Poland· PL-100452244

Bilaxten

A medicinal product containing bilastinum, registered in Poland by Menarini International Operations Luxembourg S.A..

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedBilaxtenATC—REGISTER NO.PL-100452244PACKS LISTED1CHECKEDSeptember 27, 2026

The record

At a glance

URPL (Poland)
Active substance
Bilastinum
Manufacturer
Menarini International Operations Luxembourg S.A.
Country
Poland (PL)
ATC code
—
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 1

  • gtin
    05909991516567

Regulatory notes

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

Same medicine, other countries

Bilastinum in 13 other countries

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

All bilastinum products

Authorised across Europe · EMA

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

  • Austria · Bilastin Hyperpoll, Bilastin Tiefenbacher
  • Belgium · Bellozal, Bilastine Ab
  • Bulgaria · Bilastine Stada, Биластин Мсн
  • Cyprus · Alivixa, Bilastine Delorbis
  • Czechia · Abisax, Bilastin Stada
  • Germany · Allegra Allergietabletten, Allegra Allergietabletten Kinder
  • Denmark · Bilastine Stada, Revitelle
  • Estonia · Bilastin, Bilastine Stada
  • Spain · Abisax, Abrilia
  • Finland · Bilastine Stada, Revitelle
  • France · Bilaska, Bilastine Arrow
  • United Kingdom (Northern Ireland) · Bilastine Medreich, Bilastine Milpharm
  • Greece · Bilargen, Bilastine Stada
  • Croatia · Actine, Nixar
  • Hungary · Bilastine Supremex, Bilastine Teva
  • Ireland · Bilastine Clonmel, Bilhista
  • Iceland · Bilaxten
  • Italy · Alyne, Ayrinal
  • Lithuania · Belargan, Bilastine Sandoz
  • Luxembourg · Bellozal, Bilastine Eurogenerics
  • Latvia · Bilastine Stada, Bilpexo
  • Malta · Alivixa, Bilastine Clonmel
  • Norway · Bilastine Stada, Zilas
  • Portugal · Aelardis, Alostine
  • Romania · Bilastină Gemax Pharma, Bilastină Msn
  • Sweden · Bilacina, Bilastin Teva
  • Slovenia · Bilador, Bilastin Stada
  • Slovakia · Abisax, Bilastin Stada

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 URPL (Poland). 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/7395a470-6b29-44a4-891a-f48f26d46c0e
GET /v1/drugs/7395a470-6b29-44a4-891a-f48f26d46c0e?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": "Krople do oczu, roztwór",
  "source": "urpl",
  "strength": "6 mg/ml",
  "packaging": "05909991516567 ¦ Rp ¦ 150379\n1 butelka 5 ml",
  "substance": "Bilastinum 6 mg/ml",
  "common_name": "Bilastinum",
  "pl_product_id": "100452244",
  "pozwolenie_nr": "27897",
  "auth_procedure": "DCP",
  "authorisation_validity": "2028-06-23"
}

See everything about bilastinum.

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.