Држава: Танзанија
Језик: Енглески
Извор: Tanzania Medicinces & Medical Devices Authority
Dolutegravir Sodium
Mylan Laboratories Limited, INDIA
Dolutegravir Sodium
10
Film Coated Tablet
Mylan Laboratories Limited, INDIA
Physical description: Pink colored, film coated, Oval shaped, Bicnvex tablet debossed with "D" to the left of the breakline and "T" to the right of the breakline on one side of the tablet and "M" to the left of the breakline on the other side of the tablets; Local technical representative: Synermed Pharmaceuticals (T) Limited (5197)
Registered/Compliant
2021-10-09
Effective date: 03/10/2022 TMDA/DMC/MRE/F/016 REV #:02 THEUNITEDREPUBLICOFTANZANIA MINISTRY OF HEALTH TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY PUBLIC ASSESSMENT REPORT FOR MYLTEGA DT (DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 10MG) DISPERSIBLE 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 MYLTEGA DT is a generic medicine of Tivicay 5 mg dispersible tablets (of ViiV Healthcare UK Limited, United Kingdom). The proposed product is a tablet that contains, as the active ingredient, dolutegravir sodium (hereinafter referred to as Dolutegravir), antiviral for systemic use. 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. MYLTEGA DT is approved in Tanzania for use in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg. 1.1 PRODUCT DETAILS Registration number TAN 21 HM 0396 Brand name MYLTEGA DT Generic name, strength and form 10 mg Dolutegravir (as sodium) Dispersible Tablets ATC classification J05AJ03, Antivirals for systemic use, other antivirals Distribution category POM Country of origin India Associated product N/A Marketing Authorization Holder Mylan Laboratories Limited Address: Plot No.564/A/22, Road No.92, Jubilee Hills, Hyderabad - 500096, Telangana, India. Local Technical Representative Synermed Pharmaceuticals (Tanzania) Limited Address: Plot No.: 31/32 Makaburini, Nyerere road, Dar- es- salaam, Tanzania. 1.2 ASSESSMENT PROCEDURE The application for registration of MYLTEGA DT was sub Прочитајте комплетан документ