Ireland· IE-PA-PA0865/021/002
Nebkliq 5 mg/10 mg film-coated tablet
A qc07fb12 product containing nebivolol hydrochloride + amlodipine besilate, registered in Ireland by Menarini International Operations Luxembourg S.A..
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Nebivolol hydrochloride + Amlodipine besilate
- Manufacturer
- Menarini International Operations Luxembourg S.A.
- Country
- Ireland (IE)
- ATC code
- QC07FB12
- ATC class
- QC07FB12
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA0865/021/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nebivolol hydrochloride + amlodipine besilate in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaNESYRGYMenarini International Operations Luxembourg S.A., Luxembourg
- ItalyNEBKLIQMENARINI INTERNAT. O.L.S.A
- SpainNESYRGY 5 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULAMenarini International Operations Luxembourg S.A.
- PolandNesyrgyMenarini International Operations Luxembourg S.A.
Authorised across Europe · EMA
The same active substance is authorised in 19 EEA countries. Names it is sold under:
- Belgium · Nesyrgy
- Bulgaria · Несирджи
- Cyprus · Nesyrgy
- Czechia · Nesyrgy
- Estonia · Nebkliq, Nesyrgy
- Spain · Nesyrgy
- France · Nesyrgy
- Greece · Nesyrgy
- Croatia · Nesyrgy
- Hungary · Nesyrgy
- Italy · Nebkliq, Nesyrgy
- Lithuania · Kliqqo
- Luxembourg · Nesyrgy
- Latvia · Nesyrgy
- Poland · Nesyrgy
- Portugal · Nebkliq
- Romania · Nesyrgy
- Slovenia · Nesyrgy
- Slovakia · Nesyrgy
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/49e671c0-88d8-4459-bac5-492bb2d84958 GET /v1/drugs/49e671c0-88d8-4459-bac5-492bb2d84958?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": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"QC07FB12"
],
"strength": null,
"pa_number": "PA0865/021/002",
"substances": [
"Nebivolol hydrochloride",
"Amlodipine besilate"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "13/12/2024",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about nebivolol hydrochloride + amlodipine besilate.
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.