BENDAMUSTINE LU bendamustine hydrochloride 25 mg powder for injection vial
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
12-10-2020
अनुरोध भेजा।
सक्रिय संघटक:
bendamustine hydrochloride, Quantity: 25 mg
थमां उपलब्ध:
Luminarie Pty Ltd
फार्मास्यूटिकल फॉर्म:
Injection, powder for
रचना:
Excipient Ingredients: mannitol
प्रशासन का मार्ग:
Intravenous, Intravenous Infusion
पैकेज में यूनिट:
1 vial
प्रिस्क्रिप्शन प्रकार:
(S4) Prescription Only Medicine
चिकित्सीय संकेत:
First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C). Efficacy relative to first-line therapies other than chlorambucil has not been established.,Previously untreated indolent CD20-positive, stage III-IV Non-Hodgkin?s lymphoma, in combination with rituximab.,Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma in combination with rituximab, in patient?s ineligible for autologous stem cell transplantation.,Relapsed/Refractory indolent Non-Hodgkin?s lymphoma.
उत्पाद समीक्षा:
Visual Identification: white to off-white sterile lyophilized powder; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius
प्राधिकरण का दर्जा:
Registered
प्राधिकरण की तारीख:
2020-09-23
