Ireland· IE-PA-EU/1/13/865/001-002
Tafinlar 50 mg hard capsules
A dabrafenib product containing dabrafenib, registered in Ireland by Novartis Europharm Limited.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Dabrafenib
- Manufacturer
- Novartis Europharm Limited
- Country
- Ireland (IE)
- ATC code
- L01XE23
- ATC class
- Dabrafenib
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/13/865/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
522 interactions on record for dabrafenib.
Graded by severity as the source publishes them — 79 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
Dabrafenib · interactions on record
522 records
- 79 severe
- 430 moderate
- 13 minor
Most severe, free to view
- LonafarnibA16AX20severe
- AvatrombopagB02BX08severe
- VoxelotorB06AX03severe
- RanolazineC01EB18severe
- 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
Dabrafenib in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandTafinlarOrifarm Oy
- CzechiaTAFINLARNovartis Europharm Limited, Dublin
- SwitzerlandTafinlar 50 mg, HartkapselnNovartis Pharma Schweiz AG
- FranceTAFINLAR 50 mg, géluleNOVARTIS EUROPHARM (IRLANDE)
- United KingdomTafinlar 50mg capsulesNovartis Pharmaceuticals UK Ltd
- IcelandTafinlarNovartis Europharm Limited*
- NetherlandsTafinlar 50 mg, harde capsulesNovartis Europharm Limited
- NorwayTafinlarNovartis Europharm Limited (1)
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Finlee, Tafinlar
- Liechtenstein · Finlee, Tafinlar
- Norway · Finlee, Tafinlar
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/c0332156-1a2c-446a-8625-d2e06adb8844 GET /v1/drugs/c0332156-1a2c-446a-8625-d2e06adb8844?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": "Capsule, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"L01XE23"
],
"strength": null,
"pa_number": "EU/1/13/865/001-002",
"substances": [
"Dabrafenib"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "26/08/2013",
"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 dabrafenib.
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.