Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-5238 |
| Trade Name | Dose Form | Strength | Identifier |
| Thyrax Duotab | Tablet | 0.025 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Schering-Plough a division of Schering-Plough Animal Health Limited P O Box 99851 c/o MSD Newmarket Auckland | 18/6/1992 | Approval lapsed Approval date: 23/9/1993 Notification date: 21/2/2011 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Levothyroxine sodium, hydrate 0.025mg | Industrie Chimique Mulhouse Dornach Mulhouse Cedex FRANCE | |
| Excipient | ||
| Colloidal silicon dioxide | ||
| Gelatin | ||
| Glycerol | ||
| Indigo carmine | ||
| Lactose monohydrate | ||
| Magnesium stearate | ||
| Maize starch | ||
| Purified talc | ||
| Sodium citrate dihydrate |
Production
| Manufacturing step | Manufacturer |
| Manufacture of Final Dose Form | NV Organon Kloosterstraat 6 Oss 5349 AB NETHERLANDS |
| Packing | NV Organon Kloosterstraat 6 Oss 5349 AB NETHERLANDS |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Bottle, glass, | 100 tablets | 24 months from date of manufacture stored at or below 25°C |
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 14/11/2008 | Self-Assessable Change Notification | Data sheet - miscellaneous changes; Sponsor (Self assessable) | Notified | 14/11/2008 |
