Revised: 26 August 2026
Medicines
Medsafe Product Detail |
  | |
|---|---|---|
| File ref: TT50-11479 |
| Trade Name | Dose Form | Strength | Identifier |
|---|---|---|---|
| Mounjaro | Solution for injection | 4.17 mg/mL | KwikPen |
| Sponsor | Application date | Regulatory status | Classification |
| Eli Lilly and Company (NZ) Limited P O Box 109 197 Newmarket AUCKLAND 1149 |
8/01/2025 | Consent given Approval date:22/12/2025 |
Prescription |
Composition
| Component | Ingredient | Manufacturer |
|---|---|---|
| solution for injection | Active | |
| Tirzepatide 4.17 mg/mL | Corden Pharma Colorado Inc 2075 North 55th Street Boulder Colorado 80301 UNITED STATES OF AMERICA | |
| Eli Lilly and Company Inc Lilly Corporate Center Indianapolis Indiana 46285 UNITED STATES OF AMERICA | ||
| Taixing SynTheAll Pharmaceutical Co., Ltd. 18 Tianxing Road Jiangsu Taixing Economic Development Zone Taixing, Jiangsu 225442 CHINA | ||
| Excipient | ||
| Benzyl alcohol | ||
| Dibasic sodium phosphate heptahydrate | ||
| Glycerol | ||
| Hydrochloric acid | ||
| Phenol | ||
| Sodium chloride | ||
| Sodium hydroxide | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
|---|---|
| Finished Product Testing | Eli Lilly and Company Inc Lilly Corporate Center Indianapolis Indiana 46285 UNITED STATES OF AMERICA |
| Eli Lilly Italia SpA Via Gramsci 731-733 Sesto Fiorentino Florence 50019 ITALY | |
| Lilly France SAS 2 Rue du Colonel Lilly Fegersheim 67640 FRANCE | |
| PPD Development LP 8551 Research Way, Suite 90 Middleton Wisconsin 53562 UNITED STATES OF AMERICA | |
| Manufacture of Active Ingredient | Corden Pharma Colorado Inc 2075 North 55th Street Boulder Colorado 80301 UNITED STATES OF AMERICA |
| Eli Lilly and Company Inc Lilly Corporate Center Indianapolis Indiana 46285 UNITED STATES OF AMERICA | |
| Taixing SynTheAll Pharmaceutical Co., Ltd. 18 Tianxing Road Jiangsu Taixing Economic Development Zone Taixing, Jiangsu 225442 CHINA | |
| Manufacture of Final Dose Form | Eli Lilly Italia SpA Via Gramsci 731-733 Sesto Fiorentino Florence 50019 ITALY |
| Packing | Eli Lilly Italia SpA Via Gramsci 731-733 Sesto Fiorentino Florence 50019 ITALY |
| Secondary Packaging | Eli Lilly and Company Inc Lilly Corporate Center Indianapolis Indiana 46285 UNITED STATES OF AMERICA |
| Eli Lilly Italia SpA Via Gramsci 731-733 Sesto Fiorentino Florence 50019 ITALY | |
| Lilly France SAS 2 Rue du Colonel Lilly Fegersheim 67640 FRANCE | |
| Lilly SA Avda de la Industria, 30 Alcobendas Madrid 28108 SPAIN | |
| Millmount Healthcare Limited Block-7 City North Business Campus Stamullen County Meath K32 YD60 IRELAND | |
| Millmount Healthcare Limited IDA Science and Technology Park Dundalk IRELAND | |
| NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 6 Te Kapua Drive Mangere Auckland 2022 |
Packaging
| Package | Contents | Shelf life |
|---|---|---|
| Cartridge, glass, type I glass, elastomeric closures, fitted into KwikPen x1 | 3 mL | 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days not refrigerated stored at or below 30°C protect from light |
Indications
Type 2 Diabetes Mellitus: MOUNJARO 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.
Chronic Weight Management: MOUNJARO 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:
- NLT 30 kg/m2 (obesity) or
- NLT 27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes or type 2 diabetes mellitus).
MOUNJARO is indicated for the treatment of moderate to severe obstructive sleep apnoea in adults with obesity.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
|---|---|---|---|---|---|
| 8/01/2025 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance; Additional strength - Grade 1; Additional strength - Grade 3 | Withdrawn | 1/01/1900 | |
| 17/03/2025 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances; Additional strength - Grade 1; Additional strength - Grade 3; Additional strength - Grade 5 | Granted | 22/04/2025 | Y |
| 20/02/2026 | CMN 24(5) | Indications/dosage - G3 (NCE); Data sheet - G2; Administrative fee (CMN) | Information requested | 20/03/2026 | |
| 21/03/2026 | CMN 24(5) | Data sheet - G3; Administrative fee (CMN) | Information requested | 13/04/2026 | |
| 15/07/2026 | Changed Medicine Notification | Shelf life/storage conditions - G2; Administrative fee (CMN) | Granted | 17/07/2026 |
