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Australian Public Assessment Report (AusPAR)MS-2 Step Composite Pack (mifepristone and misoprostol) was approved in females of childbearing age for the medical termination of an intrauterine pregnancy up to 70 days of gestation and for the medical management of missed miscarriage up to 70 days of gestation.
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Prescription medicine decision summaryMS-2 Step is approved for the following extension of indications:
-an extension of the current indication for the medical termination of an intrauterine pregnancy from up to 63 days' gestation to up to 70 days' gestation; and
-a new indication for the medical management of missed miscarriage up to 70 days' gestation, determined by ultrasound equivalence rather than menstrual period.
MS-2 Step contains the active ingredients mifepristone and misoprostol.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 microgram tablet blister].
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Australian Public Assessment Report (AusPAR)MS-2 Step (mifepristone & misoprostol composite pack) Product Information and Risk Management Plan changes were approved.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 microgram tablet strip].
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for MS Health Pty Ltd - Syringe, general-purpose.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for MS Health Pty Ltd - Cannula, uterine, suction.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for GyMiso misoprostol 200 microgram oral tablet blister pack.
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Australian Public Assessment Report (AusPAR)Australian Public Assessment Report for Mifepristone / misoprostol