Ireland· IE-PA-PA0865/022/002
Twilev 5 mg/5 mg film-coated tablets
A ace inhibitors, other combinations product containing ramipril + nebivolol hydrochloride, registered in Ireland by Menarini International Operations Luxembourg S.A.. The same ATC class is registered in 4 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Ramipril + nebivolol hydrochloride is registered in 4 of 19 countries.
Countries holding a registration under ATC C09BX (ace inhibitors, other combinations), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 3 of them publish a price we can compare per daily dose
Ramipril + nebivolol hydrochloride · ATC C09BX
4 / 19 countries
- Belgiumprice
- Czechiaprice
- Ireland
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Ramipril + Nebivolol hydrochloride
- Manufacturer
- Menarini International Operations Luxembourg S.A.
- Country
- Ireland (IE)
- ATC code
- C09BX
- ATC class
- ACE inhibitors, other combinations
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA0865/022/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ramipril + nebivolol hydrochloride in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaNEBOTRUVMenarini International Operations Luxembourg S.A., Luxembourg
- PolandPolpril NebiZakłady Farmaceutyczne POLPHARMA S.A.
- SpainTWILEV 10 MG / 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULAMenarini International Operations Luxembourg S.A.
Authorised across Europe · EMA
The same active substance is authorised in 16 EEA countries. Names it is sold under:
- Austria · Twilev
- Bulgaria · Полпрен, Туилев
- Czechia · Nebotruv
- Estonia · Twilev
- Spain · Twilev
- France · Nebopek
- Greece · Twilev
- Croatia · Twilev
- Italy · Ezerdence
- Lithuania · Twilev
- Latvia · Twilev
- Poland · Polpril Nebi, Twilev
- Portugal · Twilev
- Romania · Twilev
- Slovenia · Ezerdence
- Slovakia · Twilev
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/f686725e-aeee-4223-9ed1-72a142f1d941 GET /v1/drugs/f686725e-aeee-4223-9ed1-72a142f1d941?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": [
"C09BX"
],
"strength": null,
"pa_number": "PA0865/022/002",
"substances": [
"Ramipril",
"Nebivolol hydrochloride"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "09/04/2026",
"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 ramipril + nebivolol hydrochloride.
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.