EUROTAX 80 Solution for injection/concentrate for solution for infusion

מדינה: טנזניה

שפה: אנגלית

מקור: Tanzania Medicinces & Medical Devices Authority

מרכיב פעיל:

Docetaxel

זמין מ:

Eurolab (Pty) Ltd, SOUTH AFRICA

קוד ATC:

Plant alkaloids and other natural products

INN (שם בינלאומי):

Docetaxel

כמות:

80

טופס פרצבטיות:

Solution for injection/concentrate for solution for infusion

תוצרת:

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

leaflet_short:

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

מצב אישור:

Registered/Compliant

תאריך אישור:

2021-08-20

מאפייני מוצר

Effective date: 03/10/2022
_TMDA/DMC/MRE/F/016 _
_REV #:02_
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR DOXEL 80 (DOCETAXEL 80 MG/1ML
CONCENTRATE FOR SOLUTION FOR INFUSION
VERSION NUMBER 0.1
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 80 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 80 _
_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 80 Concetrate for Solution for Infusion _is
approved in Tanzania for use in _adults, elderly_.
1.1
PRODUCT DETAILS
Registration number
_TAN 21 HM 0292 _
Brand name
_Doxel 80 Concentrate for Solution for Infusion _
Generic
name,
strength and form
_Docetaxel anhydrous, 80 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, _