Stem definition | Drug id | CAS RN |
---|---|---|
Raf (Rapidely Accelerated Fibrosarcoma) kinase inhibitors | 4801 | 1195765-45-7 |
Dose | Unit | Route |
---|---|---|
0.30 | g | O |
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Hosey CM, Chan R, Benet LZ |
Vd (Volume of distribution) | 0.65 L/kg | Lombardo F, Berellini G, Obach RS |
CL (Clearance) | 2.86 mL/min/kg | Lombardo F, Berellini G, Obach RS |
fu (Fraction unbound in plasma) | 0.00 % | Lombardo F, Berellini G, Obach RS |
t_half (Half-life) | 2.60 hours | Lombardo F, Berellini G, Obach RS |
Date | Agency | Company | Orphan |
---|---|---|---|
Aug. 26, 2013 | EMA | Novartis Europharm Limited | |
May 29, 2013 | FDA | NOVARTIS PHARMS CORP | |
March 28, 2016 | PMDA | Novartis Pharma K.K. |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Pyrexia | 1313.59 | 20.70 | 919 | 11373 | 379284 | 50213548 |
Malignant neoplasm progression | 705.52 | 20.70 | 339 | 11953 | 67785 | 50525047 |
Chills | 345.58 | 20.70 | 241 | 12051 | 96446 | 50496386 |
Uveitis | 240.43 | 20.70 | 89 | 12203 | 9221 | 50583611 |
Metastases to central nervous system | 227.30 | 20.70 | 90 | 12202 | 11192 | 50581640 |
Death | 201.88 | 20.70 | 315 | 11977 | 325064 | 50267768 |
Panniculitis | 127.69 | 20.70 | 55 | 12237 | 8448 | 50584384 |
Ejection fraction decreased | 102.66 | 20.70 | 61 | 12231 | 18459 | 50574373 |
Visual impairment | 89.41 | 20.70 | 96 | 12196 | 68179 | 50524653 |
Rash | 73.62 | 20.70 | 253 | 12039 | 437218 | 50155614 |
Blood creatine phosphokinase increased | 69.77 | 20.70 | 55 | 12237 | 26312 | 50566520 |
Erythema nodosum | 67.77 | 20.70 | 28 | 12264 | 3875 | 50588957 |
Dermatitis acneiform | 66.73 | 20.70 | 28 | 12264 | 4029 | 50588803 |
Drug ineffective | 66.67 | 20.70 | 61 | 12231 | 819272 | 49773560 |
Serous retinal detachment | 52.14 | 20.70 | 12 | 12280 | 225 | 50592607 |
Chorioretinopathy | 49.92 | 20.70 | 15 | 12277 | 811 | 50592021 |
Vogt-Koyanagi-Harada disease | 47.93 | 20.70 | 10 | 12282 | 116 | 50592716 |
Second primary malignancy | 46.93 | 20.70 | 26 | 12266 | 6888 | 50585944 |
Hyperpyrexia | 43.40 | 20.70 | 19 | 12273 | 3030 | 50589802 |
Vision blurred | 42.75 | 20.70 | 72 | 12220 | 78575 | 50514257 |
Product use in unapproved indication | 41.79 | 20.70 | 89 | 12203 | 115730 | 50477102 |
Drug hypersensitivity | 41.18 | 20.70 | 6 | 12286 | 251004 | 50341828 |
Metastatic malignant melanoma | 40.81 | 20.70 | 14 | 12278 | 1160 | 50591672 |
Erythema multiforme | 40.45 | 20.70 | 26 | 12266 | 9024 | 50583808 |
Metastases to meninges | 40.39 | 20.70 | 16 | 12276 | 1986 | 50590846 |
Iridocyclitis | 40.03 | 20.70 | 16 | 12276 | 2033 | 50590799 |
BRAF V600E mutation positive | 39.81 | 20.70 | 7 | 12285 | 29 | 50592803 |
Rash maculo-papular | 39.38 | 20.70 | 40 | 12252 | 26601 | 50566231 |
Melanoma recurrent | 38.57 | 20.70 | 8 | 12284 | 90 | 50592742 |
Malignant melanoma | 37.84 | 20.70 | 26 | 12266 | 10082 | 50582750 |
Vomiting | 37.72 | 20.70 | 215 | 12077 | 460543 | 50132289 |
Metastasis | 36.87 | 20.70 | 19 | 12273 | 4356 | 50588476 |
Nausea | 36.70 | 20.70 | 294 | 11998 | 705104 | 49887728 |
Skin toxicity | 35.90 | 20.70 | 18 | 12274 | 3895 | 50588937 |
Hyperkeratosis | 34.36 | 20.70 | 19 | 12273 | 5016 | 50587816 |
Blood lactate dehydrogenase increased | 33.81 | 20.70 | 32 | 12260 | 19530 | 50573302 |
Cutaneous sarcoidosis | 33.76 | 20.70 | 9 | 12283 | 314 | 50592518 |
Off label use | 33.15 | 20.70 | 40 | 12252 | 474386 | 50118446 |
Rhabdomyolysis | 31.54 | 20.70 | 43 | 12249 | 38984 | 50553848 |
Metastases to lung | 31.34 | 20.70 | 24 | 12268 | 10996 | 50581836 |
Dehydration | 30.73 | 20.70 | 94 | 12198 | 152355 | 50440477 |
Condition aggravated | 30.70 | 20.70 | 17 | 12275 | 297041 | 50295791 |
Systemic inflammatory response syndrome | 28.93 | 20.70 | 17 | 12275 | 5032 | 50587800 |
