Krajina: Tanzánia
Jazyk: angličtina
Zdroj: Tanzania Medicinces & Medical Devices Authority
Filgrastim
Nanogen Pharmaceutical Biotechnology Joint Stock Company, VIETNAM
Immunistimulants drugs
Filgrastim
30
Solution for injection
Nanogen Pharmaceutical Biotechnology Joint Stock Company, VIETNAM
Physical description: clear, colorless solution; Local technical representative: Harsh Pharmaceuticals Limited (7972)
Registered/Compliant
2021-03-29
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: +255 (26) 2961989/2061990/+255 (22) 2450512/2450751/2452108, EMAIL: INFO@TMDA.OG.TZ, 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: +84 08 37309931/ 37309940 Email: info@nanogenpharma.com Local Technical Representative Atlas Phamacy P.O. Box 34123, Dar es Salaam, Tel: +255 2667111 Email: atlas@tz2000.com / vitusatlas@tz2000.com 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 Prečítajte si celý dokument