Poland· PL-100021683

Elmex

A kariesprophylaxe, kombinationen product containing olaflurum + dectaflurum + natrii fluoridum, registered in Poland by CP GABA GmbH. The same ATC class is registered in 4 of our 19 countries.

ATC A01AA30

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedElmexATCA01AA30REGISTER NO.PL-100021683PACKS LISTED3CHECKEDSeptember 27, 2026

Where it is registered

Kariesprophylaxe, kombinationen is registered in 4 of 19 countries.

Countries holding a registration under ATC A01AA30 (kariesprophylaxe, kombinationen), 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

Kariesprophylaxe, kombinationen · ATC A01AA30

4 / 19 countries

  • Belgiumprice
  • Icelandprice
  • 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

URPL (Poland)
Active substance
Olaflurum + Dectaflurum + Natrii fluoridum
Manufacturer
CP GABA GmbH
Country
Poland (PL)
ATC code
A01AA30
ATC class
Kariesprophylaxe, Kombinationen
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 3

  • gtin
    05909990067619
  • gtin
    05909990067626
  • gtin
    05909990334988

Regulatory notes

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

Same medicine, other countries

Kariesprophylaxe, kombinationen in 2 other countries

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

All kariesprophylaxe, kombinationen products

Authorised across Europe · EMA

The same active substance is authorised in 9 EEA countries. Names it is sold under:

  • Austria · Elmex
  • Belgium · Elmex Medical Gel
  • Germany · Dynexaminfluorid Gelée, Elmex Gelée
  • Finland · Elmex
  • Hungary · Elmex
  • Italy · Elmex
  • Luxembourg · Elmex Gelée
  • Netherlands · Elmex Medical Cariësprotectiegel
  • Slovakia · Elmex Gelée

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/7aed6d6c-f7b2-4b7f-a9e5-c9b29b12a05f
GET /v1/drugs/7aed6d6c-f7b2-4b7f-a9e5-c9b29b12a05f?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": "Żel",
  "source": "urpl",
  "strength": "12,5 mg fluoru/g",
  "packaging": "05909990067619 ¦ OTC ¦ 3585\n1 op. 25 g\nOTC ¦ Skasowane ¦ 3586\n1 op. 50 g\n05909990067626 ¦ OTC ¦ 17092\n1 op. 215 g\n05909990334988 ¦ OTC ¦ 27882\n1 tuba 38 g",
  "substance": "Olaflurum (Aminofluorek 297) 30.32 mg + Dectaflurum (Aminofluorek 335) 2.87 mg + Natrii fluoridum 22.1 mg",
  "common_name": "Olaflurum + Dectaflurum + Natrii fluoridum",
  "pl_product_id": "100021683",
  "pozwolenie_nr": "00676",
  "auth_procedure": "NAR",
  "authorisation_validity": "Bezterminowe"
}

See everything about kariesprophylaxe, kombinationen.

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.