Darunavir and Ritonavir Tablets 800/100
Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Summary of Product characteristics
(SPC)
22-03-2023
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
Darunavir , Ritonavir Tablets 800mg/100mg
Available from:
Hetero Laboratories Limited, INDIA
INN (International Name):
Darunavir and Ritonavir Tablets 800mg/100mg
Dosage:
800/100
Pharmaceutical form:
Tablets
Manufactured by:
HETERO LABS LIMITED, UNIT III, INDIA
Product summary:
Physical description: Yellow, capsule shaped, bevel edged, biconvex film coated tablets debossed with 'H' on one side and 'D24' on the other side.; Local technical representative: SURYA PHARMA LIMITED (29253)
Authorization status:
Registered/Compliant
Authorization date:
2021-10-09
Summary of Product characteristics
Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THE UNITED REPUBLIC OF TANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR DARUNAVIR ETHANOLATE 800 MG AND RITONAVIR
100MG FILM COATED TABLETS
VERSION NUMBER 01, 03/01/2023
TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA
ROAD, P. O. BOX 1253,
DODOMA – TANZANIA, TELEPHONE: +255 (26) 2961989/2061990/+255 (22)
2450512/2450751/2452108,
EMAIL: INFO@TMDA.OG.TZ, Website: WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1
1.
INTRODUCTION
Darunavir/Ritonavir tablets is an antiretroviral fixed dose bilayer
formulation of the individual
components that make up of Darunavir ethanolate and Ritonavir that has
activity against HIV-1
that can be considered as generic combination of Prezista®
(darunavir) tablet 800 mg of
Janssen Ortho LLC, Gurabo, PR 00778 and Norvir® (ritonavir) tablet
100 mg of Abbvie Inc.
North Chicago, IL 60064 USA.
Darunavir is an inhibitor of the dimerisation and of the catalytic
activity of the HIV-1 protease. It
selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins
in virus infected cells,
thereby
preventing
the
formation
of
mature
infectious
virus
particles.
Pharmacokinetic
enhancement by ritonavir is based on its potent inhibition of CYP3A-
mediated metabolism. The
degree of enhancement is related to the metabolic pathway of the co
administered protease
inhibitor and the impact of the co-administered protease inhibitor on
the metabolism of ritonavir.
Darunavir/Ritonavir
tablets
is
approved
in
Tanzania
for
use
in
combination
with
other
antiretroviral medicines for the treatment of human immunodeficiency
virus type 1 (HIV-1)
infection in adults and adolescents weighing at least 40 kg.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0402
Brand name
Darunavir/Ritonavir
Generic name, strength and form
Darunavir (as ethanolate) / Ritonavir
800mg /100mg tablets
ATC classification
Antivirals for systemic use, protease inhibitors (darunavir:
J05AR14,
Read the complete document
