Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-2062
Trade NameDose FormStrengthIdentifier
MicrolutTablet0.03 mg
SponsorApplication dateRegistration situationClassification
Bayer New Zealand Limited
P O Box 2825
Shortland Street
Auckland 1140
8/2/1973Consent given
Approval date: 8/2/1973
Prescription
 

Composition

ComponentIngredientManufacturer
tabletActive 
 Levonorgestrel 0.03 mgBayer 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 stepManufacturer
Manufacture of Final Dose FormBayer AG
Muellerstrasse 178
Berlin 13353
Germany
 Bayer Weimar GmbH und Co KG
Dobereinerstrasse 20
Weimar 99427
Germany
PackingBayer AG
Muellerstrasse 178
Berlin 13353
Germany
Secondary PackagingDHL Supply Chain (New Zealand) Ltd
6 Manu Tapu Drive
Mangere
Auckland 2022
NZ Site of Product ReleaseBayer New Zealand Limited
P O Box 0622
74 Taharoto Road
Takapuna
Auckland

Packaging

PackageContentsShelf Life
Blister pack, Sample 'credit-card' pack28 tablets60 months Not applicable stored at or below 25°C
Blister pack, 3x28, 'credit card' memo pack84 tablets60 months from date of manufacture stored at or below 25°C
Blister pack, Australian batch, KT059LF, Exp: 09.2022, 4 x 28 tablets112 tablets36 months from date of manufacture stored at or below 30°C

Indications

Oral contraception

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
30/4/2020Changed Medicine NotificationContainer/closure/packaging - Grade 4; Labelling - Grade 2Granted 22/5/20201/5/2020 
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