Trametinib (Mekinist)

Trade Name : Mekinist

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 0.5 mg/1

TRAMETINIB DIMETHYL SULFOXIDE Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Trametinib (Mekinist) which is also known as Mekinist and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 0.5 mg/1 per ml. Read more

Trametinib (Mekinist) 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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About GNH

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No data

MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-nau00efve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. (, )
MEKINIST is indicated, in combination with dabrafenib, for:

the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. (, )n
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. (, )n
the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. (, )
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

No data

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

Tablets:
Tablets: 0.5u00a0mg, 2u00a0mg ()

None.
None. ()

No data

New Primary Malignancies, Cutaneous, and Non-cutaneous,
Hemorrhage
Colitis and Gastrointestinal Perforation
Venous Thromboembolism
Cardiomyopathy
Ocular Toxicities
Interstitial Lung Disease (ILD)
Serious Febrile Reactions
Serious Skin Toxicity
Hyperglycemia
Embryo-Fetal Toxicityn- u00a0
5.12n- 8.1n- 8.3

The following clinically significant adverse reactions are described elsewhere in the labeling:
There are additional adverse reactions associated with dabrafenib. Refer to the dabrafenib 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 MEKINIST administered as a single agent in 329 patients with various solid tumors and exposure to MEKINIST administered with dabrafenib in 559 patients with unresectable or metastatic melanoma and 93 patients with NSCLC. MEKINIST as a single agent was evaluated in 329 patients including 107 (33%) exposed for u2265 6 months and 30 (9%) exposed for u2265 one year. MEKINIST as a single agent was studied in open-label, single-arm trials (N = 118) and in an open-label, randomized, active-controlled trial (N = 211; the METRIC study). The median age was 54 years, 60% were male, > 99% were white, and all patients had unresectable or metastatic melanoma. All patients received 2 mg once-daily doses of MEKINIST.
Unresectable or Metastatic BRAF V600E or V600K Mutation-Positive Melanoma
MEKINIST as a Single Agent
The safety of MEKINIST was evaluated in the METRIC study, a randomized, open-label trialu00a0of patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma receiving MEKINIST (Nu00a0=u00a0211) 2u00a0mg orally once daily or chemotherapy (Nu00a0=u00a099) (either dacarbazine 1000u00a0mg/mu00a0every 3u00a0weeks or paclitaxel 175u00a0mg/m every 3u00a0weeks)u00a0. Patients with abnormal LVEF, history of acute coronary syndrome within 6u00a0months, or current evidence of Class II or greater congestive heart failure (New York Heart Association) were excluded. The median duration of treatment with MEKINIST was 4.3u00a0months.
In this study, 9% of patients receiving MEKINIST experienced adverse reactions resulting in permanent discontinuation of trial medication. The most frequent adverse reactions resulting in permanent discontinuation of MEKINIST were decreased LVEF, pneumonitis, renal failure, diarrhea, and rash. Adverse reactions led to dose reductions in 27% of patients treated with MEKINIST. Rash and decreased LVEF were the most frequent reasons cited for dose reductions of MEKINIST. Tables 3 and 4 present adverse reactions and laboratory abnormalities, respectively, of MEKINIST as a single agent in the METRIC study.
Other clinically important adverse reactions observed in u2264 10% of patients (N = 329) receiving MEKINIST were:
Cardiac:
Gastrointestinal:
Infections:
Musculoskeletal and Connective Tissue:
Nervous System:
Ocular:
MEKINIST with Dabrafenib
The safety of MEKINIST, administered with dabrafenib, was evaluated in 559 patients with previously untreated, unresectable or metastatic, BRAF V600 mutation-positive melanoma who received MEKINIST 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 both trials, patients received MEKINIST 2 mg orally once daily and dabrafenib 150 mg orally twice daily until disease progression or unacceptable toxicity. The 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 RVO or RPED, QTcB interval u2265 480 msec, uncontrolled hypertension, uncontrolled arrhythmias, active brain metastases, or known history of glucose-6-phosphate dehydrogenase deficiency.
Among these 559 patients, 197 (35%) were exposed to MEKINIST for > 6 months to 12 months, while 185 (33%) were exposed to MEKINIST for > 1 year. The median age was 55 years (range: 18 to 91), 57% were male, and 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 MEKINIST in patients receiving MEKINIST plus dabrafenib were: pyrexia, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema.
The demographics and baseline tumor characteristics of patients enrolled in the COMBI-d studyu00a0are summarized in Clinical Studies . Patients receiving MEKINIST plus dabrafenib had a median duration of exposure of 11u00a0months (range: 3u00a0days to 30u00a0months) to MEKINIST. Among the 209 patients receiving MEKINIST plus dabrafenib, 26% were exposed to MEKINIST for > 6u00a0months to 12u00a0months while 46% were exposed to MEKINIST for > 1u00a0year.
