare A/S
- NorwayKetazedHorus Pharma
- BelgiumAltriabak 0.25 mg/mlLaboratoires Théa
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
- Finland · Ketazed, Ketotifen Stulln 0,25 Mg/Ml Silmätipat, Liuos
- France · Ketazed, Monoketo
- 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 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/6053a287-5432-4bc2-976f-393f0439fc0e GET /v1/drugs/6053a287-5432-4bc2-976f-393f0439fc0e?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\":980722800000}",
"nregistro": "63618",
"substance": "ketotifeno"
}See everything about ketotifeno.
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.