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Belgium· BE-AMP-SAM239477-00

Betahistine Apotex 16 mg

A betahistine product containing betahistine dihydrochloride, registered in Belgium by Apotex. The same ATC class is registered in 17 of our 19 countries.

ATC N07CA01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedBetahistine Apotex 16 mgATCN07CA01REGISTER NO.BE-AMP-SAM239477-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about betahistine dihydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Betahistine is registered in 17 of 19 countries.

Countries holding a registration under ATC N07CA01 (betahistine), each read from that country’s own register.

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

Betahistine · ATC N07CA01

17 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
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.

Price per daily dose

What a daily dose of betahistine costs, country by country.

Normalised to the WHO defined daily dose (24 mg), the median price runs from $0.11 in France to $0.44 in Switzerland — a ×4.0 gap.

  • 3 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Betahistine · price per daily dose (24 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$0.44
  • ES Spain$0.16
  • FR France$0.11
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Betahistine Dihydrochloride
Manufacturer
Apotex
Country
Belgium (BE)
ATC code
N07CA01
ATC class
Betahistine
Defined daily dose
24 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    1697010
  • be_apb
    0773556

Regulatory notes

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

Same medicine, other countries

Betahistine in 14 other countries

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

All betahistine products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Betahistin Accord, Betahistin Ratiopharm
  • Bulgaria · Бетасерк, Бетастад
  • Cyprus · Alfinor, Antivom
  • Czechia · Betahistin Accord, Betahistin Actavis
  • Germany · Betahistin Al, Betahistin Ratiopharm
  • Denmark · Betahistin 2care4, Betahistin Orifarm Generics
  • Estonia · Betahistine Accord, Betahistine Actavis
  • Spain · Betahistina Accord, Betahistina Aurovitas
  • Finland · Betahistin Mylan, Betahistin Orifarm Generics
  • France · Betahistine, Betahistine Accord
  • United Kingdom (Northern Ireland) · Betahistine, Betahistine Dihydrochloride
  • Greece · Antivom, Betaserc
  • Croatia · Betaserc, Urutal
  • Hungary · Betagen, Betahistin Ratiopharm
  • Ireland · Betahistine Dihydrochloride Accord Healthcare Ireland, Betahistine Dihydrochloride Azure Pharmaceuticals
  • Iceland · Menisy
  • Italy · Averbet, Betaistina Accord
  • Lithuania · Betahistine Accord, Betahistine Actavis
  • Luxembourg · Betahistine Eurogenerics, Betahistine Viatris
  • Latvia · Betahistine Accord, Betahistine Actavis
  • Malta · Betahistine Aurobindo Pharma (Malta), Betaserc
  • Netherlands · Betahistine 2hcl Accord, Betahistine 2hcl Adoh
  • Poland · Apobetina, Aurobetina
  • Portugal · Beta-Histina Aurobindo, Beta-Histina Aurovitas
  • Romania · Betahistină Atb, Betahistină Gemax Pharma
  • Sweden · Betahistin 2care4, Betahistine Stada
  • Slovenia · Betahistin Accord, Betaserc
  • Slovakia · Betahistin Actavis, Betahistin Viatris

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/18e260dd-7108-4afa-941c-b797c063c2cf
GET /v1/drugs/18e260dd-7108-4afa-941c-b797c063c2cf?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": "Tablet",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Betahistine Apotex 16 mg",
  "name_fr": "Betahistine Apotex 16 mg",
  "name_nl": "Betahistine Apotex 16 mg",
  "amp_code": "SAM239477-00",
  "strengths": [
    "16.0000",
    "16.0000",
    "140.0000"
  ],
  "pack_count": 5,
  "substances": [
    "Betahistine Dihydrochloride",
    "Lactose Monohydrate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Betahistine",
  "authorisation_numbers": [
    "BE239477"
  ]
}
API referenceMCP serverPlans

See everything about betahistine.

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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