Verquvo Film Coated Tablet

국가: 탄자니아

언어: 영어

출처: Tanzania Medicinces & Medical Devices Authority

유효 성분:

Vericiguat

제공처:

Bayer East Africa Limited, KENYA

ATC 코드:

Arteriolar smooth muscle agents acting on

INN (국제 이름):

Vericiguat

약제 형태:

Film Coated Tablet

Manufactured by:

Bayer AG, Leverkusen, GERMANY

제품 요약:

Physical description: Round, biconvex, yellow-orange film-coated tablet with a diameter of 9 mm, marked with “10” on one side and “VC” on the other side.; Local technical representative: JD PHARMACY LIMITED (6943)

승인 상태:

Registered/Compliant

승인 날짜:

2022-08-04

제품 특성 요약

TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR VERQUVO (VERICIGUAT 10 MG) FILM
COATED TABLETS
VERSION NUMBER 01, 04/01/2023
TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA
ROAD,
P. O. BOX 1253, DODOMA – TANZANIA, TELEPHONE: +255 (26)
2961989/2061990/[phone]/2450751/2452108, EMAIL:
[e-mail], Website: WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1.
INTRODUCTION
Vericiguat is a stimulator of soluble guanylate cyclase (sGC). Heart
failure is associated
with impaired synthesis of nitric oxide (NO) and decreased activity of
its receptor, sGC.
Deficiency in sGC-derived cyclic guanosine monophosphate (cGMP)
contributes to
myocardial and vascular dysfunction. Vericiguat restores the relative
deficiency in the
NO-sGC-cGMP signalling pathway by directly stimulating sGC,
independently of and
synergistically with NO, to augment the levels of intracellular cGMP,
which may improve
both myocardial and vascular function. Medicine belonging to cardiac
therapy, other
vasodilators used in cardiac diseases, ATC code: C01DX22.
Vericiguat is approved in Tanzania for the treatment of symptomatic
chronic heart failure
in adult patients with reduced ejection fraction who are stabilized
after a recent
decompensation event requiring IV therapy.
1.1.PRODUCT DETAILS
1.2.ASSESSMENT PROCEDURE
Registration number
TAN 22 HM 0310
Brand name
Verquvo 10 mg film-coated tablets
Generic
name,
strength
and
form
Vericiguat
ATC classification
C01DX22, Cardiac therapy, other vasodilators used
in cardiac diseases
Distribution category
POM
Country of origin
Germany
Associated product
The finished product is presented as a film-coated
tablet containing 2.5 mg, 5 mg or 10 mg of Vericiguat
as active substance
Marketing Authorization Holder
Bayer AG, 51368 Leverkusen Germany
Local Technical Representative
JD Pharmacy Limited,
Dar Es Salaam, Tanzania
1
Effective date: 03/10/2022
The application for registrati