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Janssen-Cilag Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (146)
Cancellation by sponsor (44)
Australian public assessment report (AusPar) (37)
Prescription medicine registration (28)
Designation or determination (6)
Prescription medicine decision summary (5)
Prescription medicine evaluation (3)

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Sponsor content

269 result(s) found, displaying 81 to 90

SIMPONI golimumab (rmc) 50 mg/4 mL concentrate for solution for infusion vial (311990)

20 November 2019

ARTG

Australian Register of Therapeutic Goods (ARTG) information for SIMPONI golimumab (rmc) 50 mg/4 mL concentrate for solution for infusion vial.
DARZALEX SC (Janssen-Cilag Pty Ltd)

6 October 2021

Prescription medicine registration

Active ingredients: daratumumab.
Notice for amivantamab (Janssen-Cilag Pty Ltd)

5 October 2021

Designation or determination

Provisional approval
AusPAR: Ad26.COV2.S

25 June 2021

Australian public assessment report (AusPar)

Australian Public Assessment Report for Ad26.COV2.S
COVID-19 VACCINE JANSSEN (Janssen-Cilag Pty Ltd)

25 June 2021

Prescription medicine registration

Active ingredients: ad26.cov2.s.
COVID-19 Vaccine Janssen

25 June 2021

Prescription medicine decision summary

Australian prescription medicine decision summary
RABZOLE rabeprazole sodium 20mg enteric-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

7 June 2021

Cancellation by sponsor

Requested by Janssen-Cilag Pty Ltd
RABGEST rabeprazole sodium 10mg enteric-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

7 June 2021

Cancellation by sponsor

Requested by Janssen-Cilag Pty Ltd
RABGEST rabeprazole sodium 20mg enteric-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

7 June 2021

Cancellation by sponsor

Requested by Janssen-Cilag Pty Ltd
RABZOLE rabeprazole sodium 10mg enteric-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

7 June 2021

Cancellation by sponsor

Requested by Janssen-Cilag Pty Ltd

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