CLOPIDOGREL ASPIRIN-MEDIS

Main information

  • Trade name:
  • CLOPIDOGREL/ASPIRIN-MEDIS 75/100 clopidogrel (as hydrogen sulfate) and aspirin 75 mg/100 mg uncoated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLOPIDOGREL/ASPIRIN-MEDIS 75/100 clopidogrel (as hydrogen sulfate) and aspirin 75 mg/100 mg uncoated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219060
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219060

CLOPIDOGREL/ASPIRIN-MEDIS 75/100 clopidogrel (as hydrogen sulfate) and aspirin 75 mg/100 mg

uncoated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

27/10/2014

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. CLOPIDOGREL/ASPIRIN-MEDIS 75/100 clopidogrel (as hydrogen sulfate) and aspirin 75 mg/100 mg

uncoated tablet blister pack

Product Type

Single Medicine Product

Effective date

8/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Clopidogrel/Aspirin is a fixed-dose combination product.,Clopidogrel/Aspirin is intended as continuation of therapy in patients with acute coronary

syndrome already initiated with separate clopidogrel and aspirin products:

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/Aspirin is indicated for the treatment of acute coronary syndrome whether or not patients undergo

cardiac revascularisation (surgical or PCI, with or without stent);

ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, Clopidogrel/Aspirin 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

Blister Pack

Al/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Not recorded

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

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. CLOPIDOGREL/ASPIRIN-MEDIS 75/100 clopidogrel (as hydrogen sulfate) and aspirin 75 mg/100 mg uncoated tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Mottled purple, oval, biconvex tablets debossed 'CL7' on one face and 'S1'

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:56:49 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

on the other

Active Ingredients

Aspirin

100 mg

clopidogrel hydrogen sulfate

97.87 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 2 of

Produced at 26.11.2017 at 03:56:49 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

23-10-2013

Danish Pharmacovigilance Update, 29 August 2013

Danish Pharmacovigilance Update, 29 August 2013

In this issue of Danish Pharmacovigilance Update: Cases of acquired haemophilia following treatment with clopidogrel (Plavix® etc.)

Danish Medicines Agency

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

19-6-2018

Iscover (Sanofi-Aventis groupe)

Iscover (Sanofi-Aventis groupe)

Iscover (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2018)3888 of Tue, 19 Jun 2018

Europe -DG Health and Food Safety

30-5-2018

Plavix (Sanofi Clir SNC)

Plavix (Sanofi Clir SNC)

Plavix (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2018)3470 of Wed, 30 May 2018

Europe -DG Health and Food Safety

3-5-2018

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Active substance: Clopidogrel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2776 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/975/T/60

Europe -DG Health and Food Safety