Reckitt Benckiser (Australia) – Nurofen Ibuprofen

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Reckitt Benckiser (Australia) Pty Ltd

I, Simon Waters, Delegate of the Secretary to the Department of Health, on receipt of an application from Reckitt Benckiser Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the products identified in paragraph (b):

1. The temporary relief of pain and/or inflammation associated with arthritis/osteoarthritis.
2.  

• NUROFEN MICRO-GRANULES Ibuprofen 200mg effervescent granules (ARTG No. 61599)
• NUROFEN LIQUID CAPSULES ibuprofen 200mg blister pack (ARTG No. 96115)
• NUROFEN MELTLETS LEMON Ibuprofen 200mg uncoated tablet blister pack (ARTG No. 120102)
• NUROFEN MELTLETS MINT Ibuprofen 200mg uncoated tablet blister pack (ARTG No. 120105
• Nurofen Tablets ibuprofen 200 mg blister pack (ARTG No. 127272)
• Nurofen Tablets ibuprofen 200 mg bottle (ARTG No. 127273)
• Nurofen Caplets ibuprofen 200 mg capsule shaped tablet blister pack (ARTG No. 127287)
• NUROFEN 400 DOUBLE STRENGTH ibuprofen 400 mg tablet blister pack (ARTG No. 141996)
• NUROFEN ZAVANCE 256mg ibuprofen sodium sugar coated tablet blister pack (ARTG No. 156293)
• NUROFEN ZAVANCE 256mg ibuprofen sodium sugar coated capsule shaped tablet blister pack (ARTG No. 156294)
• NUROFEN ZAVANCE 256mg ibuprofen sodium dihydrate sugar coated tablet bottle (ARTG No. 156645)
• NUROFEN ZAVANCE LIQUID CAPSULES ibuprofen 200mg soft capsule blister pack (ARTG No. 163477)
• NUROFEN ZAVANCE 400 DOUBLE STRENGTH ibuprofen sodium dihydrate 512 mg sugar coated tablet blister pack (ARTG No. 219883)
• NUROMOL tablet blister pack (ARTG No. 225322)

Dated this 28th day of February 2018

Simon Waters
Delegate of the Secretary to the Department of Health; and
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch