Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-11003
Trade NameDose FormStrengthIdentifier
OzempicSolution for injection1.5 mL
SponsorApplication dateRegistration situationClassification
Novo Nordisk Pharmaceuticals Ltd
P O Box 51 268
Pakuranga
Auckland
3/12/2021Not available
Approval date: 16/3/2023
Notification date: 26/4/2023
Prescription
 

Composition

ComponentIngredientManufacturer
solution for injectionActive 
 Semaglutide 1.34 mg/mLNovo 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 stepManufacturer
Finished Product TestingNovo Nordisk A/S
Brennum Park
Hillerod DK-3400
DENMARK
 Novo Nordisk A/S
Novo Alle
Bagsvaerd
Copenhagen DK-2880
DENMARK
Manufacture of Final Dose FormNovo Nordisk A/S
Brennum Park
Hillerod DK-3400
DENMARK
 Novo Nordisk A/S
Novo Alle
Bagsvaerd
Copenhagen DK-2880
DENMARK
PackingNovo Nordisk A/S
Novo Alle
Bagsvaerd
Copenhagen DK-2880
DENMARK
Secondary PackagingNovo Nordisk A/S
Brennum Park
Hillerod DK-3400
DENMARK
NZ Site of Product ReleaseNovo Nordisk Pharmaceuticals Ltd
Level 18, Office 1834, Commericial Bay Tower
11-19 Customs Street
West
Auckland 1010

Packaging

PackageContentsShelf Life
Cartridge, glass, Multi-dose cartridge (0.25 and 0.5 mg doses) closed with cap and plunger, fitted into autoinjector1.5 mL36 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 DateApplication TypeChange(s)StatusPayment DatePriority
4/4/2024Changed Medicine NotificationAdministrative fee (CMN); Data sheet - G2Awaiting payment  
8/1/2024CMN 24(5)Finished product manufacturing site; Finished product secondary packing site; Finished product testing site; Finished product manufacturing process - G4; Administrative fee (CMN)Initial evaluation24/1/2024 
5/9/2023Self-Assessable Change NotificationShelf life/storage conditions - G1 (Self assessable)Notified18/9/2023 
3/12/2021New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 16/3/20231/3/2022 
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