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Novo Nordisk Pharmaceuticals Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (87)
Cancellation by sponsor (26)
Prescription medicine registration (22)
Australian public assessment report (AusPar) (20)
Prescription medicine decision summary (7)
Designation or determination (3)
Prescription medicine evaluation (2)
Section 14, TGO91 consent (1)

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2025 (8)
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Sponsor content

168 result(s) found, displaying 61 to 70

XULTOPHY insulin degludec 100 units/mL liraglutide 3.6 mg/mL solution for injection pre-filled pen 3 mL (328580)

22 December 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for XULTOPHY insulin degludec 100 units/mL liraglutide 3.6 mg/mL solution for injection pre-filled pen 3 mL.
Notice for concizumab (Novo Nordisk Pharmaceuticals Pty Ltd)

7 July 2022

Designation or determination

Priority review
NORDITROPIN SIMPLEXX somatropin (rbe) 10mg (6.67mg/mL) injection-solution multidose cartridge Cancelled under Section 30(1)(c) of the Act

5 May 2022

Cancellation by sponsor

Requested by Novo Nordisk Pharmaceuticals Pty Ltd
NORDITROPIN SIMPLEXX somatropin (rbe) 5mg (3.33mg/mL) injection-solution multidose cartridge Cancelled under Section 30(1)(c) of the Act

5 May 2022

Cancellation by sponsor

Requested by Novo Nordisk Pharmaceuticals Pty Ltd
NORDITROPIN SIMPLEXX somatropin (rbe) 15mg (10mg/mL) injection-solution multidose cartridge Cancelled under Section 30(1)(c) of the Act

5 May 2022

Cancellation by sponsor

Requested by Novo Nordisk Pharmaceuticals Pty Ltd
WEGOVY (Novo Nordisk Pharmaceuticals Pty Ltd)

25 March 2022

Prescription medicine registration

Active ingredients: Semaglutide.
Sogroya

7 March 2022

Prescription medicine decision summary

TGA decision: Sogroya (somapacitan) is approved to treat adults with growth hormone deficiency (AGHD).
Rybelsus

22 February 2022

Prescription medicine decision summary

TGA decision: Rybelsus (semaglutide) is approved to treat type 2 diabetes mellitus
SOGROYA (Novo Nordisk Pharmaceuticals Pty Ltd)

14 February 2022

Prescription medicine registration

Active ingredients: somapacitan.
RYBELSUS (Novo Nordisk Pharmaceuticals Pty Ltd)

4 February 2022

Prescription medicine registration

Active ingredients: semaglutide.

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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.