FOSINOPRIL HCT

Main information

  • Trade name:
  • FOSINOPRIL/HCT ACTAVIS 20/12.5 fosinopril sodium 20 mg and hydrochlorothiazide 12.5 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FOSINOPRIL/HCT ACTAVIS 20/12.5 fosinopril sodium 20 mg and hydrochlorothiazide 12.5 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212128
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212128

FOSINOPRIL/HCT ACTAVIS 20/12.5 fosinopril sodium 20 mg and hydrochlorothiazide 12.5 mg tablet

blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

31/07/2013

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. FOSINOPRIL/HCT ACTAVIS 20/12.5 fosinopril sodium 20 mg and hydrochlorothiazide 12.5 mg tablet blister

pack

Product Type

Single Medicine Product

Effective date

11/03/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Mild to moderate hypertension. Treatment should not be initiated with this combination.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. FOSINOPRIL/HCT ACTAVIS 20/12.5 fosinopril sodium 20 mg and hydrochlorothiazide 12.5 mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Light orange round tablet with "FH" on one side.

Active Ingredients

Fosinopril sodium

20 mg

Hydrochlorothiazide

12.5 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 12:34:30 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

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