Country: Տանզանիա
language: անգլերեն
source: Tanzania Medicinces & Medical Devices Authority
Epirubicin Hydrochloride
Unosource Pharma Limited, INDIA
Cytotoxic antibiotics and related substances
Epirubicin Hydrochloride
2
Lyophilized Injection
Naprod Life sciences Pvt Limited, INDIA
Physical description: Orange red coloured lyophilized mass; Local technical representative: Moraf Pharmaceuticals Limited (5668)
Registered/Compliant
2019-05-15
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: +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 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 read_full_document