Dabrafenib (Tafinlar)

Trade Name : Tafinlar

Novartis Pharmaceuticals Corporation

CAPSULE

Strength 75 mg/1

DABRAFENIB MESYLATE Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Dabrafenib (Tafinlar) which is also known as Tafinlar and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 75 mg/1 per ml. Read more

Dabrafenib (Tafinlar) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma withu00a0BRAF V600E mutation as detected by an FDA-approved test. (, )
TAFINLAR is indicated, in combination with trametinib, for:
Limitations of Use

the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. (, )nttttttttt
the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. (, )
the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. (, )n
the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. (, )nttttttttt

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The recommended dosage of TAFINLAR is 150u00a0mg orally twice daily. Take TAFINLAR at least 1u00a0hour before or at least 2u00a0hours after a meal. ()

Capsules:
Capsules: 50u00a0mg, 75u00a0mg ()

None.

None. ()

No data

New Primary Malignancies, Cutaneous, and Non-cutaneous
Tumor Promotion in BRAF Wild-type Tumors:
Hemorrhage
Cardiomyopathy
Uveitis
Serious Febrile Reactions
Serious Skin Toxicity
Hyperglycemia
Glucose-6-phosphate Dehydrogenase Deficiency (G6PD):
Embryo-Fetal Toxicity

