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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)

Date

2024 (13)
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201 result(s) found, displaying 1 to 10

VABYSMO faricimab 120 mg/mL solution for injection in a pre-filled syringe (449965)

30 September 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for VABYSMO faricimab 120 mg/mL solution for injection in a pre-filled syringe.
VABYSMO (Roche Products Pty Ltd)

24 September 2024

Prescription medicine registration

Active ingredients: faricimab.
AusPAR Polivy

30 August 2024

Australian Public Assessment Report (AusPAR)

Polivy (Polatuzumab vedotin) has been approved for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma.
Columvi Roche Products Pty Ltd

Sep-2024

Prescription medicine evaluation

Active ingredient: glofitamab.
RONAPREVE casirivimab 120mg/ml and imdevimab 120mg/ml solutions for infusion or injection in 1332 mg multi dose vials Cancelled under Section 30(1)(c) of the Act

28 June 2024

Cancellation by sponsor

Requested by Roche Products Pty Ltd
RONAPREVE casirivimab 120mg/ml and imdevimab 120mg/ml solutions for infusion or injection in 300 mg single dose vials Cancelled under Section 30(1)(c) of the Act

28 June 2024

Cancellation by sponsor

Requested by Roche Products Pty Ltd
TARCEVA erlotinib 150 mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

24 June 2024

Cancellation by sponsor

Requested by Roche Products Pty Ltd
TARCEVA erlotinib 100 mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

24 June 2024

Cancellation by sponsor

Requested by Roche Products Pty Ltd
TARCEVA erlotinib 25 mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

24 June 2024

Cancellation by sponsor

Requested by Roche Products Pty Ltd
GAVRETO pralsetinib 100 mg hard capsule bottle Cancelled under Section 30(1)(c) of the Act

7 June 2024

Cancellation by sponsor

Requested by Roche Products Pty Ltd

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