Ireland· IE-PA-EU/1/98/073/003
Evista 60 mg film coated tablets
A other sex hormones and modulators of the genital system product containing raloxifene, registered in Ireland by Substipharm.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Raloxifene
- Manufacturer
- Substipharm
- Country
- Ireland (IE)
- ATC code
- G03X
- ATC class
- OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/98/073/003
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Raloxifene in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United Statesraloxifene hydrochlorideGlenmark Pharmaceuticals Inc., USA
- SpainEVISTA 60 MG COMPRIMIDOS RECUBIERTOS CON PELICULASubstipharm
- CzechiaEVISTASubstipharm, Paris
- FranceEVISTA 60 mg, comprimé pelliculéSUBSTIPHARM
- SwedenEvista 60 mg Filmdragerad tablettSubstipharm
- BelgiumOptruma 60 mgEli Lilly Nederland
- FinlandEvistaParanova Oy
- NetherlandsEvista 60 mg, omhulde tablettenSubstipharm
Authorised across Europe · EMA
The same active substance is authorised in 16 EEA countries. Names it is sold under:
- Austria · Raloxifen Stada
- Cyprus · Ostiral
- Germany · Raloxifen Al, Raloxifen-Hcl Hexal
- Spain · Raloxifeno Aurovitas, Raloxifeno Cinfamed
- France · Raloxifene Arrow, Raloxifene Biogaran
- United Kingdom (Northern Ireland) · Evirex, Ostiral
- Greece · Ostiral
- Hungary · Clastellos, Raloxibone
- Iceland · Evista, Optruma
- Italy · Raloxifene Sandoz
- Liechtenstein · Evista, Optruma
- Netherlands · Raloxifeenhydrochloride Brillpharma, Raloxifene Hydrochloride Aurobindo
- Norway · Evista, Optruma
- Portugal · Raloxifeno Ciclum, Raloxifeno Exeltis
- Romania · Raloxifen Arena
- Sweden · Raloxifen Stada
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/b984126c-e865-4047-aec1-d40c8dbb32f5 GET /v1/drugs/b984126c-e865-4047-aec1-d40c8dbb32f5?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": null,
"source": "hpra",
"atc_all": [
"G03X"
],
"strength": null,
"pa_number": "EU/1/98/073/003",
"substances": [
"Raloxifene"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "05/08/1998",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about raloxifene.
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.