Land: Tansania
Sprache: Englisch
Quelle: Tanzania Medicinces & Medical Devices Authority
Artesunate
Macleods Pharmaceuticals Limited, INDIA
Antimalarials
Artesunate
60
Powder for solution for injection
Macleods Pharmaceuticals Limited, INDIA
Physical description: White powder; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)
Registered/Compliant
2021-03-29
TMDA/DMC/MRE/F/016 Version#1 TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY PUBLIC ASSESSMENT REPORT FOR AZUNATE (ARTESUNATE 60 MG) POWDER FOR INJECTION. VERSION NUMBER 0.1, MARCH 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 1. INTRODUCTION Azunate is an artemsinin derivative medicine belonging to P01BE03 - Artemisinin and derivatives, plain group. Azunate exerts is activity by causing cleavage of endoperoxide bridge in the pharmacophore of DHA and therefore generates reactive oxygen species (ROS), which increases oxidative stress and causes malarial protein damage via alkylation. In addition, Artesunate potently inhibits the essential Plasmodium falciparum exported protein 1 (EXP1), a membrane glutathione S-transferase. As a result, the amount of glutathione in the parasite is reduced. Azunate is approved in Tanzania for use in adults and children. 1.1 PRODUCT DETAILS Registration number TAN 21 HM 0132 Brand name Azunate Generic name, strength and form Artesunate Powder for Injection of 60 mg ATC classification P01BE03 - Artemisinin and derivatives, plain Distribution category POM Country of origin India Associated product Not Applicable Marketing Authorization Holder Macleods Pharmaceuticals Limited. 304, Atlanta Arcade, Marol Church road, Andheri (East), INDIA. Local Technical Representative RK Pharmaceuticals (Tz)Limited Plot No 326, Dar es Salaam 1.2 ASSESSMENT PROCEDURE The application for registration of Azunate was submitted on 06/09/2019, the product underwent full assessment. Assessment was completed in two rounds of evaluation. Azunate was registered on 29/03/2021. 1.3 INFORMATION FOR USERS Visual description of the finished product White powder in a clear 10 mL USP type-III glass vial sealed with 20 mm grey bromo butyl rubber plugs and 20 mm chocolate brown flip off aluminum seal. Primary packing material 10 mL USP Type-III glass vial with 20 mm Grey Bromo-butyl Lesen Sie das vollständige Dokument