ROSUVASTATIN MYLAN rosuvastatin (as calcium) 20 mg film-coated tablet blister pack

Main information

  • Trade name:
  • ROSUVASTATIN MYLAN rosuvastatin (as calcium) 20 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ROSUVASTATIN MYLAN rosuvastatin (as calcium) 20 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186383
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186383

ROSUVASTATIN MYLAN rosuvastatin (as calcium) 20 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

8/03/2013

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. ROSUVASTATIN MYLAN rosuvastatin (as calcium) 20 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

12/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

Events:-

ROSUVASTATIN MYLAN 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 MYLAN 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 MYLAN is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia).,Prior to initiating therapy

with ROSUVASTATIN MYLAN, 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

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. ROSUVASTATIN MYLAN rosuvastatin (as calcium) 20 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

A pink, film coated, round, biconvex tablet debossed with 'M' on one side

and 'RS2' on other side.

Active Ingredients

Rosuvastatin calcium

20.792 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 02:52:35 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