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| ××× ×× ×× × ×ספ××
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| ×§×××¦× ×¤×¨××§×××××ת (ATC4)
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L01XE Protein kinase inhibitors
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| ×ר××× ×¤×¢×× (ATC5)
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Â
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| צ×רת ×ת×
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פ××× - PER OS
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| צ×רת ××× ××
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קפס××× ×§×©×××, HARD CAPSULE ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
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| ×ת××××
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Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Non-small cell lung cancer (NSCLC)Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.Adjuvant treatment of melanoma :Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with BRAF V600 mutation, following complete resection.BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid CancerTAFINLAR 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 optionsBRAF V600E Mutation-Positive Unresectable or Metastatic Solid TumorsTafinlar is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Limitations of Use: Dabrafenib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is indicated, in combination with trametinib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy
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| × ×ª×× × ×ס×
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ת×ר×× ××××× ×ס×
- 12/01/2014
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×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
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×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
|
| ×ש×××× ×¢× Trametinib ×××פ×× ××××××× ××ר×× × ×××× (Low grade glioma) ×××××× ×× × ×©× × ×××¢×× ×¢× ×××צ×× ×ס×× BRAF V600E, ××§× ××פ×× ×¨×ש×× ×××××. |
17/03/2024 |
××× ×§×××××× |
|
×××××× ××ר×× × ××××, Low grade glioma |
|
| ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×©××× ××ר×× × ×××× (Low grade ovarian cancer) ×× × ×ª×× ×× ×ר××¨×ª× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת. |
01/02/2023 |
××× ×§×××××× |
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Low grade ovarian cancer, סר×× ×©××× ××ר×× × ×××× |
|
| ×ש×××× ×¢× Trametinib ×××פ×× ×××× ×קרצ×× ××× ×©× ×××¢× ×××§ (Adenocarcinoma of the small intestine) ×× × ×ª××× ×× ×ר×רת×ת ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת. |
01/02/2023 |
××× ×§×××××× |
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Adenocarcinoma of the small intestine, ××× ×קרצ×× ××× ×©× ×××¢× ×××§ |
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| ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×ª×ר×××× ×¤×¤×××¨× (Papillary thyroid cancer) ×× × ×ª×× ×× ×ר××¨×ª× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת. |
01/02/2023 |
××× ×§×××××× |
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PTC, Papillary thyroid cancer, סר×× ××××ת תר×ס פפ×××¨× |
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| ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×©× ×ר×× ×××¨× (Biliary tract cancer) ×× × ×ª×× ×× ×ר××¨×ª× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת. |
01/02/2023 |
××× ×§×××××× |
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Biliary tract cancer, BTC, סר×× ×©× ×ר×× ×××¨× |
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| ×ש×××× ×¢× Trametinib ×××פ×× ×××××××ס×××× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת. |
01/02/2023 |
××× ×§×××××× |
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Ameloblastoma, ××××××ס×××× |
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| ×ש×××× ×¢× Trametinib ×××פ×× ××××××× ××ר×× ××××× (high grade glioma) ×× × ×ª××× ×× ×ר×רת×ת ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת |
01/02/2023 |
××× ×§×××××× |
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High grade glioma, ×××××× ××ר×× ××××× |
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| ×ש×××× ×¢× Trametinib ×××פ×× ××××××× ××ר×× × ×××× (low grade glioma) ×× × ×ª××× ×× ×ר×רת×ת ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת. |
01/02/2023 |
××× ×§×××××× |
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Low grade glioma, ×××××× ××ר×× × ×××× |
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| ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×¨××× ×תק×× ×ס×× BRAF V600 mutated NSCLC. |
30/01/2020 |
××× ×§×××××× |
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NSCLC, Non small cell lung cancer |
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| ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×ª×ר×××× ×ס×× BRAF mutated ATC, ×תק×× ××§××× ×× ×ר×רת×, ××××× ×©×××¦× ×ת ××פצ××ת ×××פ×× ××§××××ת. |
30/01/2020 |
××× ×§×××××× |
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ATC, Anaplastic thyroid cancer |
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| ×ש×××× ×¢× Trametinib ×××פ×× ×ש××× (Adjuvant) ×××× ××× ×ש×× III ×××ר ××¡×¨× ×××× ×©× ×××××× ××××× ××××× ×××צ×× ×-BRAF. ××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×. |
16/01/2019 |
××× ×§×××××× |
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××× ××× ×ש×× III × ×ª×× |
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| ××× ××× ×תק××ת (×ר×רת×ת ×× ×©××× × × × ×ª×××) ××××× ××××× ×××צ×× ×-BRAF |
12/01/2014 |
××× ×§×××××× |
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××× ××× ×תק××ת (×ר×רת×ת ×× ×©××× × × ×ª×××)
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ש×××ש ×ס×
-
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×ס×רת ××××× ×ס×
- ×תר××¤× ×ª×× ×ª× ×××פ×× ××קר×× ××××:
- ××× ××× ×תק××ת (×ר×רת×ת ×× ×©××× × × × ×ª×××) ××××× ××××× ×××צ×× ×-BRAF
- ×ש×××× ×¢× Trametinib ×××פ×× ×ש××× (Adjuvant) ×××× ××× ×ש×× III ×××ר ××¡×¨× ×××× ×©× ×××××× ××××× ××××× ×××צ×× ×-BRAF.
