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Belgium· BE-AMP-SAM185622-00

Mizollen 10 mg

A mizolastine product containing mizolastine, registered in Belgium by Opella Healthcare Belgium. The same ATC class is registered in 7 of our 19 countries.

ATC R06AX25

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedMizollen 10 mgATCR06AX25REGISTER NO.BE-AMP-SAM185622-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about mizolastineAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Mizolastine is registered in 7 of 19 countries.

Countries holding a registration under ATC R06AX25 (mizolastine), each read from that country’s own register.

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

Mizolastine · ATC R06AX25

7 / 19 countries

  • Belgiumprice
  • Finlandprice
  • Franceprice
  • Germany
  • Italyprice
  • Netherlands
  • 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 mizolastine costs, country by country.

Normalised to the WHO defined daily dose (10 mg), the median price runs from $0.31 in France to $0.55 in Spain — a ×1.8 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

Mizolastine · price per daily dose (10 mg)

USD · FX 28 Sept 2026

  • ES Spain$0.55
  • IT Italy$0.42
  • FR France$0.31
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
Mizolastine
Manufacturer
Opella Healthcare Belgium
Country
Belgium (BE)
ATC code
R06AX25
ATC class
Mizolastine
Defined daily dose
10 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    1344076
  • be_apb
    0760322

Regulatory notes

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

Same medicine, other countries

Mizolastine in 7 other countries

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

All mizolastine products

Authorised across Europe · EMA

The same active substance is authorised in 5 EEA countries. Names it is sold under:

  • Germany · Mizollen
  • France · Mizocler, Mizollen
  • Greece · Oriens
  • Italy · Mizollen, Zolistam
  • Netherlands · Mizollen

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/f8185d2d-3576-4e3f-b347-4c809f11780f
GET /v1/drugs/f8185d2d-3576-4e3f-b347-4c809f11780f?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": "Modified-release tablet",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Mizollen 10 mg",
  "name_fr": "Mizollen 10 mg",
  "name_nl": "Mizollen 10 mg",
  "amp_code": "SAM185622-00",
  "strengths": [
    "10.0000",
    "10.0000",
    "10.0000",
    "125.0000",
    "0.4500"
  ],
  "pack_count": 24,
  "substances": [
    "Mizolastine",
    "Lactose Monohydrate",
    "Propylene Glycol"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Mizolastine",
  "authorisation_numbers": [
    "BE185622",
    "BE380046",
    "BE380055"
  ]
}
API referenceMCP serverPlans

See everything about mizolastine.

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.

Try it freeOpen in the console