Myalgia | 28.24 | 20.70 | 80 | 12212 | 124239 | 50468593 |
Aspartate aminotransferase increased | 28.18 | 20.70 | 60 | 12232 | 77938 | 50514894 |
Vitreous floaters | 28.13 | 20.70 | 17 | 12275 | 5297 | 50587535 |
Palmar-plantar erythrodysaesthesia syndrome | 27.58 | 20.70 | 29 | 12263 | 20069 | 50572763 |
Squamous cell carcinoma | 26.84 | 20.70 | 19 | 12273 | 7720 | 50585112 |
Pneumonitis | 26.13 | 20.70 | 34 | 12258 | 29476 | 50563356 |
Retinal detachment | 26.10 | 20.70 | 16 | 12276 | 5113 | 50587719 |
Sinusitis | 25.91 | 20.70 | 5 | 12287 | 170553 | 50422279 |
C-reactive protein increased | 23.85 | 20.70 | 51 | 12241 | 66423 | 50526409 |
Abdominal discomfort | 22.86 | 20.70 | 14 | 12278 | 231627 | 50361205 |
Decreased appetite | 22.86 | 20.70 | 103 | 12189 | 200820 | 50392012 |
Haemophagocytic lymphohistiocytosis | 22.81 | 20.70 | 18 | 12274 | 8615 | 50584217 |
Keratoacanthoma | 22.61 | 20.70 | 7 | 12285 | 419 | 50592413 |
Leukoderma | 22.53 | 20.70 | 5 | 12287 | 79 | 50592753 |
Acute polyneuropathy | 22.30 | 20.70 | 6 | 12286 | 217 | 50592615 |
Electrocardiogram QT prolonged | 21.20 | 20.70 | 42 | 12250 | 51844 | 50540988 |
Alanine aminotransferase increased | 21.18 | 20.70 | 58 | 12234 | 88301 | 50504531 |
General physical health deterioration | 20.91 | 20.70 | 79 | 12213 | 142355 | 50450477 |
Basal cell carcinoma | 20.81 | 20.70 | 27 | 12265 | 23329 | 50569503 |
Infective glossitis | 20.74 | 20.70 | 4 | 12288 | 30 | 50592802 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Pyrexia | 1252.96 | 19.30 | 1034 | 12602 | 286588 | 29274303 |
Malignant neoplasm progression | 644.43 | 19.30 | 408 | 13228 | 73451 | 29487440 |
Chills | 370.13 | 19.30 | 287 | 13349 | 71013 | 29489878 |
Metastases to central nervous system | 355.62 | 19.30 | 131 | 13505 | 7000 | 29553891 |
Death | 193.51 | 19.30 | 460 | 13176 | 341624 | 29219267 |
Ejection fraction decreased | 192.43 | 19.30 | 109 | 13527 | 15869 | 29545022 |
Uveitis | 134.22 | 19.30 | 62 | 13574 | 5885 | 29555006 |
Metastases to liver | 89.32 | 19.30 | 60 | 13576 | 11796 | 29549095 |
Metastases to stomach | 74.44 | 19.30 | 15 | 13621 | 69 | 29560822 |
Visual impairment | 71.53 | 19.30 | 78 | 13558 | 29630 | 29531261 |
Second primary malignancy | 65.55 | 19.30 | 40 | 13596 | 6665 | 29554226 |
Basal cell carcinoma | 64.28 | 19.30 | 57 | 13579 | 16853 | 29544038 |
Squamous cell carcinoma | 61.19 | 19.30 | 45 | 13591 | 10206 | 29550685 |
Blood creatine phosphokinase increased | 60.91 | 19.30 | 84 | 13552 | 40560 | 29520331 |
Off label use | 58.72 | 19.30 | 33 | 13603 | 300767 | 29260124 |
Rash | 57.52 | 19.30 | 205 | 13431 | 189614 | 29371277 |
Metastases to lung | 54.99 | 19.30 | 38 | 13598 | 7817 | 29553074 |
Metastatic malignant melanoma | 54.07 | 19.30 | 23 | 13613 | 1792 | 29559099 |
Chorioretinopathy | 52.56 | 19.30 | 21 | 13615 | 1395 | 29559496 |
Melanoma recurrent | 51.66 | 19.30 | 12 | 13624 | 118 | 29560773 |
Metastases to peritoneum | 51.12 | 19.30 | 21 | 13615 | 1499 | 29559392 |
Blood lactate dehydrogenase increased | 50.75 | 19.30 | 53 | 13583 | 19156 | 29541735 |
Hyperpyrexia | 48.75 | 19.30 | 23 | 13613 | 2287 | 29558604 |
C-reactive protein increased | 48.46 | 19.30 | 79 | 13557 | 44184 | 29516707 |
Metastases to skin | 48.34 | 19.30 | 14 | 13622 | 344 | 29560547 |
Malignant melanoma | 46.30 | 19.30 | 33 | 13603 | 7128 | 29553763 |
Panniculitis | 44.94 | 19.30 | 18 | 13618 | 1203 | 29559688 |
Erythema nodosum | 42.07 | 19.30 | 16 | 13620 | 931 | 29559960 |
Serous retinal detachment | 41.89 | 19.30 | 13 | 13623 | 407 | 29560484 |
Metastases to bone | 38.88 | 19.30 | 34 | 13602 | 9864 | 29551027 |
Malignant mesenteric neoplasm | 38.51 | 19.30 | 8 | 13628 | 44 | 29560847 |
Hyperkeratosis | 38.50 | 19.30 | 22 | 13614 | 3247 | 29557644 |
