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Poland· PL-100025511

Biodacyna ophthalmicum 0,3%

A amikacin product containing amikacinum, registered in Poland by Zakłady Farmaceutyczne POLPHARMA S.A.. The same ATC class is registered in 3 of our 19 countries.

ATC S01AA21

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedBiodacyna ophthalmicum 0,3%ATCS01AA21REGISTER NO.PL-100025511PACKS LISTED1CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about amikacinumAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Amikacin is registered in 3 of 19 countries.

Countries holding a registration under ATC S01AA21 (amikacin), each read from that country’s own register.

  • This record: Poland, from URPL (Poland)
  • 2 of them publish a price we can compare per daily dose
Search amikacin products by name

Amikacin · ATC S01AA21

3 / 19 countries

  • Italyprice
  • Polandprice
  • 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.

The record

At a glance

URPL (Poland)
Active substance
Amikacinum
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Country
Poland (PL)
ATC code
S01AA21
ATC class
Amikacin
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 1

  • gtin
    05909990129317

Regulatory notes

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

Same medicine, other countries

Amikacin in 16 other countries

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

All amikacin products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Amikacin B. Braun
  • Belgium · Amikacine B. Braun, Amikacine Fresenius Kabi
  • Bulgaria · Amikacin Kabi, Амикацин Б. Браун
  • Cyprus · Amika-Synto, Amikacin Vioser
  • Czechia · Amikacin B. Braun, Amikacin Fresenius Kabi
  • Germany · Amikacin B. Braun, Amikacin Eberth
  • Denmark · Amikacin Afortas, Amikacin Macure
  • Estonia · Amikacin B. Braun
  • Spain · Amicacina, Amicacina B. Braun
  • Finland · Amikacin Afortas, Amikacin Macure
  • France · Amikacine B. Braun, Amikacine Kabi
  • United Kingdom (Northern Ireland) · Amikacin Demo Pharma Uk, Amikacin Galvany Pharma
  • Greece · Amicasil, Amikacin Anfarm
  • Croatia · Amikacin Zentiva
  • Hungary · Amikacin Anfarm, Amikacin B. Braun
  • Ireland · Amikacin, Amikacin Athlone Pharmaceuticals
  • Iceland · Arikayce Liposomal
  • Italy · Amicasil, Amikacina B. Braun
  • Liechtenstein · Arikayce Liposomal
  • Lithuania · Biodacyna
  • Luxembourg · Amikacin B. Braun, Amukin
  • Latvia · Amikacin B.Braun
  • Malta · Amikacin Tillomed Laboratories, Uzix
  • Netherlands · Amikacine Hospira
  • Norway · Amikacin Afortas, Amikacin Macure
  • Portugal · Amicacina Hikma, Amicacina Kabi
  • Romania · Amikacin Noridem, Amikacină Atb
  • Sweden · Amikacin Afortas, Amikacin Fresenius Kabi
  • Slovenia · Amikacin Kabi
  • Slovakia · Amikacin B. Braun, Amikacin Fresenius Kabi

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/bac3549f-f136-4f67-b806-e6e67cc325db
GET /v1/drugs/bac3549f-f136-4f67-b806-e6e67cc325db?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": "3 mg/ml",
  "packaging": "05909990129317 ¦ Rp ¦ 1926\n1 butelka 5 ml",
  "substance": "Amikacini sulfas 23.076 mg",
  "common_name": "Amikacinum",
  "pl_product_id": "100025511",
  "pozwolenie_nr": "01293",
  "auth_procedure": "NAR",
  "authorisation_validity": "Bezterminowe"
}
API referenceMCP serverPlans

See everything about amikacin.

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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