Astellas Pharma Australia Pty Ltd
Regulatory activities for this sponsor.
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Sponsor content
43 result(s) found, displaying 1 to 10
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Prescription medicine registrationActive ingredients: enfortumab vedotin.
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Prescription medicine registrationActive ingredients: enzalutamide.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for VEOZA fezolinetant 45 mg film coated tablet blister pack.
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Australian Public Assessment Report (AusPAR)Veoza (fezolinetant) has been approved for the treatment of moderate to severe hot flashes associated with menopause
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May-2024Prescription medicine evaluationActive ingredient: avacincaptad pegol.
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Prescription medicine decision summaryVeoza (fezolinetant) has been approved for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause.
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Prescription medicine registrationActive ingredients: fezolinetant.
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Dec-2023Prescription medicine evaluationActive ingredient: zolbetuximab.
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Designation or determinationOrphan drug
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for PADCEV enfortumab vedotin 30 mg powder for injection vial.