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Novo Nordisk Pharmaceuticals Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (88)
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)

Date

2025 (8)
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2015 (2)
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1999 (1)
1994 (1)

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Sponsor content

169 result(s) found, displaying 91 to 100

NovoEight turoctocog alfa 250 IU powder for solution for injection vial and prefilled solvent syringe Cancelled under Section 30(1)(c) of the Act

21 December 2020

Cancellation by sponsor

Requested by Novo Nordisk Pharmaceuticals Pty Ltd
NovoEight turoctocog alfa 500 IU powder for solution for injection vial and prefilled solvent syringe Cancelled under Section 30(1)(c) of the Act

21 December 2020

Cancellation by sponsor

Requested by Novo Nordisk Pharmaceuticals Pty Ltd
NovoEight turoctocog alfa 1000 IU powder for solution for injection vial and prefilled solvent syringe Cancelled under Section 30(1)(c) of the Act

21 December 2020

Cancellation by sponsor

Requested by Novo Nordisk Pharmaceuticals Pty Ltd
NovoEight turoctocog alfa 1500 IU powder for solution for injection vial and prefilled solvent syringe Cancelled under Section 30(1)(c) of the Act

21 December 2020

Cancellation by sponsor

Requested by Novo Nordisk Pharmaceuticals Pty Ltd
NovoEight turoctocog alfa 2000 IU powder for solution for injection vial and prefilled solvent syringe Cancelled under Section 30(1)(c) of the Act

21 December 2020

Cancellation by sponsor

Requested by Novo Nordisk Pharmaceuticals Pty Ltd
NovoEight turoctocog alfa 3000 IU powder for solution for injection vial and prefilled solvent syringe Cancelled under Section 30(1)(c) of the Act

21 December 2020

Cancellation by sponsor

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

17 December 2020

Prescription medicine registration

Active ingredients: insulin degludec; liraglutide.
AusPAR: Ozempic

2 December 2020

Australian public assessment report (AusPar)

Ozempic (semaglutide) has been approved for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
AusPAR: Insulin aspart (rys)

2 September 2020

Australian public assessment report (AusPar)

New AusPAR for Fiasp, Fiasp Penfill, Fiasp FlexTouch (insulin aspart rys) for the treatment of diabetes mellitus
CON-TGO91-224 - Novo Nordisk Pharmaceuticals Pty Ltd

21 August 2020

Section 14, TGO91 consent

Product(s) approved for Supply with noncompliant labelling.

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