Metastases to meninges | 38.33 | 19.30 | 16 | 13620 | 1189 | 29559702 |
Product use in unapproved indication | 35.44 | 19.30 | 104 | 13532 | 86771 | 29474120 |
Jejunal ulcer perforation | 35.28 | 19.30 | 8 | 13628 | 70 | 29560821 |
Drug interaction | 35.19 | 19.30 | 24 | 13612 | 197361 | 29363530 |
Metastases to lymph nodes | 34.31 | 19.30 | 22 | 13614 | 3995 | 29556896 |
Procalcitonin increased | 33.58 | 19.30 | 16 | 13620 | 1626 | 29559265 |
Fatigue | 33.02 | 19.30 | 254 | 13382 | 316567 | 29244324 |
Drug ineffective | 32.53 | 19.30 | 75 | 13561 | 363095 | 29197796 |
Metastasis | 32.35 | 19.30 | 20 | 13616 | 3409 | 29557482 |
Gastrointestinal wall thickening | 32.16 | 19.30 | 14 | 13622 | 1154 | 29559737 |
Haemophagocytic lymphohistiocytosis | 31.42 | 19.30 | 31 | 13605 | 10473 | 29550418 |
Metastases to heart | 30.68 | 19.30 | 8 | 13628 | 131 | 29560760 |
Brain neoplasm | 30.64 | 19.30 | 18 | 13618 | 2798 | 29558093 |
Tissue infiltration | 29.94 | 19.30 | 7 | 13629 | 71 | 29560820 |
Intestinal metastasis | 29.42 | 19.30 | 8 | 13628 | 155 | 29560736 |
Omental necrosis | 29.36 | 19.30 | 6 | 13630 | 30 | 29560861 |
Mesenteric neoplasm | 29.04 | 19.30 | 6 | 13630 | 32 | 29560859 |
Eastern Cooperative Oncology Group performance status | 28.88 | 19.30 | 6 | 13630 | 33 | 29560858 |
Ureteral disorder | 28.63 | 19.30 | 8 | 13628 | 172 | 29560719 |
Toxicity to various agents | 28.50 | 19.30 | 23 | 13613 | 173638 | 29387253 |
Decreased appetite | 28.16 | 19.30 | 137 | 13499 | 145205 | 29415686 |
Disease progression | 27.79 | 19.30 | 92 | 13544 | 81824 | 29479067 |
Vision blurred | 24.53 | 19.30 | 56 | 13580 | 40120 | 29520771 |
Anxiety | 24.09 | 19.30 | 5 | 13631 | 85360 | 29475531 |
Papilloedema | 23.08 | 19.30 | 14 | 13622 | 2306 | 29558585 |
Nausea | 21.77 | 19.30 | 216 | 13420 | 289039 | 29271852 |
Bacterial diarrhoea | 21.63 | 19.30 | 5 | 13631 | 48 | 29560843 |
Vomiting | 21.38 | 19.30 | 169 | 13467 | 212091 | 29348800 |
Tumour invasion | 20.91 | 19.30 | 7 | 13629 | 280 | 29560611 |
Inflammatory bowel disease | 20.59 | 19.30 | 13 | 13623 | 2298 | 29558593 |
Iridocyclitis | 20.55 | 19.30 | 11 | 13625 | 1429 | 29559462 |
Body temperature fluctuation | 20.48 | 19.30 | 11 | 13625 | 1439 | 29559452 |
Small intestine carcinoma | 20.42 | 19.30 | 8 | 13628 | 504 | 29560387 |
Leukoderma | 20.39 | 19.30 | 5 | 13631 | 63 | 29560828 |
Overdose | 19.95 | 19.30 | 6 | 13630 | 79813 | 29481078 |
Dermatitis acneiform | 19.85 | 19.30 | 18 | 13618 | 5473 | 29555418 |
Rectal polyp | 19.48 | 19.30 | 8 | 13628 | 570 | 29560321 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Pyrexia | 1955.22 | 18.07 | 1546 | 19976 | 557098 | 63920112 |
Malignant neoplasm progression | 1028.47 | 18.07 | 572 | 20950 | 112299 | 64364911 |
Chills | 513.41 | 18.07 | 399 | 21123 | 136865 | 64340345 |
Metastases to central nervous system | 411.60 | 18.07 | 160 | 21362 | 13752 | 64463458 |
Uveitis | 299.15 | 18.07 | 124 | 21398 | 12584 | 64464626 |
Ejection fraction decreased | 292.16 | 18.07 | 157 | 21365 | 28550 | 64448660 |
Death | 261.91 | 18.07 | 527 | 20995 | 482178 | 63995032 |
Panniculitis | 129.59 | 18.07 | 62 | 21460 | 8817 | 64468393 |
Blood creatine phosphokinase increased | 123.08 | 18.07 | 123 | 21399 | 58435 | 64418775 |
Squamous cell carcinoma | 101.01 | 18.07 | 61 | 21461 | 13808 | 64463402 |
Erythema nodosum | 93.95 | 18.07 | 39 | 21483 | 3965 | 64473245 |
Chorioretinopathy | 93.39 | 18.07 | 33 | 21489 | 2164 | 64475046 |
Blood lactate dehydrogenase increased | 91.60 | 18.07 | 81 | 21441 | 32997 | 64444213 |
Second primary malignancy | 89.17 | 18.07 | 54 | 21468 | 12283 | 64464927 |
Drug ineffective | 84.46 | 18.07 | 94 | 21428 | 840153 | 63637057 |
Rash | 83.69 | 18.07 | 338 | 21184 | 458211 | 64018999 |
Serous retinal detachment | 82.88 | 18.07 | 23 | 21499 | 675 | 64476535 |
