País: Tanzânia
Língua: inglês
Origem: Tanzania Medicinces & Medical Devices Authority
Daclatasvir Dihydrochloride
Mylan Laboratories Limited, INDIA
Daclatasvir Dihydrochloride
Daclatasvir Dihydrochloride
Daclatasvir Dihydrochloride equivalent to Daclatasvir 60 mg and Sofosbuvir 400 mg
Film Coated Tablet
Mylan Laboratories LIMITED, INDIA
Physical description: A Peach colored, modified capsule shaped, biconvex beveled edge film-coated tablet debossed with "M" on one side and "DTS" on the other side.; Local technical representative: Synermed Pharmaceuticals (T) Limited (5197)
Registered/Compliant
2023-06-01
Effective date: 03/10/2022 TMDA/DMC/MRE/F/016 Rev #:02 THE UNITED REPUBLIC OF TANZANIA MINISTRY OF HEALTH TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY PUBLIC ASSESSMENT REPORT FOR MyHEP DVIR (DACLATASVIR DIHYDROCHLORIDE EQUIVALENT TO DACLATASVIR 60 MG/ SOFOSBUVIR 400 MG) FILM-COATED TABLETS Version number 1.0 21 August, 2023 TMDA Headquarters, Plot No. 56/1, Block E, Kisasa B Centre, Hombolo 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 Leia o documento completo