Ireland· IE-PA-EU/1/17/1225/001
Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets
A direct acting antivirals product containing tenofovir alafenamide + darunavir ethanolate + emtricitabine + cobicistat, registered in Ireland by Janssen-Cilag International NV.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Tenofovir alafenamide + Darunavir ethanolate + Emtricitabine + Cobicistat
- Manufacturer
- Janssen-Cilag International NV
- Country
- Ireland (IE)
- ATC code
- J05A
- ATC class
- DIRECT ACTING ANTIVIRALS
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/17/1225/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tenofovir alafenamide + darunavir ethanolate + emtricitabine + cobicistat in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Symtuza
- Liechtenstein · Symtuza
- Norway · Symtuza
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/61371b2b-351f-4ba2-a605-f2b6d013647c GET /v1/drugs/61371b2b-351f-4ba2-a605-f2b6d013647c?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": [
"J05A"
],
"strength": null,
"pa_number": "EU/1/17/1225/001",
"substances": [
"Tenofovir alafenamide",
"Darunavir ethanolate",
"Emtricitabine",
"Cobicistat"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "21/09/2017",
"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 tenofovir alafenamide + darunavir ethanolate + emtricitabine + cobicistat.
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.