××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×. ××××× ××××ª× ×××× ××××× ×××× ×××פ×× ×תר××¤× ××ת ×××× ××תר×פ×ת ××פ×ר××ת ×××× - Encorafenib, Dabrafenib, Vemurafenib. ××¢× ××× ×× ××× ××× ×ש×× ×תק×× (×× × ×ª×× ×× ×ר×רת×) ×× ×ª×××ר ××××ª× ×××× ××× ××× ××× ×ש×× ×ר ××¡×¨× ×× ×ת××
- ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×ª×ר×××× ×ס×× BRAF mutated ATC, ×תק×× ××§××× ×× ×ר×רת×, ××××× ×©×××¦× ×ת ××פצ××ת ×××פ×× ××§××××ת
- ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×¨××× ×תק×× ×ס×× BRAF V600 mutated NSCLC
- ×ש×××× ×¢× Trametinib ×××פ×× ××××××× ××ר×× × ×××× (low grade glioma) ×× × ×ª××× ×× ×ר×רת×ת ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת
- ×ש×××× ×¢× Trametinib ×××פ×× ××××××× ××ר×× × ×××× (Low grade glioma) ×××××× ×× × ×©× × ×××¢×× ×¢× ×××צ×× ×ס×× BRAF V600E, ××§× ××פ×× ×¨×ש×× ×××××
- ×ש×××× ×¢× Trametinib ×××פ×× ××××××× ××ר×× ××××× (high grade glioma) ×× × ×ª××× ×× ×ר×רת×ת ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת
- ×ש×××× ×¢× Trametinib ×××פ×× ×××××××ס×××× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת
- ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×©× ×ר×× ×××¨× (Biliary tract cancer) ×× × ×ª×× ×× ×ר××¨×ª× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת
- ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×ª×ר×××× ×¤×¤×××¨× (Papillary thyroid cancer) ×× × ×ª×× ×× ×ר××¨×ª× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת
- ×ש×××× ×¢× Trametinib ×××פ×× ×××× ×קרצ×× ××× ×©× ×××¢× ×××§ (Adenocarcinoma of the small intestine) ×× × ×ª××× ×× ×ר×רת×ת ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת
- ×ש×××× ×¢× Trametinib ×××פ×× ×סר×× ×©××× ××ר×× × ×××× (Low grade ovarian cancer) ×× × ×ª×× ×× ×ר××¨×ª× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת
- ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ×¨××¤× ××××× ×××× ×§××××××, ×× ×¨××¤× ××××× ××× ××קר×× ×××××× ×× ×רפ××ת ××£ ×××× ×ר××.
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| ×¢××× ×ר××¤× ××××ר×ת ××¢×××
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| ××פ×ש ×××ר××
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×××ר×× ×-PubMed
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| ××××¢ ×רשת
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RxList WebMD Drugs.com
|
| ×©× ×צר×
|
NOVARTIS PHARMACEUTICAL MANUFACTURING LLC, SLOVENIA
|
| ×©× ××¢× ×ר×ש××
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NOVARTIS ISRAEL LTD
|
| ר×ש×××
|
ת×ר×× ××ש×: 03/2014. ר×ש××× ×ת×ר××: 03/2014
|
| ת×ר×× ×¢×××× ××ר××
|
15/02/19
|
ת××× ×ª ×ר×××
ת×ר×× ×¢××××: 15/02/19
GLAXO
×פ×× ×ר - Tafinlar
true
השינוי האחרון נעשה בֹ־9 במאי 2024 ב־15:46