Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Darunavir , Ritonavir Tablets 400mg/50mg
Hetero Laboratories Limited, INDIA
DIRECT ACTING ANTIVIRALS
Darunavir and Ritonavir Tablets 400mg/50mg
400/50
Tablets
Hetero Laboratories Limited, INDIA
Physical description: yellow, capsule shaped, biconvex film coated tablets debossed with 'H' on one side and 'D46' on the other side.; Local technical representative: SURYA PHARMA LIMITED (29253)
Registered/Compliant
2021-10-09
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 400 MG AND RITONAVIR 50 MG 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 400 mg of Janssen Ortho LLC, Gurabo, PR 00778 and Norvir® (ritonavir) tablet 50 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 0403 Brand name Darunavir/Ritonavir Generic name, strength and form Darunavir (as ethanolate) / Ritonavir 400mg /50mg tablets ATC classification Antivirals for systemic use, protease inhibitors (darunavir: J05AR14, r Read the complete document