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AusPAR: Levonorgestrel / ethinyloestradiol

Australian Public Assessment Report

AusPAR

AusPAR Levonorgestrel / ethinyloestradiol [PDF, 539.89 KB]

AusPAR Levonorgestrel / ethinyloestradiol [Word, 1.11 MB]

Attachment: Product Information: Levonorgestrel / ethinyloestradiol [PDF, 537.2 KB]

Attachment: Product Information: Levonorgestrel / ethinyloestradiol [Word, 1.76 MB]

Attachment: Extract from Clinical Evaluation Report: Levonorgestrel / ethinyloestradiol [PDF, 573.86 KB]

Attachment: Extract from Clinical Evaluation Report: Levonorgestrel / ethinyloestradiol [Word, 1.1 MB]

Device/Product Name

Seasonique

Active ingredients

Levonorgestrel / ethinyloestradiol

AusPAR Date

9 December 2016

Published

13 December 2016

Submission Number

PM-2015-00767-1-5

Submission Type

Major variation (change in dosage amount and regimen)

Decision

Approved