Ülke: Tanzanya
Dil: İngilizce
Kaynak: Tanzania Medicinces & Medical Devices Authority
Dolutegravir Sodium, Lamivudine , Tenofovovir Disoproxil Fumarate
Celltrion, Inc., REPUBLIC OF KOREA
Antivirals for systemic use, antivirals for treatm
Dolutegravir Sodium+ Lamivudine + Tenofovovir Disoproxil Fumarate
50/300/300
Tablets
Celltrion, Inc, REPUBLIC OF KOREA
Physical description: White color capsule shaped film coated tablets with ‘C7’ debossed on one side and plain on other side; Local technical representative: Dawa Medicare Limited (2624)
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 DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (DOLUTEGRAVIR SODIUM 50 MG + LAMIVUDINE 300 MG + TENOFOVIR DISOPROXIL FUMARATE 300 MG) FILM COATED TABLETS VERSION NUMBER 1 03 JANUARY, 2022 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. INTRODUCTION Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets is antiretroviral drug, indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and adolescents weighing at least 30 kg. Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Lamivudine, the negative enantiomer of 2'-deoxy-3'-thiacytidine, is a dideoxynucleoside analogue. Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate. Lamivudine and tenofovir are phosphorylated by cellular enzymes to form lamivudine triphosphate and tenofovir diphosphate, respectively. Lamivudine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination. Both substances are active against HIV-1 and HIV-2, as well as against hepatitis B virus. 1.1 PRODUCT DETAILS Registration number TAN 21 HM 0408 Brand name N/A Generic name, strength, and form Each film-coated tablet contains 50 mg dolutegravir (as sodium), 300 mg lamivudine and 300 mg tenofovir disoproxil fumarate ATC classification Direct acting antivirals, Antivirals for treatment of HIV infections, combinations, ATC Belgenin tamamını okuyun