Firialta 10 mg Film coated tablets

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Finerenone

Available from:

Bayer East Africa Limited, KENYA

ATC code:

Aldosterone Antagonists and Other Potassium-Sparin

INN (International Name):

Finerenone

Dosage:

10 mg

Pharmaceutical form:

Film coated tablets

Manufactured by:

Bayer AG, GERMANY

Product summary:

Physical description: Pink, oval-oblong film-coated tablet with a length of 10 mm and a width of 5 mm, marked "10" on one side and "FI" on the other side; Local technical representative: JD PHARMACY LIMITED (6943)

Authorization status:

Registered/Compliant

Authorization date:

2022-12-05

Summary of Product characteristics

TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR FIRIALTA (FINERENONE 10 MG) FILM
COATED TABLETS
VERSION NUMBER 01, 06/01/2023
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
Finerenone is a nonsteroidal, selective antagonist of the
mineralocorticoid receptor
(MR) which is activated by aldosterone and cortisol and regulates gene
transcription. Its
binding to the MR leads to a specific receptor-ligand complex that
blocks recruitment of
transcriptional coactivators implicated in the expression of
pro-inflammatory and pro-
fibrotic mediators.
Finerenone is approved in Tanzania for the treatment of chronic kidney
disease (stage 3
and 4 with albuminuria) associated with type 2 diabetes in adults.
1.1.PRODUCT DETAILS
1.2.ASSESSMENT PROCEDURE
The application for registration of Firialta 10 mg film-coated tablets
was submitted on
20/06/2022. The product underwent abridged assessment. Assessment was
completed
in one round of evaluation. Firialta 10 mg film-coated tablets was
registered on
05/12/2022.
Registration number
TAN 22 HM 0510
Brand name
Firialta 10 mg film-coated tablets
Generic
name,
strength
and
form
Finerenone
ATC classification
Diuretics,
aldosterone
antagonists,
ATC
code:
C03DA05
Distribution category
POM
Country of origin
Germany
Associated product
The finished product is presented as a film-coated
tablet containing 10 mg or 20 mg of Finerenone 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
1.3.INFORMATION FOR USERS
2. LABELLING AND PRODUCT INFORMATION
Summary of product characteristics
The SmPC included all the relevant i