Tecentriq Solution For Infussion 1200 mg/20ml

Страна: Танзания

Език: английски

Източник: Tanzania Medicinces & Medical Devices Authority

Активна съставка:

Aciclovir

Предлага се от:

F.Hoffmann-La Roche Limited, SWITZERLAND

АТС код:

Antiviral

INN (Международно Name):

Aciclovir

дозиране:

1200 mg/20ml

Лекарствена форма:

Solution For Infussion

Произведено от:

F. Hoffmann-La Roche Limited, SWITZERLAND

Каталог на резюме:

Physical description: Liquid, not more coloured than BY4, free from particles; Local technical representative: okinawa pharmacy ltd (7147)

Статус Оторизация:

Registered/Compliant

Дата Оторизация:

2021-06-03

Данни за продукта

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: [phone]; Fax: [phone]
Email: [e-mail]; 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