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Belgium· BE-AMP-SAM193471-00

Ketotifen Teva 1 mg/5 ml

A ketotifen product containing ketotifen hydrogen fumarate, registered in Belgium by Teva. The same ATC class is registered in 13 of our 19 countries.

ATC S01GX08

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedKetotifen Teva 1 mg/5 mlATCS01GX08REGISTER NO.BE-AMP-SAM193471-00PACKS LISTED1CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ketotifen hydrogen fumarateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 8 of them publish a price we can compare per daily dose
Search ketotifen products by name

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

FAMHP / AFMPS (Belgium)
Active substance
Ketotifen Hydrogen Fumarate
Manufacturer
Teva
Country
Belgium (BE)
ATC code
S01GX08
ATC class
Ketotifen
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    1434505

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
  • 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
  • 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 FAMHP / AFMPS (Belgium). 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/1032132f-2e85-4b6b-ba58-e4d5e77b34b1
GET /v1/drugs/1032132f-2e85-4b6b-ba58-e4d5e77b34b1?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": "Syrup",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Ketotifen Teva 1 mg/5 ml",
  "name_fr": "Ketotifen Teva 1 mg/5 ml",
  "name_nl": "Ketotifen Teva 1 mg/5 ml",
  "amp_code": "SAM193471-00",
  "strengths": [
    "0.2760",
    "0.2760",
    "0.2010",
    "0.2010",
    "4.0000",
    "4.0000",
    "20.0000",
    "20.0000",
    "0.3330",
    "0.3330",
    "0.1670",
    "0.1670"
  ],
  "pack_count": 1,
  "substances": [
    "Ketotifen Hydrogen Fumarate",
    "Ketotifen",
    "Disodium Hydrogen Phosphate",
    "Ethanol",
    "Methyl Parahydroxybenzoate",
    "Propyl Parahydroxybenzoate",
    "Sorbitol"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Ketotifen",
  "authorisation_numbers": [
    "BE193471"
  ]
}
API referenceMCP serverPlans

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.

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