PLATIFIRST liquid injection 50

Country: Tansanía

Tungumál: enska

Heimild: Tanzania Medicinces & Medical Devices Authority

Virkt innihaldsefni:

Cisplatin

Fáanlegur frá:

VHB MEDI SCIENCES LIMITED, INDIA

INN (Alþjóðlegt nafn):

Cisplatin

Skammtar:

50

Lyfjaform:

liquid injection

Framleitt af:

VHB MEDI SCIENCES LIMITED, INDIA

Vörulýsing:

Physical description: A clear colourless to pale yellow solution; Local technical representative: Planet Pharmaceutical Limited (6099)

Leyfisstaða:

Registered/Compliant

Leyfisdagur:

2021-06-03

Vara einkenni

TMDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR PLATIFIRST 10MG/10ML (CISPLATIN1MG/ML)
SOLUTION FOR INJECTION
VERSION NUMBER 1.0
14 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
1.
INTRODUCTION
Platifirst 10 mg/10 ml is a generic medicine of innovator product
Platinol 1mg/ml konsentrat til
infusjonsvæske (Bristol-Myers Squibb, Norway). Platifirst 10 mg/10 ml
is a platinum-based anti-
neoplastic agent. Platinum-based agents cause intrastrand and
interstrand crosslinks between
purine bases of DNA, resulting in contortion of the DNA molecule. It
is widely accepted that this
DNA damage induces apoptosis, but there may also be other mechanisms
involved in the
cytotoxic effects of cisplatin. Platifirst 10 mg/10 ml is approved in
Tanzania for use in adults and
children.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0259
Brand name
Platifirst 10 mg/10 ml
Generic name, strength and form
Each single vial of 10 ml concentrate for solution for
infusion contains 10 mg of cisplatin
ATC classification
Other
antineoplastic
agents,
Platinum
compounds
(L01XA01)
Distribution category
POM
Country of origin
India
Associated product
Platifirst 50 mg/50 ml
Marketing Authorization Holder
VHB Medi Sciences Ltd
50 AB, Govt industrial Estate,
Charkop, Kandivali (W)
Mumbai-400067,
India
Local Technical Representative
Planet Pharmaceuticals Limited
P.O. Box: 38328
Dar-es-Salam
1.2 ASSESSMENT PROCEDURE
The application for registration of Platifirst 10 mg/10 ml was
submitted on 05 December, 2017.
The product underwent full assessment. Assessment was completed in 3
(three) rounds of
evaluation and the product was registered on 02 August, 2019.
1.3 INFORMATION FOR USERS
Visual description of the finished product
A clear colorless to pale yellow solution
Primary packing material
10 mL USP type I glass vial, amber coloured
Secondary packing