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Belgium· BE-AMP-SAM498000-00

Zaldiar 37.5 mg - 325 mg

A tramadol and paracetamol product containing tramadol hydrochloride, registered in Belgium by PI Pharma. The same ATC class is registered in 13 of our 19 countries.

ATC N02AJ13

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedZaldiar 37.5 mg - 325 mgATCN02AJ13REGISTER NO.BE-AMP-SAM498000-00PACKS LISTED4CHECKEDSeptember 26, 2026

Where it is registered

Tramadol and paracetamol is registered in 13 of 19 countries.

Countries holding a registration under ATC N02AJ13 (tramadol and paracetamol), 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

Tramadol and paracetamol · ATC N02AJ13

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • 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.

Price per daily dose

What a daily dose of tramadol and paracetamol costs, country by country.

Normalised to the WHO defined daily dose (0.3 g), the median price runs from $0.16 in Spain to $4.40 in Switzerland — a ×28 gap.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Tramadol and paracetamol · price per daily dose (0.3 g)

USD · FX 28 Sept 2026

  • CH Switzerland$4.40
  • ES Spain$0.16
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Tramadol Hydrochloride
Manufacturer
PI Pharma
Country
Belgium (BE)
ATC code
N02AJ13
ATC class
Tramadol and paracetamol
Defined daily dose
0.3 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 4

2 priced
  • be_apb
    3417896
    EUR 12.07
  • be_apb
    3926698
    EUR 16.35
  • be_apb
    7717077
  • be_apb
    3417888

Regulatory notes

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

Same medicine, other countries

Tramadol and paracetamol in 16 other countries

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

All tramadol and paracetamol 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/b3e6f291-1421-4a07-af80-4b88480c577b
GET /v1/drugs/b3e6f291-1421-4a07-af80-4b88480c577b?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": "Zaldiar 37.5 mg - 325 mg",
  "name_fr": "Zaldiar 37.5 mg - 325 mg",
  "name_nl": "Zaldiar 37.5 mg - 325 mg",
  "amp_code": "SAM498000-00",
  "strengths": [
    "37.5000",
    "37.5000",
    "325.0000",
    "325.0000"
  ],
  "pack_count": 33,
  "substances": [
    "Tramadol Hydrochloride",
    "Paracetamol",
    "Lactose Monohydrate",
    "Propylene Glycol",
    "Sodium Starch Glycolate (Type A)"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Tramadol and Paracetamol",
  "authorisation_numbers": [
    "1637PI0413F003",
    "1637PI0450F003",
    "1637PI0475F003"
  ]
}

See everything about tramadol and paracetamol.

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.