Basal cell carcinoma | 82.38 | 18.07 | 74 | 21448 | 30764 | 64446446 |
Hyperpyrexia | 78.82 | 18.07 | 37 | 21485 | 5040 | 64472170 |
Metastases to liver | 77.24 | 18.07 | 64 | 21458 | 23877 | 64453333 |
Dermatitis acneiform | 74.33 | 18.07 | 42 | 21480 | 8401 | 64468809 |
Off label use | 72.47 | 18.07 | 63 | 21459 | 632743 | 63844467 |
Malignant melanoma | 71.89 | 18.07 | 48 | 21474 | 12916 | 64464294 |
C-reactive protein increased | 71.71 | 18.07 | 120 | 21402 | 94789 | 64382421 |
Metastases to lung | 67.07 | 18.07 | 49 | 21473 | 15215 | 64461995 |
Hyperkeratosis | 66.40 | 18.07 | 36 | 21486 | 6645 | 64470565 |
Melanoma recurrent | 66.37 | 18.07 | 15 | 21507 | 184 | 64477026 |
Metastatic malignant melanoma | 63.86 | 18.07 | 26 | 21496 | 2515 | 64474695 |
Metastases to stomach | 62.50 | 18.07 | 15 | 21507 | 243 | 64476967 |
Metastasis | 60.28 | 18.07 | 32 | 21490 | 5663 | 64471547 |
Metastases to meninges | 57.99 | 18.07 | 25 | 21497 | 2790 | 64474420 |
Iridocyclitis | 56.10 | 18.07 | 25 | 21497 | 3020 | 64474190 |
BRAF V600E mutation positive | 54.81 | 18.07 | 10 | 21512 | 36 | 64477174 |
Haemophagocytic lymphohistiocytosis | 54.57 | 18.07 | 46 | 21476 | 17563 | 64459647 |
Rash maculo-papular | 51.94 | 18.07 | 71 | 21451 | 46955 | 64430255 |
Visual impairment | 51.12 | 18.07 | 90 | 21432 | 73987 | 64403223 |
Drug interaction | 50.63 | 18.07 | 29 | 21493 | 362054 | 64115156 |
Cutaneous sarcoidosis | 50.34 | 18.07 | 14 | 21508 | 414 | 64476796 |
Condition aggravated | 49.06 | 18.07 | 32 | 21490 | 372394 | 64104816 |
Metastases to bone | 48.67 | 18.07 | 46 | 21476 | 20389 | 64456821 |
Procalcitonin increased | 47.66 | 18.07 | 21 | 21501 | 2470 | 64474740 |
Drug hypersensitivity | 46.73 | 18.07 | 11 | 21511 | 237804 | 64239406 |
Skin toxicity | 45.41 | 18.07 | 28 | 21494 | 6574 | 64470636 |
Metastases to lymph nodes | 45.28 | 18.07 | 31 | 21491 | 8686 | 64468524 |
Vogt-Koyanagi-Harada disease | 44.74 | 18.07 | 11 | 21511 | 198 | 64477012 |
Toxicity to various agents | 44.23 | 18.07 | 34 | 21488 | 363479 | 64113731 |
Metastases to skin | 43.97 | 18.07 | 17 | 21505 | 1435 | 64475775 |
Metastases to peritoneum | 43.49 | 18.07 | 22 | 21500 | 3525 | 64473685 |
Decreased appetite | 42.42 | 18.07 | 196 | 21326 | 281093 | 64196117 |
Product use in unapproved indication | 41.09 | 18.07 | 141 | 21381 | 176477 | 64300733 |
Rheumatoid arthritis | 40.41 | 18.07 | 4 | 21518 | 164290 | 64312920 |
Malignant mesenteric neoplasm | 39.81 | 18.07 | 8 | 21514 | 53 | 64477157 |
Vomiting | 38.83 | 18.07 | 315 | 21207 | 550802 | 63926408 |
Squamous cell carcinoma of skin | 38.82 | 18.07 | 32 | 21490 | 11844 | 64465366 |
Dehydration | 38.74 | 18.07 | 159 | 21363 | 216604 | 64260606 |
Aspartate aminotransferase increased | 38.44 | 18.07 | 107 | 21415 | 119681 | 64357529 |
Retinal detachment | 38.23 | 18.07 | 27 | 21495 | 7949 | 64469261 |
Jejunal ulcer perforation | 34.55 | 18.07 | 8 | 21514 | 110 | 64477100 |
Demyelinating polyneuropathy | 33.36 | 18.07 | 14 | 21508 | 1462 | 64475748 |
Vision blurred | 33.34 | 18.07 | 85 | 21437 | 90231 | 64386979 |
Pneumonitis | 33.21 | 18.07 | 60 | 21462 | 50305 | 64426905 |
Palmar-plantar erythrodysaesthesia syndrome | 32.56 | 18.07 | 44 | 21478 | 28775 | 64448435 |
Keratoacanthoma | 32.28 | 18.07 | 12 | 21510 | 910 | 64476300 |
Overdose | 32.09 | 18.07 | 7 | 21515 | 159559 | 64317651 |
Detachment of retinal pigment epithelium | 31.95 | 18.07 | 11 | 21511 | 667 | 64476543 |
Anxiety | 31.64 | 18.07 | 14 | 21508 | 202635 | 64274575 |
Blood alkaline phosphatase increased | 30.87 | 18.07 | 62 | 21460 | 56217 | 64420993 |
Eastern Cooperative Oncology Group performance status | 30.23 | 18.07 | 6 | 21516 | 37 | 64477173 |
General physical health deterioration | 29.72 | 18.07 | 141 | 21381 | 204284 | 64272926 |
