Germany· DE-A57-042448f5c8b22a2c
Controcar
A sodium fluoride product containing sodium fluoride, registered in Germany by Lege Artis Pharma Gmbh + Co. Kg. The same ATC class is registered in 13 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
Where it is registered
Sodium fluoride is registered in 13 of 19 countries.
Countries holding a registration under ATC A01AA01 (sodium fluoride), each read from that country’s own register.
- This record: Germany, from EMA Article 57 (European Union)
- 8 of them publish a price we can compare per daily dose
Sodium fluoride · ATC A01AA01
13 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Sodium Fluoride
- Manufacturer
- Lege Artis Pharma Gmbh + Co. Kg
- Country
- Germany (DE)
- ATC code
- A01AA01
- ATC class
- Sodium fluoride
- Defined daily dose
- 1.1 mg, O
- 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
Sodium fluoride in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United States3ECARE Dual formula WhiteningToothpaste RefillHangzhou Namei Zhikang Technology Co., Ltd.
- United KingdomColgate Duraphat 2800ppm fluoride toothpasteColgate-Palmolive (UK) Ltd
- FinlandDuraphatColgate-Palmolive A/S
- CzechiaZYMAFLUORMylan IRE Healthcare Limited, Dublin
- BelgiumFluocaril Bi-Fluore 250 Muntsmaak 250 mg/100 gU.Labs
- SwedenDentan 0,05 % MunsköljvätskaCooper Consumer Health B.V.
- FranceDURAPHAT 50 mg/ml, suspension dentaireCOLGATE PALMOLIVE
- Polandelmex DuraphatCP GABA GmbH
Authorised across Europe · EMA
The same active substance is authorised in 14 EEA countries. Names it is sold under:
- Austria · Zymafluor
- Belgium · Z-Fluor
- Czechia · Zymafluor
- Finland · Duraphat
- France · Duraphat, Fluodontyl
- United Kingdom (Northern Ireland) · Duraphat, Fluoride Morningside Healthcare
- Greece · Duraphat
- Iceland · Duraphat
- Italy · Zymafluor
- Netherlands · Duraphat
- Norway · Duraphat, Flux F Med Banansmak
- Poland · Medelmex Duraphat
- Portugal · Duraphat, Maxflúor
- Sweden · Dentan, Dentan Mint
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/5d4591ac-aa52-4b54-b3cf-d274dc8828e4 GET /v1/drugs/5d4591ac-aa52-4b54-b3cf-d274dc8828e4?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": "Sodium Fluoride",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about 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.