Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-4890/2 |
| Trade Name | Dose Form | Strength | Identifier |
| Habitrol Mint | Chewing gum | 2 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Novartis Consumer Health Australasia Pty Ltd (NZ) 54 Carbine Road Mt Wellington AUCKLAND | 30/11/1995 | Approval lapsed Approval date: 27/3/1997 Notification date: 30/5/2013 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| chewing gum | Active | |
| Nicotine 2mg | Siegfried Ltd Untere Bruhlstrasse 4 Zofingen CH-4800 Switzerland | |
| Excipient | ||
| Acesulfame | ||
| Amberlite | ||
| Butylated hydroxytoluene | ||
| Calcium carbonate | ||
| Carnauba wax | ||
| Eucalyptus | ||
| Glycerol | ||
| Gum base Danoja NOF | ||
| Gum base Danoja | ||
| Mentha x piperita | ||
| Menthol | ||
| Purified talc | ||
| Saccharin | ||
| Saccharin sodium | ||
| Sodium bicarbonate | ||
| Sodium carbonate | ||
| Sorbitol | ||
| Water |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Steins Laboratorium A/S Hjaltesvej 8 Holstebro DK-7500 Denmark |
| Steins Laboratorium A/S Ladelundsvej 85 DK-6650 Brorup Denmark | |
| Manufacture of Final Dose Form | Fertin Pharma A/S Dandyvej 19 Vejle DK-7100 Denmark |
| Packing | Novartis Consumer Health Units 4 & 10, Wimsey Way Alfreton Trading Estate Somercotes Derbyshire DE55 4PT United Kingdom |
| Pacific Pharmaceuticals Limited (part of Mylan) 5 Monier Place Mount Wellington AUCKLAND | |
| Pacific Pharmaceuticals Limited (part of Mylan) 5 Prescott Street Mt Wellington AUCKLAND | |
| Pacific Pharmaceuticals Limited (part of Mylan) 67-71,72, 74, 76 Leonard Road Mt Wellington AUCKLAND 1060 | |
| Probiotec Pharma Pty Ltd 73 - 83 Cherry Lane Laverton North VIC 3026 Australia | |
| Secondary Packaging | Contract Pharmaceutical Services of Australia Pty Ltd 44 - 48 Waterloo Rd (No longer operational 28.4.06 North Ryde NSW 2113 Australia |
| DHL Exel Supply Chain (Australia) Pty Ltd 16 Picrite Close Greystanes NSW 2145 Australia | |
| DHL Supply Chain (New Zealand) Ltd 6 Manu Tapu Drive Mangere Auckland 2022 | |
| DHL Supply Chain (New Zealand) Ltd Cnr George Bolt Memorial Drive & Manu Tapu Drive Mangere AUCKLAND | |
| Packcentre Marketing Services Pty Ltd 1-5 Siddons Way Hallam VIC 3803 Australia | |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
| Pharmapak Technologies Pty Ltd 7 Inman Road Dee Why NSW 2099 Australia | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, 12 | 12 pieces | 24 months from date of manufacture stored at or below 25°C |
| Blister pack, 24 | 24 pieces | 24 months from date of manufacture stored at or below 25°C |
| Blister pack, 96 | 96 pieces | 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 |
| 18/8/2006 | Changed Medicine Notification | Finished product manufacturing site - Grade 1; Active ingredient specifications/test methods - Grade 2; Administrative fee (CMN) | Granted 5/9/2006 | 21/8/2006 |
