ROSUKEM

Main information

  • Trade name:
  • ROSUKEM rosuvastatin (as calcium) 10 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ROSUKEM rosuvastatin (as calcium) 10 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214900
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214900

ROSUKEM rosuvastatin (as calcium) 10 mg 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

19/09/2014

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. ROSUKEM rosuvastatin (as calcium) 10 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

14/06/2017

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 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 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 (including 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

PVC/PVDC/Al

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. ROSUKEM rosuvastatin (as calcium) 10 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Round, pink, biconvex tablet debossed with 'ST 2' on one side

Active Ingredients

Rosuvastatin calcium

10.42 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 26.11.2017 at 09:09:31 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

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

19-12-2008

Consultation responses on the future reimbursement status of dihydropyridine calcium antagonists (C08CA)

Consultation responses on the future reimbursement status of dihydropyridine calcium antagonists (C08CA)

The Danish Medicines Agency's assessment of the future reimbursement status of the dihydropyridine calcium antagonists (C08CA) were submitted for consultation with 11 November 2008 as the consultation deadline.

Danish Medicines Agency

29-10-2008

Reassessment of reimbursement status for medicinal products in ATC group C08CA

Reassessment of reimbursement status for medicinal products in ATC group C08CA

The Danish Medicines Agency has assessed the question of the future reimbursement status for medicinal products in ATC group C08CA (dihydropyridine calcium channel blockers) which are used for the treatment of cardiovascular diseases.

Danish Medicines Agency

8-9-2008

Reassessment of reimbursement status of medicinal products for cardiovascular diseases – additional recommendation from the Reimbursement Committee

Reassessment of reimbursement status of medicinal products for cardiovascular diseases – additional recommendation from the Reimbursement Committee

The Danish Medicines Agency has asked the Reimbursement Committee to reassess the reimbursement status of medicinal products authorised for marketing in Denmark in the ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

14-2-2008

Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases

Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases

Following a request from the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status for medicinal products authorised for marketing in Denmark in ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

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