Sanofi-Aventis Australia Pty Ltd
Regulatory activities for this sponsor.
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Sponsor content
689 result(s) found, displaying 41 to 50
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for BEYFORTUS nirsevimab 100mg in 1mL solution for injection prefilled syringe.
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Australian Public Assessment Report (AusPAR)Beyfortus (nirsevimab) has been approved for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season. It is also for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
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Cancellation by sponsorRequested by Sanofi-Aventis Australia Pty Ltd
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Cancellation by sponsorRequested by Sanofi-Aventis Australia Pty Ltd
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Cancellation by sponsorRequested by Sanofi-Aventis Australia Pty Ltd
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Cancellation by sponsorRequested by Sanofi-Aventis Australia Pty Ltd
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Cancellation by sponsorRequested by Sanofi-Aventis Australia Pty Ltd
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for XENPOZYME olipudase alfa 20mg powder for injection vial.
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Designation or determinationPriority review
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Cancellation by sponsorRequested by Sanofi-Aventis Australia Pty Ltd