Ireland· IE-PA-PA22835/003/001
Novistig 0.5 mg/ml + 2.5 mg/ml solution for injection
A glycopyrronium bromid product containing glycopyrronium bromide + neostigmine metilsulfate, registered in Ireland by Sintetica GmbH. 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 + Neostigmine Metilsulfate
- Manufacturer
- Sintetica GmbH
- 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_numberPA22835/003/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Glycopyrronium bromid in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandCopnegEQL Pharma AB
- NorwayCopnegEQL Pharma AB
- SwedenCopneg 0,5 mg/ml + 2,5 mg/ml Injektionsvätska, lösningEQL Pharma AB
- United StatesPREVDUOEndo USA
Authorised across Europe · EMA
The same active substance is authorised in 13 EEA countries. Names it is sold under:
- Austria · Combistig
- Belgium · Robinul-Neostigmine
- Denmark · Copneg, Robinul-Neostigmin
- Estonia · Glynex
- Finland · Copneg, Glycostigmin
- United Kingdom (Northern Ireland) · Glycopyrrolate And Neostigmine Metilsulfate Mercury Pharmaceuticals Ltd,, Glycopyrronium Bromide And Neostigmine Metilsulfate Martindale Pharmaceuticals
- Croatia · Novistig
- Hungary · Novistig
- Luxembourg · Robinul-Neostigmine
- Norway · Copneg, Robinul-Neostigmin
- Poland · Novistig
- Sweden · Copneg, Robinul
- Slovenia · Novistig
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/e1596475-86c0-4677-a1b1-d25c0a335b7a GET /v1/drugs/e1596475-86c0-4677-a1b1-d25c0a335b7a?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": "Solution for injection",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"A03AB02"
],
"strength": null,
"pa_number": "PA22835/003/001",
"substances": [
"Glycopyrronium bromide",
"Neostigmine Metilsulfate"
],
"legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "29/01/2021",
"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.