Hypophysitis | 29.44 | 18.07 | 17 | 21505 | 3542 | 64473668 |
Metastases to adrenals | 29.31 | 18.07 | 12 | 21510 | 1177 | 64476033 |
Omental necrosis | 29.21 | 18.07 | 6 | 21516 | 45 | 64477165 |
BRAF gene mutation | 29.09 | 18.07 | 6 | 21516 | 46 | 64477164 |
Hepatocellular injury | 28.70 | 18.07 | 53 | 21469 | 45182 | 64432028 |
Gastrointestinal wall thickening | 28.60 | 18.07 | 14 | 21508 | 2091 | 64475119 |
Disease progression | 28.58 | 18.07 | 108 | 21414 | 141572 | 64335638 |
Palmoplantar keratoderma | 28.48 | 18.07 | 9 | 21513 | 417 | 64476793 |
Intestinal metastasis | 28.13 | 18.07 | 8 | 21514 | 257 | 64476953 |
Nausea | 27.83 | 18.07 | 391 | 21131 | 785409 | 63691801 |
Mesenteric neoplasm | 27.67 | 18.07 | 6 | 21516 | 60 | 64477150 |
Autoimmune colitis | 27.50 | 18.07 | 12 | 21510 | 1379 | 64475831 |
Hypersensitivity | 27.05 | 18.07 | 16 | 21506 | 196436 | 64280774 |
Abdominal lymphadenopathy | 26.52 | 18.07 | 11 | 21511 | 1115 | 64476095 |
Sinusitis | 26.28 | 18.07 | 8 | 21514 | 145920 | 64331290 |
Gamma-glutamyltransferase increased | 26.08 | 18.07 | 53 | 21469 | 48457 | 64428753 |
Tumour invasion | 25.82 | 18.07 | 8 | 21514 | 347 | 64476863 |
Myalgia | 25.72 | 18.07 | 113 | 21409 | 158504 | 64318706 |
Rhabdomyolysis | 25.63 | 18.07 | 78 | 21444 | 91648 | 64385562 |
Concomitant disease aggravated | 25.62 | 18.07 | 25 | 21497 | 11517 | 64465693 |
Alanine aminotransferase increased | 25.62 | 18.07 | 103 | 21419 | 138928 | 64338282 |
Papilloedema | 24.92 | 18.07 | 18 | 21504 | 5487 | 64471723 |
Metastases to heart | 24.67 | 18.07 | 7 | 21515 | 223 | 64476987 |
Therapeutic product effect incomplete | 24.22 | 18.07 | 3 | 21519 | 103479 | 64373731 |
Influenza like illness | 23.74 | 18.07 | 59 | 21463 | 61643 | 64415567 |
Dyspnoea | 23.62 | 18.07 | 142 | 21380 | 718532 | 63758678 |
Fatigue | 23.52 | 18.07 | 365 | 21157 | 748365 | 63728845 |
Ureteral disorder | 23.05 | 18.07 | 8 | 21514 | 497 | 64476713 |
Lipase increased | 22.71 | 18.07 | 26 | 21496 | 14376 | 64462834 |
Body temperature fluctuation | 22.71 | 18.07 | 14 | 21508 | 3284 | 64473926 |
Erysipelas | 22.69 | 18.07 | 21 | 21501 | 9060 | 64468150 |
Product dose omission issue | 22.67 | 18.07 | 19 | 21503 | 194728 | 64282482 |
Fall | 22.55 | 18.07 | 68 | 21454 | 416758 | 64060452 |
Erythema multiforme | 22.52 | 18.07 | 27 | 21495 | 15674 | 64461536 |
Blood pressure increased | 22.44 | 18.07 | 15 | 21507 | 172537 | 64304673 |
Intentional product use issue | 21.76 | 18.07 | 3 | 21519 | 95361 | 64381849 |
Weight increased | 21.15 | 18.07 | 24 | 21498 | 213324 | 64263886 |
Insomnia | 21.01 | 18.07 | 21 | 21501 | 197815 | 64279395 |
Joint swelling | 20.52 | 18.07 | 25 | 21497 | 215357 | 64261853 |
Paronychia | 20.20 | 18.07 | 17 | 21505 | 6475 | 64470735 |
Musculoskeletal stiffness | 20.04 | 18.07 | 8 | 21514 | 123198 | 64354012 |
Small intestine carcinoma | 19.39 | 18.07 | 8 | 21514 | 800 | 64476410 |
Left ventricular dysfunction | 19.32 | 18.07 | 26 | 21496 | 16928 | 64460282 |
Bacterial diarrhoea | 18.86 | 18.07 | 5 | 21517 | 123 | 64477087 |
Immunisation reaction | 18.36 | 18.07 | 4 | 21518 | 41 | 64477169 |
Disseminated intravascular coagulation | 18.17 | 18.07 | 36 | 21486 | 32312 | 64444898 |
Leukoderma | 18.17 | 18.07 | 5 | 21517 | 142 | 64477068 |
Tissue infiltration | 18.16 | 18.07 | 7 | 21515 | 586 | 64476624 |
None
Source | Code | Description |
---|---|---|
ATC | L01EC02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS B-Raf serine-threonine kinase (BRAF) inhibitors |
FDA MoA | N0000175076 | Protein Kinase Inhibitors |
MeSH PA | D000970 | Antineoplastic Agents |
MeSH PA | D004791 | Enzyme Inhibitors |
MeSH PA | D047428 | Protein Kinase Inhibitors |
FDA EPC | N0000175605 | Kinase Inhibitor |
FDA MoA | N0000185506 | Cytochrome P450 3A4 Inducers |
