Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Bevacizumab
Intas Pharmaceuticals Limited, INDIA
Other antineoplastic agents
Bevacizumab
400
Intravenous Infusion
Intas Pharmaceuticals Limited, INDIA
Physical description: Clear to slightly opalescent, colourless to pale brown solution; Local technical representative: PHARMAJEN LIMITED (61840)
Registered/Compliant
2020-09-25
TMDA/DMC/MRE/F/016 Version#1 TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY PUBLIC ASSESSMENT REPORT FOR BEVAMAB 400 (BEVACIZUMAB 400 MG/16 ML) CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION VERSION NUMBER 1.0 11 APRIL, 2022 P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tanzania Tel: +255-22-2450512/2450751/ 2452108; Fax: +255-22-2450793 Email: info@tmda.go.tz; Website: mwww.tmda.go.tz 1. INTRODUCTION Bevamab 400 has been developed by Intas as a proposed biosimilar product to the reference medicinal product Avastin of Genentech/Roche having bevacizumab as the active substance. Bevamab 400 is antineoplastic medicine belongs to the pharmacotherapeutic group “monoclonal antibodies” (ATC code: L01XC07). Bevacizumab (Avastin, Genentech/Roche) is a recombinant humanised monoclonal antibody of the immunoglobulin (Ig) G1 class that selectively binds to Vascular endothelial growth factor (VEGF). The binding of bevacizumab to VEGF inhibits the binding of VEGF to its receptors on the surface of endothelial cells, Flt-1 (also known as VEGF receptor-1 [VEGFR-1]) and kinase insert domain receptor (also known as VEGF receptor-2 [VEGFR-2]). Neutralizing the biological activity of VEGF inhibits the formation of new tumour vasculature, causes regression in newly-formed tumour vasculature, and normalises the remaining tumour vasculature, thereby inhibiting tumour growth. Bevamab 400 is approved in Tanzania for use only in adult patients. 1.1 PRODUCT DETAILS Registration number TAN 20 HM 0411 Brand name Bevamab 400 Generic name, strength and form Each vial contains; 400mg/16mL (25mg/mL) ATC classification ATC code L01FG01 - antineoplastic agents, other antineoplastic agents, monoclonal antibodies Distribution category POM Country of origin India Associated product Bevamab 100 Marketing Authorization Holder Intas Pharmaceuticals Limited, Plot No. 423/P/A. Sarkhej – Bavla, Highway, Village: Moraiya, Taluka: Sanand Ahmedabad – 382 213, Gujarat, India E-mail: Balaji_Sunkara@intaspharma.com Local Technical Re Read the complete document