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AusPAR: Dapagliflozin propanediol monohydrate

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Australian Public Assessment Report

7 March 2017
NOTE: Regarding use of the trade name 'Empliciti'.

This AusPAR published in February 2013 describes the registration submission (PM-2010-03812-3-5) for dapagliflozin propanedial monohydrate which is currently marketed under the trade name Forxiga. Several trade names including Empliciti were approved with this submission, were subsequently registered and are referenced in this AusPAR.

In June 2013, the product containing dapagliflozin propanedial monohydrate with the trade name Empliciti was removed from the register. The trade name Empliciti is now used in relation to registered prescription medicines containing the active ingredient elotuzumab (300 mg and 400 mg lyophilised powder for IV infusion). This is consistent with the use of this trade name in other jurisdictions.

AusPAR Details
AusPAR
Active Ingredient
Dapagliflozin propanediol monohydrate
Product Name
Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride / Empliciti / Forxiga
Sponsor
Bristol-Myers Squibb Australia Pty Ltd / AstraZeneca Pty Ltd
Submission Number
PM-2010-03812-35
Submission Type
New chemical entity
Decision
Approved
AusPAR Date
14 January 2013
Publication Date

7 March 2017