Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-7777/1 |
| Trade Name | Dose Form | Strength | Identifier |
| Abacavir | Oral solution | 20 mg/mL | 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: 29/7/2010 Notification date: 2/12/2010 | Prescription |
| Reference product: Ziagen Oral solution 20 mg/mL | |||
Composition
| Component | Ingredient | Manufacturer |
| oral solution | Active | |
| Abacavir sulfate 23.4 mg/mL equivalent to 20 mg/mL abacavir | Mylan Laboratories Limited Unit 8, Getula Chodavaram Poosapatirega Mandal Vizianagaram District Andhra Pradesh 535 204 INDIA | |
| Excipient | ||
| Banana flavour PHS-139122 | ||
| Citric acid monohydrate | ||
| Methyl hydroxybenzoate | ||
| Propyl hydroxybenzoate | ||
| Propylene glycol | ||
| Purified water | ||
| Saccharin sodium | ||
| Sodium citrate dihydrate | ||
| Sorbitol | ||
| Strawberry flavour PHS-132963 |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Cipla Ltd Unit I, Plot No. L-139, S-103, & M-62 Verna Industrial Estate Verna, Salcette Goa 403 722 INDIA |
| Manufacture of Final Dose Form | Cipla Ltd Unit I, Plot No. L-139, S-103, & M-62 Verna Industrial Estate Verna, Salcette Goa 403 722 INDIA |
| Packing | Cipla Ltd Unit I, Plot No. L-139, S-103, & M-62 Verna Industrial Estate Verna, Salcette Goa 403 722 INDIA |
| NZ Site of Product Release | REX Medical Ltd Unit 18/273 Neilson Street Onehunga Auckland 1061 |
Packaging
| Package | Contents | Shelf Life |
| Bottle, White HDPE bottle and white CRC cap (240 ml) | 240 mL | 24 months from date of manufacture stored at or below 25°C 2 months opened stored at or below 25°C |
Indications
Abacavir oral solution is 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 | zAdditional dose form - Grade 1 | Granted 29/7/2010 | 3/8/2006 |
