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Roche Products Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (79)
Cancellation by sponsor (45)
Australian Public Assessment Report (AusPAR) (40)
Prescription medicine registration (29)
Prescription medicine decision summary (5)
Prescription medicine evaluation (3)

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2024 (13)
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201 result(s) found, displaying 21 to 30

Columvi

23 August 2023

Prescription medicine decision summary

Columvi (glofitamab) is provisionally approved to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
RISTOVA rituximab 500 mg/50 mL injection vial Cancelled under Section 30(1)(c) of the Act

3 August 2023

Cancellation by sponsor

Requested by Roche Products Pty Ltd
RISTOVA rituximab 100 mg/10 mL injection vial Cancelled under Section 30(1)(c) of the Act

3 August 2023

Cancellation by sponsor

Requested by Roche Products Pty Ltd
AVASTIN bevacizumab 400mg/16mL injection vial Cancelled under Section 30(1)(c) of the Act

3 August 2023

Cancellation by sponsor

Requested by Roche Products Pty Ltd
AVASTIN bevacizumab 100mg/4mL injection vial Cancelled under Section 30(1)(c) of the Act

3 August 2023

Cancellation by sponsor

Requested by Roche Products Pty Ltd
MABTHERA rituximab 500mg/50mL injection vial Cancelled under Section 30(1)(c) of the Act

3 August 2023

Cancellation by sponsor

Requested by Roche Products Pty Ltd
MABTHERA rituximab 100mg/10mL injection vial Cancelled under Section 30(1)(c) of the Act

3 August 2023

Cancellation by sponsor

Requested by Roche Products Pty Ltd
HERCLON trastuzumab (rch) 150 mg powder for injection vial Cancelled under Section 30(1)(c) of the Act

3 August 2023

Cancellation by sponsor

Requested by Roche Products Pty Ltd
COLUMVI (Roche Products Pty Ltd)

3 August 2023

Prescription medicine registration

Active ingredients: glofitamab.
EVRYSDI (Roche Products Pty Ltd)

19 May 2023

Prescription medicine registration

Active ingredients: risdiplam.

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