Sweden· SE-20190708000014

ARIKAYCE liposomal 590 mg Dispersion för nebulisator

A medicinal product containing amikacin, registered in Sweden by Insmed Netherlands B.V..

Checked against Swedish Medical Products Agency (Sweden) on October 1, 2026

Informational only — not a medical device.

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The record

At a glance

Swedish Medical Products Agency (Sweden)

Active substance: Amikacin
Manufacturer: Insmed Netherlands B.V.
Country: Sweden (SE)
ATC code: —
Reimbursed: Not published by this register
Source register: Swedish Medical Products Agency (Sweden)
Last checked: October 1, 2026

Packs & prices · 1

se_varunummer
20190708000014

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
Poland · Amikacin B. Braun, Amikacin Kabi,
Portugal · Amicacina Hikma, Amicacina Kabi
Romania · Amikacin Noridem, Amikacină Atb
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 Swedish Medical Products Agency (Sweden). 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/d12540a8-4060-431b-aa0d-5dd728609786
GET /v1/drugs/d12540a8-4060-431b-aa0d-5dd728609786?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.

{
  "source": "lakemedelsverket",
  "doc_types": [
    "EMA",
    "EPAR"
  ],
  "se_npl_id": "20190708000014",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20190708000014",
  "product_doc_link": "https://www.ema.europa.eu/en/medicines/human/EPAR/arikayce-liposomal"
}

API reference MCP server Plans

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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