תבנית:תרופה/אופדיבו - Opdivo: הבדלים בין גרסאות

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מ (החלפת טקסט – "עלון לצרכן ערבית" ב־"עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية")
 
שורה 11: שורה 11:
 
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Unresectable or Metastatic Melanoma:Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced(unresectable or metastatic) melanoma in adults.Adjuvant Treatment of Melanoma:Opdivo is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resectionMetastatic Non-Small Cell Lung Cancer:- Opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.- Opdivo is indicated for the treatment of patients with metastatic non small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.Renal Cell Carcinoma:Opdivo as a single agent is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.Opdivo in combination with ipilimumab is indicated for the first line treatment of patients with intermediate or poor risk, advanced renal cell carcinoma (RCC).-OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced RCCClassical Hodgkin Lymphoma:Opdivo is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:* autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or* 3 or more lines of systemic therapy that includes autologous HSCT.Squamous Cell Carcinoma of the Head and Neck:Opdivo is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient(dMMR) Metastatic Colorectal Cancer:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.Urothelial carcinoma:OPDIVO is indicated for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.Opdivo (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:- have disease progression during or following platinum-containing chemotherapy- have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.- Hepatocellular Carcinoma:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) Child-Pugh A who have been previously treated with sorafenib.Small Cell Lung Cancer (SCLC):Opdivo is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum based chemotherapy and at least one other line of therapy.Esophageal carcinoma:--OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).-OPDIVO is indicated for the treatment of patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapyMalignant Pleural MesotheliomaOPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
+
Unresectable or Metastatic Melanoma:Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and pediatric patients 12 years and older.Adjuvant Treatment of Melanoma:OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, IIC, III, or IV melanoma.Metastatic Non-Small Cell Lung Cancer:- Opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.- Opdivo is indicated for the treatment of adult patients with metastatic non small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.Renal Cell Carcinoma:- Opdivo as a single agent is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.- Opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with intermediate or poor risk, advanced renal cell carcinoma (RCC).- OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.Classical Hodgkin Lymphoma:Opdivo is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:* autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or* 3 or more lines of systemic therapy that includes autologous HSCT.Squamous Cell Carcinoma of the Head and Neck:Opdivo is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient(dMMR) Metastatic Colorectal Cancer:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.Urothelial carcinoma:- OPDIVO is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.- Opdivo (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: * have disease progression during or following platinum-containing chemotherapy * have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.Hepatocellular Carcinoma:Opdivo, in combination with ipilimumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) Child-Pugh A who have been previously treated with sorafenib.Esophageal cancer:-OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). -OPDIVO is indicated for the treatment of adult patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.- OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.-OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Malignant Pleural Mesothelioma:OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma:OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer:OPDIVO, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
 
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|שם יצרן=[[BRISTOL - MYERS SQUIBB HOLDINGS PHARMA, LTD, LIABILITY COMPANY, USA]]
 
|שם יצרן=[[BRISTOL - MYERS SQUIBB HOLDINGS PHARMA, LTD, LIABILITY COMPANY, USA]]
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|קישור למאגר משרד הבריאות1=[https://israeldrugs.health.gov.il/#!/medDetails/153%2055%2034333%2000 אופדיבו] במאגר משרד הבריאות
 
|קישור למאגר משרד הבריאות1=[https://israeldrugs.health.gov.il/#!/medDetails/153%2055%2034333%2000 אופדיבו] במאגר משרד הבריאות
 
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_356472721.pdf עלון לרופא 14.01.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_14_115612124.pdf עלון לרופא 30.04.2024]
 
|עלון לצרכן={{רווח קשיח}}
 
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_576694121.pdf עלון לצרכן עברית 30.01.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_13_44671824.pdf עלון לצרכן עברית 31.12.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_576690621.pdf עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية 30.01.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_13_44671324.pdf עלון לצרכן אנגלית - Patient information leaflet{{כ}} 31.12.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_576692521.pdf עלון לצרכן אנגלית - Patient information leaflet{{כ}} 30.01.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_13_44671024.pdf עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية 31.12.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528215421.pdf כרטיס מידע בטיחותי למטופלים רוסית 05.07.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_7_138192523.pdf כרטיס מידע בטיחותי למטופלים רוסית 17.04.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528214821.pdf כרטיס מידע בטיחותי למטופלים עברית 05.07.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_7_138192023.pdf כרטיס מידע בטיחותי למטופלים ערבית 17.04.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528213821.pdf כרטיס מידע בטיחותי למטופלים אנגלית 05.07.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_7_138191723.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי ערבית 17.04.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528213221.pdf כרטיס מידע בטיחותי למטופלים ערבית 05.07.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_7_138190523.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי רוסית 17.04.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528210221.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי רוסית 05.07.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_7_138189723.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי עברית 17.04.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528208821.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי עברית 05.07.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_7_138189123.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי אנגלית 17.04.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528207021.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי אנגלית 05.07.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_7_138188523.pdf כרטיס מידע בטיחותי למטופלים אנגלית 17.04.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528205221.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי ערבית 05.07.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_7_138186523.pdf כרטיס מידע בטיחותי למטופלים עברית 17.04.2023]
 
|החמרות לעלון={{רווח קשיח}}
 
|החמרות לעלון={{רווח קשיח}}
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_14_118410924.pdf החמרה לעלון 30.04.2024]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_12_14273524.pdf החמרה לעלון 31.12.2023]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_9_267516323.pdf החמרה לעלון 30.06.2023]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_6_10361623.pdf החמרה לעלון 05.12.2022]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_5_911707822.pdf החמרה לעלון 24.07.2022]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_3_381755122.pdf החמרה לעלון 31.12.2021]
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*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_2_296203722.pdf החמרה לעלון 30.12.2021]
 
