SOVALDI

Main information

  • Trade name:
  • SOVALDI sofosbuvir 400 mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SOVALDI sofosbuvir 400 mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211019
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211019

SOVALDI sofosbuvir 400 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Gilead Sciences Pty Ltd

Postal Address

Level 6 / 417 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

30/06/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. SOVALDI sofosbuvir 400 mg tablet bottle

Product Type

Single Medicine Product

Effective date

11/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

SOVALDI is indicated for the treatment of adults with chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

(see CLINICAL TRIALS and DOSAGE AND ADMINISTRATION section for detailed information on the studied combinations, dose regimens, and

treatment durations for different subgroups of CHC patients)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

5 Years

Store below 30

degrees Celsius

Child resistant closure

Store at room

temperature

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets

(S4) Prescription Only Medicine

Components

1. SOVALDI sofosbuvir 400 mg tablet bottle

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Film coated, yellow, capsule shaped tablet with 'GSI' on one side and '7977'

on the other side

Active Ingredients

sofosbuvir

400 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 01:40:48 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

10-7-2018

Sovaldi (Gilead Sciences Ireland UC)

Sovaldi (Gilead Sciences Ireland UC)

Sovaldi (Active substance: sofosbuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4482 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2798/T/51

Europe -DG Health and Food Safety

11-6-2018

Harvoni (Gilead Sciences Ireland UC)

Harvoni (Gilead Sciences Ireland UC)

Harvoni (Active substance: ledipasvir/sofosbuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3759 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3850/T/67

Europe -DG Health and Food Safety

11-6-2018

Vosevi (Gilead Sciences Ireland UC)

Vosevi (Gilead Sciences Ireland UC)

Vosevi (Active substance: sofosbuvir / velpatasvir / voxilaprevir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3775 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4350/T/15

Europe -DG Health and Food Safety

30-5-2018

Epclusa (Gilead Sciences Ireland UC)

Epclusa (Gilead Sciences Ireland UC)

Epclusa (Active substance: sofosbuvir/velpatasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3452 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4210/T/27

Europe -DG Health and Food Safety