Ireland· IE-PA-EU/1/14/967/001
REZOLSTA 800 mg/150 mg film-coated tablets
A darunavir and cobicistat product containing darunavir + cobicistat, registered in Ireland by Janssen-Cilag International NV. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
Darunavir and cobicistat · ATC J05AR14
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- United Kingdom
The record
At a glance
HPRA (Ireland)- Active substance
- Darunavir + 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_numberEU/1/14/967/001
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
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.
Same medicine, other countries
Darunavir and cobicistat in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsRezolsta 600 mg/90 mg dispergeerbare tablettenJanssen-Cilag International NV
- CanadaPREZCOBIXJANSSEN INC
- SpainREZOLSTA 800 MG/150 MG COMPRIMIDOS RECUBIERTOS CON PELICULAJanssen-Cilag International N.V
- United KingdomRezolsta 800mg/150mg tabletsJanssen-Cilag Ltd
- NorwayRezolstaJanssen-Cilag International N.V.
- PolandRezolstaJanssen-Cilag International N.V.
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/77ab4ba2-eb7f-4df7-82ab-aacc34973cde GET /v1/drugs/77ab4ba2-eb7f-4df7-82ab-aacc34973cde?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": [
"J05AR",
"J05AR14"
],
"strength": null,
"pa_number": "EU/1/14/967/001",
"substances": [
"Darunavir",
"Cobicistat"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "19/11/2014",
"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 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.