PHARMACY HEALTH LORATADINE HAYFEVER & ALLERGY RELIEF 10 mg tablet blister pack (new formulation)

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

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Active ingredient:
loratadine
Available from:
AVALLON PHARMACEUTICALS PTY LTD
Authorization status:
Registered
Authorization number:
345775

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Public Summary

Summary for ARTG Entry:

345775

PHARMACY HEALTH LORATADINE HAYFEVER & ALLERGY RELIEF 10 mg tablet blister pack (new

formulation)

ARTG entry for

Medicine Registered

Sponsor

Soul Pattinson Manufacturing Pty Ltd

Postal Address

Locked Bag 3002, Hawthorn BC, VIC, 3122

Australia

ARTG Start Date

12/10/2020

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 . PHARMACY HEALTH LORATADINE HAYFEVER & ALLERGY RELIEF 10 mg tablet blister pack (new

formulation)

Product Type

Single Medicine Product

Effective Date

12/10/2020

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

For relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and chronic urticaria in adults & children 12 years & older.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S2) Pharmacy Medicine

70 tablets

(S2) Pharmacy Medicine

60 tablets

(S2) Pharmacy Medicine

90 tablets

(S2) Pharmacy Medicine

50 tablets

(S2) Pharmacy Medicine

40 tablets

(S2) Pharmacy Medicine

20 tablets

(S2) Pharmacy Medicine

100 tablets

(S2) Pharmacy Medicine

10 tablets

(S2) Pharmacy Medicine

80 tablets

(S2) Pharmacy Medicine

Components

Public Summary

Page 1 of

Produced at 12.01.2021 at 01:03:11 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

1 .

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White, oval tablets, scored with a notch and code LT 10 on one side

Active Ingredients

loratadine

10 mg

Other Ingredients (Excipients)

colloidal anhydrous silica

lactose monohydrate

magnesium stearate

maize starch

© 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 01:03:11 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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