Blooms

Main information

  • Trade name:
  • Blooms The Chemist Carvedilol carvedilol 3.125mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Blooms The Chemist Carvedilol carvedilol 3.125mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210740
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210740

Blooms The Chemist Carvedilol carvedilol 3.125mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

7/08/2014

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. Blooms The Chemist Carvedilol carvedilol 3.125mg tablet blister pack

Product Type

Single Medicine Product

Effective date

9/01/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Carvedilol is indicated for the treatment of hypertension. Data have not been provided to support the use of this drug in renovascular disease.,Carvedilol

is indicated for the treatment of patients with symptomatic mild to severe (NYHA Class II¹ IV) congestive heart failure as an adjunct to conventional

treatments (e.g. diuretics, digoxin, ACE-inhibitors and vasodilators).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

18 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Blooms The Chemist Carvedilol carvedilol 3.125mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, oval, biconvex and film-coated tablet, engraved 'APO' on one side

and 'C3' on the other side.

Active Ingredients

Carvedilol

3.125 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 02:08:45 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