Ireland· IE-PA-EU/1/14/941/001-002
VIZAMYL 400 MBq/mL solution for injection
A other central nervous system diagnostic radiopharmaceuticals product containing flutemetamol (18f), registered in Ireland by GE Healthcare AS. The same ATC class is registered in 2 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Flutemetamol (18f) is registered in 2 of 19 countries.
Countries holding a registration under ATC V09AX (other central nervous system diagnostic radiopharmaceuticals), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
Flutemetamol (18f) · ATC V09AX
2 / 19 countries
- Denmark
- Ireland
The record
At a glance
HPRA (Ireland)- Active substance
- Flutemetamol (18F)
- Manufacturer
- GE Healthcare AS
- Country
- Ireland (IE)
- ATC code
- V09AX
- ATC class
- Other central nervous system diagnostic radiopharmaceuticals
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/14/941/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Flutemetamol (18f) in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaVIZAMYLGE Healthcare AS, Oslo
- SpainVIZAMYL 400 MBq/ml solucion inyectable Flutemetamol (18F)Ge Healthcare As
- FinlandVizamylGE Healthcare AS
- FranceVIZAMYL 400 MBq/ml, solution injectableGE HEALTHCARE (NORVEGE)
- NetherlandsVIZAMYL 400 MBq/ml oplossing voor injectieGE Healthcare AS
- SwedenVIZAMYL 400 MBq/ml Injektionsvätska, lösningGE Healthcare AS
- United StatesVizamylGE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- United Kingdom (Northern Ireland) · Vizamyl
- Iceland · Vizamyl
- Liechtenstein · Vizamyl
- Norway · Vizamyl
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/38ebe49a-c9f0-4cf5-980f-382ac53348b1 GET /v1/drugs/38ebe49a-c9f0-4cf5-980f-382ac53348b1?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": [
"V09AX"
],
"strength": null,
"pa_number": "EU/1/14/941/001-002",
"substances": [
"Flutemetamol (18F)"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "22/08/2014",
"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 flutemetamol (18f).
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.