CRESTAT rosuvastatin (as calcium) 10 mg tablets blister

Main information

  • Trade name:
  • CRESTAT rosuvastatin (as calcium) 10 mg tablets blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CRESTAT rosuvastatin (as calcium) 10 mg tablets blister
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 183265
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

183265

CRESTAT rosuvastatin (as calcium) 10 mg tablets blister

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

14/05/2012

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. CRESTAT rosuvastatin (as calcium) 10 mg tablets blister

Product Type

Single Medicine Product

Effective date

16/11/2012

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 = 50 years old and women = 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

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. CRESTAT rosuvastatin (as calcium) 10 mg tablets blister

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, round, biconvex tablets, debossed with "R9UN 10" on one side and

on the other side scored.

Active Ingredients

Rosuvastatin calcium

10.4 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 29.11.2017 at 06:17:24 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