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Novo Nordisk Pharmaceuticals Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (93)
Cancellation by sponsor (26)
Prescription medicine registration (23)
Australian public assessment report (AusPar) (20)
Prescription medicine decision summary (7)
Designation or determination (3)
Prescription medicine evaluation (3)
Section 14, TGO91 consent (1)

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2026 (5)
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Sponsor content

176 result(s) found, displaying 71 to 80

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.
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.
RYBELSUS (Novo Nordisk Pharmaceuticals Pty Ltd)

4 February 2022

Prescription medicine registration

Active ingredients: semaglutide.
REFIXIA nonacog beta pegol 2000 IU powder and solvent for solution for injection (308424)

4 September 2019

ARTG

Australian Register of Therapeutic Goods (ARTG) information for REFIXIA nonacog beta pegol 2000 IU powder and solvent for solution for injection.
REFIXIA nonacog beta pegol 1000 IU powder and solvent for solution for injection (308425)

4 September 2019

ARTG

Australian Register of Therapeutic Goods (ARTG) information for REFIXIA nonacog beta pegol 1000 IU powder and solvent for solution for injection.

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