CHEMMART

Main information

  • Trade name:
  • CHEMMART SIMVASTATIN simvastatin 80 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHEMMART SIMVASTATIN simvastatin 80 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211959
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211959

CHEMMART SIMVASTATIN simvastatin 80 mg 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

6/08/2013

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. CHEMMART SIMVASTATIN simvastatin 80 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

21/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with simvastatin, secondary causes of

hypercholesterolaemia (eg poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other

drug therapy, alcoholism) should be identified and treated. Simvastatin is indicated in patients at high risk of CHD (coronary heart disease) (with or

without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with

existing CHD to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. These

effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and

smoking.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/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. CHEMMART SIMVASTATIN simvastatin 80 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink coloured, capsule-shaped, biconvex film-coated tablets debossed with

'SVN 80' on one side and 'NEO' on the other side.

Active Ingredients

Simvastatin

80 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 12:48:17 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

22-8-2018

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5632 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/T/20

Europe -DG Health and Food Safety

12-6-2018

Cholib (Mylan Products Limited)

Cholib (Mylan Products Limited)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Renewal - Commission Decision (2018)3153 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/R/17

Europe -DG Health and Food Safety