MYLTEGA DT Film Coated Tablet 10

Država: Tanzanija

Jezik: angleščina

Source: Tanzania Medicinces & Medical Devices Authority

Aktivna sestavina:

Dolutegravir Sodium

Dostopno od:

Mylan Laboratories Limited, INDIA

INN (mednarodno ime):

Dolutegravir Sodium

Odmerek:

10

Farmacevtska oblika:

Film Coated Tablet

Izdeluje:

Mylan Laboratories Limited, INDIA

Povzetek izdelek:

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)

Status dovoljenje:

Registered/Compliant

Datum dovoljenje:

2021-10-09

Lastnosti izdelka

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