Bicalutamide Tablets 50
Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Summary of Product characteristics
(SPC)
28-09-2022
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Active ingredient:
Bicalutamide
Available from:
Intas Pharmaceuticals Limited, INDIA
ATC code:
Hormone antagonists and related agents?
INN (International Name):
Bicalutamide
Dosage:
50
Pharmaceutical form:
Tablets
Manufactured by:
Intas Pharmaceuticals Limited, INDIA
Product summary:
Physical description: White to off white, round, biconvex, film-coated tablets debossed 'B 50' on one side and plain on other side; Local technical representative: MURJI BROTHERS (8448)
Authorization status:
Registered/Compliant
Authorization date:
2021-06-03
Summary of Product characteristics
TMDA/DMC/MRE/F/016
Revision#
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR INTAS (BICALUTAMIDE 50MG) FILM
COATED TABLETS
VERSION NUMBER 1.0
14
TH APRIL, 2022
P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tanzania
Tel: +255-22-2450512/2450751/ 2452108; Fax: +255-22-2450793
Email: info@tmda.go.tz; Website: mwww.tmda.go.tz
TANZANIA PUBLIC
ASSESSMENT REPORT
_TMDA/DMC/MRE/F/016 _
_REV #:_
1.
INTRODUCTION
INTAS Bicalutamide is a generic medicine of CASODEX® of AstraZeneca.
INTAS Bicalutamide
is an anticancer medicine belonging to Antineoplastic and
Immunomodulating Agents, Anti-
androgens group. INTAS Bicalutamide exerts is activity by binding to
androgen receptors without
activating gene expression, and thus inhibits the androgen stimulus.
INTAS Bicalutamide is approved in Tanzania for use in adults and
elderly.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0214
Brand name
INTAS Bicalutamide
Generic name, strength and form
Bicalutamide
50 mg film coated tablets
ATC classification
ATC code L02BB03
Anti-androgens
Distribution category
POM
Country of origin
India
Associated product
NA
Marketing Authorization Holder
Intas Pharmaceuticals Limited
Corporate House, Near Sola Bridge, S.G. Highway,
Thaltej, Ahmedabad-380054, Gujarat,
INDIA.
Telephone: +9179 39837909
Email: alkesh_shah@intaspharma.com
Local Technical Representative
Lifeline Pharmacy Ltd
Plot no. 540, Kalenga Street, Upanga, P.O. BOX
76969, Dar esSalaam,
TANZANIA.
Telephone: (255) 713244004
Email: lifelineupanga@gmail.com
1.2 ASSESSMENT PROCEDURE
The application for registration of INTAS Bicalutamide was submitted
on 10
th
October, 2018. The
product underwent
joint EAC
assessment. Assessment was completed in 2 rounds of evaluation.
INTAS Bicalutamide was registered on <03
rd
June 2021
1.3 INFORMATION FOR USERS
Visual description of the finished product
White
to
off
white,
round,
biconvex,
film
coated tablets debossed ‘B 50’ on one
side and plain on other side.
Primary packing material
Clear PVC/PVdC-Alu bl
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