Germany· DE-A57-451df9d21ed48bd0
Medelmex Duraphat
A medicinal product containing fluoride, registered in Germany by Cp Gaba Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Fluoride
- Manufacturer
- Cp Gaba 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
Fluoride in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwedenNatriumfluorid Morningside 5 mg/g TandkrämMorningside Healthcare (Malta) Limited
- NorwayNatriumfluorid MorningsideMorningside Healthcare (Malta) Limited
- United States365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityWHOLE FOODS
Authorised across Europe · EMA
The same active substance is authorised in 10 EEA countries. Names it is sold under:
- Denmark · Duraphat, Fluorid Morningside
- Finland · Duraphat, Natriumfluoridi Morningside
- United Kingdom (Northern Ireland) · Duraphat, Duraphat Protify
- Greece · Duraphat
- Ireland · Duraphat
- Netherlands · Dentigel, Duraphat
- Norway · Duraphat, Natriumfluorid Morningside
- Poland · Elmex Duraphat
- Portugal · Duraphat 5000
- Sweden · Natriumfluorid Morningside, Top Dent
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/e1c6d0a6-1a2c-4bd4-9a74-d873877a6bdd GET /v1/drugs/e1c6d0a6-1a2c-4bd4-9a74-d873877a6bdd?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": "Fluoride",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about 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.