Belgium· BE-AMP-SAM112743-00
Zaditen 1 mg
A ketotifen product containing ketotifen hydrogen fumarate, registered in Belgium by Alfasigma. The same ATC class is registered in 11 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Ketotifen is registered in 11 of 19 countries.
Countries holding a registration under ATC R06AX17 (ketotifen), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 6 of them publish a price we can compare per daily dose
Ketotifen · ATC R06AX17
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Ireland
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
Price per daily dose
What a daily dose of ketotifen costs, country by country.
Normalised to the WHO defined daily dose (2 mg), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Ketotifen · price per daily dose (2 mg)
USD · FX 28 Sept 2026
- IT Italy$0.20
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Ketotifen Hydrogen Fumarate
- Manufacturer
- Alfasigma
- Country
- Belgium (BE)
- ATC code
- R06AX17
- ATC class
- Ketotifen
- Defined daily dose
- 2 mg, O
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb0099382
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
108 interactions on record for ketotifen.
Graded by severity as the source publishes them — 108 info. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Ketotifen · interactions on record
108 records
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.
- CzechiaKETOTIFEN ALSTADA Arzneimittel AG, Bad Vilbel
- United KingdomKetotifen 1mg capsulesSpecial Order
- FranceZADITEN 1 mg, géluleALFASIGMA (ITALIE)
- NorwayKetotifen stadaStada
- United StatesAlawayBausch & Lomb Incorporated
- NetherlandsAltriabak 0,25 mg/ml, oogdruppels, oplossingLaboratoires Théa
- SpainBENTIFEN 0,25mg/ml COLIRIO EN SOLUCIONLaboratoires Thea
- FinlandBentifenNovartis Healthcare A/S
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/c0e8b6ad-b8e1-4201-838d-c9e9458eec51 GET /v1/drugs/c0e8b6ad-b8e1-4201-838d-c9e9458eec51?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": "Capsule, hard",
"source": "afmps",
"status": "REVOKED",
"name_en": "Zaditen 1 mg",
"name_fr": "Zaditen 1 mg",
"name_nl": "Zaditen 1 mg",
"amp_code": "SAM112743-00",
"strengths": [
"1.3800",
"1.3800",
"1.0000",
"1.0000"
],
"pack_count": 1,
"substances": [
"Ketotifen Hydrogen Fumarate",
"Ketotifen"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Ketotifen",
"authorisation_numbers": [
"BE112743"
]
}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.