ROVASTA rosuvastatin (as calcium) 20 mg tablet blister pack

Main information

  • Trade name:
  • ROVASTA rosuvastatin (as calcium) 20 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ROVASTA rosuvastatin (as calcium) 20 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 184703
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184703

ROVASTA rosuvastatin (as calcium) 20 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

28/08/2012

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. ROVASTA rosuvastatin (as calcium) 20 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

5/06/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of Cardiovascular

Events,Rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or

equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease

(hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). Rosuvastatin is indicated to:,? Reduce the risk of nonfatal

myocardial infarction,? Reduce the risk of nonfatal stroke,? Reduce the risk of coronary artery revascularisation procedures.,In patients with

hypercholesterolaemia,Rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding Heterozygous Familial

Hypercholesterolaemia).,Prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus,

hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Other composite

material

3 Years

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

3 Years

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. ROVASTA rosuvastatin calcium 20 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light pink to pink round film coated tablets with RT3 debossed on one side

and plain on other side

Active Ingredients

Rosuvastatin calcium

20.79 mg

Public Summary

Page 1 of

Produced at 29.11.2017 at 04:37:33 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

© 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 2 of

Produced at 29.11.2017 at 04:37:33 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