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Safety Information

Revised: 10 January 2017

Dear Healthcare Professional Letters

This section provides copies of letters sent to healthcare professionals by the therapeutic products industry. These letters detail possible safety or quality concerns, they are published here on behalf of the industry. These letters are provided voluntarily and this section may not be comprehensive.

Date sent Product Reason
14 December 2016 Erivedge (PDF 110 KB, 2 pages) Extension of Pregnancy Prevention Duration for Women of Childbearing Potential and Interval before Blood Donation and Lactation
15 August 2016 Noxafil (PDF 212 KB, 2 pages) Posaconazole tablets and oral suspension are not interchangeable
2 June 2016 Erivedge (PDF 111 KB, 2 pages) Risk of premature epiphyseal fusion
24 May 2016 Invokana (PDF 71 KB, 2 pages) Advice on the risk of lower limb amputations primarily of the toe during treatment with canagliflozin
8 December 2015 Cellcept (PDF 100 KB, 3 pages) New restrictions on use due to teratogenic risk
1 December 2015 Tarceva (PDF 91 KB, 2 pages) Indication restricted to EGFR-activating mutations only
9 July 2015 Forxiga (PDF 28 KB, 2 pages) Risk of ketoacidosis
29 April 2015 Motilium (PDF 344 KB, 1 page) New recommendations to minimise cardiac risks
8 December 2014 Reminyl (PDF 669 KB, 1 page) Serious skin reactions
26 November 2014 Dilatrend tablets (PDF 335 KB, 2 pages) Severe cutaneous adverse reactions
5 August 2014 Cal.D. Forte tablets (PDF 310 KB, 1 page) Update on stability issues
5 August 2014 Topamax tablets (PDF 142 KB, 1 page) Additional warnings and precautions - Visual field defects
4 August 2014 Concerta tablets (PDF 181 KB, 1 page) Additional precaution - Priapism
1 July 2014 Bacillus Calmette-Guerin (BCG) vaccine (PDF 304 KB, 2 pages) Supply of unapproved medicine under S29 of the Medicines Act
20 May 2014 Piportil depot Injection (PDF 34 KB, 1 page) Update to supply issues
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