The following clinically significant adverse reactions are described elsewhere in the labeling:
There are additional adverse reactions associated with trametinib. Refer to the trametinib prescribing information for additional information.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described in the Warnings and Precautions section reflect exposure to TAFINLAR administered as a single agent in 586 patients with various solid tumors and exposure to TAFINLAR administered with trametinib in 559 patients with unresectable or metastatic melanoma and 93 patients with NSCLC.u00a0The safety of TAFINLAR as a single agent was evaluated in 586 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, previously treated or untreated, who received TAFINLAR 150u00a0mg orally twice daily until disease progression or unacceptable toxicity, including 181 patients treated for at least 6u00a0months and 86 additional patients treated for more than 12u00a0months. TAFINLAR was studied in open-label, single-arm trials and in an open-label, randomized, active-controlled trial. The median daily dose of TAFINLAR was 300u00a0mg (range: 118 to 300u00a0mg).
Metastatic or Unresectable BRAF V600E or V600K Mutation-Positive Melanoma
TAFINLAR as a Single Agent
The safety of TAFINLAR was evaluated in BREAK-3, a multicenter, international, open-label, randomized (3:1), controlled trial allocated 250 patients with unresectable or metastatic BRAF V600E mutation-positive melanoma to receive TAFINLAR 150 mg orally twice daily (n = 187) or dacarbazine 1000 mg/m intravenously every 3 weeks (n = 63) . The trial excluded patients with abnormal left ventricular ejection fraction (LVEF) or cardiac valve morphology (u2265 Grade 2), corrected QT interval u2265 480 milliseconds on electrocardiogram, or a known history of glucose-6-phosphate dehydrogenase deficiency. The median duration on treatment was 4.9 months for patients treated with TAFINLAR and 2.8 months for dacarbazine-treated patients. The population exposed to TAFINLAR was 60% male, 99% white, and had a median age of 53 years.
The most common adverse reactions (u2265 20%) in patients treated with TAFINLAR were, in order of decreasing frequency: hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and palmar-plantar erythrodysesthesia syndrome (PPES).
The incidence of adverse events resulting in permanent discontinuation of study medication in the BREAK-3 study was 3% for patients treated with TAFINLAR and 3% for patients treated with dacarbazine. The most frequent (u2265 2%) adverse reactions leading to dose reduction of TAFINLAR were pyrexia (9%), PPES (3%), chills (3%), fatigue (2%), and headache (2%). Table 3 and Table 4 present adverse reactions and laboratory abnormalities, respectively, of TAFINLAR as a single agent in the BREAK-3 study.
Other clinically important adverse reactions observed in less than 10% of patients (Nu00a0=u00a0586) treated with TAFINLAR were:
Gastrointestinal:
Immune System:
Renal and Urinary:
TAFINLAR with Trametinib
The safety of TAFINLAR when administered with trametinib was evaluated in 559 patients with previously untreated, unresectable or metastatic, BRAF V600E or V600K mutation-positive melanoma who received TAFINLAR in two trials, the COMBI-d study (n = 209) a multicenter, double-blind, randomized (1:1), active controlled trial and the COMBI-v study (n = 350) a multicenter, open-label, randomized (1:1), active controlled trial. In the COMBI-d and COMBI-v studies, patients received TAFINLAR 150 mg orally twice daily and trametinib 2 mg orally once daily until disease progression or unacceptable toxicity. Both trials excluded patients with abnormal LVEF, history of acute coronary syndrome within 6 months, history of Class II or greater congestive heart failure (New York Heart Association), history of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED), QTcB interval u2265 480 msec, treatment refractory hypertension, uncontrolled arrhythmias, active brain metastases, or a known history of G6PD deficiency n
Among these 559 patients, 199 (36%) were exposed to TAFINLAR for > 6 months to 12 months while 185 (33%) were exposed to TAFINLAR for u2265 1 year. The median age was 55 years (range: 18 to 91), 57% were male, 98% were white, 72% had baseline ECOG performance status 0 and 28% had ECOG performance status 1, 64% had M1c stage disease, 35% had elevated lactate dehydrogenase (LDH) at baseline and 0.5% had a history of brain metastases.
The most common adverse reactions (u2265 20%) for TAFINLAR in patients receiving TAFINLAR plus trametinib in the COMBI-d and COMBI-v studiesu00a0were: pyrexia, rash, chills, headache, arthralgia, and cough. The demographics and baseline tumor characteristics of patients enrolled in the COMBI-d study are summarized in Clinical Studies . Patients receiving TAFINLAR plus trametinib had a median duration of exposure of 11u00a0months (range: 3u00a0daysu00a0to 30u00a0months) to TAFINLAR. Among the 209 patients receiving TAFINLAR plus trametinib, 26% were exposed to TAFINLAR for > 6u00a0months to 12u00a0months while 46% were exposed to TAFINLAR for > 1u00a0year.
In the COMBI-d study, adverse reactions resulting in discontinuation of TAFINLAR occurred in 11% of patients receiving TAFINLAR plus trametinib; the most frequent was pyrexia (1.9%). Adverse reactions leading to dose reductions of TAFINLAR occurred in 26% of patients receiving TAFINLAR plus trametinib; the most frequent were pyrexia (14%), neutropenia (1.9%), rash (1.9%), and chills (1.9%). Adverse reactions leading to dose interruptions of TAFINLARu00a0occurred in 56% of patients receiving TAFINLAR plus trametinib; the most frequent were pyrexia (35%), chills (11%), vomiting (7%), nausea (5%), and decreased ejection fraction (5%).u00a0
Table 5 and Table 6 present adverse reactions and laboratory abnormalities, respectively, observed in the COMBI-d study.
Other clinically important adverse reactions for TAFINLAR across the COMBI-d and COMBI-v studiesu00a0(Nu00a0=u00a0559) observed in less than 10% of patients receiving TAFINLAR in combination with trametinib were:
Gastrointestinal:
Subcutaneous Tissue:
Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma
The safety of TAFINLAR when administered with trametinib was evaluated in 435 patients with Stage III melanoma with BRAF V600E or V600K mutations following complete resection who received at least one dose of study therapy in the COMBI-AD study []. Patients received TAFINLAR 150 mg orally twice daily and trametinib 2 mg orally once daily for 12 months. The trial excluded patients with abnormal left ventricular ejection fraction; history of acute coronary syndromes, coronary angioplasty, or stenting within 6 months; Class II or greater congestive heart failure (New York Heart Association); QTc interval u2265 480 msec; treatment-refractory hypertension; uncontrolled arrhythmias; or history of retinal vein occlusion. The median age of patients who received TAFINLAR in combination with trametinib was 50 years (range: 18 to 89), 56% were male, 99% were white, 92% had baseline ECOG performance status 0, and 8% had baseline ECOG performance status of 1. Patients receiving TAFINLAR in combination with trametinib had a median duration of exposure of 11 months (range: 0 to 12) to TAFINLAR. Among the 435 patients receiving TAFINLAR in combination with trametinib, 71% were exposed to TAFINLAR for > 6 months.
The most common adverse reactions (u2265 20%) in patients receiving TAFINLAR in combination with trametinib were: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia.
Adverse reactions resulting in discontinuation, dose reduction, or dose interruption of TAFINLAR occurred in 25%, 35%, and 66% of patients, respectively; the most frequent for each were pyrexia and chills.
Table 7 summarizes adverse reactions that occurred in at least 20% of patients receiving TAFINLAR in combination with trametinib.
Other clinically important adverse reactions observed in less than 20% of patients in the COMBI-AD study receiving TAFINLAR in combination with trametinib were blurred vision (6%), ejection fraction decreased (5%), and rhabdomyolysis (< 1%).
The laboratory abnormalities are summarized in Table 8.
Metastatic, BRAF V600E-Mutation Positive Non-Small Cell Lung Cancer
The safety of TAFINLAR when administered with trametinib was evaluated in 93 patients with previously untreated (nu00a0=u00a036) and previously treated (nu00a0=u00a057) metastatic BRAF V600E mutation-positive NSCLC in a multicenter, multi-cohort, non-randomized, open-label trial (Study BRF113928). Patients received TAFINLAR 150u00a0mg orally twice daily and trametinib 2u00a0mg orally once daily until disease progression or unacceptable toxicity. The trial excluded patients with abnormal left ventricular ejection fraction, history of acute coronary syndrome within 6u00a0months, history of Class II or greater congestive heart failure (New York Heart Association), QTc interval u2265 480u00a0msec, treatment refractory hypertension, uncontrolled arrhythmias, active brain metastases, history of interstitial lung disease or pneumonitis, or history or current retinal vein occlusionu00a0n
Among these 93 patients, 53 (57%) were exposed to TAFINLAR and trametinib for > 6u00a0months andu00a027 (29%) were exposed to TAFINLAR and trametinib for u2265 1u00a0year. The median age was 65u00a0years (range: 41 to 91); 46% were male; 85% were white; 32% had baseline ECOG performance status 0 andu00a061% had ECOG performance status 1;u00a098% had non-squamous histology; and 12% were current smokers, 60% were former smokers, and 28% had never smoked.
The most common adverse reactions (u2265 20%) in these 93 patients were: pyrexia, fatigue, nausea, vomiting,u00a0diarrhea,u00a0dry skin,u00a0decreased appetite, edema, rash,u00a0chills, hemorrhage, cough, and dyspnea.
Adverse reactions resulting in discontinuation of TAFINLAR occurred in 18% of patients; the most frequent were pyrexia (2.2%), decreased ejection fraction (2.2%), and respiratory distress (2.2%). Adverse reactions leading to dose reductions of TAFINLAR occurred in 35% of patients; the most frequent were pyrexia (10%), diarrhea (4.3%), nausea (4.3%), vomiting (4.3%), and neutropenia (3.2%). Adverse reactions leading to dose interruptions of TAFINLAR occurred in 62% of patients; the most frequent were pyrexia (27%), vomiting (11%), neutropenia (8%), and chills (6%).
Table 9 and Table 10 present adverse reactions and laboratory abnormalities, respectively, of TAFINLAR in combination with trametinib in Study BRF113928.
Other clinically important adverse reactions for TAFINLAR observed in less than 10% of patients with NSCLC receiving TAFINLAR in combination with trametinib were:
Gastrointestinal:
Renal and Urinary:
Locally Advanced or Metastatic, BRAF V600E-Mutation Positive Anaplastic Thyroid Cancer
The safety of TAFINLAR when administered with trametinib was evaluated in a nine-cohort, multicenter, non-randomized, open-label study in patients with rare cancers with the BRAF V600E mutation, including locally advanced or metastatic ATC (Study BRF117019). At the time of the safety analysis, a total of 100 patients were enrolled in the trial, 16 of whom were enrolled in the ATC cohort. The primary safety population included all patients who received at least one dose of TAFINLAR or trametinib. Patients received TAFINLAR 150 mg orally twice daily and trametinib 2 mg orally once daily until disease progression or unacceptable toxicity.
Among these 100 patients, 46 (46%) were exposed to TAFINLAR and trametinib for > 6 months and 23 (23%) were exposed to TAFINLAR and trametinib for u2265 1 year. The median age was 59.5 years (range: 18 to 85); 62% were male; 85% were white; and 31% had baseline ECOG performance status 0 and 59% had ECOG performance status 1.
The adverse reaction profile among all patients and among patients in the ATC cohort was similar to that observed in other approved indications.
Most common adverse reactions (u2265 20%) for TAFINLAR as a single agent are hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and palmar-plantar erythrodysesthesia syndrome. ()
Most common adverse reactions (u2265 20%) for TAFINLAR, in combination with trametinib,u00a0include:
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .

