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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.

ATC J05A

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSymtuza 800 mg/150 mg/200 mg/10 mg fi…ATCJ05AREGISTER NO.IE-PA-EU/1/17/1225/001PACKS LISTED1CHECKEDSeptember 28, 2026

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_number
    EU/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.

All tenofovir alafenamide + darunavir ethanolate + emtricitabine + cobicistat products

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.