Ireland· IE-PA-PA25222/001/001
Qsiva 3.75 mg/23 mg hard modified-release capsules
A centrally acting antiobesity products product containing phentermine hydrochloride + topiramate, registered in Ireland by Vivus B.V..
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Phentermine hydrochloride + Topiramate
- Manufacturer
- Vivus B.V.
- Country
- Ireland (IE)
- ATC code
- A08AA
- ATC class
- Centrally acting antiobesity products
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA25222/001/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Phentermine hydrochloride + topiramate in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United Statesphentermine and topiramatePrasco Laboratories
- CzechiaQSIVAVivus B.V., Amsterdam
- PolandQsivaVivus BV
- SwedenQsiva 11,25 mg/69 mg Kapsel med modifierad frisättning, hårdVIVUS BV
- NorwayQsivaVIVUS BV
- FinlandQsivaVIVUS BV
Authorised across Europe · EMA
The same active substance is authorised in 16 EEA countries. Names it is sold under:
- Czechia · Qsiva
- Denmark · Qsiva
- Finland · Qsiva
- Greece · Qsymia
- Croatia · Qsiva
- Hungary · Qsiva
- Iceland · Qsiva
- Lithuania · Qsiva
- Malta · Qsiva
- Norway · Qsiva
- Poland · Qsiva
- Portugal · Qsiva
- Romania · Qsiva
- Sweden · Qsiva
- Slovenia · Qsiva
- Slovakia · Qsiva
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/dd54c906-f19a-4c1b-9dde-cd1454fbee9f GET /v1/drugs/dd54c906-f19a-4c1b-9dde-cd1454fbee9f?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": "Modified-release capsule, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"A08AA"
],
"strength": null,
"pa_number": "PA25222/001/001",
"substances": [
"Phentermine hydrochloride",
"Topiramate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "18/10/2024",
"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 phentermine hydrochloride + topiramate.
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.