Drug Database
Back to search

Ireland· IE-PA-EU/1/07/436/1-2

Isentress 400 mg Film-coated tablet

A raltegravir product containing raltegravir potassium, registered in Ireland by Merck Sharp & Dohme BV,.

ATC J05AX08

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedIsentress 400 mg Film-coated tabletATCJ05AX08REGISTER NO.IE-PA-EU/1/07/436/1-2PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about raltegravir potassiumAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

HPRA (Ireland)
Active substance
Raltegravir potassium
Manufacturer
Merck Sharp & Dohme BV,
Country
Ireland (IE)
ATC code
J05AX08
ATC class
Raltegravir
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/07/436/1-2

Regulatory notes

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

Interactions

63 interactions on record for raltegravir.

Graded by severity as the source publishes them — 15 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 raltegravir against other medicinesHow interaction checks work

Raltegravir · interactions on record

63 records

  • 15 severe
  • 22 moderate
  • 18 minor

Most severe, free to view

  • Magnesium carbonateA02AA01severe
  • Magnesium hydroxideA02AA04severe
  • Kombinationen von AluminiumsalzenA02AB10severe
  • Calcium carbonateA02AC01severe

8 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • 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

Raltegravir in 15 other countries

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

All raltegravir products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Bulgaria · Raltegravir Viatris, Ралтегравир Зентива
  • Cyprus · Raltegravir Viatris
  • Germany · Raltegravir Axiromed, Raltegravir Beta
  • Denmark · Raltegravir Viatris, Raltegravir Zentiva
  • Estonia · Raltegravir Viatris, Raltegravir Zentiva
  • Spain · Raltegravir Dr. Reddys, Raltegravir Zentiva
  • Finland · Raltegravir Viatris, Raltegravir Zentiva
  • France · Raltegravir Biogaran, Raltégravir Biogaran
  • United Kingdom (Northern Ireland) · Raltegravir Amarox, Raltegravir Dr. Reddy's Laboratories (Uk)
  • Greece · Ralpecin, Raltegravir Viatris
  • Croatia · Raltegravir Viatris
  • Iceland · Isentress, Raltegravir Zentiva
  • Italy · Raltegravir Dr. Reddy’s, Raltegravir Mylan
  • Liechtenstein · Isentress
  • Lithuania · Raltegravir Zentiva
  • Latvia · Raltegravir Viatris, Raltegravir Zentiva
  • Malta · Raltegravir Viatris
  • Netherlands · Raltegravir Rockmed Pharma, Raltegravir Viatris
  • Norway · Isentress, Raltegravir Viatris
  • Poland · Raltegravir Viatris
  • Portugal · Raltegravir Mylan, Raltegravir Zentiva
  • Romania · Raltegravir Viatris, Raltegravir Zentiva
  • Sweden · Raltegravir Zentiva

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/f257f99a-48bc-494a-91f4-632ae4a1dca6
GET /v1/drugs/f257f99a-48bc-494a-91f4-632ae4a1dca6?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": [
    "J05AX",
    "J05AX08"
  ],
  "strength": null,
  "pa_number": "EU/1/07/436/1-2",
  "substances": [
    "Raltegravir potassium"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "20/12/2007",
  "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 raltegravir.

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