Revised: 12 May 2026
Medicines
Medsafe Product Detail |
  | |
|---|---|---|
| File ref: TT50-11298a |
| Trade Name | Dose Form | Strength | Identifier |
|---|---|---|---|
| Wegovy | Solution for injection | 1.34 mg/mL | 0.5 mg FlexTouch |
| Sponsor | Application date | Registration situation | Classification |
| Novo Nordisk Pharmaceuticals Ltd P O Box 51 268 Pakuranga Auckland |
8/05/2024 | Consent given Approval date:20/03/2025 Notification date: 20/06/2025 |
Prescription |
Composition
| Component | Ingredient | Manufacturer |
|---|---|---|
| solution for injection | Active | |
| Semaglutide 1.34 mg/mL | 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 1 Hilleroed DK-3400 DENMARK |
| Novo Nordisk A/S Novo Alle 1 Bagsvaerd Hovedstaden DK-2880 DENMARK | |
| Manufacture of Active Ingredient | Novo Nordisk A/S Hallas Alle Kalundborg DK-4400 DENMARK |
| Manufacture of Final Dose Form | Novo Nordisk A/S Brennum Park 1 Hilleroed DK-3400 DENMARK |
| Novo Nordisk A/S Novo Alle 1 Bagsvaerd Hovedstaden DK-2880 DENMARK | |
| Secondary Packaging | Novo Nordisk A/S Brennum Park 1 Hilleroed DK-3400 DENMARK |
| NZ Site of Product Release | Novo Nordisk Pharmaceuticals Ltd Level 18, O |
Packaging
| Package | Contents | Shelf life |
|---|---|---|
| Cartridge, glass, Multi-dose cartridge with rubber cap and plunger, fitted into an autoinjector | 1 pieces | 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 weeks opened stored at or below 30°C protect from light 6 weeks opened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light |
Indications
Weight Management
Adults:
Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) in adults with an initial Body Mass Index (BMI) of:
- greater than or equal to 30 kg/m2 (obesity), or
- greater than or equal to 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity (see Section 5.1 Pharmacodynamic Properties - Clinical trials in data sheet).
Adolescents (12 years and above)
Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with initial:
- obesity* and
- body weight above 60 kg.
Treatment with Wegovy should be re-evaluated and discontinued if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.
*Obesity (BMI greater than or equal to the 95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in datasheet).
Reduction in risk of major adverse cardiovascular events
Wegovy is indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with established cardiovascular disease, with a Body Mass Index (BMI) greater than or equal to 27 kg/m2, and without established Type 1 or Type 2 diabetes (see Section 5.1 Pharmacodynamic Properties - Clinical trials in data sheet).
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
|---|---|---|---|---|---|
| 8/05/2024 | New Higher-risk Medicine Application | New higher-risk medicine that does not contain a new active substance; Additional strength - Grade 1 | Granted | 14/05/2024 | Y |
| 25/08/2025 | Self-Assessable Change Notification | Test methods and specifications - G1 (Self assessable) | Notified | 10/09/2025 | |
| 20/04/2026 | Self-Assessable Change Notification | Test methods and specifications - G1 (Self assessable) | Notified | 1/05/2026 | |
| 30/04/2026 | CMN 24(5) | Indications/dosage - G3 (other); Administrative fee (CMN) | Awaiting payment | 1/01/1900 | |
| 1/05/2026 | Changed Medicine Notification | Data sheet - G2; Administrative fee (CMN) | Awaiting payment | 1/01/1900 | |
| 5/05/2026 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 11/05/2026 |
