Ireland· IE-PA-EU/1/19/1389/001
Epidyolex 100 mg/ml oral solution
A other antiepileptics product containing cannabidiol, registered in Ireland by Jazz Pharmaceuticals Ireland Limited.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- CANNABIDIOL
- Manufacturer
- Jazz Pharmaceuticals Ireland Limited
- Country
- Ireland (IE)
- ATC code
- N03AX
- ATC class
- Other antiepileptics
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/19/1389/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Cannabidiol in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaEPIDYOLEXJazz Pharmaceuticals Ireland Ltd, Dublin
- United StatesEpidiolexJazz Pharmaceuticals, Inc.
- FinlandEpidyolexJazz Pharmaceuticals Ireland Limited
- FranceEPIDYOLEX 100 mg/mL, solution buvableJAZZ PHARMACEUTICALS IRELAND LIMITED (IRLANDE)
- BelgiumEpidyolex 100 mg/mlJazz Pharmaceuticals Ireland
- NetherlandsEpidyolex 100 mg/ml, drankJazz Pharmaceuticals Ireland Limited
- NorwayEpidyolexJazz Pharmaceuticals Ireland Limited
- PolandEpidyolexJazz Pharmaceuticals Ireland Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Epidyolex
- Liechtenstein · Epidyolex
- Norway · Epidyolex
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/eb45d0c2-ea42-4aaa-a6cd-34c296abaf30 GET /v1/drugs/eb45d0c2-ea42-4aaa-a6cd-34c296abaf30?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": "Oral solution",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"N03AX"
],
"strength": null,
"pa_number": "EU/1/19/1389/001",
"substances": [
"CANNABIDIOL"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "19/09/2019",
"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 cannabidiol.
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.