In the COMBI-d study, adverse reactions leading to discontinuation of MEKINIST occurred in 11% of patients receiving MEKINIST plus dabrafenib; the most frequent were pyrexia (1.4%) and decreased ejection fraction (1.4%). Adverse reactions leading to dose reductions of MEKINIST occurred in 18% of patients receiving MEKINIST plus dabrafenib; the most frequent were pyrexia (2.9%), neutropenia (1.9%), decreased ejection fraction (1.9%), and rash (1.9%). Adverse reactions leading to dose interruptions of MEKINIST occurred in 46% of patients receiving MEKINIST plus dabrafenib; the most frequent were pyrexia (18%), chills (7%), vomiting (6%), and decreased ejection fraction (4.8%).
Table 5 and Table 6 present selected adverse reactions and laboratory abnormalities, respectively, of MEKINIST observed in the COMBI-d study.
Other clinically important adverse reactionsu00a0for MEKINIST observed in less than 10% of patients receiving MEKINIST in combination with dabrafenib (Nu00a0=u00a0559) were:
Cardiac:
Musculoskeletal:
Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma
The safety of MEKINIST when administered with dabrafenib 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 MEKINIST 2 mg orally once daily and dabrafenib 150 mg orally twice daily for 12 months. The trial excluded patients with abnormal LVEF; 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 RVO.
Patients receiving MEKINIST in combination with dabrafenib had a median duration of exposure of 11 months (range: 0 to 12) to MEKINIST. Among the 435 patients receiving MEKINIST in combination with dabrafenib, 72% were exposed to MEKINIST for > 6 months. The median age of patients who received MEKINIST in combination with dabrafenib 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 1.
The most common adverse reactions (u2265 20%) in patients receiving MEKINIST in combination with dabrafenib were: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia.
Adverse reactions resulting in discontinuation and dose interruptions of MEKINIST occurred in 24% and 54% of patients, respectively; the most frequent for each were pyrexia and chills. Adverse reactions leading to dose reductions of MEKINIST occurred in 23% of patients; the most frequent were pyrexia and decreased ejection fraction.
Table 7 summarizes adverse reactions that occurred in at least 20% of the patients receiving MEKINIST in combination with dabrafenib.
Other clinically important adverse reactions observed in less than 20% of patients in the COMBI-AD study receiving MEKINIST in combination with dabrafenib were: blurred vision (6%), decreased ejection fraction (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 MEKINIST when administered with dabrafenib was evaluated in 93 patients with previously untreated (n = 36) and previously treated (n = 57) metastatic BRAF V600E mutation-positive NSCLC in a multicenter, multi-cohort, non-randomized, open-label trial (Study BRF113928). Patients received MEKINIST 2 mg orally once daily and dabrafenib 150 mg orally twice daily until disease progression or unacceptable toxicity. The trial 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), QTc interval u2265 480 msec, treatment refractory hypertension, uncontrolled arrhythmias, active brain metastases, history of ILD or pneumonitis, or history or current RVO n
Among these 93 patients, 53 (57%) were exposed to for > 6u00a0months and 27 (29%) were exposed to MEKINIST and dabrafenib for u2265 1u00a0year. The median age was 65u00a0years (range: 41 to 91), 46% were male, 85% were white;u00a032% had baseline ECOG performance status 0 and 61% had ECOG performance status 1; 98% 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, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea.
Adverse reactions resulting in discontinuation of MEKINIST occurred in 19% 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 MEKINIST occurred in 30% of patients receiving MEKINIST plus dabrafenib; the most frequent were pyrexia (5%), nausea (4.3%), vomiting (4.3%), diarrhea (3.2%), and neutropenia (3.2%). Adverse reactions leading to dose interruptions of MEKINIST occurred in 57% of patients receiving MEKINIST plus dabrafenib; the most frequent were pyrexia (16%), vomiting (10%), neutropenia (8%), nausea (5%), and decreased ejection fraction (5%).
Table 9 and Table 10 present adverse reactions and laboratory abnormalities, respectively, of MEKINIST in combination with dabrafenib in Study BRF113928.
Locally Advanced or Metastatic, BRAF V600E Mutation-Positive, Anaplastic Thyroid Cancer
The safety of MEKINIST when administered with dabrafenib 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 MEKINIST or dabrafenib. Patients received MEKINIST 2 mg orally once daily and dabrafenib 150 mg orally twice daily until disease progression or unacceptable toxicity.
Among these 100 patients, 46 (46%) were exposed to MEKINIST and dabrafenib for > 6 months and 23 (23%) were exposed to MEKINIST and dabrafenib 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 MEKINIST as a single agent include rash, diarrhea, and lymphedema. ()
Most common adverse reactions (u2265 20%) for MEKINIST with dabrafenib include:
nttttttttttTo 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, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema. (n n n
Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia. ()
NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea. ()nttttttttt

