Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-11003 |
| Trade Name | Dose Form | Strength | Identifier |
| Ozempic | Solution for injection | 1.5 mL | |
| Sponsor | Application date | Registration situation | Classification |
| Novo Nordisk Pharmaceuticals Ltd P O Box 51 268 Pakuranga Auckland | 3/12/2021 | Not available Approval date: 16/3/2023 Notification date: 26/4/2023 | 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 Hillerod DK-3400 Denmark |
| Novo Nordisk A/S Novo Alle Bagsvaerd Copenhagen DK-2880 Denmark | |
| Manufacture of Final Dose Form | Novo Nordisk A/S Brennum Park Hillerod DK-3400 Denmark |
| Novo Nordisk A/S Novo Alle Bagsvaerd Copenhagen DK-2880 Denmark | |
| Packing | Novo Nordisk A/S Novo Alle Bagsvaerd Copenhagen DK-2880 Denmark |
| Secondary Packaging | Novo Nordisk A/S Brennum Park Hillerod DK-3400 Denmark |
| NZ Site of Product Release | Novo Nordisk Pharmaceuticals Ltd Level 18, Office 1834, Commericial Bay Tower 11-19 Customs Street West Auckland 1010 |
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 | 1.5 mL | 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.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 3/12/2021 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 16/3/2023 | 1/3/2022 |
