SITAGLIPTIN SANDOZ sitagliptin (as hydrochloride monohydrate) 100 mg film-coated tablet blister pack

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

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Active ingredient:
sitagliptin hydrochloride monohydrate
Available from:
Sandoz Pty Ltd
Authorization status:
Registered
Authorization number:
323916

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Public Summary

Summary for ARTG Entry:

323916

SITAGLIPTIN SANDOZ sitagliptin (as hydrochloride monohydrate) 100 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

10/11/2020

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 . SITAGLIPTIN SANDOZ sitagliptin (as hydrochloride monohydrate) 100 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective Date

10/11/2020

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

SITAGLIPTIN SANDOZ is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and

exercise:,- as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin

cannot be used.,- as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione where the use of a thiazolidinedione is

considered appropriate.,- as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide

adequate glycaemic control.,- as add-on combination therapy with insulin (with or without metformin).

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

24 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 . SITAGLIPTIN SANDOZ sitagliptin (as hydrochloride monohydrate) 100 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light brown, round, biconvex film coated tablet debossed with ST 100 on one side

Active Ingredients

Public Summary

Page 1 of

Produced at 13.01.2021 at 01:07:05 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

sitagliptin hydrochloride monohydrate

113.37 mg

Other Ingredients (Excipients)

calcium hydrogen phosphate

croscarmellose sodium

hyprolose

hypromellose

iron oxide black

iron oxide red

iron oxide yellow

macrogol 6000

magnesium stearate

microcrystalline cellulose

purified talc

sodium stearylfumarate

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 13.01.2021 at 01:07:05 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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