MEKINIST is indicated for use in combination with dabrafenib. Refer to the dabrafenib labeling for additional risk information that applies to combination use treatment.

No data

Lactation:
Females and Males of Reproductive Potential:

The highest doses of MEKINIST evaluated in clinical trials were 4 mg orally once daily and 10 mg administered orally once daily on 2 consecutive days followed by 3 mg once daily. In seven patients treated on one of these two schedules, there were two cases of RPEDs for an incidence of 28%.
Since trametinib is highly bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with MEKINIST.

Trametinib dimethyl sulfoxide is a kinase inhibitor. The chemical name is acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4- iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl- 2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]-, compound with 1,1u2019-sulfinylbis[methane] (1:1). It has a molecular formula CHFINOu2022CHOS with a molecular mass of 693.53 g/mol. Trametinib dimethyl sulfoxide has the following chemical structure:
Trametinib dimethyl sulfoxide is a white to almost white powder. It is practically insoluble in the pH range of 2 to 8 in aqueous media.
MEKINIST (trametinib) tablets for oral use are supplied as 0.5u00a0mg and 2u00a0mg tablets for oral administration. Each 0.5u00a0mg tablet contains 0.5635u00a0mg trametinib dimethyl sulfoxide equivalent to 0.5u00a0mg of trametinib non-solvated parent. Each 2u00a0mg tablet contains 2.254u00a0mg trametinib dimethyl sulfoxide equivalent to 2u00a0mg of trametinib non-solvated parent.
The inactive ingredients of MEKINIST tablets are: u00a0colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate (vegetable source), mannitol, microcrystalline cellulose, and sodium lauryl sulfate. hypromellose, iron oxide red (2u00a0mg tablets), iron oxide yellow (0.5u00a0mg tablets), polyethylene glycol, polysorbate 80 (2u00a0mg tablets), and titanium dioxide.

