Država: Tanzanija
Jezik: engleski
Izvor: Tanzania Medicinces & Medical Devices Authority
Capecitabine
Khandelwal Laboratories Private Limited, INDIA
Antimetabolites
Capecitabine
500 mg/tablet
Film Coated Tablet
Khandelwal Laboaratories Private Limited, INDIA
Physical description: Biconvex circular buff coloured film coated tablets; Local technical representative: Salama Pharmaceuticals Limited
Registered/Compliant
2021-06-03
Effective date: 03/10/2022 TMDA/DMC/MRE/F/016 REV #:02 THEUNITEDREPUBLICOFTANZANIA MINISTRYOFHEALTH TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY PUBLIC ASSESSMENT REPORT FOR CAPXCEL (CAPECITABINE 500 MG) FILM COATED TABLETS VERSION NUMBER 01 3 RD JANUARY, 2022 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 Capxcel is a generic medicine of Xeloda. Capxcel is a non-cytotoxic fluoropyrimidine carbamate medicine belonging to L01BC06 cytostatic (antimetabolite) group. Capxcel is a precursor of the cytotoxic moiety 5-fluorouracil (5-FU). Capecitabine is activated via several enzymatic steps. The enzyme involved in the final conversion to 5-FU, thymidine phosphorylase (ThyPase), is found in tumour tissues, but also in normal tissues, albeit usually at lower levels. In human cancer xenograft models capecitabine demonstrated a synergistic effect in combination with docetaxel, which may be related to the upregulation of thymidine phosphorylase by docetaxe. Capxcel is approved in Tanzania for use in adults. 1.1 PRODUCT DETAILS Registration number TAN 21 HM 0225 Brand name Capxcel Generic name, strength and form Capecitabine 500 mg film coated tablets ATC classification L01BC06 cytostatic (antimetabolite) Distribution category POM Country of origin India Associated product State any other product of formulation, strength or site that is linked or associated with the product if applicable Marketing Authorization Holder Khandelwal Laboratories Pvt., Ltd 79/87, D.Lad Path, Mumbai - 400033, India E-MAIL:export@khhandelwallab.com Local Technical Representative Salama Pharmaceuticals Ltd. Plot No. 4, block 28, Aggrey/Nyamwezi Street, Kariakoo, Dar es Salaam, Tanzania 1.2 ASSESSMENT PROCEDURE The application for registration of Capxcel was submitted on 11 th April, 2019. The product und Pročitajte cijeli dokument