EUROTAX 20 Solution for injection/concentrate for solution for infusion

국가: 탄자니아

언어: 영어

출처: Tanzania Medicinces & Medical Devices Authority

유효 성분:

Docetaxel

제공처:

Eurolab (Pty) Ltd, SOUTH AFRICA

ATC 코드:

Plant alkaloids and other natural products

INN (국제 이름):

Docetaxel

복용량:

20

약제 형태:

Solution for injection/concentrate for solution for infusion

Manufactured by:

S.C. SINDAN-PHARMA S.R.L., Romania

제품 요약:

Physical description: Clear, oily, pale yellow solution; Local technical representative: BB PHARMA CONSULTANCY LTD (3955)

승인 상태:

Registered/Compliant

승인 날짜:

2021-08-20

제품 특성 요약

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR DOXEL 20 (DOCETAXEL 20 MG/1ML
CONCENTRATE FOR SOLUTION FOR INFUSION
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: [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
Doxel 20 Concetrate for Solution for Infusion is a generic medicine of
Taxotere. Doxel
20 Concetrate for Solution for Infusion is an antioneoplastic medicine
belonging to
L01CD02; antineoplastic and immunomodulating agents, taxanes group.
Doxel 20
concentrate for solution for Infusion.
Docetaxel is an antineoplastic agent which acts by
promoting
the
assembly
of
tubulin
into
stable
microtubules
and
inhibits
their
disassembly which leads to a marked decrease of free tubulin. The
binding of docetaxel
to microtubules does not alter the number of protofilaments. Docetaxel
has been
shown in vitro to disrupt the microtubular network in cells which is
essential for vital
mitotic and interphase cellular functions.
Doxel 20 Concetrate for Solution for Infusion is
approved in Tanzania for use in adults, elderly.
1.1
PRODUCT DETAILS
Registration number
TAN 21 HM 0291
Brand name
Doxel 20 Concentrate for Solution for Infusion
Generic
name,
strength and form
Docetaxel anhydrous, 20 mg Concentrate for Solution for
Infusion
ATC classification
Taxanes, ATC Code: L01CD02
Distribution category
POM
Country of origin
Italy
Associated product
State any other product of formulation, strength or site that is
linked or associated with the product if applicable
Marketing
Authorization Holder
Eurolab (Pty) Ltd,
Woodmead
Office
Park,
3
Stirrup
Lane,
Van
Reenens
Avenue,Woodmead, 2144
South Africa
Local
Technical
Representative
BB Pharma Consultancy Limited,
Mabibo External, EPZA