MyHep DVIR Film Coated Tablet Daclatasvir Dihydrochloride equivalent to Daclatasvir 60 mg and Sofosbuvir 400 mg

País: Tanzânia

Língua: inglês

Origem: Tanzania Medicinces & Medical Devices Authority

Ingredientes ativos:

Daclatasvir Dihydrochloride

Disponível em:

Mylan Laboratories Limited, INDIA

Código ATC:

Daclatasvir Dihydrochloride

DCI (Denominação Comum Internacional):

Daclatasvir Dihydrochloride

Dosagem:

Daclatasvir Dihydrochloride equivalent to Daclatasvir 60 mg and Sofosbuvir 400 mg

Forma farmacêutica:

Film Coated Tablet

Fabricado por:

Mylan Laboratories LIMITED, INDIA

Resumo do produto:

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)

Status de autorização:

Registered/Compliant

Data de autorização:

2023-06-01

Características técnicas

                                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
                                
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