GINIB 100 MG Tablet, Film-coated

国家: 坦桑尼亚

语言: 英文

来源: Tanzania Medicinces & Medical Devices Authority

有效成分:

Imatinib

可用日期:

Eurolab (Pty) Ltd, SOUTH AFRICA

ATC代码:

Other antineoplastic agents

INN（国际名称）:

Imatinib

剂量:

100 mg

药物剂型:

Tablet, Film-coated

厂商:

REMEDICA LTD, CYPRUS

產品總結:

Physical description: Dark yellow to brownish-orange, round shaped, film-coated tablets with a breakline on one side and ''100'' on the other side; Local technical representative: BB PHARMA CONSULTANCY LTD (3955)

授权状态:

Registered/Compliant

授权日期:

2022-01-10

产品特点

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR PUBLIC ASSESSMENT REPORT FOR GINIB 100
(IMATINIB
MESYLATE EQUIVALENT TO IMATINIB 100 MG) FILM-COATED TABLETS
VERSION NUMBER 01, 03/01/2023
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.
INTRODUCTION
GINIB 100 is a generic medicine of Glivec 100 film coated tablets of
Novartis pharma GmbH, is
an antineoplastic agent of protein-tyrosine kinase inhibitor family
which potently inhibits the Bcr-
Abl tyrosine kinase at the in vitro, cellular and in vivo levels. The
compound selectively inhibits
proliferation and induces apoptosis in Bcr-Abl positive cell lines as
well as fresh leukaemic cells
from Philadelphia chromosome positive CML patients. GINIB 100 is
approved in Tanzania for
use
only
in
adult
patients
with
myelodysplastic/myeloproliferative
diseases
(MDS/MPD),
unresectable
dermatofibrosarcoma
protuberans
(DFSP),
unresectable
and/or
metastatic
malignant gastrointestinal stromal tumours (GIST), and
hypereosinophilic syndrome (HES)
and/or chronic eosinophilic leukaemia (CEL).
And in adult and paediatric patients with newly diagnosed Philadelphia
chromosome (bcr-abl)
positive (Ph+) chronic myeloid leukaemia (CML).
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0009
Brand name
GINIB 100
Generic name, strength, and form
Each film-coated tablet contains 100 mg imatinib (as
mesilate)
ATC classification
ATC
Code-L01XE01
Antineoplastic
and
Immunomodulating agents, Protein Kinase Inhibitors
Distribution category
POM
Country of origin
Cyprus
Associated product
GINIB 400 film coated tablets
Marketing Authorization Holder
Eurolab (Pty) Ltd
Woodmead Office Park, 3 Stirrup Lane
Van Reenens, Woodmead, 2144
South Africa