Unresectable or metastatic melanoma: pyrexia, rash, chills, headache, arthralgia, and cough. ()n
Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia. ()n
NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite,u00a0edema, rash, chills, hemorrhage, cough, and dyspnea. ()

No data

Avoid concurrent administration of strong inhibitors of CYP3A4 or CYP2C8. ()n
Concomitant use with agents that are sensitive substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19, or CYP2B6 may result in loss of efficacy of these agents. ()

No data

Lactation:
Females and Males of Reproductive Potential:

There is no information on overdosage of TAFINLAR.u00a0Since dabrafenib is highly bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with TAFINLAR.

Dabrafenib mesylate is a kinase inhibitor. The chemical name for dabrafenib mesylate is N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene sulfonamide, methanesulfonate salt. It has the molecular formula CHFNOSu2022CHOS and a molecular weight of 615.68 g/mol. Dabrafenib mesylate has the following chemical structure:
Dabrafenib mesylate is a white to slightly colored solid with three pKs: 6.6, 2.2, and -1.5. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media.
TAFINLARu00a0(dabrafenib) capsules for oral use are supplied as 50u00a0mg andu00a075u00a0mg capsules for oral administration. Each 50u00a0mg capsule contains 59.25u00a0mg dabrafenib mesylate equivalent to 50u00a0mg of dabrafenib free base. Each 75u00a0mg capsule contains 88.88u00a0mg dabrafenibu00a0mesylate equivalent to 75u00a0mg of dabrafenib free base. The inactive ingredients of TAFINLAR are colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Capsule shells containu00a0hypromellose, red iron oxide (E172), and titanium dioxide (E171).

No data

No data

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50u00a0mg capsules:u00a0Dark red capsule imprinted with u2018GSu00a0TEWu2019 and u201850u00a0mgu2019 available in bottles of 120 (NDC 0078-0682-66). Each bottle contains a silica gel desiccant.
75u00a0mg capsules:u00a0Dark pink capsule imprinted with u2018GSu00a0LHFu2019 and u201875u00a0mgu2019 available in bottles of 120 (NDC 0078-0681-66). Each bottle contains a silica gel desiccant.
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00baC to 30u00b0C (59u00baF to 86u00b0F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
New Cutaneous and Non-cutaneous Malignancies
Advise patients that TAFINLAR increases the risk of developing new primary cutaneous and non-cutaneous malignancies. Advise patients to contact their healthcare provider immediately for any new lesions, changes to existing lesions on their skin, or signs and symptoms of other malignancies .
Hemorrhage
Advise patients that TAFINLAR when administered with trametinib increases the risk of intracranial and gastrointestinal hemorrhage and to contact their healthcare provider to seek immediate medical attention for signs or symptoms of unusual bleeding or hemorrhage n n n .
Cardiomyopathy
Advise patients that TAFINLAR can cause cardiomyopathy and to immediately report any signs or symptoms of heart failure to their healthcare provider n n n n .
Uveitis
Advise patients that TAFINLAR can cause uveitis, including iritis and iridocyclitis and to contact their healthcare provider if they experience any changes in their vision .
Serious Febrile Reactions
Advise patients that TAFINLAR can cause pyrexia including serious febrile reactions. Inform patients that the incidence and severity of pyrexia are increased when TAFINLAR is given in combination with trametinib. Instruct patients to contact their healthcare provider if they develop fever while taking TAFINLAR n n n
Serious Skin Toxicities
Advise patients that TAFINLAR can cause serious skin toxicities and to contact their healthcare provider for progressive or intolerable rash n n n n .
Hyperglycemia
Advise patients that TAFINLAR can impair glucose control in diabetic patients resulting in the need for more intensive hypoglycemic treatment and to contact their healthcare provider to report symptoms of severe hyperglycemia n n .
Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency
Advise patients that TAFINLAR may cause hemolytic anemia in patients with G6PD deficiency. Advise patients with known G6PD deficiency to contact their healthcare provider to report signs or symptoms of anemia or hemolysis n n n n n .ntttttt
Embryo-Fetal Toxicity
Infertility
ntttttttAdvise males and females of reproductive potential of the potential risk for impaired fertility with TAFINLAR n
Lactation
ntttttttAdvise women not to breastfeed during treatment with TAFINLAR and for 2 weeks after the last dose of TAFINLAR n
Administration
ntttttttInstruct patients to take TAFINLAR at least 1 hour before or at least 2 hours after a meal .ntttttt
THxID is a trademark of bioMu00e9rieux.
Oncomine Dx Target Test is a trademark of Life Technologies Corporation, a part of Thermo Fisher Scientific Inc.
Distributed by: Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9 Novartis
T2019-113

No data

PRINCIPAL DISPLAY PANEL
NDC 0078-0682-66
Tafinlar (Dabrafenib) Capsules
50 mg
Rx only
120 Capsules
Dispense with Medication Guide attached or provided separately.
NOVARTIS

PRINCIPAL DISPLAY PANEL
NDC 0078-0681-66
Tafinlar (Dabrafenib) Capsules
75 mg
Rx only
120 Capsules
Dispense with Medication Guide attached or provided separately.
NOVARTIS

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Dabrafenib (Tafinlar)

Trade Name : Tafinlar

CAPSULE

Delivery Process

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Packaging and Delivery

About GNH

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Dabrafenib (Tafinlar)

Trade Name : Tafinlar

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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