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Ireland· IE-PA-EU/1/16/1116/002

Epclusa 200 mg/50 mg film-coated tablets

A sofosbuvir and velpatasvir product containing sofosbuvir, registered in Ireland by Gilead Sciences Ireland UC. The same ATC class is registered in 16 of our 19 countries.

ATC J05AP55

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedEpclusa 200 mg/50 mg film-coated tabl…ATCJ05AP55REGISTER NO.IE-PA-EU/1/16/1116/002PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Sofosbuvir and velpatasvir is registered in 16 of 19 countries.

Countries holding a registration under ATC J05AP55 (sofosbuvir and velpatasvir), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 11 of them publish a price we can compare per daily dose

Sofosbuvir and velpatasvir · ATC J05AP55

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
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
Sofosbuvir
Manufacturer
Gilead Sciences Ireland UC
Country
Ireland (IE)
ATC code
J05AP55
ATC class
Sofosbuvir and velpatasvir
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/16/1116/002

Regulatory notes

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

Interactions

80 interactions on record for sofosbuvir and velpatasvir.

Graded by severity as the source publishes them — 14 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

Sofosbuvir and velpatasvir · interactions on record

80 records

  • 14 severe
  • 61 moderate
  • 5 minor

Most severe, free to view

  • OmeprazoleA02BC01severe
  • PantoprazoleA02BC02severe
  • LansoprazoleA02BC03severe
  • RabeprazoleA02BC04severe
  • 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

Sofosbuvir and velpatasvir in 14 other countries

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

All sofosbuvir and velpatasvir products

Authorised across Europe · EMA

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

  • Iceland · Sovaldi
  • Liechtenstein · Sovaldi
  • Norway · Sovaldi

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/4ddf2fa9-72d5-4b37-82fc-6faeed8a8e60
GET /v1/drugs/4ddf2fa9-72d5-4b37-82fc-6faeed8a8e60?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",
    "J05AP55"
  ],
  "strength": null,
  "pa_number": "EU/1/16/1116/002",
  "substances": [
    "Sofosbuvir"
  ],
  "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "25/08/2020",
  "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 sofosbuvir and velpatasvir.

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.