Is Dabrafenib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Dabrafenib, including TAFINLAR 50MG CAPSULE(28) (50 mg, Capsule, hard, SAR 2821.45); TAFINLAR 75MG CAPSULE(28) (75 mg, Capsule, hard, SAR 4142.10).

Is Dabrafenib approved by the US FDA?

Drugs@FDA lists 4 application product lines for Dabrafenib, including TAFINLAR (Prescription); TAFINLAR (Prescription); TAFINLAR (Prescription); TAFINLAR (Prescription).

Is Dabrafenib authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Dabrafenib: Tafinlar, Finlee.

Are there safety signals or safety updates for Dabrafenib?

EMA PRAC: 14 entries; US FDA: 2 entries (latest 2026-03-26).

Active substance

Dabrafenib

SFDA 4
US FDA 4
EMA 2
Health Canada 3
Safety 16

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TAFINLAR 50MG CAPSULE(28)	50 mg	Capsule, hard · Oral use	28 Bottle	SAR 2821.45	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
TAFINLAR 75MG CAPSULE(28)	75 mg	Capsule, hard · Oral use	28 Bottle	SAR 4142.10	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
TAFINLAR 50MG CAPSULE(120)	50 mg	Capsule, hard · Oral use	120 Bottle	SAR 12091.95	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Withdrawn by MAH · Not Marketed
TAFINLAR 75MG CAPSULE(120)	75 mg	Capsule, hard · Oral use	120 Bottle	SAR 17751.80	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

GASTRIC CANCER; MALIGNANT NEOPLASM OF THE PANCREAS; MELANOMA; NEUROENDOCRINE TUMORS; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; THYROID CANCER-ANAPLASTIC CARCINOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TAFINLAR	EQ 50MG BASE; EQ 75MG BASE	capsule · oral	NOVARTIS	Prescription	29 May 2013
TAFINLAR	EQ 10MG BASE	tablet, for suspension · oral	NOVARTIS	Prescription	16 Mar 2023
TAFINLAR	75MG	capsule · oral	NOVARTIS	Prescription	16 Mar 2023
TAFINLAR	10MG	tablet · oral suspension	NOVARTIS	Prescription	16 Mar 2023

EMA European Union — centrally authorised medicines

Tafinlar Novartis Europharm Limited · Authorised · authorised 26 Aug 2013 · ATC L01EC02

Therapeutic indication (EMA)

Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).

Finlee Novartis Europharm Limited · Authorised · authorised 15 Nov 2023 · ATC L01EC02

Therapeutic indication (EMA)

Low-grade glioma Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. High-grade glioma Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TAFINLAR	02409607	50 MG	CAPSULE · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
TAFINLAR	02409615	75 MG	CAPSULE · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
TAFINLAR	02540053	10 MG	TABLET FOR SUSPENSION · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 26 Mar 2026 TAFINLAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Mar 2026 TAFINLAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 4 Sep 2025 PRAC signal: Tattoo associated skin reaction
Action for MAH: update of the product information: Yes
EMA PRAC 13 Mar 2025 PRAC signal: Tattoo associated skin reaction
Action for MAH: update of the product information: No
EMA PRAC 16 May 2024 PRAC signal: Acute febrile neutrophilic dermatosis
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jan 2024 PRAC signal: Acute febrile neutrophilic dermatosis
Action for MAH: update of the product information: No
EMA PRAC 30 Nov 2023 PRAC signal: Peripheral neuropathy
Action for MAH: update of the product information: Yes
EMA PRAC 6 Jul 2023 PRAC signal: Peripheral neuropathy
Action for MAH: update of the product information: No
EMA PRAC 13 Jan 2023 PRAC signal: Haemophagocytic lymphohistiocytosis
Action for MAH: update of the product information: Yes
EMA PRAC 1 Sep 2022 PRAC signal: Haemophagocytic lymphohistiocytosis
Action for MAH: update of the product information: No
EMA PRAC 29 Oct 2020 PRAC signal: Sarcoidosis
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jul 2020 PRAC signal: Sarcoidosis
Action for MAH: update of the product information: No
EMA PRAC 14 May 2020 PRAC signal: Disseminated intravascular coagulation (DIC)
Action for MAH: update of the product information: No
EMA PRAC 16 Jan 2020 PRAC signal: Disseminated intravascular coagulation (DIC)
Action for MAH: update of the product information: No
EMA PRAC 9 Jun 2017 PRAC signal: Sepsis
Action for MAH: update of the product information: No

All safety entries for dabrafenib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.