COVID-19 vaccine safety report (1 December 2022)

1 December 2022 - To 27 November 2022, the TGA has received 709 reports which have been assessed as likely to ...

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Croma Australia, a subsidiary of Hugel Aesthetics, receives TGA approval in Australia for Letybo (letibotulinumtoxinA) for the treatment of glabellar lines

28 November 2022 - Approval is supported by positive results from three completed Phase 3 trials that enrolled more than 1000 ...

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An open letter to doctors from the TGA

28 November 2022 - The TGA welcomes feedback and is committed to continuously improving processes and communications.  ...

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Hugel's 'Letybo' first in Korea to obtain marketing approval from Australia

 24 November 2022 - Obtained marketing approval on the 23rd (local time) from the TGA of Australia for the indication of ...

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COVID-19 vaccine safety report (17 November 2022)

17 November 2022 - To 13 November 2022, the TGA has received 706 reports which have been assessed as likely to ...

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Amarin announces Vazkepa (icosapent ethyl) approved by the TGA in Australia

15 November 2022 - Marks fifth regulatory approval for Vascepa/Vazkepa franchise in key international markets in 2022. ...

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TGA grants provisional determination to Pfizer’s COVID-19 bivalent (Comirnaty Bivalent Omicron BA.4/BA.5) booster dose vaccine

16 November 2022 - On 15 November 2022, the TGA granted a provisional determination to Pfizer’s bivalent COVID-19 vaccine candidate: tozinameran ...

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ATAGI recommendations on use of the Pfizer COVID-19 vaccine for children aged 6 months to 4 years

15 November 2022 - On 29 September 2022, the TGA provisionally approved Comirnaty (Pfizer) COVID-19 vaccine for use in children ...

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ATAGI recommendations on use of the Pfizer bivalent (Original/Omicron BA.1) COVID-19 vaccine

15 November 2022 - On 27 October 2022, the TGA provisionally approved the Pfizer (Comirnaty) Bivalent Original/Omicron BA.1 vaccine (subsequently referred ...

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ATAGI update on boosters following COVID-19 meeting on 11 November 2022

15 November 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their meeting on 11 November ...

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COVID-19 vaccine safety report (3 November 2022)

3 November 2022 - To 30 October 2022, the TGA has received 704 reports which have been assessed as likely to ...

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New COVID-19 variant leads to increase in cases

8 November 2022 - A statement from Professor Paul Kelly, Australian Government Chief Medical Officer, on the increase in COVID-19 cases ...

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TGA provisionally approves Pfizer bivalent COVID-19 vaccine for use as a booster dose in adults

28 October 2022 - On 27 October 2022, the TGA provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron ...

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ATAGI recommendations for a booster dose of the paediatric Pfizer COVID-19 vaccine in children aged 5 to 11 years

24 October 2022 - Recommendations from the Australian Technical Advisory Group on Immunisation on Pfizer booster doses for children aged 5 ...

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COVID-19 vaccine safety report (20 October 2022)

20 October 2022 - To 16 October 2022, the TGA has received 705 reports which have been assessed as likely to ...

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