Drug Database
Back to search

Ireland· IE-PA-EU/1/14/967/002

REZOLSTA 675 mg/150 mg film-coated tablets

A darunavir and cobicistat product containing darunavir ethanolate + cobicistat, registered in Ireland by Janssen-Cilag International NV. The same ATC class is registered in 12 of our 19 countries.

ATC J05AR14

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedREZOLSTA 675 mg/150 mg film-coated ta…ATCJ05AR14REGISTER NO.IE-PA-EU/1/14/967/002PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about darunavir ethanolate + cobicistatAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Darunavir and cobicistat is registered in 12 of 19 countries.

Countries holding a registration under ATC J05AR14 (darunavir and cobicistat), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 7 of them publish a price we can compare per daily dose
Search darunavir and cobicistat products by name

Darunavir and cobicistat · ATC J05AR14

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • United Kingdom
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Darunavir ethanolate + Cobicistat
Manufacturer
Janssen-Cilag International NV
Country
Ireland (IE)
ATC code
J05AR14
ATC class
Darunavir and cobicistat
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/14/967/002

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

541 interactions on record for darunavir and cobicistat.

Graded by severity as the source publishes them — 243 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check darunavir and cobicistat against other medicinesHow interaction checks work

Darunavir and cobicistat · interactions on record

541 records

  • 243 severe
  • 277 moderate
  • 21 minor

Most severe, free to view

  • CisaprideA03FA02severe
  • NaloxegolA06AH03severe
  • LoperamideA07DA03severe
  • EluxadolineA07DA06severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Darunavir and cobicistat in 3 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All darunavir and cobicistat products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Rezolsta
  • Liechtenstein · Rezolsta
  • Norway · Rezolsta

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/ec003e4e-2396-4c46-9600-21ff3150651c
GET /v1/drugs/ec003e4e-2396-4c46-9600-21ff3150651c?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": [
    "J05AR14"
  ],
  "strength": null,
  "pa_number": "EU/1/14/967/002",
  "substances": [
    "Darunavir ethanolate",
    "Cobicistat"
  ],
  "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "18/07/2025",
  "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
}
API referenceMCP serverPlans

See everything about darunavir and 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.

Try it freeOpen in the console