Dicorate ER 500 Tablets 500 mg

Země: Tanzanie

Jazyk: angličtina

Zdroj: Tanzania Medicinces & Medical Devices Authority

Aktivní složka:

Divalproex Sodium

Dostupné s:

Sun Pharmaceutical Industries Limited, INDIA

ATC kód:

Antiepileptics, other antiepileptics

INN (Mezinárodní Name):

Divalproex Sodium

Dávkování:

500 mg

Léková forma:

Tablets

Výrobce:

SUN PHARMACEUTICALS INDUSTRIES LIMITED, INDIA

Přehled produktů:

Physical description: White, oval, biconvex coated tablet plain on both side; Local technical representative: Salama Pharmaceuticals Limited (9410)

Stav Autorizace:

Registered/Compliant

Datum autorizace:

2021-03-29

Charakteristika produktu

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRY OF HEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR DICORATE ER 500 (DIVALPROEX SODIUM
500MG) EXTENDED-RELEASE TABLET
VERSION NUMBER 01
3
RD JANUARY, 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
Dicorate ER 500 is a generic medicine of Depakote. Dicorate ER 500 is
a Antiepileptics
medicine
belonging
to
N05AX
Psycholeptics,
Antipsychotics,
Other
Antipsychotic
group. Dicorate ER 500 exerts is activity by potentiation of the
inhibitory action of
gamma amino-butyric acid (GABA) through an action on the further
synthesis or further
metabolism of GABA
.
Dicorate ER 500 is approved in Tanzania for use in adults,
elderly.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0190
Brand name
Dicorate ER 500
Generic
name,
strength
and
form
Divalproex sodium Equivalent To Valproic Acid 500
mg
ATC classification
N05AX
Psycholeptics, Antipsychotics, Other Antipsychotic
Distribution category
POM
Country of origin
India
Associated product
Dicorate ER 250
Marketing Authorization Holder
Sun Pharmaceutical Industries ltd,
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregoan (E),
Mumbai, Maharashtra
INDIA
Local
Technical
Representative
Salama Pharmaceuticals Limited
P.O. Box 65235,
Dar es Salaam
1.2
ASSESSMENT PROCEDURE
The application for registration of Dicorate ER 500 was submitted on
24
th
March, 2020.
The product underwent full assessment. Assessment was completed in two
rounds of
evaluation. Dicorate ER 500 was registered on 29
th
march, 2021.
1.3
INFORMATION FOR USERS
Visual
description
of
the
finished
product
Grey color, oval, biconvex, coated tablet plain
on both sides
Effective date: 03/10/2022
2
Primary packing material
Aluminium printed foi