Poland· PL-100107002

Debretin

A trimebutine product containing trimebutini maleas, registered in Poland by Zakłady Farmaceutyczne POLPHARMA S.A.. The same ATC class is registered in 6 of our 19 countries.

ATC A03AA05

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedDebretinATCA03AA05REGISTER NO.PL-100107002PACKS LISTED9CHECKEDSeptember 27, 2026

Where it is registered

Trimebutine is registered in 6 of 19 countries.

Countries holding a registration under ATC A03AA05 (trimebutine), each read from that country’s own register.

  • This record: Poland, from URPL (Poland)
  • 4 of them publish a price we can compare per daily dose

Trimebutine · ATC A03AA05

6 / 19 countries

  • Canada
  • Franceprice
  • Japan
  • Norwayprice
  • 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.

Price per daily dose

What a daily dose of trimebutine costs, country by country.

Normalised to the WHO defined daily dose (0.6 g), so markets compare like for like.

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

Trimebutine · price per daily dose (0.6 g)

USD · FX 28 Sept 2026

  • FR France$0.54
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

URPL (Poland)
Active substance
Trimebutini maleas
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Country
Poland (PL)
ATC code
A03AA05
ATC class
Trimebutine
Defined daily dose
0.6 g, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 9

  • gtin
    05909990927012
  • gtin
    05909990927029
  • gtin
    05909990927036
  • gtin
    05909990927043
  • gtin
    05909990927050
  • gtin
    05909990927067
  • gtin
    05909990927074
  • gtin
    05909990927081
  • gtin
    05909990079667

Regulatory notes

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

Same medicine, other countries

Trimebutine in 5 other countries

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

All trimebutine products

Authorised across Europe · EMA

The same active substance is authorised in 7 EEA countries. Names it is sold under:

  • Bulgaria · Трибутин
  • Spain · Polibutin
  • France · Debricalm, Debridat
  • Greece · Garapepsin, Ibutin
  • Italy · Debridat, Digerent
  • Portugal · Debridat
  • Romania · Colperin, Debridat

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 URPL (Poland). 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/a6a1f12f-dc0c-4617-a9c9-c04245b79466
GET /v1/drugs/a6a1f12f-dc0c-4617-a9c9-c04245b79466?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": "Tabletki powlekane",
  "source": "urpl",
  "strength": "100 mg",
  "packaging": "05909990927012 ¦ Rp ¦ 18629\n20 tabl. w blistrze\n05909990927029 ¦ Rp ¦ 18630\n40 tabl. w blistrach\n05909990927036 ¦ Rp ¦ 18631\n60 tabl. w blistrach\n05909990927043 ¦ Rp ¦ 18632\n100 tabl. w blistrach\n05909990927050 ¦ Rp ¦ Skasowane ¦ 18633\n20 tabl. w pojemniku\n05909990927067 ¦ Rp ¦ Skasowane ¦ 18636\n40 tabl. w pojemniku\n05909990927074 ¦ Rp ¦ Skasowane ¦ 18637\n60 tabl. w pojemniku\n05909990927081 ¦ Rp ¦ Skasowane ¦ 18638\n100 tabl. w pojemniku\n05909990079667 ¦ Rp ¦ 46263\n30 tabl. w blistrach",
  "substance": "Trimebutini maleas 100 mg",
  "common_name": "Trimebutini maleas",
  "pl_product_id": "100107002",
  "pozwolenie_nr": "09270",
  "auth_procedure": "NAR",
  "authorisation_validity": "Bezterminowe"
}

See everything about trimebutine.

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.