Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-7777 |
| Trade Name | Dose Form | Strength | Identifier |
| Abacavir | Film coated tablet | 300 mg | Rex |
| Sponsor | Application date | Registration situation | Classification |
| REX Medical Ltd P O Box 18119 Glen Innes AUCKLAND 1743 | 27/7/2006 | Not available Approval date: 26/8/2010 Notification date: 2/12/2010 | Prescription |
| Reference product: Ziagen Film coated tablet 300 mg | |||
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Abacavir sulfate 351.39mg equivalent to 300 mg abacavir | Mylan Laboratories Limited Unit 8, Getula Chodavaram Poosapatirega Mandal Vizianagaram District Andhra Pradesh 535 204 INDIA | |
| Excipient | ||
| Colloidal silicon dioxide | ||
| Hypromellose | ||
| Magnesium stearate | ||
| Maize starch | ||
| Microcrystalline cellulose | ||
| Opadry yellow 15C52843 | ||
| Sodium starch glycolate |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Cipla Ltd Manufacturing Division Plot No. A-33/1/2 Patalganga Industrial Area District Raigad, (Maharashtra) 410 220 INDIA |
| Manufacture of Final Dose Form | Cipla Ltd Manufacturing Division Plot No. A-33/1/2 Patalganga Industrial Area District Raigad, (Maharashtra) 410 220 INDIA |
| Packing | Cipla Ltd Manufacturing Division Plot No. A-33/1/2 Patalganga Industrial Area District Raigad, (Maharashtra) 410 220 INDIA |
| NZ Site of Product Release | REX Medical Ltd Unit 18/273 Neilson Street Onehunga Auckland 1061 |
Packaging
| Package | Contents | Shelf Life |
| Bottle, HDPE bottle with 38mm CRC cap and 1g silical gel bag (60 tablets) | 60 tablets | 24 months from date of manufacture stored at or below 30°C |
Indications
Abacavir tablets are indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 25/5/2020 | Self-Assessable Change Notification | Data sheet - reformatting only (Self assessable) | Notified | 29/5/2020 | |
| 27/7/2006 | New Intermediate-risk Medicine Application | New medicine that does not contain a new active substance | Granted 26/8/2010 | 3/8/2006 |
