
× ×ª×× × ×ª×¨×פ×
××רש×

| ××× ×× ×× × ×ספ××
|
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| ×§×××¦× ×¤×¨××§×××××ת (ATC4)
|
L01EE Mitogen-activated protein kinase (MEK) 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 ××× ××
|
×××××ת ×צ×פ×ת פ×××, FILM COATED TABLETS ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
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| ×ת××××
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Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy. Non-small cell lung cancer (NSCLC) :Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.Adjuvant treatment of melanoma :Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a 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 TumorsMekinist is indicated, in combination with dabrafenib, 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: Trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibitionTrametinib is indicated, in combination with dabrafenib, 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×
- 12/01/2017
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×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
|
×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
|
| ×ש×××× ×¢× Dabrafenib ×××פ×× ××××××× ××ר×× × ×××× (Low grade glioma) ×××××× ×× × ×©× × ×××¢×× ×¢× ×××צ×× ×ס×× BRAF V600E, ××§× ××פ×× ×¨×ש×× ×××××.
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17/03/2024 |
××× ×§×××××× |
|
Glioma (low grade) |
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| ×ש×××× ×¢× Dabrafenib ×××פ×× ×××××××ס×××× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת. |
01/02/2023 |
××× ×§×××××× |
|
××××××ס××××, Ameloblastoma |
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| ×ש×××× ×¢× Dabrafenib ×××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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Glioma (high grade) |
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| ×ש×××× ×¢× Dabrafenib ×××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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Glioma (low grade) |
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| ×ש×××× ×¢× Dabrafenib ×××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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סר×× ×ª×ר×××× ×¤×¤××ר×, PTC, Papillary thyroid cancer |
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| ×ש×××× ×¢× Dabrafenib ×××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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סר×× ××ר×× ××ר×, Biliary tract cancer |
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| ×ש×××× ×¢×Dabrafenib ×××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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××× ×קרצ×× ××× ×©× ×××¢× ×××§, Small intestine adenocarcinoma |
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| ×ש×××× ×¢× Dabrafenib ×××פ×× ×סר×× ×¨××× ×תק×× ×ס×× BRAF V600 mutated NSCLC. |
30/01/2020 |
××× ×§×××××× |
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NSCLC |
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| ×ש×××× ×¢× Dabrafenib ×××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×××× ×¢× Dabrafenib ×××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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| ×ש×××× ×¢× Dabrafenib ××× ××× ×תק××ת (×ר×רת×ת ×× ×©××× × × × ×ª×××) ××××× ××××× ×××צ×× ×-BRAF. |
12/01/2017 |
××× ×§×××××× |
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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×× ××××:
- ×ש×××× ×¢× Dabrafenib ×××פ×× ×××× ××× ×תק××ת (×ר×רת×ת ×× ×©××× × × × ×ª×××) ××××× ××××× ×××צ×× ×-BRAF
- ×ש×××× ×¢× Dabrafenib ×××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×××× ×¢× Dabrafenib ×××פ×× ×סר×× ×ª×ר×××× ×ס×× BRAF mutated ATC, ×תק×× ××§××× ×× ×ר×רת×, ××××× ×©×××¦× ×ת ××פצ××ת ×××פ×× ××§××××ת
- ×ש×××× ×¢× Dabrafenib ×××פ×× ×סר×× ×¨××× ×תק×× ×ס×× BRAF V600 mutated NSCLC
- ×ש×××× ×¢× Dabrafenib ×××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×××× ×¢× Dabrafenib ×××פ×× ××××××× ××ר×× × ×××× (Low grade glioma) ×××××× ×× × ×©× × ×××¢×× ×¢× ×××צ×× ×ס×× BRAF V600E, ××§× ××פ×× ×¨×ש×× ×××××
- ×ש×××× ×¢× Dabrafenib ×××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×××× ×¢× Dabrafenib ×××פ×× ×××××××ס×××× ×¢× ×××צ×× ×ס×× BRAF V600E, ×××ר ×תק×××ת ×××× ×××פ×× ×§××× ×× ××שר ×× ×§××××ת ××פצ××ת ××פ××××ת ×××פ××ת
- ×ש×××× ×¢× Dabrafenib ×××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×××× ×¢× Dabrafenib ×××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×××× ×¢× Dabrafenib ×××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×××× ×¢× Dabrafenib ×××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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Â
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|
ת××× ×ª ×ר×××
ת×ר×× ×¢××××: 25/05/2024
GLAXO
××§×× ××¡× - Mekinist
true
×××ר××
×צפ××× ×××××¢ ××ר×× ×ר×פ××× ×ש
××××× ×¡ ××ש××× ×. ×× ××× × ×¨×©×× ××× ×¡ ×
×רש×× ×ר×פ××× ××× ×©× ×קצ××¢×ת רפ×××××.
השינוי האחרון נעשה בֹ־23 בספטמבר 2025 ב־03:52