Iceland· IS-IS/1/26/002/01
Septabene mjúkur engiferkjarni
A benzydamine product containing cetylpyridinium chloride monohydrate, registered in Iceland by KRKA tovarna zdravil d.d. Novo mesto. The same ATC class is registered in 8 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
Benzydamine is registered in 8 of 19 countries.
Countries holding a registration under ATC R02AX03 (benzydamine), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 7 of them publish a price we can compare per daily dose
Benzydamine · ATC R02AX03
8 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- Cetylpyridinium chloride monohydrate
- Manufacturer
- KRKA tovarna zdravil d.d. Novo mesto
- Country
- Iceland (IS)
- ATC code
- R02AX03
- ATC class
- Benzydamine
- Defined daily dose
- 9 mg, O
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 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
Benzydamine in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesAHLO PRO Healthy GumsGervest USA Inc
- United KingdomAnbesol liquidAlliance Pharmaceuticals Ltd
- CanadaANTISEPTIC ORAL RINSESAGE PRODUCTS LLC
- FranceNOVOPTINE 0,1 mg/0,4 ml, collyre en récipient unidoseSIFI (ITALIE)
- CzechiaHALSETGebro Pharma GmbH, Fieberbrunn
- NorwayPyriseptKaro Pharma AS
- PolandHalsetBiofarm Sp. z o.o.
- GermanyAnginettenDivapharma Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 10 EEA countries. Names it is sold under:
- Austria · Halset
- Czechia · Halset, Neoseptolete Třešeň
- Germany · Anginetten, Halstabletten - Akute Hals- Und Rachenhilfe Zur Anwendung Bei Erwachsenen Und Kindern Ab 3 Jahren
- France · Sedacollyre
- United Kingdom (Northern Ireland) · Antiseptic, First Aid Antiseptic
- Italy · Cetilsan, Cetilsan Senza Zucchero
- Malta · Cetilsan Sugar Free
- Norway · Pyrisept
- Poland · Halset, Septolete Junior
- Slovenia · Neoseptolete Z Okusom Divje Češnje, Neoseptolete Z Okusom Limone
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 Icelandic Medicines Agency (Iceland). 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/92c6a710-5060-42bb-94ce-94d1f84b3155 GET /v1/drugs/92c6a710-5060-42bb-94ce-94d1f84b3155?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": "Munnsogstafla",
"source": "lyfjastofnun",
"atc_raw": "R02AX03",
"marketed": true,
"strength": "3 mg /1 mg",
"ma_number": "IS/1/26/002/01",
"substance": "Cetylpyridinium chloride monohydrate",
"other_info": null,
"legal_status": "(L) Ekki lyfseðilsskylt",
"ma_issued_serial": "46080"
}See everything about benzydamine.
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.