SOUL PATTINSON IBUPROFEN 200 mg TABLETS (reformulation) film-coated tablet blister pack

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

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Active ingredient:
ibuprofen
Available from:
AVALLON PHARMACEUTICALS PTY LTD
Authorization status:
Registered
Authorization number:
348852

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Public Summary

Summary for ARTG Entry:

348852

SOUL PATTINSON IBUPROFEN 200 mg TABLETS (reformulation) film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

AVALLON PHARMACEUTICALS PTY LTD

Postal Address

Level 5 ;, 7 Eden Park Drive, Macquarie Park, NSW, 2113

Australia

ARTG Start Date

18/11/2020

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 . SOUL PATTINSON IBUPROFEN 200 mg TABLETS (reformulation) film-coated tablet blister pack

Product Type

Single Medicine Product

Effective Date

18/11/2020

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

For the temporary relief of pain and/or inflammation associated with headache, migraine headache, tension headache, neuralgia, muscular pain, backache,

fibrositis, arthritis, osteoarthritis, rheumatic pain, tennis elbow, dental pain, period pain, sinus pain, sore throat, and cold & flu. Reduces fever.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

4 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

36 Tablets

(S2) Pharmacy Medicine

50 Tablets

(S2) Pharmacy Medicine

48 Tablets

(S2) Pharmacy Medicine

12 Tablets

Not Scheduled after consideration by Committee

100 Tablets

(S2) Pharmacy Medicine

10 tablets

Not Scheduled after consideration by Committee

20 Tablets

Not Scheduled after consideration by Committee

72 Tablets

(S2) Pharmacy Medicine

24 Tablets

Not Scheduled after consideration by Committee

96 Tablets

(S2) Pharmacy Medicine

40 Tablets

(S2) Pharmacy Medicine

Components

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:45:19 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

1 .

Dosage Form

Tablet, film coated

Route of Administration

Oral

Oral

Visual Identification

White to off-white, pillow-shaped, film coated tablets; plain on both sides.

Active Ingredients

ibuprofen

200 mg

Other Ingredients (Excipients)

colloidal anhydrous silica

croscarmellose sodium

hypromellose

lactose monohydrate

macrogol 6000

microcrystalline cellulose

povidone

purified talc

purified water

sodium lauryl sulfate

stearic acid

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 10:45:19 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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