Germany· DE-A57-6f8472b72349b1e8
Sab Simplex
A dimeticone product containing dimeticone, registered in Germany by Pfizer Pharma Gmbh. The same ATC class is registered in 5 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
Where it is registered
Dimeticone is registered in 5 of 19 countries.
Countries holding a registration under ATC P03AX05 (dimeticone), each read from that country’s own register.
- This record: Germany, from EMA Article 57 (European Union)
- 1 of them publish a price we can compare per daily dose
Dimeticone · ATC P03AX05
5 / 19 countries
- Canada
- Germany
- Japan
- United Kingdom
- United Statesprice
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Dimeticone
- Manufacturer
- Pfizer Pharma Gmbh
- Country
- Germany (DE)
- ATC code
- P03AX05
- ATC class
- Dimeticone
- 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
Dimeticone in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United States3M Cavilon Durable BarrierSolventum US LLC
- United KingdomBoots Lip & Cold Sore creamThe Boots Company Plc
- CanadaBAZA CLEANSE & PROTECTCOLOPLAST A/S
- PolandEsputiconPrzedsiębiorstwo Farmaceutyczno-Chemiczne "Synteza" Sp. z o.o.
- FrancePOLYSILANE UPSA, gel oral en sachet-doseUPSA
- FinlandCeolatSolvay Pharmaceuticals GmbH
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Finland · Cuplaton
- France · Polysilane
- United Kingdom (Northern Ireland) · Hedrin
- Ireland · Dentinox Infant Colic Drops
- Poland · Esputicon
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/20e4eb6f-8585-4d30-afdd-6491cd2d100b GET /v1/drugs/20e4eb6f-8585-4d30-afdd-6491cd2d100b?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": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Dimeticone",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about dimeticone.
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.