×××ר××
×צפ××× ×××××¢ ××ר×× ×ר×פ××× ×ש
××××× ×¡ ××ש××× ×. ×× ××× × ×¨×©×× ××× ×¡ ×
×רש×× ×ר×פ××× ××× ×©× ×קצ××¢×ת רפ×××××.
× ×ª×× × ×ª×¨×פ×
××רש×

| ××× ×× ×× × ×ספ××
|
|
| ×§×××¦× ×¤×¨××§×××××ת (ATC4)
|
L01FF PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
|
| ×ר××× ×¤×¢×× (ATC5)
|
Â
|
| צ×רת ×ת×
|
תת-×¢××¨× - S.C
|
| צ×רת ××× ××
|
ת×××¡× ×××רק×, SOLUTION FOR INJECTION ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
|
| ×ת××××
|
Urothelial Carcinoma⢠TECENTRIQ (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours have a PDL1 expression ⥠5%.⢠TECENTRIQ is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.- Non-Small Cell Lung Cancer⢠TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic nonsmall cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ⥠50% of tumor cells [TC ⥠50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ⥠10% of the tumor area [IC ⥠10%]), as determined by an approved test, with no EGFR or ALK genomic tumor aberrations.⢠TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.⢠TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated only after failure of appropriate targeted therapies.⢠TECENTRIQ is indicated for the treatment of patients with metastatic NSCLC who are naïve to anti-PD-L1 or anti-PD-1 therapies and have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.⢠TECENTRIQ as monotherapy, is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ⥠50% of tumor cells (TCs).- Locally Advanced or Metastatic Triple-Negative Breast CancerTecentriq, in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors have PD-L1 expression â¥1% and who have not received prior chemotherapy for metastatic disease.- Small Cell Lung Cancer TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).- Hepatocellular CarcinomaTECENTRIQ, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.- MelanomaTECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.- Alveolar Soft Part SarcomaTECENTRIQ, as a single agent, is indicated for the treatment of adult a patients with unresectable or metastatic alveolar soft part sarcoma (ASPS).
|
| × ×ª×× × ×ס×
|
ת×ר×× ××××× ×ס×
- 12/01/2017
|
×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
|
×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
|
| ×תר××¤× ×ª×× ×ª× ×××× ×תרפ×× ×××פ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××××× ××¢×× × ×¢× ××× ××××: 1. ×§××× ××פ×× ×××××ª×¨×¤× ×§××× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ×××××ª× ××ר×רת×ת; 2. ××××ª× ×תק××× ×ת×× 12 ×××ש×× ×××פ×× ×××××ª×¨×¤× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ××ס×רת ×ש×××× (adjuvant) ×× noeoadjuvant. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
|
12/01/2017 |
××× ×§×××××× |
|
Urothelial cancer |
|
| ×××× ×תרפ×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× Non small cell lung cancer (NSCLC) ×××××× ×©××××ª× ×תק××× ×××ר ×§× ××פ×× ×××××ª×¨×¤× ×§××× ×××סס פ×××× ××. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
|
12/01/2018 |
××× ×§×××××× |
|
NSCLC, non small cell lung cancer |
|
| ×ש×××× ×¢× ××××תרפ×× ××××× ×¡×¨×× ×©× ×תק×× ××§××× ×× × ×ª×× ×× ×ר××¨×ª× ×ס×× triple negative (TNBC) ××××× PDL1 ××¢×¨× ×©× 1% ×××¢××, ×שר ××¨× ×§××× ××פ×× ×××××ª×¨×¤× ×××××ª× ××תק××ת ×× ××ר×רת×ת. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
