Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-8585a
Trade NameDose FormStrengthIdentifier
Next ChoiceTablet0.75 mgArrow
SponsorApplication dateRegistration situationClassification
Teva Pharma (New Zealand) Limited
P O Box 128 244
Remuera
Auckland 1541
16/6/2011Not available
Approval date: 15/9/2011
Notification date: 30/1/2015
Prescription
Reference product: Next Choice Tablet 750 mcg

Composition

ComponentIngredientManufacturer
tabletActive 
 Levonorgestrel 0.75 mgScinoPharm 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 stepManufacturer
Finished Product TestingWatson 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 FormWatson Laboratories Inc
100 Business Center Drive
Corona, California 92880
United States of America
PackingWatson Laboratories Inc
100 Business Center Drive
Corona, California 92880
United States of America
Secondary PackagingThermo-Pak Company Inc
360 Balm Ct
Wood Dale IL 60191
United States of America
NZ Site of Product ReleaseTeva Pharma (New Zealand) Limited
Level 14, 41 Shortland Street
Auckland 1010

Packaging

PackageContentsShelf Life
Blister pack, PVC/Aluminium 2 tablet within a cardboard tri-fold sleeve. 5 sleeves per pack10 tablets24 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 DateApplication TypeChange(s)StatusPayment DatePriority
28/6/2017Self-Assessable Change NotificationSponsor (Self assessable)Notified10/7/2017 
16/6/2011New Intermediate-risk Medicine ApplicationAdditional classification (with/without new name)Granted 15/9/201117/6/2011 
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