BEVAMAB Solution for injection/concentrate for solution for infusion 100

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Bevacizumab

Available from:

Intas Pharmaceuticals Limited, INDIA

ATC code:

Other antineoplastic agents

INN (International Name):

Bevacizumab

Dosage:

100

Pharmaceutical form:

Solution for injection/concentrate for solution for infusion

Manufactured by:

Intas Pharmaceuticals Limited, INDIA

Product summary:

Physical description: Concentrate for solution for infusion; Local technical representative: PHARMAJEN LIMITED (61840)

Authorization status:

Registered/Compliant

Authorization date:

2022-04-11

Summary of Product characteristics

TMDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR BEVAMAB 100 (BEVACIZUMAB 100 MG/ 4
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: [phone]; Fax: [phone]
Email: [e-mail]; Website: mwww.tmda.go.tz
1.
INTRODUCTION
Bevamab 100 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 100 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 100 is approved in
Tanzania for use only in adult patients.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0107
Brand name
Bevamab 100
Generic name, strength and form
Each vial contains; 100mg/4mL (25mg/mL)
ATC classification
ATC
code
L01FG01
-
antineoplastic
agents,
other
antineoplastic agents, monoclonal antibodies
Distribution category
POM
Country of origin
India
Associated product
Bevamab 400
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: [e-mail]
Local Technical Rep