Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-8007c |
| Trade Name | Dose Form | Strength | Identifier |
| Eutroxsig | Tablet | 50 mcg | |
| Sponsor | Application date | Registration situation | Classification |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 22/8/2007 | Not available Approval date: 11/2/2010 Notification date: 8/9/2015 | Prescription |
| Reference product: Eltroxin Tablet 100 mcg New formulation | |||
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Levothyroxine sodium 50ug | Peptido GmbH AM Kraftwerk 6 Bexbach D-66450 GERMANY | |
| Excipient | ||
| Dextrin | ||
| Lactose | ||
| Magnesium stearate | ||
| Maize starch |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Aspen Pharma Pty Ltd 96 Merrindale Drive Croydon VIC 3136 AUSTRALIA |
| Manufacture of Final Dose Form | Aspen Pharma Pty Ltd 300 Frankston-Dandenong Road Dandenong VIC 3175 AUSTRALIA |
| Packing | Aspen Pharma Pty Ltd 300 Frankston-Dandenong Road Dandenong VIC 3175 AUSTRALIA |
| NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, aluminium/aluminium 200 tablets | 200 tablets | 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 weeks opened stored at or below 25°C. For tablets transferred to a Webster pack only. 2 weeks unopened stored at or below 25°C. For in-use blister strips |
Indications
EUTROXSIG is indicated for the management of demonstrated thyroid hormone deficiency.
EUTROXSIG is also used to suppress thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid.
This product should only be prescribed for use in new patients, or those who cannot tolerate other thyroxine products.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 2/9/2019 | Changed Medicine Notification | Active ingredient manufacturing process - Grade 1; Administrative fee (CMN) | Granted 7/11/2019 | 13/9/2019 | |
| 21/1/2010 | New Intermediate-risk Medicine Application | New medicine that does not contain a new active substance | Granted 11/2/2010 | 29/1/2010 | |
| 22/9/2008 | Provisional Consent (Section 23) | New intermediate-risk prescription medicine | Granted 5/2/2009 | 23/9/2008 | Y |
| 22/8/2007 | New Intermediate-risk Medicine Application | New intermediate-risk prescription medicine; Additional strength - Grade 1 | Withdrawn 26/11/2007 | 22/8/2007 |
