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Janssen-Cilag Pty Ltd

Regulatory activities for this sponsor.

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ARTG (142) ARTG (142)
Cancellation by sponsor (44) Cancellation by sponsor (44)
Australian Public Assessment Report (AusPAR) (34)
Prescription medicine registration (23)
Prescription medicine evaluation (7) Prescription medicine evaluation (7)
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261 result(s) found, displaying 31 to 40

RYBREVANT Janssen-Cilag Pty Ltd

Apr-2024

Prescription medicine evaluation

Active ingredient: amivantamab.
LAZCLUZE Janssen-Cilag Pty Ltd

Apr-2024

Prescription medicine evaluation

Active ingredient: lazertinib mesilate monohydrate.
Notice for macitentan (Janssen-Cilag Pty Ltd)

16 February 2024

Designation or determination

Orphan drug
TECVAYLI teclistamab 10mg/mL solution for injection vial (387621)

14 June 2023

ARTG

Australian Register of Therapeutic Goods (ARTG) information for TECVAYLI teclistamab 10mg/mL solution for injection vial.
TECVAYLI teclistamab 90mg/mL solution for injection vial (387622)

14 June 2023

ARTG

Australian Register of Therapeutic Goods (ARTG) information for TECVAYLI teclistamab 90mg/mL solution for injection vial.
Cellular Therapies - T cells-Ciltacabtagene autoleucel, cryopreserved-T-CARVYKTI - Janssen-Cilag Pty Ltd - Injection, intravenous infusion - Bag (410143)

6 June 2023

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Cellular Therapies - T cells-Ciltacabtagene autoleucel, cryopreserved-T-CARVYKTI - Janssen-Cilag Pty Ltd - Injection, intravenous infusion - Bag.
JURNISTA hydromorphone hydrochloride 4 mg prolonged release tablet blister pack Cancelled under Section 30(1)(c) of the Act

12 December 2023

Cancellation by sponsor

Requested by Janssen-Cilag Pty Ltd
JURNISTA hydromorphone hydrochloride 64 mg prolonged release tablet blister pack Cancelled under Section 30(1)(c) of the Act

12 December 2023

Cancellation by sponsor

Requested by Janssen-Cilag Pty Ltd
JURNISTA hydromorphone hydrochloride 32 mg prolonged release tablet blister pack Cancelled under Section 30(1)(c) of the Act

12 December 2023

Cancellation by sponsor

Requested by Janssen-Cilag Pty Ltd
JURNISTA hydromorphone hydrochloride 8 mg prolonged release tablet blister pack Cancelled under Section 30(1)(c) of the Act

12 December 2023

Cancellation by sponsor

Requested by Janssen-Cilag Pty Ltd

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The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.

Janssen-Cilag Pty Ltd

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