Ireland· IE-PA-EU/1/13/894/001-002
Sovaldi 400 mg film-coated tablets
A sofosbuvir product containing sofosbuvir, registered in Ireland by Gilead Sciences Ireland UC.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Sofosbuvir
- Manufacturer
- Gilead Sciences Ireland UC
- Country
- Ireland (IE)
- ATC code
- J05AX15
- ATC class
- Sofosbuvir
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/13/894/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
11 interactions on record for sofosbuvir.
Graded by severity as the source publishes them — 4 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 · interactions on record
11 records
- 4 severe
- 5 moderate
- 1 minor
Most severe, free to view
- LorlatinibL01ED05severe
- LorlatinibL01XE44severe
- EnzalutamideL02BB04severe
- ApalutamideL02BB05severe
1 more interaction 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.
Same medicine, other countries
Sofosbuvir in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSOVALDIGilead Sciences Ireland UC, Carrigtohill
- SwitzerlandSovaldi 400 mg, FilmtablettenGilead Sciences Switzerland Sàrl
- SpainSOVALDI 400mg comprimidos recubiertos con peliculaGilead Sciences Ireland Unlimited Company
- FinlandSovaldiGilead Sciences Ireland UC
- FranceSOVALDI 400 mg, comprimé pelliculéGILEAD SCIENCES IRELAND UC (IRLANDE)
- IcelandSovaldiGilead Sciences Ireland UC*
- NetherlandsSovaldi 400 mg filmomhulde tablettenGilead Sciences Ireland UC
- NorwaySovaldiGilead Sciences Ireland UC
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/25eccc14-539f-44d2-9c6f-75623cbfc724 GET /v1/drugs/25eccc14-539f-44d2-9c6f-75623cbfc724?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",
"J05AX15"
],
"strength": null,
"pa_number": "EU/1/13/894/001-002",
"substances": [
"Sofosbuvir"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": null,
"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.
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.