Ireland· IE-PA-PA25377/001/001
Sativex oromucosal spray
A cannabinoide (inkl. spasmolytika) product containing delta-9-tetrahydrocannabinol botanical drug substance (thc bds) + cannabidiol, registered in Ireland by CNX Therapeutics Ireland Limited. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Cannabinoide (inkl. spasmolytika) is registered in 11 of 19 countries.
Countries holding a registration under ATC N02BG10 (cannabinoide (inkl. spasmolytika)), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Cannabinoide (inkl. spasmolytika) · ATC N02BG10
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Delta-9-tetrahydrocannabinol botanical drug substance (thc bds) + CANNABIDIOL
- Manufacturer
- CNX Therapeutics Ireland Limited
- Country
- Ireland (IE)
- ATC code
- N02BG10
- ATC class
- Cannabinoide (inkl. Spasmolytika)
- Defined daily dose
- 42 mg, SL
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA25377/001/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Cannabinoide (inkl. spasmolytika) in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NorwaySativex2care4 ApS
- GermanySativexCnx Therapeutics Ireland Limited
- SpainSATIVEX 2,7 MG/2,5 MG SOLUCION PARA PULVERIZACION BUCALCnx Therapeutics Ireland Limited
- United KingdomSativex oromucosal spraySVX Therapeutics Ltd
- IcelandSativexCNX Therapeutics Ireland Limited
- NetherlandsSativex, spray voor oromucosaal gebruikCNX Therapeutics Ireland Limited
- CanadaSATIVEXJAZZ PHARMACEUTICALS OPERATIONS UK LIMITED
- PolandSativexCNX Therapeutics lreland Ltd.
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Austria · Sativex
- Belgium · Sativex
- Czechia · Sativex
- Germany · Sativex
- Denmark · Sativex
- Spain · Sativex
- Finland · Sativex
- France · Sativex
- United Kingdom (Northern Ireland) · Sativex
- Greece · Avidekel/ Tikun, Capjera
- Iceland · Sativex
- Luxembourg · Sativex
- Netherlands · Sativex
- Norway · Sativex
- Slovakia · Sativex
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/6e620a83-e509-4dd6-a016-a032fbbc9911 GET /v1/drugs/6e620a83-e509-4dd6-a016-a032fbbc9911?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": "Oromucosal spray, solution",
"routes": [
"Oromucosal use"
],
"source": "hpra",
"atc_all": [
"N02B",
"N02BG10"
],
"strength": null,
"pa_number": "PA25377/001/001",
"substances": [
"Delta-9-tetrahydrocannabinol botanical drug substance (thc bds)",
"CANNABIDIOL"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "18/07/2014",
"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 cannabinoide (inkl. spasmolytika).
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.