Capxcel Film Coated Tablet 500 mg/tablet
Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Summary of Product characteristics
(SPC)
22-03-2023
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Active ingredient:
Capecitabine
Available from:
Khandelwal Laboratories Private Limited, INDIA
ATC code:
Antimetabolites
INN (International Name):
Capecitabine
Dosage:
500 mg/tablet
Pharmaceutical form:
Film Coated Tablet
Manufactured by:
Khandelwal Laboaratories Private Limited, INDIA
Product summary:
Physical description: Biconvex circular buff coloured film coated tablets; Local technical representative: Salama Pharmaceuticals Limited
Authorization status:
Registered/Compliant
Authorization date:
2021-06-03
Summary of Product characteristics
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
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