Belgium· BE-AMP-SAM502977-00
Sialanar 320 µg/ml
A glycopyrronium bromid product containing glycopyrronium bromide, registered in Belgium by Proveca Pharma. The same ATC class is registered in 12 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Glycopyrronium Bromide
- Manufacturer
- Proveca Pharma
- Country
- Belgium (BE)
- ATC code
- A03AB02
- ATC class
- Glycopyrronium bromid
- Defined daily dose
- 3 mg, O
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb4412169
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
- FinlandSialanarProveca Pharma Limited
- IrelandSialanar 320 micrograms/ml oral solutionProveca 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
- 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
- Ireland · Axhidrox, Glycopyrronium Bromide Ethypharm
- 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 FAMHP / AFMPS (Belgium). 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/b690674d-c1e0-41bb-82c8-f0740ba4c2f5 GET /v1/drugs/b690674d-c1e0-41bb-82c8-f0740ba4c2f5?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Sialanar 320 µg/ml",
"name_fr": "Sialanar 320 µg/ml",
"name_nl": "Sialanar 320 µg/ml",
"amp_code": "SAM502977-00",
"strengths": [
"400.0000",
"400.0000",
"320.0000",
"320.0000",
"2.3000"
],
"pack_count": 2,
"substances": [
"Glycopyrronium Bromide",
"Glycopyrronium",
"Sodium Benzoate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Glycopyrronium Bromide",
"authorisation_numbers": [
"EU/1/16/1135/001",
"EU/1/16/1135/002"
]
}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.