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Ireland· IE-PA-EU/1/16/1135/001

Sialanar 320 micrograms/ml oral solution

A glycopyrronium bromid product containing glycopyrronium bromide, registered in Ireland by Proveca Pharma Limited. The same ATC class is registered in 12 of our 19 countries.

ATC A03AB02

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSialanar 320 micrograms/ml oral solut…ATCA03AB02REGISTER NO.IE-PA-EU/1/16/1135/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Glycopyrronium bromid is registered in 12 of 19 countries.

Countries holding a registration under ATC A03AB02 (glycopyrronium bromid), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 7 of them publish a price we can compare per daily dose

Glycopyrronium bromid · ATC A03AB02

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • United Statesprice
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
Glycopyrronium bromide
Manufacturer
Proveca Pharma Limited
Country
Ireland (IE)
ATC code
A03AB02
ATC class
Glycopyrronium bromid
Defined daily dose
3 mg, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/16/1135/001

Regulatory notes

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

Same medicine, other countries

Glycopyrronium bromid in 9 other countries

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

All glycopyrronium bromid products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Axhidrox, Glycopyrroniumbromid Accord
  • Belgium · Axhidroks, Robinul
  • Bulgaria · Axhidrox, Амидил Амихалер
  • Cyprus · Glycopyrronium Bromide Accord, Robinul
  • Czechia · Amidil Amihaler, Axhidrox
  • Germany · Axhidrox, Glycopyrronium Axiromed
  • Denmark · Axhidrox, Glycopirronium Medical Valley
  • Estonia · Axhidrox
  • Finland · Axhidrox, Glykopyrroniumbromidi Accord
  • France · Glycopyrronium Biogaran, Glycopyrronium Wolff
  • United Kingdom (Northern Ireland) · Assicco, Glycopyrrolate Mercury Pharmaceuticals
  • Greece · Axhidrox, Glycopyrronium Verisfield
  • Croatia · Axhidrox
  • Hungary · Axhidrox, Rybrila
  • Iceland · Seebri Breezhaler, Sialanar
  • Italy · Axhidrox, Glicopirronio Bromuro Accord
  • Liechtenstein · Seebri Breezhaler, Sialanar
  • Lithuania · Akshidroz
  • Luxembourg · Axhidroks, Robinul
  • Latvia · Axhidrox
  • Malta · Glycopyrronium Morningside
  • Netherlands · Axhidrox, Dusmyla
  • Norway · Axhidrox, Glycopirronium Medical Valley
  • Poland · Amidil Amihaler, Axhidrox
  • Portugal · Glicopirrónio Axidrox
  • Romania · Axhidrox
  • Sweden · Axhidrox, Glycopirronium Medical Valley
  • Slovenia · Axhidrox
  • Slovakia · Axhidrox

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/9af07456-e06e-45ce-9f0b-bb45ba58eb70
GET /v1/drugs/9af07456-e06e-45ce-9f0b-bb45ba58eb70?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": "Oral solution",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "A03AB",
    "A03AB02"
  ],
  "strength": null,
  "pa_number": "EU/1/16/1135/001",
  "substances": [
    "Glycopyrronium bromide"
  ],
  "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "15/09/2016",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about glycopyrronium bromid.

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.