Ficocyte Solution for injection 30

Страна: Танзания

Език: английски

Източник: Tanzania Medicinces & Medical Devices Authority

Активна съставка:

Filgrastim

Предлага се от:

Nanogen Pharmaceutical Biotechnology Joint Stock Company, VIETNAM

АТС код:

Immunistimulants drugs

INN (Международно Name):

Filgrastim

дозиране:

30

Лекарствена форма:

Solution for injection

Произведено от:

Nanogen Pharmaceutical Biotechnology Joint Stock Company, VIETNAM

Каталог на резюме:

Physical description: clear, colorless solution; Local technical representative: Harsh Pharmaceuticals Limited (7972)

Статус Оторизация:

Registered/Compliant

Дата Оторизация:

2021-03-29

Данни за продукта

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR FICOCYTE (FILGRASTIM 30 MU/0.5 ML)
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
VERSION NUMBER 1
31
ST DECEMBER, 2022
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
Ficocyte is a generic medicine of Neupogen. Ficocyte is an
Immunostimulants medicine
belonging to L03AA02 ATC code group description> group. Ficocyte
exerts its activity
by . Ficocyte is approved in
Tanzania for use
in adults or children.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0094
Brand name
Ficocyte
Generic
name,
strength
and
form
Filgrastim
ATC classification
L03AA02, Granulocyte colony-stimulating factor
Distribution category
POM
Country of origin
Vietnam
Associated product
State any other product of formulation, strength or
site that is linked or associated with the product if
applicable
Marketing Authorization Holder
Nanogen
Pharmaceutical
Biotechnology
Co.,
Limited
Lot I – 5C Saigon Hitech Park, Tang Nhon Phu A
Ward, District 9, HCM City
VIETNAM
Tel: [phone]
Email: [e-mail]
Local
Technical
Representative
Atlas Phamacy
P.O. Box 34123,
Dar es Salaam,
Tel: [phone]
Email: [e-mail] / [e-mail]
1.2
ASSESSMENT PROCEDURE
The application for registration of Ficocyte was submitted on <2012>.
The product
underwent full assessment. Assessment was completed in four rounds of
evaluation.
Ficocyte was registered on 29
th
March, 2021
1.3
INFORMATION FOR USERS
Visual
description
of
the
finished
clear, colorless solution
Effective date: 03/10/2022
2
product
Primary packing material
0.5 mL colorless glass prefilled syringe, with
needle a