Spain· ES:1231767001
FINLEE 10 MG COMPRIMIDOS DISPERSABLES
A medicinal product containing dabrafenib, registered in Spain by Novartis Europharm Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- dabrafenib
- Manufacturer
- Novartis Europharm Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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.
- BelgiumFinlee 10 mgNovartis Europharm
- CanadaTAFINLARNOVARTIS PHARMACEUTICALS CANADA INC
- SwitzerlandTafinlar 10 mg, Tablette zur Herstellung einer Suspension zum EinnehmenNovartis Pharma Schweiz AG
- FinlandFinleeNovartis Europharm Limited
- FranceFINLEE 10 mg, comprimé dispersibleNOVARTIS EUROPHARM (IRLANDE)
- United KingdomFinlee 10mg dispersible tabletsNovartis Pharmaceuticals UK Ltd
- IrelandFinlee 10 mg dispersible tabletsNovartis Europharm Limited
- NetherlandsFinlee 10 mg, dispergeerbare tablettenNovartis Europharm Limited
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 AEMPS CIMA (Spain). 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/a630d62b-6db6-4beb-aafa-7ba231922d46 GET /v1/drugs/a630d62b-6db6-4beb-aafa-7ba231922d46?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.
{
"cpresc": "Diagnóstico Hospitalario",
"estado": "{\"aut\":1712927161000}",
"nregistro": "1231767001",
"substance": "dabrafenib"
}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.