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Status of action on products containing meloxicam

15 April 2005

On February 10th 2005 the TGA notified Boerhinger Ingelheim and Arrow Pharmaceuticals that amendments were required to the product information provided with their products Mobic (meloxicam) and Movalis (meloxicam). These amendments were imposed as a condition of registration of Mobic and Movalis. This notification takes into consideration the recommendations made at the meeting of the Australian Drug Evaluation Committee (ADEC) at which the safety of the COX-2 inhibitor drugs was considered. The TGA's intention to make these changes was also publicised in a media release by the regulator on February 10th 2005. TGA specified that the amendments to the product information would be effective as of March 11th 2005.

On March 10th Boerhinger Ingelheim and Arrow obtained an interlocutory order from the Federal Court to prevent the implementation of the amendments requested by TGA pending a final ruling by the Court. This order was made following a preliminary hearing in judicial review proceedings challenging TGA's decision, in which the applicant's allegations focus on what are said to be procedural defects in the decision making process.

TGA has, therefore, been prevented from implementing the proposed amendments to the product information of Mobic and Movalis at this time.

The decision made by the TGA to amend the product information of Mobic and Meloxicam has not been altered, however this decision may be subject to internal review on merits (and subsequently by the Administrative Appeals Tribunal).