CARVILIN-12.5 Tablets

국가: 탄자니아

언어: 영어

출처: Tanzania Medicinces & Medical Devices Authority

유효 성분:

Carvedilol

제공처:

Lincoln Pharmaceuticals Limited, INDIA

ATC 코드:

Beta blocking agents, selective

INN (국제 이름):

Carvedilol

복용량:

12.5

약제 형태:

Tablets

Manufactured by:

Lincoln Pharmaceuticals Limited, INDIA

제품 요약:

Physical description: Orange coloured, round shaped, biconvex, film coated tablet, breaklinie on one side and plain on other side; Local technical representative: Heko Pharmacy Limited (7718)

승인 상태:

Registered/Compliant

승인 날짜:

2021-08-20

제품 특성 요약

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR CARVILIN - 12.5 (CARVEDILOL USP 12.5 MG)
TABLETS
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
Carvilin-12.5is
a
generic
medicine
of
coreg®
25
mg
(carvedilol tablets 25 mg) of glaxosmithkline, USA. Carvilin-12.5 is
an antihypetensive
medicine belonging to C07AG02 Cardiovascular System - Beta blocking
agents’ group.
Carvilin-12.5 is a vasodilatory non-selective beta-blocker, which
reduces the peripheral
vascular resistance by selective alpha 1- receptor blockade and
suppresses the renin-
angiotensin system through non-selective beta-blockade
.
Carvilin-12.5is approved in
Tanzania for use in adults and elderly.
1.1
PRODUCT DETAILS
Registration number
TAN 21 HM 0283
Brand name
Carvilin-12.5
Generic
name,
strength
and
form
Carvedilol 12.5 mg film coated tablets
ATC classification
C07AG02
Cardiovascular System - Beta blocking agents
Distribution category
POM
Country of origin
India
Associated product
Marketing Authorization Holder
Lincoln Pharmaceuticals Limited,
TrimuL Estate, Khantraj, TALUKA: Kalol, District:
Gandhinagar, Gujarat,
INDIA.
Email: [e-mail]
Local
Technical
Representative
Heko Pharmacy Ltd
P.
O.
BOX
2657,
Plot
No.32/57,
Sikukuu/Tandamti
Street, Kariakoo,
DAR ES SALAAM.
Email: [e-mail]
1.2
ASSESSMENT PROCEDURE
The application for registration of Carvilin-12.5 was submitted on
. The
product underwent full assessment. Assessment was completed in
rounds of
evaluation. Carvilin-12.5 was registered on 20
th
August, 2021
Effective date: 03/10/2022
2
1.3
INFORMATION FOR USERS
Visual
description
of
the
fini