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Germany· DE-A57-86b1fd5e72f18dcb

Dynexaminfluorid Gelée

A medicinal product containing dectaflur, olaflur, sodium fluoride, registered in Germany by Chemische Fabrik Kreussler & Co. Gmbh.

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedDynexaminfluorid GeléeATC—REGISTER NO.DE-A57-86b1fd5e72f18d…PACKS LISTED0CHECKEDSeptember 30, 2026

The record

At a glance

EMA Article 57 (European Union)
Active substance
Dectaflur, Olaflur, Sodium Fluoride
Manufacturer
Chemische Fabrik Kreussler & Co. Gmbh
Country
Germany (DE)
ATC code
—
Reimbursed
Not published by this register
Source register
EMA Article 57 (European Union)
Last checked
September 30, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

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

Same medicine, other countries

Dectaflur, olaflur, sodium fluoride in 2 other countries

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

All dectaflur, olaflur, sodium fluoride 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
  • Finland · Elmex
  • Hungary · Elmex
  • Italy · Elmex
  • Luxembourg · Elmex Gelée
  • Netherlands · Elmex Medical Cariësprotectiegel
  • Poland · Elmex
  • 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 EMA Article 57 (European Union). 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/d72da943-8144-4515-91e0-227acf5fd6c7
GET /v1/drugs/d72da943-8144-4515-91e0-227acf5fd6c7?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.

{
  "pzn": null,
  "route": "Dental Use",
  "source": "ema_art57_de",
  "ma_number": null,
  "substance": "Dectaflur, Olaflur, Sodium Fluoride",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}

See everything about dectaflur, olaflur, sodium fluoride.

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.