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.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
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_numberEU/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.
- CzechiaSIALANARProveca Pharma Limited, Dublin
- BelgiumSialanar 320 µg/mlProveca Pharma
- FinlandSialanarProveca Pharma Limited
- NorwaySialanarProveca Pharma Limited
- SwedenSialanar 320 mikrogram/ml Oral lösningProveca Pharma Ltd
- United StatesCuvposaMerz Pharmaceuticals, LLC
- United KingdomAssicco 1mg tabletsMorningside Healthcare Ltd
- CanadaCUVPOSAMEDEXUS PHARMACEUTICALS INC.
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.