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Recalls and suspensions

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Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

23 September 2021
Consumer and regulatory updates

CHATTANOOGA Ultrasound Gel Products and Lotions

14 September 2021
Recall due to risk of bacterial contamination

Neutrogena Ultra Sheer Body Mist Sunscreen Spray SPF 50+ (aerosol sunscreen)

2 August 2021
Recall - Possible presence of benzene

Ospolot (sulthiame) tablets 200 mg

3 June 2021
Product Defect Alert - child-resistant caps may not function correctly

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Safety information

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COVID-19 vaccine weekly safety report - 14-10-2021

14 October 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

Shortages of tocilizumab (Actemra) medicines

14 October 2021
The TGA published an Actemra (tocilizumab) shortage - consumer information sheet produced by Pain Australia

Pentosan polysulfate sodium (Elmiron)

11 October 2021
Safety advisory - Risk of pigmentary maculopathy (changes in the retina of the eye), especially after long-term use

Pentosan polysulfate sodium and pigmentary maculopathy

11 October 2021
Health professionals are advised that the Product Information for pentosan polysulfate sodium has been updated with a warning about potential pigmentary maculopathy, especially after long-term use.

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News

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TGA Provisional Approval of Roche Products Pty Ltd COVID-19 treatment, casirivimab + imdevimab (RONAPREVE)

18 October 2021
The TGA has provisionally approved the use of the Roche Products Pty Ltd combination therapy, casirivimab + imdevimab (RONAPREVE), for the treatment and prevention of COVID-19 in specific target populations.

COVID-19 rapid antigen self-tests that are approved in Australia

15 October 2021
A list of self-tests that are approved in Australia

Brukinsa

15 October 2021
Australian prescription medicine decision summary

Webinar: Consent to supply medical devices that are non-compliant with the Essential Principles (EPs)

15 October 2021
This webinar will guide you through the new online form to request TGA approval to supply a medical device that is non-compliant with the EPs.

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