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Roche Products Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (82)
Cancellation by sponsor (49)
Australian public assessment report (AusPar) (43)
Prescription medicine registration (33)
Prescription medicine decision summary (5)
Designation or determination (3)
Prescription medicine evaluation (2)

Date

2026 (6)
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Sponsor content

217 result(s) found, displaying 41 to 50

MABTHERA SC rituximab (rch) 1600 mg/13.4 mL solution for injection vial Cancelled under Section 30(1)(c) of the Act

2 November 2023

Cancellation by sponsor

Requested by Roche Products Pty Ltd
MABTHERA SC rituximab (rch) 1400 mg/11.7 mL solution for injection vial Cancelled under Section 30(1)(c) of the Act

2 November 2023

Cancellation by sponsor

Requested by Roche Products Pty Ltd
AusPAR: Gavreto

18 October 2023

Australian public assessment report (AusPar)

Gavreto (pralsetinib) has been approved for the treatment of locally advanced or metastatic RET fusion-positive non-small cell lung cancer.
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)
COLUMVI (Roche Products Pty Ltd)

3 August 2023

Prescription medicine registration

Active ingredients: glofitamab.
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

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