Ireland· IE-PA-EU/1/17/1221/001-012
Kisqali 200 mg film-coated tablets
A other antineoplastic agents product containing ribociclib, registered in Ireland by Novartis Europharm Limited. The same ATC class is registered in 5 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Ribociclib is registered in 5 of 19 countries.
Countries holding a registration under ATC L01X (other antineoplastic agents), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 3 of them publish a price we can compare per daily dose
Ribociclib · ATC L01X
5 / 19 countries
- Belgiumprice
- Canada
- Finlandprice
- Ireland
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Ribociclib
- Manufacturer
- Novartis Europharm Limited
- Country
- Ireland (IE)
- ATC code
- L01X
- ATC class
- OTHER ANTINEOPLASTIC AGENTS
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/17/1221/001-012
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ribociclib in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaKISQALINovartis Europharm Limited, Dublin
- United StatesKISQALINovartis Pharmaceuticals Corporation
- SpainKISQALI 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULANovartis Europharm Limited
- BelgiumKisqali 200 mgNovartis Europharm
- NetherlandsKisqali 200 mg filmomhulde tablettenNovartis Europharm Limited
- NorwayKisqaliNovartis Europharm Limited (1)
- PolandKisqaliNovartis Europharm Limited
- SwedenKisqali 200 mg Filmdragerad tablettNovartis Europharm Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Kisqali
- Liechtenstein · Kisqali
- Norway · Kisqali
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/d7f2c532-88b0-48ae-8ad6-7951a9d4ec0c GET /v1/drugs/d7f2c532-88b0-48ae-8ad6-7951a9d4ec0c?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": [
"L01X"
],
"strength": null,
"pa_number": "EU/1/17/1221/001-012",
"substances": [
"Ribociclib"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "22/08/2017",
"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 ribociclib.
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.