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 AG 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 |