Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-2062 |
Trade Name | Dose Form | Strength | Identifier |
Microlut | Tablet | 0.03 mg | |
Sponsor | Application date | Registration situation | Classification |
Bayer New Zealand Limited P O Box 2825 Shortland Street Auckland 1140 | 8/2/1973 | Consent given Approval date: 8/2/1973 | Prescription |
Composition
Component | Ingredient | Manufacturer |
tablet | Active | |
Levonorgestrel 0.03mg | Bayer AG Ernst-Schering Strasse 14 Bergkamen 59192 GERMANY | |
Excipient | ||
Calcium carbonate | ||
Glycol montanate | ||
Lactose monohydrate | ||
Macrogol 6000 | ||
Magnesium stearate | ||
Maize starch | ||
Povidone | ||
Purified talc | ||
Sucrose |
Production
Manufacturing step | Manufacturer |
Manufacture of Final Dose Form | Bayer AG Muellerstrasse 178 Berlin 13353 GERMANY |
Bayer Weimar GmbH und Co KG Dobereinerstrasse 20 Weimar 99427 GERMANY | |
Packing | Bayer AG Muellerstrasse 178 Berlin 13353 GERMANY |
Secondary Packaging | DHL Supply Chain (New Zealand) Ltd 6 Manu Tapu Drive Mangere Auckland 2022 |
NZ Site of Product Release | Bayer New Zealand Limited P O Box 0622 74 Taharoto Road Takapuna Auckland |
Packaging
Package | Contents | Shelf Life |
Blister pack, Sample 'credit-card' pack | 28 tablets | 60 months Not applicable stored at or below 25°C |
Blister pack, 3x28, 'credit card' memo pack | 84 tablets | 60 months from date of manufacture stored at or below 25°C |
Blister pack, Australian batch, KT059LF, Exp: 09.2022, 4 x 28 tablets | 112 tablets | 36 months from date of manufacture stored at or below 30°C |
Indications
Oral contraception
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
30/4/2020 | Changed Medicine Notification | Container/closure/packaging - Grade 4; Labelling - Grade 2 | Granted 22/5/2020 | 1/5/2020 |