Dolutegravir,Lamivudine and tenofovir Disoproxil Fumarate 50mg/300mg/300mg Tablets. 50/300/300

البلد: تانزانيا

اللغة: الإنجليزية

المصدر: Tanzania Medicinces & Medical Devices Authority

العنصر النشط:

Dolutegravir Sodium, Lamivudine , Tenofovovir Disoproxil Fumarate

متاح من:

Celltrion, Inc., REPUBLIC OF KOREA

ATC رمز:

Antivirals for systemic use, antivirals for treatm

INN (الاسم الدولي):

Dolutegravir Sodium+ Lamivudine + Tenofovovir Disoproxil Fumarate

جرعة:

50/300/300

الشكل الصيدلاني:

Tablets

المصنعة من قبل:

Celltrion, Inc, REPUBLIC OF KOREA

ملخص المنتج:

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)

الوضع إذن:

Registered/Compliant

تاريخ الترخيص:

2021-10-09

خصائص المنتج

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: [phone]/+255 (22)
2450512/2450751/2452108,
EMAIL: [e-mail], 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