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_356472921.pdf החמרה לעלון 14.01.2021]
 
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_356472921.pdf החמרה לעלון 14.01.2021]
 
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_17_463259820.pdf החמרה לעלון 26.11.2020]
 
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_17_463259820.pdf החמרה לעלון 26.11.2020]
שורה 44: שורה 51:
 
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/ArcRishum01_10_166479416.doc החמרה לעלון 22.05.2015] {{DOC}}
 
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/ArcRishum01_10_166479416.doc החמרה לעלון 22.05.2015] {{DOC}}
 
|מספר רישום={{{מספר רישום|153 55 34333 00}}}
 
|מספר רישום={{{מספר רישום|153 55 34333 00}}}
|תאריך עדכון=[[עדכון אחרון::15/07/15]]
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|תאריך עדכון=22/05/2024
 
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|שיווק הופסק={{{שיווק הופסק|לא}}}
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|שיווק הופסק=לא
 
|שם ללא מינון=אופדיבו - Opdivo
 
|שם ללא מינון=אופדיבו - Opdivo
 
|שם ללא מינון באנגלית‎=Opdivo
 
|שם ללא מינון באנגלית‎=Opdivo

גרסה אחרונה מתאריך 21:53, 21 במאי 2024



נתוני תרופה
במרשם RxIcon.png
קבוצה פרמקולוגית (ATC4) L01XC
Monoclonal antibodies
מרכיב פעיל (ATC5) Nivolumab 10MG/ML ‏L01XC17
צורת מתן תוך-ורידי - I.V
צורת מינון תרכיז להכנת תמיסה לאינפוזיה, CONCENTRATE FOR SOLUTION FOR INFUSION
למניעת מינון יתר או הרעלה יש ליטול את התרופה בהתאם למינון המומלץ כפי שמופיע בעלון לצרכן
התוויה

Unresectable or Metastatic Melanoma:Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and pediatric patients 12 years and older.Adjuvant Treatment of Melanoma:OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, IIC, III, or IV melanoma.Metastatic Non-Small Cell Lung Cancer:- Opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.- Opdivo is indicated for the treatment of adult patients with metastatic non small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.Renal Cell Carcinoma:- Opdivo as a single agent is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.- Opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with intermediate or poor risk, advanced renal cell carcinoma (RCC).- OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.Classical Hodgkin Lymphoma:Opdivo is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:* autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or* 3 or more lines of systemic therapy that includes autologous HSCT.Squamous Cell Carcinoma of the Head and Neck:Opdivo is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient(dMMR) Metastatic Colorectal Cancer:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.Urothelial carcinoma:- OPDIVO is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.- Opdivo (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: * have disease progression during or following platinum-containing chemotherapy * have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.Hepatocellular Carcinoma:Opdivo, in combination with ipilimumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) Child-Pugh A who have been previously treated with sorafenib.Esophageal cancer:-OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). -OPDIVO is indicated for the treatment of adult patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.- OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.-OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Malignant Pleural Mesothelioma:OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma:OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer:OPDIVO, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

תבנית:נתוני סל/תרופה/אופדיבו - Opdivo
עלון לרופא והחמרות לעלון

 

 

עלון לצרכן  
ערכים בוויקירפואה ערכים קשורים בוויקירפואה
אופדיבו במאגר משרד הבריאות
חיפוש מאמרים -
מידע ברשת -
שם יצרן BRISTOL - MYERS SQUIBB HOLDINGS PHARMA, LTD, LIABILITY COMPANY, USA
שם בעל הרישום BRISTOL - MYERS SQUIBB, ISRAEL
רישיון תאריך הגשה: 10/2014. רישיון מתאריך: 03/2015
תאריך עדכון אחרון 22/05/2024


תאריך עדכון: 22/05/2024 BRISTOL MYERS SQUIBB

אופדיבו - Opdivo true



דף זה נוצר על ידי בוט ומגדיר תבנית עם פרטי התרופה.

  • דף התרופה: אופדיבו - Opdivo
  • לדריסה ידנית של פרטי התרופה: ניתן לערוך את דף התרופה לעיל. לדוגמה החליפו את:
{{תרופה/אופדיבו - Opdivo}}

ב:

{{תרופה/אופדיבו - Opdivo
| שם הפרמטר=ערך חדש (דורס את הערך שהבוט הגדיר)
}}