Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-2593b |
| Trade Name | Dose Form | Strength | Identifier |
| Eltroxin | Tablet | 50 mcg | New formulation |
| Sponsor | Application date | Registration situation | Classification |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 23/3/2004 | Consent given Approval date: 16/11/2006 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Levothyroxine sodium, hydrate 55.63ug (pentahydrate equivalent to 50 mcg of anhydrous substance) | Sandoz GmbH Schaftenau Plant Biochemiestrasse 10 Langkampfen 6336 AUSTRIA | |
| Excipient | ||
| Colloidal silicon dioxide | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Pregelatinised maize starch | ||
| Purified talc |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | ACI Analytic Consulting Institut GmbH Am Rottgen 126 Neuss 41468 GERMANY |
| Analytisches Zentrum Biopharm GmbH Berlin Bitterfelder Strasse 19 Berlin 12681 GERMANY | |
| Aspen Bad Oldesloe GmbH 32-36 Industriestrasse Bad Oldesloe D-23843 GERMANY | |
| Manufacture of Final Dose Form | Aspen Bad Oldesloe GmbH 32-36 Industriestrasse Bad Oldesloe D-23843 GERMANY |
| Packing | Aspen Bad Oldesloe GmbH 32-36 Industriestrasse Bad Oldesloe D-23843 GERMANY |
| 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 |
| Bottle, plastic, HDPE with PP cap | 100 tablets | 24 months from date of manufacture stored at or below 25°C protect from light |
| Bottle, plastic, HDPE with PP cap | 200 tablets | 24 months from date of manufacture stored at or below 25°C protect from light |
| Bottle, plastic, Polypropylene bottles with LDPE closures | 1000 tablets | 24 months from date of manufacture stored at or below 25°C protect from light |
Indications
Levothyroxine is indicated for the treatment of hypothyroidism.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 20/3/2024 | Self-Assessable Change Notification | Data sheet - G1 (Self assessable) | Notified | 11/4/2024 | |
| 9/2/2024 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 22/2/2024 |
