Sweden· SE-20000630000221
Zaditen 0,25 mg/ml Ögondroppar, lösning i endosbehållare
A medicinal product containing ketotifen hydrogen fumarate, registered in Sweden by Laboratoires THEA.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Ketotifen Hydrogen Fumarate
- Manufacturer
- Laboratoires THEA
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20000630000221
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ketotifen hydrogen fumarate 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
- CzechiaZADITEN SDULaboratoires Thea, Clermont-Ferrand
- FinlandBentifenNovartis Healthcare A/S
- NetherlandsAltriabak 0,25 mg/ml, oogdruppels, oplossingEuro Registratie Collectief B.V.
- NorwayKetazedHorus Pharma
- PolandKetotifen StullnPharma Stulln GmbH
- FranceKETAZED 0,25 mg/mL, collyre en solutionHORUS PHARMA
- BelgiumAltriabak 0.25 mg/mlPI Pharma
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
- 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
- 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 Swedish Medical Products Agency (Sweden). 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/f56ab579-ea83-49ba-b10a-22cd55351955 GET /v1/drugs/f56ab579-ea83-49ba-b10a-22cd55351955?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.
{
"source": "lakemedelsverket",
"doc_types": [
"SmPC",
"PL"
],
"se_npl_id": "20000630000221",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20000630000221",
"product_doc_link": "https://docetp.mpa.se/LMF/Zaditen%20eye%20drops%2C%20solution%20in%20single%20dose%20containers%20ENG%20SmPC_09001bee807a8485.pdf"
}See everything about ketotifen hydrogen fumarate.
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.