Maa: Tansania
Kieli: englanti
Lähde: Tanzania Medicinces & Medical Devices Authority
Metoprolol
ILKO ILAC SAN VE TIC. A.S., TURKEY
Selective calcium channel blockers with mainly vas
Metoprolol
25 mg
Tablet, Film-coated
ilko ilac San. ve Tic. A.S, TURKEY
Physical description: Homogeneous, white coloured, oval, biconvex, scored on both side film coated tablets; Local technical representative: GENERICS & SPECIALITIES LIMITED (9801)
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 PULSATYL SDK (METOPROLOL SUCCINATE 23.75 MG EQUIVALENT TO METOPROLOL TARTRATE 25 MG) CONTROLLED RELEASE FILM COATED TABLETS VERSION NUMBER 1 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 PULSATYL SDK is a generic medicine of Lopressor. PULSATYL SDK is an antihypertensive medicine belonging to C07AB02- Beta-receptor blocker, selective group. Metoprolol is a beta-1 selective beta blocker. It has a relatively greater blocking effect on beta receptors (i.e. those mediating adrenergic stimulation of heart rate and contractility and release of the fatty acids from fat stores) than on beta receptors which are chiefly involved in broncho and vasodilation. Metoprolol only exhibits insignificant membrane stabilising effect and has no agonist effect. Metoprolol reduces or blocks the stimulating effect of catecholamines (particularly released in case of physical or mental stress) on the heart. Metoprolol reduces tachycardia, decreases the cardiac output and the contractility, and lowers the blood pressure. If required, metoprolol may be administered concomitantly with a beta-2 agonist to patients with symptoms of obstructive pulmonary disease. PULSATYL SDK is approved in Tanzania for use in adults and elderly. 1.1 PRODUCT DETAILS Registration number TAN 21 HM 0324 Brand name PULSATYL SDK Generic name, strength and form Metoprolol succinate ATC classification C07AB02- Beta-receptor blocker, selective Distribution category POM Country of origin Turkey Associated product State any other product of formulation, strength or site that is linked or associated with the product if applicable Market Lue koko asiakirja