DESONEX desloratadine 5 mg tablet film coated blister pack

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

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Active ingredient:
desloratadine
Available from:
Bayer Australia Ltd
Authorization status:
Registered
Authorization number:
352515

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Public Summary

Summary for ARTG Entry:

352515

DESONEX desloratadine 5 mg tablet film coated blister pack

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182, Gordon NSW 2072, Gordon, NSW, 2072

Australia

ARTG Start Date

5/01/2021

Product Category

Medicine

Status

Active

Approval Area

Non-Prescription Medicines

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 . DESONEX desloratadine 5 mg tablet film coated blister pack

Product Type

Single Medicine Product

Effective Date

5/01/2021

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

The rapid relief of symptoms associated with seasonal allergic rhinitis. The nasal symptoms of allergic rhinitis include rhinorrhoea, sneezing and

nasal,itching. Allergic rhinitis is also associated with non-nasal symptoms such as ocular itching, tearing and itching of the eyes or palate., The relief

of,symptoms associated with perennial allergic rhinitis. The symptomatic relief of itching and reduction in the size and number of hives associated

with,chronic idiopathic urticaria.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

2 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

2,3,5,7,10,14,15,20,25,28,30,42,45,50,60

(S2) Pharmacy Medicine

1 tablet (sample pack)

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

Components

1 .

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light blue round, central circular debossed on one side of the tablet, plain on the other side, film-coated tablets

Public Summary

Page 1 of

Produced at 11.01.2021 at 07:30:19 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

desloratadine

5 mg

Other Ingredients (Excipients)

calcium hydrogen phosphate dihydrate

Carnauba Wax

hypromellose

indigo carmine

lactose monohydrate

macrogol 400

maize starch

microcrystalline cellulose

purified talc

purified water

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 11.01.2021 at 07:30:19 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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