GABICA-50 Capsules

Država: Tanzanija

Jezik: engleski

Izvor: Tanzania Medicinces & Medical Devices Authority

Aktivni sastojci:

Pregabalin

Dostupno od:

Getz Pharma Private Limited, PAKISTAN

ATC koda:

Antiepileptic drugs

INN (International ime):

Pregabalin

Doziranje:

50

Farmaceutski oblik:

Capsules

Proizveden od:

Getz Pharma (Pvt) Limited, PAKISTAN

Proizvod sažetak:

Physical description: Hard gelatin capsule with pink opaque cap and yellow opaque body printed Getz logo and 50mg in black containing white powder; Local technical representative: Planet Pharmaceutical Limited

Status autorizacije:

Registered/Compliant

Datum autorizacije:

2021-08-20

Svojstava lijeka

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 GABICA
TM 50 MG (PREGABALIN 50 MG) HARD
GELATIN CAPSULES
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
Gabica
TM
50 mg is a generic medicine of Lyrica 50 mg hard capsules of Pfizer
Limited,
is an analogue of the neurotransmitter gamma-aminobutyric acid (GABA).
Pregabalin
decreases central neuronal excitability by binding to an auxiliary
subunit (α2-δ protein)
of
a
voltage-gated
calcium
channel
on
neurons
in
the
central
nervous
system.
Pregabalin
reduces
the
release
of
several
neurotransmitters,
including
glutamate,
noradrenaline, and substance. Gabica
TM
50 mg is approved in Tanzania for use only in
adult patients.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0331
Brand name
Gabica
TM
50 mg
Generic
name,
strength,
and
form
Each
hard
gelatin
capsule
contains
50
mg
Pregabalin
ATC classification
ATC
Code-
N03AX16
(Anti–epileptics,
other
antiepileptics)
Distribution category
POM
Country of origin
Pakistan
Associated product
Gabica
TM
150 mg and Gabica
TM
75 mg
Marketing Authorization Holder
Getz Pharma (Pvt) Limited
29-30/27, Korangi Industrial Area, Karachi-74900
Pakistan
Local
Technical
Representative
Planet Pharmaceuticals Limited
P. O. Box 38328,
Dar es Salaam
1.2 ASSESSMENT PROCEDURE
The application for registration of Gabica
TM
50 mg was submitted on 23/07/2020. The
product underwent full assessment. Assessment was completed in 3
(three) rounds of
evaluation and the product was registered on 20/08/2021.
1.3 INFORMATION FOR USERS
Visual
description
of
the
finished
product
Hard gelatin capsule with pink opaque cap
and yellow opaque body printed Getz lo