Belgium· BE-AMP-SAM410277-00

Dexdor 100 µg

A dexmedetomidine product containing dexmedetomidine hydrochloride, registered in Belgium by Orion. The same ATC class is registered in 17 of our 19 countries.

ATC N05CM18

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedDexdor 100 µgATCN05CM18REGISTER NO.BE-AMP-SAM410277-00PACKS LISTED3CHECKEDSeptember 26, 2026

Where it is registered

Dexmedetomidine is registered in 17 of 19 countries.

Countries holding a registration under ATC N05CM18 (dexmedetomidine), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 9 of them publish a price we can compare per daily dose

Dexmedetomidine · ATC N05CM18

17 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • 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
Dexmedetomidine Hydrochloride
Manufacturer
Orion
Country
Belgium (BE)
ATC code
N05CM18
ATC class
Dexmedetomidine
Defined daily dose
1 mg, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

  • be_apb
    2895449
  • be_apb
    0750273
  • be_apb
    2895431

Regulatory notes

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

Interactions

79 interactions on record for dexmedetomidine.

Graded by severity as the source publishes them — 60 moderate. 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

Dexmedetomidine · interactions on record

79 records

  • 60 moderate
  • 19 info

Most severe, free to view

  • PapaverineA03AD01moderate
  • DiphenhydraminA04AB05moderate
  • DronabinolA04AD10moderate
  • NabiloneA04AD11moderate
  • 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

Dexmedetomidine in 15 other countries

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

All dexmedetomidine products

Authorised across Europe · EMA

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

  • Austria · Dexmedetomidin Altan, Dexmedetomidin Altan Pharmaceuticals, S.A.
  • Bulgaria · Dexmedetomidine Ever Valinject, Dexmedetomidine Kalceks
  • Cyprus · Dexmedetomidine Baxter, Dexmedetomidine Ever Valinject
  • Czechia · Dexmedetomidine B. Braun, Dexmedetomidine Ever Pharma
  • Germany · Dexmedetomidin B. Braun, Dexmedetomidin Baxter
  • Denmark · Dexmedetomidin Kalceks, Dexmedetomidin Viatris
  • Estonia · Dexmedetomidine Auxilia, Dexmedetomidine Kabi
  • Spain · Dexmedetomidina Altan, Dexmedetomidina B. Braun
  • Finland · Dexmedetomidine B. Braun, Dexmedetomidine Baxter
  • France · Dexmedetomidine Altan, Dexmedetomidine Ever Pharma
  • United Kingdom (Northern Ireland) · Dexmedetomidine 100 Micrograms/Ml Concentrate For Solution For Infusion, Dexmedetomidine Altan Pharma
  • Greece · Dexmedetomidine /Kabi, Dexmedetomidine Ariti
  • Croatia · Deksmedetomidin Kabi, Deksmedetomidin Kalceks
  • Hungary · Dexmedetomidin Ever Pharma, Dexmedetomidine Kabi
  • Ireland · Dexmedetomidine As Kalceks, Dexmedetomidine B. Braun
  • Iceland · Dexdor, Dexmedetomidine Rph Pharma
  • Italy · Dexmedetomidina Galenica Senese, Dexmedetomidina Hikma
  • Liechtenstein · Dexdor
  • Lithuania · Dexmedetomidine Kabi, Dexmedetomidine Kalceks
  • Luxembourg · Dexmedetomidine Baxter, Dexmedetomidine Kabi
  • Latvia · Dexmedetomidine Kalceks, Dexmedetomidine Pharmidea
  • Malta · Dexmedetomidine Ever Valinject
  • Netherlands · Dexmedetomidine Altan Pharmaceuticals, S.A., Dexmedetomidine B. Braun
  • Norway · Dexdor, Dexmedetomidine B. Braun
  • Poland · Dexmedetomidine Ever Pharma, Dexmedetomidine Farmak
  • Portugal · Dexmedetomidina A.Forall, Dexmedetomidina Acure
  • Romania · Dexmedetomidină Kabi, Dexmedetomidină Kalceks
  • Sweden · Dexmedetomidine B. Braun, Dexmedetomidine Baxter
  • Slovenia · Deksmedetomidin Kalceks, Deksmedetomidin Viatris
  • Slovakia · Dexmedetomidine B. Braun, Dexmedetomidine Ever Pharma

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/8962dfc7-f3ff-4374-bc49-4cf3f1987b99
GET /v1/drugs/8962dfc7-f3ff-4374-bc49-4cf3f1987b99?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": "Concentrate for solution for infusion",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Dexdor 100 µg",
  "name_fr": "Dexdor 100 µg",
  "name_nl": "Dexdor 100 µg",
  "amp_code": "SAM410277-00",
  "strengths": [
    "100.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Dexmedetomidine Hydrochloride",
    "Dexmedetomidine",
    "Sodium Chloride"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Dexmedetomidine",
  "authorisation_numbers": [
    "EU/1/11/718/002",
    "EU/1/11/718/001"
  ]
}

See everything about dexmedetomidine.

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.