Verquvo Tablets

Land: Tanzania

Språk: engelska

Källa: Tanzania Medicinces & Medical Devices Authority

Aktiva substanser:

Vericiguat

Tillgänglig från:

Bayer East Africa Limited, KENYA

ATC-kod:

Arteriolar smooth muscle agents acting on

INN (International namn):

Vericiguat

Läkemedelsform:

Tablets

Tillverkad av:

Bayer AG, Leverkusen, GERMANY

Produktsammanfattning:

Physical description: Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm, marked with “5” on one side and “VC” on the other side.; Local technical representative: JD PHARMACY LIMITED (6943)

Bemyndigande status:

Registered/Compliant

Tillstånd datum:

2022-08-04

Produktens egenskaper

TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR VERQUVO (VERICIGUAT 5 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 0312
Brand name
Verquvo 5 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, 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 registration of Veri