Sitapril 100 Film Coated Tablet

Land: Tansania

Sprache: Englisch

Quelle: Tanzania Medicinces & Medical Devices Authority

Wirkstoff:

Sitagliptin Phosphate Monohydrate

Verfügbar ab:

Ajanta Pharma Limited, INDIA

ATC-Code:

Drugs used in diabetes, blood glucose lowering dru

INN (Internationale Bezeichnung):

Sitagliptin Phosphate Monohydrate

Dosierung:

100

Darreichungsform:

Film Coated Tablet

Hergestellt von:

Ajanta Pharma Limited, INDIA

Produktbesonderheiten:

Physical description: Beige colored, round, film coated tablets debossed ‘ST3’ on one side and plain on other side; Local technical representative: ASTRA PHARMA (T) Limited (4645)

Berechtigungsstatus:

Registered/Compliant

Berechtigungsdatum:

2021-10-09

Fachinformation

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THE UNITED REPUBLIC OF TANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR SITAPRIL 100® (SITAGLIPTIN PHOSPHATE
MONOHYDRATE EQUIVALENT TO SITAGLIPTIN 100 MG) FILM COATED TABLETS
VERSION NUMBER 01, 03/01/2023
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
Sitapril 100® is a s a generic medicine of Janumet ® (Sitagliptin
Phosphate Monohydrate 100
mg) tablets, Merck Sharp & Dohme (UK) Limited. Sitapril 100® is an
Anti-Diabetic medicine
belonging to Dipeptidyl peptidase 4 (DPP-4) inhibitors group. Sitapril
100® exerts is activity by
increasing the levels of the Incretin hormones Glucagon-like Peptide-1
(GLP- 1) and glucose-
dependent insulinotropic polypeptide (GIP). Sitapril 100® is approved
in Tanzania for use in
adults only.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0399
Brand name
Sitapril 100®
Generic name, strength and form
Sitagliptin Phosphate Monohydrate 100 mg Film Coated
Tablets
ATC classification
ATC Code-A10BH01
Anti-Diabetic, Dipeptidyl peptidase 4 (DPP-4) inhibitors
Distribution category
POM
Country of origin
India
Associated product
Sitapril 25® and Sitapril 50®
Marketing Authorization Holder
Ajanta Pharma Limited
Address: Ajanta House, Charkop, Kandivli (W), Mumbai
400067, India
Local Technical Representative
Astra Pharma (T) Limited.
Address: Plot no-12, Vingunguti Industrial Area, Nyerere
Road, opp: Pepsi tanzania Ltd,
Dar -Es- Salaam.
1.2 ASSESSMENT PROCEDURE
The application for registration of Sitapril 100® was submitted on
29/01/2021. The product
underwent full assessment. Assessment was completed in 2(two) rounds
of evaluation. Sitapril
100® was registered on 09/10/2021.
1.3 INFORMATION FOR USERS
Visual description of the f