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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 21 to 30

AusPAR: Polivy

11 September 2024

Australian public assessment report (AusPar)

Polivy (polatuzumab vedotin) was approved for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma.
HERCEPTIN trastuzumab (rch) 60mg powder for injection vial Cancelled under Section 30(1)(c) of the Act

6 September 2024

Cancellation by sponsor

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

6 September 2024

Cancellation by sponsor

Requested by Roche Products Pty Ltd
Roche Products Pty Ltd - Specimen receptacle IVDs Cancelled under Section 41GL(d) of the Act

23 August 2024

Cancellation by sponsor

Requested by Roche Products Pty Ltd
Notice for delandistrogene moxeparvovec (Roche Products Pty Ltd)

7 August 2024

Designation or determination

Orphan drug
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

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