Revised: 12 May 2026
Medicines
Medsafe Product Detail |
||
|---|---|---|
| File ref: TT50-11003b |
| Trade Name | Dose Form | Strength | Identifier |
|---|---|---|---|
| Ozempic | Solution for injection | 2 mg/3mL | |
| Sponsor | Application date | Registration situation | Classification |
| Novo Nordisk Pharmaceuticals Ltd Level 18, Office 1834, Commericial Bay Tower 11-19 Customs Street West Auckland 1010 |
16/04/2025 | Not available Approval date:9/04/2026 Notification date: 22/04/2026 |
Prescription |
Composition
| Component | Ingredient | Manufacturer |
|---|---|---|
| solution for injection | Active | |
| Semaglutide 0.68 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 Hillerod DK-3400 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 | |
| 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 Hillerod DK-3400 DENMARK |
| Novo Nordisk Pharmaceutical Industries LP 3612 Powhatan Road Clayton North Carolina 27527 UNITED STATES OF AMERICA | |
| Packing | Novo Nordisk A/S Brennum Park Hillerod DK-3400 DENMARK |
| Novo Nordisk Pharmaceutical Industries LP 3612 Powhatan Road Clayton North Carolina 27527 UNITED STATES OF AMERICA | |
| Secondary Packaging | Novo Nordisk A/S Brennum Park Hillerod DK-3400 DENMARK |
| Novo Nordisk Pharmaceutical Industries LP 3612 Powhatan Road Clayton North Carolina 27527 UNITED STATES OF AMERICA | |
| Novo Nordisk Tianjin No. 99 Nanhai Road,TEDA Tianjin 300457 CHINA | |
| NZ Site of Product Release | Novo Nordisk Pharmaceuticals Ltd Level 18, O |
Packaging
| Package | Contents | Shelf life |
|---|---|---|
| Cartridge, glass, Multi-dose cartridge (0.25 and 0.5 mg doses) closed with cap and plunger, fitted into autoinjector | 1 syringes | 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 |
Indications
Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
- as monotherapy when metformin is not tolerated or contraindicated
- in addition to other medicinal products for the treatment of type 2 diabetes.
Ozempic is indicated as an adjunct to standard of care therapy to reduce the risk of sustained decline of kidney function and to reduce the risk of cardiovascular death in adults with Type 2 diabetes and chronic kidney disease (see section 5.1 Pharmacodynamic Properties - Clinical Efficacy and Safety).
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
|---|---|---|---|---|---|
| 16/04/2025 | New Higher-risk Medicine Application | Abridged new higher-risk medicine not containing a new active substance | Granted | 1/08/2025 | |
| 4/05/2026 | Changed Medicine Notification | Data sheet - G2; Administrative fee (CMN) | Awaiting payment | 1/01/1900 |
