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Belgium· BE-AMP-SAM497395-00

Skudexa 75 mg - 25 mg

A tramadol und dexketoprofen product containing tramadol hydrochloride, registered in Belgium by Menarini International Operations Luxembourg. The same ATC class is registered in 7 of our 19 countries.

ATC N02AJ14

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedSkudexa 75 mg - 25 mgATCN02AJ14REGISTER NO.BE-AMP-SAM497395-00PACKS LISTED1CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about tramadol hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Tramadol und dexketoprofen is registered in 7 of 19 countries.

Countries holding a registration under ATC N02AJ14 (tramadol und dexketoprofen), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 5 of them publish a price we can compare per daily dose
Search tramadol und dexketoprofen products by name

Tramadol und dexketoprofen · ATC N02AJ14

7 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Finlandprice
  • Ireland
  • Netherlands
  • Polandprice
  • Switzerlandprice
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
Tramadol Hydrochloride
Manufacturer
Menarini International Operations Luxembourg
Country
Belgium (BE)
ATC code
N02AJ14
ATC class
Tramadol und Dexketoprofen
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    3549474

Regulatory notes

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

Same medicine, other countries

Tramadol und dexketoprofen in 16 other countries

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

All tramadol und dexketoprofen products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Lanalget Retard, Tradolan
  • Bulgaria · Маброн, Трамадол Крка
  • Cyprus · Mabron, Mabron Retard
  • Czechia · Mabron, Mabron Retard
  • Germany · Adamon Inject, Adamon Kaps
  • Denmark · Dolatramyl, Dolol
  • Estonia · Mabron, Mabron Retard
  • Spain · Adolonta, Adolonta Retard
  • Finland · Tradolan Retard, Tramadol Hexal
  • France · Biodalgic, Contramal
  • United Kingdom (Northern Ireland) · Brimisol Pr, Larapam
  • Greece · Tramal, Tramal Sr
  • Croatia · Awardix, Lumidol
  • Hungary · Adamon, Contramal
  • Ireland · Tradol, Tradol Sr
  • Iceland · Tradolan, Tramadol Actavis
  • Italy · Contramal, Fortradol
  • Lithuania · Mabron, Tramadol Basi
  • Luxembourg · Contramal Retard, Tradonal
  • Latvia · Mabron, Mabron Sr
  • Malta · Mabron Retard, Rofy
  • Netherlands · Tramadol Hcl Cf, Tramadol Hcl Nevik
  • Norway · Dolatramyl, Nobligan
  • Poland · Poltram, Poltram 100
  • Portugal · Mabron, Paxilfar
  • Romania · Clorhidrat De Tramadol Bioeel, Mabron
  • Sweden · Dolatramyl, Tradolan
  • Slovenia · Doloris, Tadol
  • Slovakia · Adamon Sr, Mabron

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/bf695ea1-6476-47ed-adbc-62380dc02a19
GET /v1/drugs/bf695ea1-6476-47ed-adbc-62380dc02a19?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": "Film-coated tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Skudexa 75 mg - 25 mg",
  "name_fr": "Skudexa 75 mg - 25 mg",
  "name_nl": "Skudexa 75 mg - 25 mg",
  "amp_code": "SAM497395-00",
  "strengths": [
    "75.0000",
    "36.9000",
    "25.0000",
    "1.8300"
  ],
  "pack_count": 27,
  "substances": [
    "Tramadol Hydrochloride",
    "Dexketoprofen Trometamol",
    "Dexketoprofen",
    "Sodium Stearyl Fumarate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Tramadol and Dexketoprofen",
  "authorisation_numbers": [
    "BE497395",
    "BE497404",
    "BE497413"
  ]
}
API referenceMCP serverPlans

See everything about tramadol und dexketoprofen.

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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