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Roche Products Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (82)
Cancellation by sponsor (50)
Australian Public Assessment Report (AusPAR) (43)
Prescription medicine registration (33)
Prescription medicine decision summary (5)
Designation or determination (3)
Prescription medicine evaluation (3)

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Sponsor content

219 result(s) found, displaying 31 to 40

COLUMVI glofitamab (rch) 10 mg/10 mL concentrated solution for infusion vial (392331)

9 August 2023

ARTG

Australian Register of Therapeutic Goods (ARTG) information for COLUMVI glofitamab (rch) 10 mg/10 mL concentrated solution for infusion vial.
COLUMVI glofitamab (rch) 2.5 mg/2.5 mL concentrated solution for infusion vial (389650)

9 August 2023

ARTG

Australian Register of Therapeutic Goods (ARTG) information for COLUMVI glofitamab (rch) 2.5 mg/2.5 mL concentrated solution for infusion vial.
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
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
XOFLUZA baloxavir marboxil 80 mg film-coated tablet blister pack (388092)

2 May 2023

ARTG

Australian Register of Therapeutic Goods (ARTG) information for XOFLUZA baloxavir marboxil 80 mg film-coated tablet blister pack.

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