Lamivudine and Tenofovir Disoproxil Fumarate Tablets 300/300
Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Summary of Product characteristics
(SPC)
28-02-2024
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Active ingredient:
Lamivudine, Tenofovir Disoproxil Fumarate
Available from:
CIPLA QUALITY CHEMICAL INDUSTRIES Limited, UGANDA
ATC code:
DIRECT ACTING ANTIVIRALS
INN (International Name):
Lamivudine, Tenofovir Disoproxil Fumarate
Dosage:
300/300
Pharmaceutical form:
Tablets
Manufactured by:
CIPLA QUALITY CHEMICAL INDUSTRIES Limited., UGANDA
Product summary:
Physical description: White to off white colored, capsule shaped, biconvex, film coated tablet with “LT” debossed on one side and plain on other side; Local technical representative: Salama Pharmaceuticals Limited (9410)
Authorization status:
Registered/Compliant
Authorization date:
2023-06-01
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 LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE
300MG/300MG FILM COATED TABLETS
Version number 1.0
21 August, 2023
TMDA Headquarters, Plot No. 56/1, Block E, Kisasa B Centre, Hombolo 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
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