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Belgium· BE-AMP-SAM485315-00

Ketotifen Bipharma 0.25 mg/ml

A ketotifen product containing ketotifen hydrogen fumarate, registered in Belgium by Bipharma. 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 Bipharma 0.25 mg/mlATCS01GX08REGISTER NO.BE-AMP-SAM485315-00PACKS LISTED0CHECKEDSeptember 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
Bipharma
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 · 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 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/9e52e42e-7148-420a-be9f-149fff91325a
GET /v1/drugs/9e52e42e-7148-420a-be9f-149fff91325a?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": "Eye drops, solution in single-dose container",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Ketotifen Bipharma 0.25 mg/ml",
  "name_fr": "Ketotifen Bipharma 0.25 mg/ml",
  "name_nl": "Ketotifen Bipharma 0.25 mg/ml",
  "amp_code": "SAM485315-00",
  "strengths": [
    "0.3450",
    "0.3450",
    "0.2500",
    "0.2500",
    "21.2500",
    "0.7500"
  ],
  "pack_count": 5,
  "substances": [
    "Ketotifen Hydrogen Fumarate",
    "Ketotifen",
    "Glycerol",
    "Sodium Hydroxide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Ketotifen",
  "authorisation_numbers": [
    "BE485315"
  ]
}
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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