Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-8160 |
| Trade Name | Dose Form | Strength | Identifier |
| Victoza | Solution for injection | 6 mg/mL | |
| Sponsor | Application date | Registration situation | Classification |
| Novo Nordisk Pharmaceuticals Ltd P O Box 51 268 Pakuranga Auckland | 16/7/2008 | Consent given Approval date: 24/6/2010 Notification date: 24/3/2023 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| solution for injection | Active | |
| Liraglutide 6 mg/mL | Novo Nordisk A/S Novo Alle Bagsvaerd Copenhagen DK-2880 DENMARK | |
| Novo Nordisk A/S Hallas Alle Kalundborg DK-4400 DENMARK | ||
| Excipient | ||
| Dibasic sodium phosphate dihydrate | ||
| Hydrochloric acid | ||
| Phenol | ||
| Propylene glycol | ||
| Sodium hydroxide | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Novo Nordisk A/S Brennum Park Hillerod DK-3400 DENMARK |
| Novo Nordisk A/S Novo Alle Bagsvaerd Copenhagen DK-2880 DENMARK | |
| Manufacture of Final Dose Form | Novo Nordisk A/S Novo Alle Bagsvaerd Copenhagen DK-2880 DENMARK |
| Packing | Novo Nordisk A/S Brennum Park Hillerod DK-3400 DENMARK |
| Novo Nordisk A/S Hallas Alle Kalundborg DK-4400 DENMARK | |
| Novo Nordisk A/S Novo Alle Bagsvaerd Copenhagen DK-2880 DENMARK | |
| Novo Nordisk Pharmaceutical Industries, LP 3612 Powhatan Road Clayton North Carolina 27527 UNITED STATES OF AMERICA | |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
| NZ Site of Product Release | Novo Nordisk Pharmaceuticals Ltd 58 Richard Pearse Drive Airport Oaks Auckland |
Packaging
| Package | Contents | Shelf Life |
| Cartridge, glass, 1 pen pack | 1 dose units | 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months opened stored at or below 30°C protect from light. or in a refrigerator at 2° to 8°C |
| Cartridge, glass, 2 pen pack | 2 dose units | 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months opened stored at or below 30°C protect from light. or in a refrigerator at 2° to 8°C |
| Cartridge, glass, 3 pen pack | 3 dose units | 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months opened stored at or below 30°C protect from light. or in a refrigerator at 2° to 8°C |
Indications
Glycaemic control
Victoza is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus.
Prevention of cardiovascular events:
Victoza is indicated to prevent Major Adverse Cardiovascular Events (MACE: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus at high cardiovascular risk, as an adjunct to standard of care therapy.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 1/3/2024 | Changed Medicine Notification | Data sheet - G2 | Granted 4/4/2024 | 22/3/2024 | |
| 29/6/2023 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 17/7/2023 | |
| 16/7/2008 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 24/6/2010 | 16/7/2008 |
