France· FR:61477322
TAFINLAR 50 mg, gélule
A medicinal product containing mésilate de dabrafénib, registered in France by NOVARTIS EUROPHARM (IRLANDE), on the national reimbursement list.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- MÉSILATE DE DABRAFÉNIB
- Manufacturer
- NOVARTIS EUROPHARM (IRLANDE)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cip133400927549670flacon(s) polyéthylène haute densité (PEHD) de 120 gélule(s)EUR 3
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mésilate de dabrafénib in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandTafinlarNovartis Europharm Limited
- CzechiaTAFINLARNovartis Europharm Limited, Dublin
- SwitzerlandTafinlar 50 mg, HartkapselnNovartis Pharma Schweiz AG
- United KingdomTafinlar 50mg capsulesNovartis Pharmaceuticals UK Ltd
- IrelandTafinlar 50 mg hard capsulesNovartis Europharm Limited
- 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 Base de données publique des médicaments — BDPM (France). 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/c89b10b5-8d96-4329-a1f9-91b4717a205f GET /v1/drugs/c89b10b5-8d96-4329-a1f9-91b4717a205f?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.
{
"cis": "61477322",
"date_amm": "2013-08-26",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/13/865",
"substance": "MÉSILATE DE DABRAFÉNIB",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "gélule",
"voies_administration": "orale",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about mésilate de dabrafénib.
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.