PLAVICOR 75, clopidogrel (as hydrogen sulfate) 75 mg, film coated tablets, bottle pack

Main information

  • Trade name:
  • PLAVICOR 75, clopidogrel (as hydrogen sulfate) 75 mg, film coated tablets, bottle pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PLAVICOR 75, clopidogrel (as hydrogen sulfate) 75 mg, film coated tablets, bottle pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 187038
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

187038

PLAVICOR 75, clopidogrel (as hydrogen sulfate) 75 mg, film coated tablets, bottle pack

ARTG entry for

Medicine Registered

Sponsor

Pharmacor Pty Ltd

Postal Address

Suite 501,7 Oaks Ave,Dee Why, NSW, 2099

Australia

ARTG Start Date

17/05/2012

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. PLAVICOR 75, clopidogrel (as hydrogen sulfate) 75 mg, film coated tablets, bottle pack

Product Type

Single Medicine Product

Effective date

25/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history

of symptomatic atherosclerotic disease. ,Acute Coronary Syndrome: Clopidogrel Tablets is indicated in combination with aspirin for patients with: ,-

Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke,

vascular death or refractory ischaemia). Clopidogrel Tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo

cardiac revascularization (surgical or PCI, with or without stent); ,- ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic

events. In this population, Clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death,

re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

36 Months

Store below 25

degrees Celsius

Child resistant closure

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

112 Tablets in bottle pack

(S4) Prescription Only Medicine

90 Tablets in bottle pack

(S4) Prescription Only Medicine

120 Tablets in bottle pack

(S4) Prescription Only Medicine

30 Tablets in bottle pack

(S4) Prescription Only Medicine

Components

1. PLAVICOR 75, Clopidogrel Tablets, 75 mg, film coated tablets, bottle pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink coloured, round, biconvex, film coated tablets, debossed with 'Cl' on

one side and plain on other side.

Active Ingredients

clopidogrel hydrogen sulfate

97.875 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 02:19:38 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