Prezel 75 Hard Gelatin Capsules

Država: Tanzanija

Jezik: engleski

Izvor: Tanzania Medicinces & Medical Devices Authority

Aktivni sastojci:

Pregabalin

Dostupno od:

Ind-Swift Limited, INDIA

ATC koda:

Antiepileptic drugs

INN (International ime):

Pregabalin

Doziranje:

75

Farmaceutski oblik:

Hard Gelatin Capsules

Proizveden od:

Ind-Swift Limited, INDIA

Proizvod sažetak:

Physical description: Size '4' hard gelatin capsules, Reddish brown cap with creamish color body; Local technical representative: Planet Pharmaceutical Limited (6099)

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
PREZEL 75 (PREGABALIN 75 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
Prezel 75 is a generic medicine of Lyrica 75 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.
Prezel 75 is approved in
Tanzania for use only in adult patients.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0161
Brand name
Prezel 75
Generic name, strength, and form
Each hard gelatin capsule contains 75 mg Pregabalin
ATC classification
ATC
Code-
N03AX16
(Anti–epileptics,
other
antiepileptics)
Distribution category
POM
Country of origin
India
Associated product
Prezel 150
Marketing Authorization Holder
Ind-Swift Limited
Off. NH-21,
Village Jawaharpur,
Tehsil Derabassi,
Distt. SAS Nagar (Mohali),
Punjab 140507, India
Local Technical Representative
Planet Pharmaceuticals Limited
P. O. Box 38328,
Dar es Salaam
1.2 ASSESSMENT PROCEDURE
The application for registration of
Prezel 75 was submitted on 20/05/2020. 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
Size '4' hard gelatin capsules, reddish brown cap
with creamish color body
Primary packing material
Blister