Tivicay 5mg Dispersible Tablets

Država: Tanzanija

Jezik: engleski

Izvor: Tanzania Medicinces & Medical Devices Authority

Aktivni sastojci:

Dolutegravir Sodium

Dostupno od:

GlaxoSmithKline Pharmaceutical Kenya Limited, KENYA

ATC koda:

DIRECT ACTING ANTIVIRALS

INN (International ime):

Dolutegravir Sodium

Doziranje:

5

Farmaceutski oblik:

Dispersible Tablets

Proizveden od:

Glaxo Wellcome S.A, SPAIN

Proizvod sažetak:

Physical description: Dolutegravir Dispersible Tablets, 5 mg, for oral administration are round (6 mm diameter), biconvex, white, film coated tablets, debossed “SV H7S” on one face and “5” on the other face; Local technical representative: JD PHARMACY LIMITED (6943)

Status autorizacije:

Registered/Compliant

Datum autorizacije:

2021-10-09

Svojstava lijeka

TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR TIVICAY (DOLUTEGRAVIR SODIUM
EQUIVALENT TO DOLUTEGRAVIR 5 MG) 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/[phone]/2450751/2452108, EMAIL:
[e-mail], Website: WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1.
INTRODUCTION
The drug product is an immediate release tablet for oral
administration. Tivicay is
presented as dispersible tablet containing 5 mg of dolutegravir (as
dolutegravir sodium
salt) as active substance, 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.
Tivicay 5 mg 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 6 years of age or older
and weighing at least
14 kg.
1.1.PRODUCT DETAILS
1.2.ASSESSMENT PROCEDURE
The application for registration of Tivicay 5 mg was submitted on
05/08/2020. The
product underwent full assessment. Assessment was completed in 2(two)
rounds of
evaluation. Tivicay 5 mg was registered on 09/10/2021.
1.3.INFORMATION FOR USERS
Registration number
TAN 21 HM 0400
Brand name
Tivicay 5 mg
Generic
name,
strength
and
form
5 mg Dolutegravir (as sodium) Dispersible Tablets
ATC classification
J05AJ03, Antivirals for systemic use, other antivirals
Distribution category
POM
Country of origin
India
Associated product
Tivicay 50 mg, Tivicay 25 mg, and Tivicay 10 mg
Marketing Authorization Holder
GlaxoSmithKline Pharmaceutical Kenya Limited
P.O. Box 78392-00507, Likoni Road Industrial Area
Nairobi Kenya
Local Technica