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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 (32)
Prescription medicine decision summary (5)
Prescription medicine evaluation (2)
Designation or determination (1)

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Sponsor content

214 result(s) found, displaying 41 to 50

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)
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
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
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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