Finland· FI-REL-REL53442
Natriumoksibaatti Kalceks
A sodium oxybate product containing sodium oxybate, registered in Finland by AS Kalceks. The same ATC class is registered in 14 of our 19 countries.
Checked against Fimea (Finland) on
Informational only — not a medical device.
Where it is registered
Sodium oxybate is registered in 14 of 19 countries.
Countries holding a registration under ATC N07XX04 (sodium oxybate), each read from that country’s own register.
- This record: Finland, from Fimea (Finland)
- 8 of them publish a price we can compare per daily dose
Sodium oxybate · ATC N07XX04
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
Fimea (Finland)- Active substance
- Sodium oxybate
- Manufacturer
- AS Kalceks
- Country
- Finland (FI)
- ATC code
- N07XX04
- ATC class
- Sodium oxybate
- Defined daily dose
- 7.5 g, O
- Reimbursed
- Not published by this register
- Source register
- Fimea (Finland)
- Last checked
- September 27, 2026
Packs & prices · 1
1 priced- fi_myyntilupa100964180 mlEUR 156.31
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
65 interactions on record for sodium oxybate.
Graded by severity as the source publishes them — 54 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Sodium oxybate · interactions on record
65 records
- 54 severe
- 11 moderate
Most severe, free to view
- MetoclopramideA03FA01severe
- ThiethylperazinA04AB03severe
- DiphenhydraminA04AB05severe
- DronabinolA04AD10severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
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.
- SwedenNatriumoxibat Kalceks 500 mg/ml Oral lösningAS KALCEKS
- 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 freeNeuraxpharm 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
- 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
- Sweden · Natriumoxibat Kalceks, Natriumoxibat Reig Jofre
- 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 Fimea (Finland). 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/a6a64bed-9270-451a-b855-c5e7c3b18755 GET /v1/drugs/a6a64bed-9270-451a-b855-c5e7c3b18755?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.
{
"ddd": "7.5",
"form": "oraaliliuos",
"route": "Suun kautta",
"ddd_unit": "g",
"strength": "500 mg/ml",
"atc_label": "natriumoksibaatti",
"ma_number": "36401",
"auth_status": "Myyntilupa myönnetty",
"eu_ma_number": null,
"fimea_rel_id": "REL53442",
"authorised_at": "2019-09-30"
}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.