Oseltamivir GH Oseltamivir (as phosphate) 45 mg capsule blister pack

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

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Active ingredient:
oseltamivir phosphate
Available from:
Lupin Australia Pty Limited
Authorization status:
Registered
Authorization number:
328423

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Public Summary

Summary for ARTG Entry:

328423

Oseltamivir GH Oseltamivir (as phosphate) 45 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Lupin Australia Pty Limited

Postal Address

Suite 2 Level 2 19-23 Prospect Street, Box Hill, VIC, 3128

Australia

ARTG Start Date

3/12/2020

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 . Oseltamivir GH Oseltamivir (as phosphate) 45 mg capsule blister pack

Product Type

Single Medicine Product

Effective Date

3/12/2020

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

Oseltamivir is indicated for the treatment of infections due to influenza A and B viruses in adults and children including full-term neonates. Treatment should

commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,Oseltamivir is indicated for the prevention of

influenza in adults and children aged 1 year and older. Vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

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

PVC/PE/PVDC/Al

24 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

10's

(S4) Prescription Only Medicine

Components

1 . Oseltamivir GH Oseltamivir (as phosphate) 45 mg capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Size 4 capsule with grey opaque cap and body imprinted with 45 mg on cap and LU on body in blue ink containing white to

off-white granular powder.

Active Ingredients

oseltamivir phosphate

59.114 mg

Other Ingredients (Excipients)

Public Summary

Page 1 of

Produced at 12.01.2021 at 05:28:07 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

croscarmellose sodium

ethanol absolute

Gelatin

iron oxide black

povidone

pregelatinised maize starch

purified talc

purified water

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 12.01.2021 at 05:28:07 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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