Sweden· SE-20180928000062
Natriumoxibat Kalceks 500 mg/ml Oral lösning
A medicinal product containing sodium oxybate, registered in Sweden by AS KALCEKS.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Sodium Oxybate
- Manufacturer
- AS KALCEKS
- 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_varunummer20180928000062
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sodium oxybate in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United Statessodium oxybateXLCare Pharmaceuticals, Inc.
- FinlandNatriumoksibaatti AscendAscend GmbH
- BelgiumOxybate Accord 500 mg/mlAccord Healthcare
- NorwayNatriumoksybat KalceksAS Kalceks
- CzechiaSODIUM OXYBATE KALCEKSAS Kalceks, Riga
- IrelandSodium oxybate 500 mg/ml oral solutionAS Kalceks
- IcelandXyremUCB Pharma S.A.*
- United KingdomSodium oxybate 500mg/ml oral solution sugar freeReig Jofre UK Ltd
Authorised across Europe · EMA
The same active substance is authorised in 22 EEA countries. Names it is sold under:
- Austria · Alcover, Natriumoxybat Kalceks
- Belgium · Oxybate Accord, Oxybate Kalceks
- Czechia · Sodium Oxybate Kalceks
- Germany · Natriumoxybat Accord, Natriumoxybat Aristo
- Denmark · Natriumoxybat, Natriumoxybat Kalceks
- Estonia · Sodium Oxybate Kalceks
- Spain · Anartex, Oxibato De Sodio Kalceks
- Finland · Natriumoksibaatti Kalceks, Natriumoxibat Reig Jofre
- France · Gamma-Oh, Oxybate De Sodium Kalceks
- United Kingdom (Northern Ireland) · Sodium Oxybate As Kalceks, Sodium Oxybate Reig Jofre Uk
- Greece · Oxybatin
- Ireland · Sodium Oxybate As Kalceks
- Iceland · Xyrem
- Italy · Alcover, Sodio Oxibato Accord
- Liechtenstein · Xyrem
- Lithuania · Sodium Oxybate Kalceks
- Latvia · Nartex
- Netherlands · Natriumoxybaat Accord, Natriumoxybaat Aristo
- Norway · Natriumoksybat Kalceks, Oxiore
- Poland · Sodium Oxybate Accord
- Slovenia · Natrijev Oksibat Accord, Natrijev Oksibat Kalceks
- Slovakia · Sodium Oxybate Kalceks
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/19a9eaba-6964-4f65-a5d6-77c0a5dc5ac8 GET /v1/drugs/19a9eaba-6964-4f65-a5d6-77c0a5dc5ac8?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": [
"PL",
"SmPC"
],
"se_npl_id": "20180928000062",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20180928000062",
"product_doc_link": "https://docetp.mpa.se/LMF/Natriumoxibat%20Kalceks%20oral%20solution%20SmPC_09001bee807a4ad6.pdf"
}See everything about sodium oxybate.
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.