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Belgium· BE-AMP-SAM534871-00

Oxybate Mylan 300 mg/ml

A sodium oxybate product containing sodium oxybate, registered in Belgium by Viatris GX. The same ATC class is registered in 14 of our 19 countries.

ATC N07XX04

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOxybate Mylan 300 mg/mlATCN07XX04REGISTER NO.BE-AMP-SAM534871-00PACKS LISTED0CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about sodium oxybateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 8 of them publish a price we can compare per daily dose
Search sodium oxybate products by name

Sodium oxybate · ATC N07XX04

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
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

FAMHP / AFMPS (Belgium)
Active substance
Sodium Oxybate
Manufacturer
Viatris GX
Country
Belgium (BE)
ATC code
N07XX04
ATC class
Sodium oxybate
Defined daily dose
7.5 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 0

No packs listed by the register for this record.

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
Check sodium oxybate against other medicinesHow interaction checks work

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All sodium oxybate products

Authorised across Europe · EMA

The same active substance is authorised in 22 EEA countries. Names it is sold under:

  • Austria · Alcover, Natriumoxybat 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
  • 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 FAMHP / AFMPS (Belgium). 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/fe0aa3b7-cc79-4137-bb44-bd822b47d658
GET /v1/drugs/fe0aa3b7-cc79-4137-bb44-bd822b47d658?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": "Oral solution",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Oxybate Mylan 300 mg/ml",
  "name_fr": "Oxybate Mylan 300 mg/ml",
  "name_nl": "Oxybate Mylan 300 mg/ml",
  "amp_code": "SAM534871-00",
  "strengths": [
    "300.0000",
    "300.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Sodium Oxybate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Sodium Oxybate",
  "authorisation_numbers": [
    "BE534871"
  ]
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console