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Recalls and suspensions

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Infants' Friend oral liquid

23 December 2020
Recall due to presence of chloroform

Tenofovir Disoproxil Emtricitabine Mylan 300/200

23 December 2020
Recall - potential for split tablets to lead to ineffective dose

Product defect alert for some Softmed branded surgical masks

14 November 2020
The Product Defect Alert follows the comprehensive review and laboratory testing carried out by the TGA

Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil

9 October 2020
Update - Infringement notices issued

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Safety information

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Medicines containing Eucommia ulmoides (known as Du-Zhong or Tu-chung)

13 January 2021
Safety advisory – contains latex (statement includes Chinese translation 中文翻译)

Zostavax vaccine

22 December 2020
Safety advisory - risk of infection with the vaccine virus

Shortage of Estradot (estradiol) 25 and 75

18 December 2020
The TGA is extending the Serious Shortage Substitution Notice (SSSN) for Estradot 25 and issuing a new SSSN for Estradot 75

Use of face masks during MRI examinations

18 December 2020
Patients may be injured if they wear face masks (such as surgical or non-surgical masks and respirators) with metal parts and coatings during an MRI examination

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News

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Norwegian investigation of COVID-19 vaccination risks for elderly, very frail patients

17 January 2021
In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine

Regulation of software based medical devices

15 January 2021
Information and guidance on the regulation of Software as a Medical Device

Prescription medicines: applications under evaluation

15 January 2021
A list of applications for new medicines or new uses for existing medicines that are currently under evaluation by the TGA

Database of section 19A approvals to import and supply medicines to address medicine shortages

15 January 2021
Section 19A database has been updated to include new approvals

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