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Kyowa Kirin Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

Designation or determination (6)
ARTG (4)
Prescription medicine registration (3)
Australian public assessment report (AusPar) (2)
Prescription medicine decision summary (2)
Prescription medicine evaluation (1)

Date

2025 (1)
2024 (2)
2022 (1)
2021 (10)
2020 (2)
2019 (2)

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Sponsor content

18 result(s) found, displaying 11 to 18

CRYSVITA (Kyowa Kirin Australia Pty Ltd)

3 September 2021

Prescription medicine registration

Active ingredients: burosumab.
AusPAR: Mogamulizumab

10 May 2021

Australian public assessment report (AusPar)

Australian Public Assessment Report for Mogamulizumab
Poteligeo

15 February 2021

Prescription medicine decision summary

Australian prescription medicine decision summary
POTELIGEO (Kyowa Kirin Australia Pty Ltd)

6 January 2021

Prescription medicine registration

Active ingredients: mogamulizumab.
Notice for burosumab (Kyowa Kirin Australia Pty Ltd)

16 July 2020

Designation or determination

Orphan drug
Notice for burosumab (Kyowa Kirin Australia Pty Ltd)

16 July 2020

Designation or determination

Priority review
Notice for mogamulizumab (Kyowa Kirin Australia Pty Ltd)

11 December 2019

Designation or determination

Orphan drug
Notice for burosumab (Kyowa Kirin Australia Pty Ltd)

16 July 2019

Designation or determination

Orphan drug

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The Department of Health, Disability and Ageing acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.