No data

Carcinogenicity studies with trametinib have not been conducted. Trametinib was not genotoxic in studies evaluating reverse mutations in bacteria, chromosomal aberrations in mammalian cells, and micronuclei in the bone marrow of rats.
Trametinib may impair fertility in humans. In female rats given trametinib for up to 13u00a0weeks, increased follicular cysts and decreased corpora lutea were observed at doses u2265 0.016u00a0mg/kg/day (approximately 0.3 times the human exposure at the recommended dose based on AUC). In rat and dog toxicity studies up to 13u00a0weeks in duration, there were no treatment effects observed on male reproductive tissuesu00a0.ntttttttt

No data

0.5u00a0mg tablets: Yellow, modified oval, biconvex, film-coated tablets with u2018GSu2019 debossed on one face and u2018TFCu2019 on the opposing face and are available in bottles of 30 (NDC 0078-0666-15).
2u00a0mg tablets: Pink, round, biconvex, film-coated tablets with u2018GSu2019 debossed on one face and u2018HMJu2019 on the opposing face and are available in bottles of 30 (NDC 0078-0668-15).
Store refrigerated at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F). Dispense in original bottle. Do not remove desiccant. Protect from moisture and light. Do not place medication in pill boxes.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
New Cutaneous and Non-cutaneous Malignancies
Advise patients that MEKINIST administered with dabrafenib can result in the development of new primary cutaneous and non-cutaneous malignancies. Advise patients to contact their doctor immediately for any new lesions, changes to existing lesions on their skin, or other signs and symptoms of malignancies .
Hemorrhage
Advise patients that MEKINIST administered with dabrafenib increases the risk of intracranial and gastrointestinal hemorrhage. Advise patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of unusual bleeding or hemorrhage n n n .
Colitis and Gastrointestinal Perforation
Advise patients that MEKINIST can cause colitis and gastrointestinal perforation and to contact their healthcare provider for signs or symptoms of colitis or gastrointestinal perforation .
Venous Thrombosis
Advise patients that MEKINIST administered with dabrafenib increases the risks of PE and DVT. Advise patients to seek immediate medical attention for sudden onset of difficulty breathing, leg pain, or swelling .
Cardiomyopathy
Advise patients that MEKINIST can cause cardiomyopathy and to immediately report any signs or symptoms of heart failure to their healthcare provider n n n n .
Retinal n- Pigmentn- Epithelial Detachment
Advise patients that MEKINIST can cause severe visual disturbances that can lead to blindness and to contact their healthcare provider if they experience any changes in their vision n n n n n .
Interstitial Lung Disease
Advise patients that MEKINIST can cause ILD (or pneumonitis). Advise patients to contact their healthcare provider as soon as possible if they experience signs such as cough or dyspnea .
Serious Febrile Reactions
Advise patients that MEKINIST administered with dabrafenib can cause serious febrile reactions. Instruct patients to contact their healthcare provider if they develop fever while taking MEKINIST with dabrafenib n n n
Serious Skin Toxicities
Advise patients that MEKINIST can cause serious skin toxicities which may require hospitalization and to contact their healthcare provider for progressive or intolerable rash n n n n .
Hypertension
Advise patients that MEKINIST can cause hypertension and that they need to undergo blood pressure monitoring and to contact their healthcare provider if they develop symptoms of hypertension such as severe headache, blurry vision, or dizziness.
Diarrhea
Advise patients that MEKINIST often causes diarrhea which may be severe in some cases. Inform patients of the need to contact their healthcare provider if severe diarrhea occurs during treatment.
Embryo-Fetal Toxicity
Lactation
ntttttttAdvise women not to breastfeed during treatment with MEKINIST and for 4 months after the last dose n
Infertility
ntttttttAdvise females of reproductive potential of the potential risk for impaired fertility n
Administration
ntttttttMEKINIST should be taken at least 1 hour before or at least 2 hours after a meal .ntttttt
THxID BRAF assay 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
T2019-114

No data

PRINCIPAL DISPLAY PANEL
NDC 0078-0666-15
Mekinistn
(trametinib) Tablets
0.5 mg*
Rx only
30 Tablets
Novartis

PRINCIPAL DISPLAY PANEL
NDC 0078-0668-15
Mekinistn
(trametinib) Tablets
2 mg*
Rx only
30 Tablets
Novartis

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Trametinib (Mekinist)

Trade Name : Mekinist

TABLET, FILM COATED

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

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Trametinib (Mekinist)

Trade Name : Mekinist

TABLET, FILM COATED

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)

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