AusPAR: Levonorgestrel / ethinyloestradiol

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Australian Public Assessment Report

13 December 2016
AusPAR Details
AusPAR
AusPAR Levonorgestrel / ethinyloestradiol (pdf, 540 KB)
AusPAR Levonorgestrel / ethinyloestradiol (docx, 1 MB)
Attachment: Product Information: Levonorgestrel / ethinyloestradiol (pdf, 537 KB)
Attachment: Product Information: Levonorgestrel / ethinyloestradiol (docx, 2 MB)
Attachment: Extract from Clinical Evaluation Report: Levonorgestrel / ethinyloestradiol (pdf, 574 KB)
Attachment: Extract from Clinical Evaluation Report: Levonorgestrel / ethinyloestradiol (docx, 1 MB)
Active Ingredient
Levonorgestrel / ethinyloestradiol
Product Name
Seasonique
Sponsor
Teva Pharma Australia Pty Ltd
Submission Number
PM-2015-00767-1-5
Submission Type
Major variation (change in dosage amount and regimen)
Decision
Approved
AusPAR Date
9 December 2016
Publication Date

13 December 2016
Category: 
Prescription medicines
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/733452