Germany· DE-A57-1f9d33cde5010ac6
Ketotifen Penta Arzneimittel
A medicinal product containing ketotifen hydrogen fumarate, registered in Germany by Penta Arzneimittel Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Ketotifen Hydrogen Fumarate
- Manufacturer
- Penta Arzneimittel Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
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
- 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
- NorwayKetazedHorus Pharma
- FinlandBentifenNovartis Healthcare A/S
- FranceKETAZED 0,25 mg/mL, collyre en solutionHORUS 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
- 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
- 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 EMA Article 57 (European Union). 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/551c0acd-cadf-4796-b50f-f1bf236719e9 GET /v1/drugs/551c0acd-cadf-4796-b50f-f1bf236719e9?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.
{
"pzn": null,
"route": "Ocular Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Ketotifen Hydrogen Fumarate",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.