Czechia· CZ-0214819

ZADITEN SDU

A ketotifen product containing ketotifen hydrogen fumarate, registered in Czechia by Laboratoires Thea, Clermont-Ferrand. The same ATC class is registered in 13 of our 19 countries.

ATC S01GX08

Checked against SÚKL (Czech Republic) on

Informational only — not a medical device.

SOURCE REGISTER · CZSÚKL (Czech Republic)normalisedZADITEN SDUATCS01GX08REGISTER NO.CZ-0214819PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Ketotifen is registered in 13 of 19 countries.

Countries holding a registration under ATC S01GX08 (ketotifen), each read from that country’s own register.

  • This record: Czechia, from SÚKL (Czech Republic)
  • 8 of them publish a price we can compare per daily dose

Ketotifen · ATC S01GX08

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

SÚKL (Czech Republic)
Active substance
KETOTIFEN HYDROGEN FUMARATE
Manufacturer
Laboratoires Thea, Clermont-Ferrand
Country
Czechia (CZ)
ATC code
S01GX08
ATC class
Ketotifen
Reimbursed
Not published by this register
Source register
SÚKL (Czech Republic)
Last checked
September 28, 2026

Packs & prices · 1

1 priced
  • cz_kod_sukl
    0214819
    30X0,4ML II
    CZK 304.39

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Ketotifen in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All ketotifen products

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
  • 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
  • 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 SÚKL (Czech Republic). 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/ff49078c-324a-4b3e-8905-4a272c968e86
GET /v1/drugs/ff49078c-324a-4b3e-8905-4a272c968e86?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.

{
  "form": "OPH GTT SOL MDC",
  "source": "sukl",
  "strength": "0,25MG/ML",
  "pack_size": "30X0,4ML II",
  "substance": "KETOTIFEN HYDROGEN FUMARATE",
  "cz_kod_sukl": "0214819",
  "product_type": "CH",
  "substance_codes": "9905",
  "registration_state": "R",
  "registration_number": "64/212/05-C"
}

See everything about ketotifen.

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.