Peg Neukine Solution for injection 6 mg/0.6ml

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Pegfilgrastim

Available from:

Intas Pharmaceuticals Limited, INDIA

ATC code:

Immunistimulants drugs

INN (International Name):

Pegfilgrastim

Dosage:

6 mg/0.6ml

Pharmaceutical form:

Solution for injection

Manufactured by:

Intas Pharmaceuticals Limited, INDIA

Product summary:

Physical description: Clear, colourless solution; Local technical representative: PHARMAJEN LIMITED (61840)

Authorization status:

Registered/Compliant

Authorization date:

2020-12-24

Summary of Product characteristics

TMDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR PEG NEUKINE (PEGFILGRASTIM 6 MG/ 0.6
ML) SOLUTION FOR INJECTION
VERSION NUMBER 0.1
MARCH 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
Peg Neukine is a generic medicine of Pegfilgrastim. Peg Neukine is an
antioneoplastic and
immunomodulating medicine belonging to colony stimulating factor
group. Peg Neukine exerts
its activity by acting on hematopoietic cells through binding to
specific cell surface receptors,
thereby stimulating proliferation, differentiation, commitment, and
end cell functional activation.
Peg Neukine is approved in Tanzania for use in adults and children.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0032
Brand name
Peg Neukine
Generic name, strength and form
Pegfilgrastim PFS 6 mg/0.6 mL
ATC classification
L03AA02
Distribution category
POM
Country of origin
India
Associated product
Nil
Marketing Authorization Holder
Intas Pharmaceuticals Limited,
Plot No. 423/P/A
Sarkhej – Bavla Highway,
Moraiya, Taluka: Sanand,
Ahmedabad – 382 213,
Gujarat, India.
Local Technical Representative
Metro Pharmaceuticals Limited,
P. O. Box 2797,
Indira Gandhi Street,
Dar es Salaam.
1.2 ASSESSMENT PROCEDURE
The application for registration of Peg Neukine was submitted on
28.11.2019. The product
underwent full assessment. Assessment was completed in two (2) rounds
of evaluation. Peg
Neukine was registered on 24/12/2020.
1.3 INFORMATION FOR USERS
Visual description of the finished product
Clear and colorless liquid
Primary packing material
1 mL glass (USP Type 1), single-use, pre-filled
syringe
Secondary packing materials
Printed carton box along with package insert
Shelf-life and storage condition
36 months
Route of administration
Subcutaneous use
Therapeutic indications
Reduction in the duration of neutropenia and the
incidence of febrile neutropeni