Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-8585a |
Trade Name | Dose Form | Strength | Identifier |
Next Choice | Tablet | 0.75 mg | Arrow |
Sponsor | Application date | Registration situation | Classification |
Teva Pharma (New Zealand) Limited P O Box 128 244 Remuera Auckland 1541 | 16/6/2011 | Not available Approval date: 15/9/2011 Notification date: 30/1/2015 | Prescription |
Reference product: Next Choice Tablet 750 mcg |
Composition
Component | Ingredient | Manufacturer |
tablet | Active | |
Levonorgestrel 0.75mg | ScinoPharm Taiwan Ltd 1 Nan-Ke 8th Road Shan-Hua Tainan 74144 TAIWAN | |
Excipient | ||
Colloidal silicon dioxide | ||
Lactose monohydrate | ||
Magnesium stearate | ||
Maize starch | ||
Povidone | ||
Sunset yellow FCF |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Watson Laboratories Inc 100 Business Center Drive Corona, California 92880 UNITED STATES OF AMERICA |
Watson Laboratories Inc 311 Bonnie Circle Corona, California 92880 UNITED STATES OF AMERICA | |
Manufacture of Final Dose Form | Watson Laboratories Inc 100 Business Center Drive Corona, California 92880 UNITED STATES OF AMERICA |
Packing | Watson Laboratories Inc 100 Business Center Drive Corona, California 92880 UNITED STATES OF AMERICA |
Secondary Packaging | Thermo-Pak Company Inc 360 Balm Ct Wood Dale IL 60191 UNITED STATES OF AMERICA |
NZ Site of Product Release | Teva Pharma (New Zealand) Limited Level 14, 41 Shortland Street Auckland 1010 |
Packaging
Package | Contents | Shelf Life |
Blister pack, PVC/Aluminium 2 tablet within a cardboard tri-fold sleeve. 5 sleeves per pack | 10 tablets | 24 months from date of manufacture stored at or below 25°C |
Indications
NEXT CHOICE is an oral emergency contraceptive indicated for use within 72 hours of unprotected intercourse. It should be used only as an emergency measure.
Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
28/6/2017 | Self-Assessable Change Notification | Sponsor (Self assessable) | Notified | 10/7/2017 | |
16/6/2011 | New Intermediate-risk Medicine Application | Additional classification (with/without new name) | Granted 15/9/2011 | 17/6/2011 |