FDA MoA | N0000185507 | Cytochrome P450 2C9 Inducers |
FDA MoA | N0000185607 | Cytochrome P450 2C19 Inducers |
FDA MoA | N0000187063 | Cytochrome P450 2C8 Inducers |
FDA MoA | N0000187064 | Cytochrome P450 2B6 Inducers |
FDA MoA | N0000190107 | Organic Anion Transporting Polypeptide 1B1 Inhibitors |
FDA MoA | N0000190108 | Organic Anion Transporting Polypeptide 1B3 Inhibitors |
FDA MoA | N0000190110 | Organic Anion Transporter 1 Inhibitors |
FDA MoA | N0000190111 | Organic Anion Transporter 3 Inhibitors |
FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
CHEBI has role | CHEBI:35610 | antineoplastic agents |
CHEBI has role | CHEBI:75047 | BRAF inhibitors |
CHEBI has role | CHEBI:149553 | anticoronaviral drug |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Metastatic malignant melanoma | indication | 443493003 | |
Malignant Melanoma with BRAF V600E Mutation | indication | 830150003 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 8.56 | acidic |
pKa2 | 3.35 | Basic |
pKa3 | 0.43 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8835443 | June 10, 2025 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8835443 | June 10, 2025 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8835443 | June 10, 2025 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8835443 | June 10, 2025 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8835443 | June 10, 2025 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8835443 | June 10, 2025 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8835443 | June 10, 2025 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8835443 | June 10, 2025 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 9233956 | May 4, 2029 | TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 9233956 | May 4, 2029 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 9233956 | May 4, 2029 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 9233956 | May 4, 2029 | TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATIONS AFTER CONFIRMING THE PRESENCE OF BRAF V600E MUTATION |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 9233956 | May 4, 2029 | TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 9233956 | May 4, 2029 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 9233956 | May 4, 2029 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 9233956 | May 4, 2029 | TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATIONS AFTER CONFIRMING THE PRESENCE OF BRAF V600E MUTATION |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 7994185 | Jan. 20, 2030 | TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 7994185 | Jan. 20, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 7994185 | Jan. 20, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 7994185 | Jan. 20, 2030 | TREATMENT OF MELANOMA |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8415345 | Jan. 20, 2030 | TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8415345 | Jan. 20, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8415345 | Jan. 20, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8415345 | Jan. 20, 2030 | TREATMENT OF MELANOMA |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 7994185 | Jan. 20, 2030 | TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 7994185 | Jan. 20, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 7994185 | Jan. 20, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 7994185 | Jan. 20, 2030 | TREATMENT OF MELANOMA |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8415345 | Jan. 20, 2030 | TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8415345 | Jan. 20, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8415345 | Jan. 20, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8415345 | Jan. 20, 2030 | TREATMENT OF MELANOMA |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8703781 | Oct. 15, 2030 | TAFINLAR IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8703781 | Oct. 15, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8703781 | Oct. 15, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8703781 | Oct. 15, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8952018 | Oct. 15, 2030 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8703781 | Oct. 15, 2030 | TAFINLAR IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8703781 | Oct. 15, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8703781 | Oct. 15, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8703781 | Oct. 15, 2030 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 8952018 | Oct. 15, 2030 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST. |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 10869869 | Aug. 30, 2033 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | 10869869 | Aug. 30, 2033 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR 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 |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | Oct. 6, 2022 | ADDITION OF STUDY BRF117277, A NON-RANDOMIZED, OPEN-LABEL, MULTI-CENTER, MULTI-COHORT TRIAL OF DABRAFENIB PLUS TRAMETINIB IN SUBJECTS WITH BRAF MUTATION-POSITIVE MELANOMA THAT HAS METASTASIZED TO THE BRAIN |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | Oct. 6, 2022 | ADDITION OF STUDY BRF117277, A NON-RANDOMIZED, OPEN-LABEL, MULTI-CENTER, MULTI-COHORT TRIAL OF DABRAFENIB PLUS TRAMETINIB IN SUBJECTS WITH BRAF MUTATION-POSITIVE MELANOMA THAT HAS METASTASIZED TO THE BRAIN |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | June 22, 2024 | DABRAFENIB IN COMBINATION WITH TRAMETINIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | June 22, 2024 | DABRAFENIB IN COMBINATION WITH TRAMETINIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | April 30, 2025 | TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR 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 |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | April 30, 2025 | TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR 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 |
EQ 50MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | May 4, 2025 | TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS |
EQ 75MG BASE | TAFINLAR | NOVARTIS | N202806 | May 29, 2013 | RX | CAPSULE | ORAL | May 4, 2025 | TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Serine/threonine-protein kinase B-raf | Kinase | INHIBITOR | IC50 | 9.16 | WOMBAT-PK | CHEMBL | |||
Tyrosine-protein kinase ABL1 | Kinase | Kd | 5.81 | CHEMBL | |||||
Tyrosine-protein kinase Lck | Kinase | Kd | 6.11 | CHEMBL | |||||
Tyrosine-protein kinase Yes | Kinase | Kd | 5.89 | CHEMBL | |||||
Tyrosine-protein kinase Fyn | Kinase | Kd | 6.09 | CHEMBL | |||||
RAF proto-oncogene serine/threonine-protein kinase | Kinase | IC50 | 6.82 | CHEMBL | |||||
Cyclin-dependent kinase 1 | Kinase | Kd | 6.44 | CHEMBL | |||||
Cyclin-dependent kinase 2 | Kinase | Kd | 7.72 | CHEMBL | |||||
Tyrosine-protein kinase HCK | Kinase | Kd | 5.78 | CHEMBL | |||||
Tyrosine-protein kinase JAK2 | Kinase | Kd | 5.49 | CHEMBL | |||||
GTPase KRas | Enzyme | IC50 | 5.23 | CHEMBL | |||||
Tyrosine-protein kinase CSK | Kinase | Kd | 6.07 | CHEMBL | |||||
Hepatocyte growth factor receptor | Kinase | Kd | 5.79 | CHEMBL | |||||
Tyrosine-protein kinase Lyn | Kinase | Kd | 5.87 | CHEMBL | |||||
LIM domain kinase 1 | Kinase | Kd | 7.48 | CHEMBL | |||||
Cyclin-dependent-like kinase 5 | Kinase | Kd | 5.97 | CHEMBL | |||||
Serine/threonine-protein kinase PLK4 | Kinase | Kd | 6.28 | CHEMBL | |||||
Abelson tyrosine-protein kinase 2 | Kinase | Kd | 6.52 | CHEMBL | |||||
Tyrosine-protein kinase Fgr | Kinase | Kd | 5.81 | CHEMBL | |||||
