ATORVASTATIN SANDOZ atorvastatin 40 mg film-coated tablet blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
atorvastatin calcium trihydrate
Available from:
Sandoz Pty Ltd
Authorization status:
Registered
Authorization number:
325194

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Public Summary

Summary for ARTG Entry:

325194

ATORVASTATIN SANDOZ atorvastatin 40 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road, Macquarie Park, NSW, 2113

Australia

ARTG Start Date

10/12/2020

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 . ATORVASTATIN SANDOZ atorvastatin 40 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective Date

10/12/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Atorvastatin Sandoz is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.

Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic

syndrome, dysproteinaemia, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,Atorvastatin Sandoz is indicated

in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular

disease, peripheral vascular disease or existing asymptomatic CHD to reduce the risk of non-fatal myocardial infarction (MI) and non-fatal stroke.,These

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

smoking

Warnings

See Product Information and Consumer Medicine Information for this product

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

20 Months

Store below 30

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1 . ATORVASTATIN SANDOZ atorvastatin 40 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, round, biconvex film coated tablet debossed with A40 on one side, and cross scored breaking notch on

the other side

Public Summary

Page 1 of

Produced at 12.01.2021 at 11:17:56 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

Active Ingredients

atorvastatin calcium trihydrate

43.3 mg

Other Ingredients (Excipients)

calcium carbonate

croscarmellose sodium

hyprolose

hypromellose

lactose monohydrate

macrogol 6000

magnesium stearate

microcrystalline cellulose

polysorbate 80

titanium dioxide

© 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 12.01.2021 at 11:17:56 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

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