Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-3763/10 |
| Trade Name | Dose Form | Strength | Identifier |
| Nicorette Icy Mint Gum | Chewing gum | 2 mg | |
| Sponsor | Application date | Registration situation | Classification |
| JNTL Consumer Health (New Zealand) Limited P O Box 147247 Ponsonby Auckland 1144 | 12/12/2008 | Consent given Approval date: 16/12/2009 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| chewing gum | Active | |
| Nicotine polacrilex 10mg equivalent to 2 mg Nicotine. Plus 10% overage | Siegfried AG Untere Bruhlstrasse 4 Zofingen CH-4800 SWITZERLAND | |
| Cambrex Charles City Inc 1205 11th Street Charles City Iowa 50616 UNITED STATES OF AMERICA | ||
| Pfizer Cork Limited Inchera Little Island Cork IRELAND | ||
| Excipient | ||
| Acesulfame potassium | ||
| Cafosa 258 soft | ||
| Carnauba wax | ||
| Hypromellose | ||
| Levomenthol | ||
| Magnesium oxide | ||
| Peppermint oil | ||
| Polysorbate 80 | ||
| Sodium bicarbonate | ||
| Sodium carbonate | ||
| Starch | ||
| Sucralose | ||
| Titanium dioxide | ||
| Winterfresh flavour RDE4-149 0488110 | ||
| Xylitol | ||
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | McNeil AB Norrbroplatsen 2 Helsingborg SE-251 09 SWEDEN |
| Manufacture of Final Dose Form | McNeil AB Norrbroplatsen 2 Helsingborg SE-251 09 SWEDEN |
| Packing | DHL Supply Chain (New Zealand) Ltd 6 Manu Tapu Drive Mangere Auckland 2022 |
| McNeil AB Norrbroplatsen 2 Helsingborg SE-251 09 SWEDEN | |
| Secondary Packaging | Access Industries for the Disabled Ltd t/a Access Industries 1 Millner Ave Horsley Park NSW 2175 AUSTRALIA |
| NZ Site of Product Release | JNTL Consumer Health (New Zealand) Limited Cider Building Level 9/4 Williamson Avenue Grey Lynn Auckland 1021 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, PVC/Al blister pack | 15 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 30 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 75 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 105 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 150 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 200 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 210 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 300 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 310 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 315 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 325 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 340 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 355 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 370 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 385 pieces | 36 months unopened stored at or below 25°C |
| Blister pack, PVC/Al blister pack | 400 pieces | 36 months unopened stored at or below 25°C |
| Tablet container, PET laminated cardboard | 25 pieces | 36 months unopened stored at or below 25°C 3 months opened stored at or below 25°C |
| Tablet container, PET laminated cardboard | 100 pieces | 36 months unopened stored at or below 25°C 3 months opened stored at or below 25°C |
Indications
For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms thus:
Facilitating smoking cessation in smokers motivated to quit.
Helping smokers to temporarily abstain from smoking.
Facilitating smoking reduction in smokers unable or unwilling to quit.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 10/11/2023 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 21/11/2023 | |
| 12/12/2008 | New Lower-risk Medicine Application | New lower-risk medicine; Additional strength - Grade 2; Additional name - Grade 1 | Granted 16/12/2009 | 12/12/2008 |
