Ireland· IE-PA-EU/1/14/958/004
Harvoni 33.75 mg/150 mg Coated granules
A sofosbuvir and ledipasvir product containing ledipasvir + sofosbuvir, registered in Ireland by Gilead Sciences Ireland UC. The same ATC class is registered in 13 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Sofosbuvir and ledipasvir is registered in 13 of 19 countries.
Countries holding a registration under ATC J05AP51 (sofosbuvir and ledipasvir), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Sofosbuvir and ledipasvir · ATC J05AP51
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Ledipasvir + Sofosbuvir
- Manufacturer
- Gilead Sciences Ireland UC
- Country
- Ireland (IE)
- ATC code
- J05AP51
- ATC class
- Sofosbuvir and ledipasvir
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/14/958/004
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sofosbuvir and ledipasvir in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesHarvoniGilead Sciences, Inc
- CzechiaHARVONIGilead Sciences Ireland UC, Carrigtohill
- SwedenHarvoni 33,75 mg/150 mg Dragerat granulat i dospåseGilead Sciences Ireland UC
- United KingdomHarvoni 33.75mg/150mg granules sachetsGilead Sciences Ltd
- PolandHarvoniGilead Sciences Ireland UC
- NetherlandsHarvoni 33,75 mg/150 mg, granulaatGilead Sciences Ireland UC
- IcelandHarvoniGilead Sciences Ireland UC*
- FinlandHarvoniGilead Sciences Ireland UC
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Harvoni
- Liechtenstein · Harvoni
- Norway · Harvoni
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/a19cbfd3-c110-4a55-a6ae-bafd7f90c3f5 GET /v1/drugs/a19cbfd3-c110-4a55-a6ae-bafd7f90c3f5?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": "Granules",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"J05AP51"
],
"strength": null,
"pa_number": "EU/1/14/958/004",
"substances": [
"Ledipasvir",
"Sofosbuvir"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "03/07/2020",
"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 ledipasvir.
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.