4-EPEEDO-10 Lyophilized Injection 2

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Epirubicin Hydrochloride

Available from:

Unosource Pharma Limited, INDIA

ATC code:

Cytotoxic antibiotics and related substances

INN (International Name):

Epirubicin Hydrochloride

Dosage:

2

Pharmaceutical form:

Lyophilized Injection

Manufactured by:

Naprod Life sciences Pvt Limited, INDIA

Product summary:

Physical description: Orange red coloured lyophilized mass; Local technical representative: Moraf Pharmaceuticals Limited (5668)

Authorization status:

Registered/Compliant

Authorization date:

2019-05-15

Summary of Product characteristics

TMDA/DMC/MRE/F/016
Revision#
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR
4-EPEEDO-10 (EPIRUBICIN
HYDROCHLORIDE 10MG/VIAL) LYOPHILIZED
INJECTION
VERSION NUMBER 1.0
14
TH
APRIL, 2022
P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tanzania
Tel: [phone]; Fax: [phone]
Email: [e-mail]; Website: mwww.tmda.go.tz
TANZANIA PUBLIC
ASSESSMENT REPORT
_TMDA/DMC/MRE/F/016 _
_REV #:_
1.
INTRODUCTION
4-EPEEDO-10 is a generic medicine of Ellence or Pharmorubicin
(Epirubicin hydrochloride 2
mg/ml) Solution for Injection or Infusion of Pfizer. 4-EPEEDO-
10 is
an anticancer
medicine
belonging to
Antineoplastic agents,
Anthracyclines and related substances
group. 4-EPEEDO-
10
exerts is activity by
binding to DNA. Cell culture studies have shown rapid cell
penetration, localisation in the nucleus and inhibition of nucleic
acid synthesis and mitosis.
Epirubicin
has proved to be active on a wide spectrum of experimental tumours
including
L1210 and P388 leukaemias, sarcomas SA180 (solid and ascitic forms),
B16 melanoma,
mammary carcinoma, Lewis lung carcinoma and colon carcinoma 38. It has
also shown
activity
against
human
tumours
transplanted
into
athymic
nude
mice
(melanoma,
mammary lung, prostatic and ovarian carcinomas).
4-EPEEDO-
10
is approved in Tanzania
for use in adults
1.1 PRODUCT DETAILS
Registration number
TZ 19 H 0124
Brand name
4-EPEEDO-10
Generic
name,
strength
and
form
Epirubicin hydrochloride 2 mg/ml)
Lyophilized
Injection
ATC classification
ATC code: L01DB03
Antineoplastic
agents,
Anthracyclines
and
related
substances
Distribution category
POM
Country of origin
INDIA
Associated product
NA
Marketing Authorization Holder
Naprod Life sciences Pvt.
Ltd
,
Tarapur
Industrial
area,
Boisar,
Dist;
Thane-401506,
Maharashtra, INDIA
Local Technical Representative
Jilichem(T)Ltd
Pharmaceutical & Surgical Wholesale, Nyerere Road,
block B-2, Opp Super Doll, Behind Victoria
Complex
(
Lifemate Furniture), P O Box 22400, Dar es Salaam,
Tanzania
1.2 AS