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Ireland· IE-PA-PA1347/049/001

Septabene 1.5 mg/ml + 5.0 mg/ml oromucosal spray, solution

A sonstige antiseptika product containing benzydamine hydrochloride + cetylpyridinium chloride, registered in Ireland by KRKA, d.d., Novo mesto. The same ATC class is registered in 10 of our 19 countries.

ATC R02AA20

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSeptabene 1.5 mg/ml + 5.0 mg/ml oromu…ATCR02AA20REGISTER NO.IE-PA-PA1347/049/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about benzydamine hydrochloride + cetylpyridinium chlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Sonstige antiseptika is registered in 10 of 19 countries.

Countries holding a registration under ATC R02AA20 (sonstige antiseptika), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 6 of them publish a price we can compare per daily dose
Search sonstige antiseptika products by name

Sonstige antiseptika · ATC R02AA20

10 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Ireland
  • Netherlands
  • Polandprice
  • Spainprice
  • Switzerlandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
BENZYDAMINE HYDROCHLORIDE + Cetylpyridinium chloride
Manufacturer
KRKA, d.d., Novo mesto
Country
Ireland (IE)
ATC code
R02AA20
ATC class
Sonstige Antiseptika
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA1347/049/001

Regulatory notes

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

Same medicine, other countries

Sonstige antiseptika in 5 other countries

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

All sonstige antiseptika products

Authorised across Europe · EMA

The same active substance is authorised in 22 EEA countries. Names it is sold under:

  • Austria · Tantum Verde Protect
  • Bulgaria · Септолете Тотал, Септолете Тотал Евкалипт
  • Cyprus · Bencet Mouth Spray
  • Czechia · Benzydamin/Cetylpyridinium Chlorid Krka, Benzydamin/Cetylpyridinium Chlorid Krka D.D.
  • Germany · Septolete, Septolete Mit Cola-Geschmack
  • Denmark · Septabene, Septabene Citron Og Honning
  • Estonia · Septolete Omni, Septolete Omni Eucalyptus
  • Spain · Septolete
  • Finland · Septabene, Septabene Cola
  • Greece · Bencet Mouth Spray
  • Croatia · Septolete Duo, Septolete Duo Eukaliptus
  • Hungary · Septolete Extra, Septolete Extra Citrom-Bodza
  • Iceland · Septabene, Septabene Citron Og Honning
  • Italy · Gola Action, Gola Action Senza Zucchero
  • Lithuania · Benzydamine Hydrochloride/Cetylpyridinium Chloride Farmak, Septabene
  • Latvia · Septabene, Septabene Ar Citrona Un Ingvera Garšu
  • Malta · Septolete Total Cola, Septolete Total Eucalyptus
  • Poland · Septogard Plus, Septolete Core Smak Imbirowy
  • Portugal · Septolete Duo Cola, Septolete Duo Eucalipto
  • Romania · Septerloz Mentă, Septolete Omni
  • Slovenia · Septabene, Septabene Z Okusom Evkalipta
  • Slovakia · Septolete Extra, Septolete Extra Eukalyptus

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 HPRA (Ireland). 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/c4983a8a-7518-4b8f-b2e3-e9dd4c9eeb42
GET /v1/drugs/c4983a8a-7518-4b8f-b2e3-e9dd4c9eeb42?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": "Oromucosal spray, solution",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "R02AA",
    "R02AA20"
  ],
  "strength": null,
  "pa_number": "PA1347/049/001",
  "substances": [
    "BENZYDAMINE HYDROCHLORIDE",
    "Cetylpyridinium chloride"
  ],
  "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "10/07/2015",
  "dispensing_status": "Product not subject to medical prescription",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

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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.

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