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Roche Products Pty Ltd

Regulatory activities for this sponsor.

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ARTG (82) ARTG (82)
Cancellation by sponsor (48) Cancellation by sponsor (48)
Australian Public Assessment Report (AusPAR) (42)
Prescription medicine registration (31)
Prescription medicine decision summary (5)
Prescription medicine evaluation (2) Prescription medicine evaluation (2)
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211 result(s) found, displaying 31 to 40

INVIRASE saquinavir 500mg (as mesilate) film-coated tablet bottle Cancelled under Section 30(1)(c) of the Act

18 September 2023

Cancellation by sponsor

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

3 August 2023

Prescription medicine registration

Active ingredients: glofitamab.

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The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.

Roche Products Pty Ltd

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