Ireland· IE-PA-EU/1/23/1746/001
Pylclari 1000 MBq/mL solution for injection
A piflufolastat (18f) product containing 2-(3-{1-carboxy-5-[(6-[(18)f]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid, registered in Ireland by Curium Pet France. The same ATC class is registered in 10 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Piflufolastat (18f) is registered in 10 of 19 countries.
Countries holding a registration under ATC V09IX16 (piflufolastat (18f)), 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
Piflufolastat (18f) · ATC V09IX16
10 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- 2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid
- Manufacturer
- Curium Pet France
- Country
- Ireland (IE)
- ATC code
- V09IX16
- ATC class
- Piflufolastat (18F)
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/23/1746/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Piflufolastat (18f) in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesPIFLUFOLASTAT F-18Aphelion LLC
- CzechiaPYLCLARICURIUM PET FRANCE, Saint-Beauzire
- SpainPYLCLARI 1.000 MBQ/ML SOLUCION INYECTABLECurium Pet France
- FinlandPylclariCurium Pet France
- NetherlandsPylclari 1.500 MBq/ml oplossing voor injectieCurium Pet France
- SwedenPylclari 1 000 MBq/ml Injektionsvätska, lösningCurium PET France
- BelgiumPylclari 1000 MBq/mlCurium Pet France
- FrancePYLCLARI 1 500 MBq/mL, solution injectableCURIUM PET FRANCE
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Iceland · Pylclari
- Norway · Pylclari
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/ceb10737-2bbd-4051-adac-7368c78389a4 GET /v1/drugs/ceb10737-2bbd-4051-adac-7368c78389a4?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": [
"V09IX",
"V09IX16"
],
"strength": null,
"pa_number": "EU/1/23/1746/001",
"substances": [
"2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "24/07/2023",
"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 piflufolastat (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.