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AbbVie Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (148)
Cancellation by sponsor (87)
Prescription medicine registration (25)
Australian public assessment report (AusPar) (22)
Designation or determination (7)
Prescription medicine evaluation (2)
Prescription medicine decision summary (1)
Section 14, TGO91 consent (1)

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Sponsor content

293 result(s) found, displaying 31 to 40

Notice for mirvetuximab soravtansine (Abbvie Pty Ltd)

20 November 2024

Designation or determination

Orphan drug
AusPAR: Vyalev

14 November 2024

Australian public assessment report (AusPar)

Vyalev (foslevodopa and foscarbidopa) was approved to treat idiopathic Parkinson’s disease with severe motor fluctuations despite optimised alternative pharmacological treatment.
SKYRIZI (Abbvie Pty Ltd)

12 November 2024

Prescription medicine registration

Active ingredients: Risankizumab.
VYALEV foslevodopa 2400 mg/10 mL and foscarbidopa 120 mg/10 mL solution for subcutaneous infusion vial (372902)

27 March 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for VYALEV foslevodopa 2400 mg/10 mL and foscarbidopa 120 mg/10 mL solution for subcutaneous infusion vial.
Abbvie Pty Ltd - Pharmaceutical management support software, professional-use Cancelled under Section 41GL(d) of the Act

31 October 2024

Cancellation by sponsor

Requested by Abbvie Pty Ltd
HUMIRA adalimumab (rch) 40 mg solution for injection pre-filled syringe Cancelled under Section 30(1)(c) of the Act

18 October 2024

Cancellation by sponsor

Requested by Abbvie Pty Ltd
HUMIRA adalimumab (rch) 20 mg solution for injection pre-filled syringe Cancelled under Section 30(1)(c) of the Act

18 October 2024

Cancellation by sponsor

Requested by Abbvie Pty Ltd
HUMIRA adalimumab (rch) 40 mg solution for injection pre-filled pen Cancelled under Section 30(1)(c) of the Act

18 October 2024

Cancellation by sponsor

Requested by Abbvie Pty Ltd
HUMIRA (Abbvie Pty Ltd)

1 October 2024

Prescription medicine registration

Active ingredients: Adalimumab.
Abbvie Pty Ltd - Oral/enteral syringe Cancelled under Section 41GL(d) of the Act

20 September 2024

Cancellation by sponsor

Requested by Abbvie Pty Ltd

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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.