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30/01/2020 |
××× ×§×××××× |
|
TNBC, Triple negative breast cancer |
|
| ××× ×תרפ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××§× ××פ×× ×¨×ש×× ××××× ××¢×× × ×¢× ××× ××××: ×. ××× × ×ת××× ×××פ×× ××ש×× ×××××ª×¨×¤× ××××× Cisplatin ××××× PDL1 ××¤× PD-L1 stained tumor infiltrating cells [IC] covering > 5%. ××¢× ××× ×× ×××× ×©××× × ×ת××× ×××פ×× ××ש×× ×××××ª×¨×¤× ××××× Cisplatin ××××ר ××¢×× × ×¢× ××× ××××: 1. ס×××ס תפק××× ××¤× WHO ×× ECOG ××¢× 2 ×× ××¤× Karnofsky performance status ××¢×¨× ××× 60% ×-70%. 2. פ×× ×× ×§×¨×××× ×× (× ××× ×× ×××ש×) × ××× ×-60 ×"×/××§× 3. ××××× ×©×××¢× ×××××××ר×× ××¢×¨× ×××× ×-2 ××¤× CTCAE; 4. × ××ר×פת×× ×¤×¨×פר××××ת ××¢×¨× ×××× ×-2 ××¤× CTCAE; 5. ×× ×¡×¤××§× ××××ת ××ר×× III ××¤× ×-NYHA. ×. ××× × ×ת××× ×××פ×× ××ש×× ××××תרפ×× ××××× ×ª×¨×××ת פ×××× ×× ××ש××, ××× ×ª××ת ×ר×ת ××××× PDL1. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
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30/01/2020 |
××× ×§×××××× |
|
Urothelial cancer |
|
| ×ש×××× ×¢× ××××תרפ×× ×-Bevacizumab ××§× ××פ×× ×¨×ש×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× NSCLC ×××××× ×¢× ×¨××ת ××××× PDL1 ×ר×× × ×××× ×-50% (×××× ××××× ×©××× × ×××××× PDL1), ש××× × ×××××× ×××צ××ת ×ס×× EGFR, ALK, ROS1. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
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30/01/2021 |
××× ×§×××××× |
|
NSCLC, non small cell lung cancer |
|
| ×××× ×תרפ×× ×× ×ש×××× ×¢× ××××תרפ×× ×-Bevacizumab ××§× ××פ×× ×¨×ש×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× NSCLC ×××××× ××××××× ××××× PDL1 ×ר×× ×©× 50% ×××¢××, ש××× × ×××××× ×××צ××ת ×ס×× EGFR, ALK, ROS1. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
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30/01/2021 |
××× ×§×××××× |
|
NSCLC, non small cell lung cancer |
|
| ×ש×××× ×¢× Bevacizumab, ×××פ×× ×סר×× ×פ××צ×××××¨× ×× × ×ª×× ×× ×ר×רת×, ×××××× ×©××¨× ×§×××× ××פ×× ×¡×ס××× ××××ת×. ××××× ××××ª× ×××× ××××× ×××× ×××ת ××תר×פ×ת ××××ת â Atezolizumab + Bevacizumab, Lenvatinib, Sorafenib. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
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01/03/2021 |
××× ×§×××××× |
|
Hepatocellular carcinoma |
|
| ×××× ×תרפ×× ×××פ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××××× ××¢×× × ×¢× ××× ××××: ×. ××××ª× ×תק××× ×××ר שק××× ××פ×× ×××××ª×¨×¤× ×§××× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ×××××ª× ××ר×רת×ת; ×. ××××ª× ×תק××× ×ת×× 12 ×××ש×× ×××פ×× ×××××ª×¨×¤× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ××ס×רת ×ש×××× (adjuvant) ×× noeoadjuvant. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
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03/02/2022 |
××× ×§×××××× |
|
Urothelial cancer |
|
| ××× ×תרפ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×××פ×× ×××××ª×¨×¤× ×××סס פ×××× ××, ×סר×× ×¨××× ×ס×× NSCLC ש××× ×××× II ×¢× IIIa, ××××× PDL1 ×ר×× ×©× 50% ×××¢×× ×ת×× ××××××, ×ש××× × ×××× ×××צ××ת ×ס×× EGFR ×× ALK. ××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors. ×ש×× ×××× × ×ª×× ×××× ××××× ×××× ×××פ×× ×ר×× × ×ת××× ×-Nivolumab ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×-Atezolizumab. ××¢× ××× ×× ×¡×¨×× ×¨××× ×ש×× ×תק×× (×× × ×ª×× ×× ×ר×רת×) ×× ××××ר ××××ª× ×××× ××× ×¡×¨×× ×¨××× ×ש×× ×ר ××¡×¨× ×× ×ת××.
