Australian public assessment for Ibuprofen - Therapeutic Goods ...

I. Introduction to product submission
Submission details
AusPAR Caldolor Ibuprofen Phebra Pty Ltd PM-2010-02393-3-1
Final 2 January 2013
Therapeutic Goods Administration
Type of Submission Major Variation (New dose form/New route of administration)
Decision: Approved
Date of Decision: 28 February 2012
Active ingredient(s): Ibuprofen
Product Name(s): Caldolor
Sponsor’s Name and Address: Phebra Pty Ltd
Locked Bag 3003, Hunters Hill, NSW 2110
Dose form(s): Concentrated injection
Strength(s): 400 mg/4 mL and 800 mg/8 mL
Container(s): Glass vial
Pack size(s): 10 vials per carton
Approved Therapeutic use: Caldolor injection is indicated in adults for the
management of acute mild to moderate post operative
pain and moderate to severe post-operative pain with
adjunctive reduced morphine dosage, where an IV route
of administration is considered clinically necessary.
Route(s) of administration: Intravenous (IV)
Caldolor is indicated for the reduction of fever in adults
where an IV route of administration is considered
clinically necessary
Dosage: See Product Information (Attachment 1).
ARTG Number (s) 175191 and 175190
Product background
Ibuprofen is a non-steroidal anti-inflammatory drug and a non-selective inhibitor of cyclooxygenase
(COX)-1 and -2. It was first marketed in Australia in 1969. It is now registered
by a large number of companies in a range of oral dosage forms. This AusPAR describes
application by Phebra Pty ltd to register the first injectable form of ibuprofen, Caldolor, for
the management of mild to moderate pain, the management of moderate to severe pain as
an adjunct to opioid analgesics and for the reduction of fever in adults. At this time, there
are no parenteral formulations of ibuprofen approved in Australia for use in fever or pain.
The product is supplied at a concentration of 100 mg/mL, which must be diluted to 4
mg/mL or less before administration. Ibuprofen is currently marketed as 200 mg and 400
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