Mega menu

Home
Product regulation
Product regulation

Understand your obligations and access industry Guidance and other information about the products we regulate.
Safety and shortages
Safety and shortages

Access information about product recalls, shortages and other alerts, and learn how we manage safety.
Resources and guidance
Resources and guidance

Get information to help you understand our work, regulations and industry obligations.
Business services
Business services

Access our systems to submit applications, manage forms, make payments and communicate securely.

Janssen-Cilag Pty Ltd

Regulatory activities for this sponsor.

- LinkedIn
- (Twitter)
- Facebook
- Email

Loading...

Type

ARTG (145)
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)

Date

2025 (25)
2024 (16)
2023 (16)
2022 (13)
2021 (15)
2020 (25)
2019 (7)
2018 (9)
2017 (19)
2016 (19)
2015 (7)
2014 (12)
2013 (5)
2012 (5)
2011 (4)
2010 (19)
2009 (6)
2008 (2)
2007 (5)
2006 (3)
2005 (5)
2003 (6)
2002 (2)
2000 (9)
1998 (9)
1996 (1)
1994 (1)
1993 (3)

Search

Sponsor content

268 result(s) found, displaying 41 to 50

SPORANOX itraconazole 100mg capsule blister pack Cancelled under Section 30(1)(c) of the Act

13 June 2024

Cancellation by sponsor

Requested by Janssen-Cilag Pty Ltd
AusPAR: Tecvayli

9 May 2024

Australian public assessment report (AusPar)

Tecvayli (teclistamab) has been provisionally approved for the treatment of relapsed or refractory multiple myeloma in adult patients.
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.
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.
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.
Notice for macitentan (Janssen-Cilag Pty Ltd)

16 February 2024

Designation or determination

Orphan drug
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

Pages

First page
Previous page
Page 1
Page 2
Page 3
Page 4
Current page 5
Page 6
Page 7
Page 8
Page 9
…
Next page
Last page

Is there anything wrong with this page?

Help us improve

Using our website

Accessibility
Privacy
Security
Disclaimer
Copyright
Freedom of information
Acronyms and glossary terms

Quick links

Search our databases
Report a problem or side effect
TGA Business Services
Special Access Scheme
Authorised Prescriber
Office of Drug Control
State and territory contacts

Connect with us

Email subscriptions
Contact us
Facebook
(formerly Twitter)
Youtube
Instagram
LinkedIn

Help us improve

We are always looking for ways to improve our website.

Provide feedback

The Department of Health, Disability and Ageing 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.