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01/02/2023 |
××× ×§×××××× |
|
NSCLC, non small cell lung cancer |
|
| ××× ×תרפ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×××פ×× ×××××ª×¨×¤× ×××סס פ×××× ××, ×סר×× ×¨××× ×ס×× NSCLC ש××× ×××× II ×¢× IIIa, ××××× PDL1 ×ר×× ×©× 50% ×××¢×× ×ת×× ××××××, ×ש××× × ×××× ×××צ××ת ×ס×× EGFR ×× ALK. ××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors. ×ש×× ×××× × ×ª×× ×××× ××××× ×××× ×××פ×× ×ר×× × ×ת××× ×-Nivolumab ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×-Atezolizumab ×× Pembrolizumab. ××¢× ××× ×× ×¡×¨×× ×¨××× ×ש×× ×תק×× (×× × ×ª×× ×× ×ר×רת×) ×× ××××ר ××××ª× ×××× ××× ×¡×¨×× ×¨××× ×ש×× ×ר ××¡×¨× ×× ×ת××.
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17/03/2024 |
××× ×§×××××× |
|
×סר×× ×¨××× ×ס×× NSCLC ש××× ×××× II ×¢× IIIa |
|
| ×××× ×תרפ××, ×××פ×× ×××××ר×× ××××××× ×× × ×©× ×ª××× ×××¢×× ×¢× ×¡×¨×§××× ×ס×× Alveolar soft part sarcoma (ASPS) ×× × ×ª××× ×× ×ר×רת×ת.
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17/03/2024 |
××× ×§×××××× |
|
סרק××× ×ס×× Alveolar soft part sarcoma (ASPS) |
|
| ×ש×××× ×¢× Bevacizumab, ×××פ×× ×סר×× ×פ××צ×××××¨× ×× × ×ª×× ×× ×ר×רת×, ×××××× ×©××¨× ×§×××× ××פ×× ×¡×ס××× ××××ת×. ××××× ××××ª× ×××× ××××× ×××× ×××ת ××תר×פ×ת ××××ת â Atezolizumab + Bevacizumab, Lenvatinib, Sorafenib, Durvalumab + Tremelimumab. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
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17/03/2024 |
××× ×§×××××× |
|
×××פ×× ×סר×× ×פ××צ×××××¨× ×× × ×ª×× ×× ×ר××¨×ª× |
|
|
| ש×××ש ×ס×
|
×ס×רת ××××× ×ס×
- ×תר××¤× ×ª×× ×ª× ×××פ×× ××קר×× ××××:
- ×××× ×תרפ×× ×××פ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××××× ××¢×× × ×¢× ××× ××××:
- ××××ª× ×תק××× ×××ר שק××× ××פ×× ×××××ª×¨×¤× ×§××× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ×××××ª× ××ר×רת×ת;
- ××××ª× ×תק××× ×ת×× 12 ×××ש×× ×××פ×× ×××××ª×¨×¤× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ××ס×רת ×ש×××× (adjuvant) ×× noeoadjuvant.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ××× ×תרפ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××§× ××פ×× ×¨×ש×× ××××× ××¢×× × ×¢× ××× ××××:
- ××× × ×ת××× ×××פ×× ××ש×× ×××××ª×¨×¤× ××××× Cisplatin ××××× PDL1 ××¤× PD-L1 stained tumor infiltrating cells [IC] covering > 5 ××××××
××¢× ××× ×× ×××× ×©××× × ×ת××× ×××פ×× ××ש×× ×××××ª×¨×¤× ××××× Cisplatin ××××ר ××¢×× × ×¢× ××× ××××:
- ס×××ס תפק××× ××¤× WHO ×× ECOG ××¢× 2 ×× ××¤× Karnofsky performance status ××¢×¨× ××× 60 ×××××× ×-70 ××××××
- פ×× ×× ×§×¨×××× ×× (× ××× ×× ×××ש×) × ××× ×-60 ×××××××ר/××§×
- ××××× ×©×××¢× ×××××××ר×× ××¢×¨× ×××× ×-2 ××¤× CTCAE
- × ××ר×פת×× ×¤×¨×פר×ת ××¢×¨× ×××× ×-2 ××¤× CTCAE
- ×× ×¡×¤××§× ××××ת ××ר×× III ××¤× ×-NYHA
- ××× × ×ת××× ×××פ×× ××ש×× ××××תרפ×× ××××× ×ª×¨×××ת פ×××× ×× ××ש××, ××× ×ª××ת ×ר×ת ××××× PDL1.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ××× ×תרפ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×××פ×× ×××××ª×¨×¤× ×××סס פ×××× ××, ×סר×× ×¨××× ×ס×× NSCLC ש××× ×××× II ×¢× IIIa, ××××× PDL1 ×ר×× ×©× 50 ×××××× ×××¢×× ×ת×× ××××××, ×ש××× × ×××× ×××צ××ת ×ס×× EGFR ×× ALK.