Tyrosine-protein kinase FRK | Kinase | Kd | 6.14 | CHEMBL | |||||
Receptor-interacting serine/threonine-protein kinase 2 | Kinase | IC50 | 7.11 | CHEMBL | |||||
Cyclin-dependent kinase 16 | Kinase | Kd | 7.89 | CHEMBL | |||||
Activin receptor type-1B | Kinase | Kd | 6.22 | CHEMBL | |||||
TGF-beta receptor type-2 | Kinase | Kd | 5.60 | CHEMBL | |||||
Cyclin-dependent kinase 6 | Kinase | Kd | 6.50 | CHEMBL | |||||
Protein-tyrosine kinase 6 | Kinase | Kd | 5.85 | CHEMBL | |||||
Non-receptor tyrosine-protein kinase TNK1 | Kinase | Kd | 7.18 | CHEMBL | |||||
Cyclin-dependent kinase 17 | Kinase | Kd | 7.44 | CHEMBL | |||||
Mitogen-activated protein kinase kinase kinase MLT | Kinase | Kd | 6.74 | CHEMBL | |||||
LIM domain kinase 2 | Kinase | Kd | 7.09 | CHEMBL | |||||
Serine/threonine-protein kinase Nek1 | Kinase | Kd | 6.32 | CHEMBL | |||||
Maternal embryonic leucine zipper kinase | Kinase | Kd | 5.74 | CHEMBL | |||||
Serine/threonine-protein kinase SIK2 | Kinase | Kd | 6.19 | CHEMBL | |||||
Calcium/calmodulin-dependent protein kinase type IV | Kinase | Kd | 5.64 | CHEMBL | |||||
Mitogen-activated protein kinase kinase kinase 11 | Kinase | Kd | 6 | CHEMBL | |||||
Serine/threonine-protein kinase Nek9 | Kinase | Kd | 7.28 | CHEMBL | |||||
TGF-beta receptor type-1 | Kinase | IC50 | 5.43 | CHEMBL | |||||
Ephrin type-A receptor 1 | Kinase | Kd | 6.15 | CHEMBL | |||||
Serine/threonine-protein kinase D2 | Kinase | Kd | 7.47 | CHEMBL | |||||
Serine/threonine-protein kinase D3 | Kinase | Kd | 6.92 | CHEMBL | |||||
Receptor-interacting serine/threonine-protein kinase 1 | Kinase | IC50 | 4.27 | CHEMBL | |||||
Cyclin-dependent kinase 4 | Kinase | Kd | 6.90 | CHEMBL | |||||
Ephrin type-B receptor 6 | Kinase | Kd | 6.38 | CHEMBL | |||||
Serine/threonine-protein kinase/endoribonuclease IRE1 | Kinase | Kd | 5.84 | CHEMBL | |||||
Interleukin-1 receptor-associated kinase 1 | Kinase | Kd | 5.81 | CHEMBL | |||||
Serine/threonine-protein kinase ULK1 | Kinase | Kd | 6.73 | CHEMBL | |||||
Serine/threonine-protein kinase ULK3 | Kinase | Kd | 5.83 | CHEMBL | |||||
Serine/threonine-protein kinase SIK3 | Kinase | Kd | 5.70 | CHEMBL | |||||
Eukaryotic translation initiation factor 2-alpha kinase 1 | Kinase | Kd | 6.02 | CHEMBL | |||||
Dual specificity mitogen-activated protein kinase kinase 5 | Kinase | Kd | 5.64 | CHEMBL | |||||
Dual serine/threonine and tyrosine protein kinase | Kinase | IC50 | 4.53 | CHEMBL | |||||
Receptor-interacting serine/threonine-protein kinase 3 | Kinase | IC50 | 8.70 | CHEMBL | |||||
Serine/threonine-protein kinase A-Raf | Kinase | IC50 | 7.59 | CHEMBL | |||||
Serine/threonine-protein kinase/endoribonuclease IRE2 | Kinase | Kd | 6.94 | CHEMBL |
ID | Source |
---|---|
D10064 | KEGG_DRUG |
1195768-06-9 | SECONDARY_CAS_RN |
4032496 | VANDF |
CHEBI:75045 | CHEBI |
P06 | PDB_CHEM_ID |
CHEMBL2028663 | ChEMBL_ID |
CHEMBL2105729 | ChEMBL_ID |
CHEMBL523411 | ChEMBL_ID |
C561627 | MESH_SUPPLEMENTAL_RECORD_UI |
6494 | IUPHAR_LIGAND_ID |
9458 | INN_ID |
DB08912 | DRUGBANK_ID |
QGP4HA4G1B | UNII |
44462760 | PUBCHEM_CID |
1424911 | RXNORM |
203107 | MMSL |
29476 | MMSL |
29650 | MMSL |
d08103 | MMSL |
015042 | NDDF |
015043 | NDDF |
703641001 | SNOMEDCT_US |
703642008 | SNOMEDCT_US |
703646006 | SNOMEDCT_US |
C3467876 | UMLSCUI |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Tafinlar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0681 | CAPSULE | 75 mg | ORAL | NDA | 32 sections |
Tafinlar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0681 | CAPSULE | 75 mg | ORAL | NDA | 32 sections |
Tafinlar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0682 | CAPSULE | 50 mg | ORAL | NDA | 32 sections |
Tafinlar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0682 | CAPSULE | 50 mg | ORAL | NDA | 32 sections |