Krajina: Tanzánia
Jazyk: angličtina
Zdroj: Tanzania Medicinces & Medical Devices Authority
Carvedilol
Lincoln Pharmaceuticals Limited, INDIA
Beta blocking agents, selective
Carvedilol
12.5
Tablets
Lincoln Pharmaceuticals Limited, INDIA
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)
Registered/Compliant
2021-08-20
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: +255 (26) 2961989/2061990/+255 (22) 2450512/2450751/2452108, EMAIL: INFO@TMDA.OG.TZ, 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: info@lincolnpharma.com Local Technical Representative Heko Pharmacy Ltd P. O. BOX 2657, Plot No.32/57, Sikukuu/Tandamti Street, Kariakoo, DAR ES SALAAM. Email: hekopharmacy@cats-net.com 1.2 ASSESSMENT PROCEDURE The application for registration of Carvilin-12.5 was submitted on. The product underwent full assessment. Assessment was completed in Prečítajte si celý dokumentrounds 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