××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors. ×ש×× ×××× × ×ª×× ×××× ××××× ×××× ×××פ×× ×ר×× × ×ת××× ×-Nivolumab ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×-Atezolizumab ×× Pembrolizumab. ××¢× ××× ×× ×¡×¨×× ×¨××× ×ש×× ×תק×× (×× × ×ª×× ×× ×ר×רת×) ×× ××××ר ××××ª× ×××× ××× ×¡×¨×× ×¨××× ×ש×× ×ר ××¡×¨× ×× ×ת××
- ×××× ×תרפ×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× (Non small cell lung cancer (NSCLC ×××××× ×©××××ª× ×תק××× ×××ר ×§× ××פ×× ×××××ª×¨×¤× ×§××× ×××סס פ×××× ××.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×××× ×תרפ×× ×× ×ש×××× ×¢× ××××תרפ×× ×-Bevacizumab ××§× ××פ×× ×¨×ש×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× NSCLC ×××××× ××××××× ××××× PDL1 ×ר×× ×©× 50 ×××××× ×××¢××, ש××× × ×××××× ×××צ××ת ×ס×× EGFR, ALK, ROS1.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×ש×××× ×¢× ××××תרפ×× ×-Bevacizumab ××§× ××פ×× ×¨×ש×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× NSCLC ×××××× ×¢× ×¨××ת ××××× PDL1 ×ר×× × ×××× ×-50 ×××××× (×××× ××××× ×©××× × ×××××× PDL1), ש××× × ×××××× ×××צ××ת ×ס×× EGFR, ALK, ROS1.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×ש×××× ×¢× ××××תרפ×× ××××× ×¡×¨×× ×©× ×תק×× ××§××× ×× × ×ª×× ×× ×ר××¨×ª× ×ס×× (triple negative (TNBC ××××× PDL1 ××¢×¨× ×©× 1 ×××××× ×××¢××, ×שר ××¨× ×§××× ××פ×× ×××××ª×¨×¤× ×××××ª× ××תק××ת ×× ××ר×רת×ת.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×ש×××× ×¢× Bevacizumab, ×××פ×× ×סר×× ×פ××צ×××××¨× ×× × ×ª×× ×× ×ר×רת×, ×××××× ×©××¨× ×§×××× ××פ×× ×¡×ס××× ××××ת×.
××××× ××××ª× ×××× ××××× ×××× ×××ת ××תר×פ×ת ××××ת - Atezolizumab + Bevacizumab, Lenvatinib, Sorafenib, Durvalumab + Tremelimumab. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×××× ×תרפ××, ×××פ×× ×××××ר×× ××××××× ×× × ×©× ×ª××× ×××¢×× ×¢× ×¡×¨×§××× ×ס×× (Alveolar soft part sarcoma (ASPS ×× × ×ª××× ×× ×ר×רת×ת
- ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ×¨××¤× ××××× ×××× ×§×××××× ×× ×¨××¤× ××××× ×××ר×××××× ××××¤× ×××ר×××××× ××× ×§×××××ת.
|
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| ×¢××× ×ר××¤× ××××ר×ת ××¢×××
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השינוי האחרון נעשה בֹ־13 בנובמבר 2025 ב־13:15