Country: Տանզանիա
language: անգլերեն
source: Tanzania Medicinces & Medical Devices Authority
Aciclovir
F.Hoffmann-La Roche Limited, SWITZERLAND
Antiviral
Aciclovir
1200 mg/20ml
Solution For Infussion
F. Hoffmann-La Roche Limited, SWITZERLAND
Physical description: Liquid, not more coloured than BY4, free from particles; Local technical representative: okinawa pharmacy ltd (7147)
Registered/Compliant
2021-06-03
TMDA/DMC/MRE/F/016 Revision# TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY PUBLIC ASSESSMENT REPORT FOR TECENTRIQ (ATEXOLIZUMAB 1200 MG/20 ML) CONCENTRATE FOR SOLUTION FOR INFUSION VERSION NUMBER 1.0 14 TH 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 TANZANIA PUBLIC ASSESSMENT REPORT _TMDA/DMC/MRE/F/016 _ _REV #:_ 1. INTRODUCTION Tecentriq is an anticancer is a medicine belonging to antineoplastic agents, monoclonal antibodies. Tecentriq exerts is activity by binding to Programmed death-ligand 1 (PD-L1) may be expressed on tumour cells and/or tumour-infiltrating immune cells, and can contribute to the inhibition of the antitumour immune response in the tumour microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T-cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production. Tecentriq is an Fc-engineered, humanised immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and provides a dual blockade of the PD-1 and B7.1 receptors, releasing PD-L1/PD-1 mediated inhibition of the immune response, including reactivating the antitumour immune response without inducing antibody-dependent cellular cytotoxicity. Atezolizumab spares the PD-L2/PD-1 interaction allowing PD-L2/PD-1 mediated inhibitory signals to persist. Tecentriq is approved in Tanzania for use in adults only 1.1 PRODUCT DETAILS Registration number TAN 21 HM 0228 Brand name Tecentriq Generic name, strength and form Atexolizumab 1200 Mg/20 mL, Concentrate for Solution for Infusion ATC classification ATC code: L01XC32 antineoplastic agents, monoclonal antibodies Distribution category POM Country of origin Switzerland Associated product NA Marketing Authorization Holder F. Hoffmann- La Roche Ltd Grenzacherstrasse 124, 4070 Basel Switzerland Local Technical Representative Okinawa Pharmacy Ltd, Plot No. 2319/9 Makunganya read_full_document