Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-5763 |
| Trade Name | Dose Form | Strength | Identifier |
| EpiPen | Solution for injection | 1 mg/mL | |
| Sponsor | Application date | Registration situation | Classification |
| Viatris Limited P O Box 11183 Ellerslie AUCKLAND 1542 | 8/7/1996 | Consent given Approval date: 7/2/1997 | Restricted |
| Reference product: Adrenaline (Min-I-Jet) Solution for injection 1 mg/mL 1:1000 | |||
Composition
| Component | Ingredient | Manufacturer |
| solution for injection | Active | |
| Adrenaline 1 mg/mL | Syn-Tech Chem. & Pharm. Co. Limited No. 168 Kai Yuan Road Hsin-Ying 73055 TAIWAN | |
| Excipient | ||
| Hydrochloric acid | ||
| Nitrogen | ||
| Sodium chloride | ||
| Sodium metabisulfite | ||
| Water |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Alcami Carolinas Corporation 2320 Scientific Park Drive Wilmington North Carolina 28405-1800 UNITED STATES OF AMERICA |
| Alcami Carolinas Corporation 4260 Forest Park Ave Suite 201, St. Louis Missouri 63108 UNITED STATES OF AMERICA | |
| Meridian Medical Technologies Inc 1945 Craig Rd St Louis Missouri 63146-4105 UNITED STATES OF AMERICA | |
| Meridian Medical Technologies Inc 8053 Litzsinger Road St Louis Missouri 63144 UNITED STATES OF AMERICA | |
| Manufacture of Final Dose Form | Meridian Medical Technologies Inc 2555 Hermelin Drive St Louis Missouri 63144-2591 UNITED STATES OF AMERICA |
| Overlabelling | ABS (AUS) Pty Ltd 18 Distribution Place Seven Hills NSW 2147 AUSTRALIA |
| Probiotec Pharma Pty Ltd 83 and 85 Cherry Lane Laverton North VIC 3026 AUSTRALIA | |
| Packing | Meridian Medical Technologies Inc 1945 Craig Rd St Louis Missouri 63146-4105 UNITED STATES OF AMERICA |
| Secondary Packaging | ABS (AUS) Pty Ltd 18 Distribution Place Seven Hills NSW 2147 AUSTRALIA |
| Probiotec Pharma Pty Ltd 83 and 85 Cherry Lane Laverton North VIC 3026 AUSTRALIA | |
| NZ Site of Product Release | Viatris Limited 2B George Bourke Drive Mt. Wellington Auckland 1060 |
Packaging
| Package | Contents | Shelf Life |
| Cartridge, glass, New Generation Auto-Injector 2mL, giving 0.3mL dose | 1 dose units | 24 months from date of manufacture stored at or below 25°C protect from light |
| Cartridge, glass, New Generation Auto-Injector 2mL, giving 0.3mL dose | 2 dose units | 24 months from date of manufacture stored at or below 25°C protect from light |
| Syringe, glass, spring loaded inj. device | 0.3 mL | 24 months from date of manufacture stored at or below 25°C protect from light. Excursions permitted to 15°C |
Indications
The emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings or bites, foods, drugs or other allergens.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 5/4/2024 | Changed Medicine Notification | Finished product testing and/or primary packing site; Editorial updates to Module 3 documents; Administrative fee (CMN) | Awaiting payment |
