פרטים כלליים
שם
Name
אוגיברי 420 מ"ג
OGIVRI 420 MG
יצרן
MYLAN PHARMACEUTICALS PRIVATE LTD, INDIA
בעל רישום
DEXCEL LTD, ISRAEL
שימוש
צורת מינון
Dosage Form
POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION
דרך מתן
Usage Form
תוך-ורידי
I.V
תמונה חסרה
מחירים לצרכן
לא נמצא מידע
חומר פעיל
חומר פעיל
כמות
420 MG/VIAL
תרופות אחרות בעלות אותם מרכיבים
ATC
עלונים
עדכון רישום
סוג עדכון
תאריך עדכון
02.08.2021
02.08.2021
11.03.2020
11.03.2020
התוויה מאושרת
Ogivri is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: 1. As a single agent for the treatment of those patients who have received one or more chemotherapy regiments for their metastatic disease. 2. In combination with Paclitaxel or Docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. In combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer. Early breast cancer (EBC) :Ogivri is indicated to treat patients with HER2-positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding Anthracyclines. Ogivri should only be used in patients whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.HER2 metastatic gastric cancer (mGC).Ogivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.Ogivri should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.
בסל הבריאות
כן
מספר רישום
162-70-35705-00
תנאי ניפוק
תרופה במרשם
מגבלות
תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת