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Pierre Fabre Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

Cancellation by sponsor (29)
ARTG (27)
Prescription medicine registration (3)
Prescription medicine evaluation (2)
Australian public assessment report (AusPar) (1)
Designation or determination (1)

Date

2025 (16)
2024 (4)
2023 (7)
2022 (9)
2021 (4)
2020 (6)
2019 (3)
2018 (2)
2017 (4)
2015 (4)
2005 (2)
1998 (2)

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Sponsor content

63 result(s) found, displaying 41 to 50

Eau Thermale Avene Summer Essentials Cancelled under Section 30(1)(c) of the Act

14 April 2022

Cancellation by sponsor

Requested by Pierre Fabre Australia Pty Ltd
JAVLOR vinflunine ditartrate 250mg/10mL concentrated injection vial Cancelled under Section 30(1)(c) of the Act

28 June 2021

Cancellation by sponsor

Requested by Pierre Fabre Australia Pty Ltd
JAVLOR vinflunine ditartrate 100mg/4mL concentrated injection vial Cancelled under Section 30(1)(c) of the Act

28 June 2021

Cancellation by sponsor

Requested by Pierre Fabre Australia Pty Ltd
JAVLOR vinflunine ditartrate 50mg/2mL concentrated injection vial Cancelled under Section 30(1)(c) of the Act

28 June 2021

Cancellation by sponsor

Requested by Pierre Fabre Australia Pty Ltd
BRAFTOVI (Pierre Fabre Australia Pty Ltd)

13 May 2021

Prescription medicine registration

Active ingredients: encorafenib.
BRAFTOVI encorafenib 50 mg capsule blister pack (295764)

3 January 2019

ARTG

Australian Register of Therapeutic Goods (ARTG) information for BRAFTOVI encorafenib 50 mg capsule blister pack.
BRAFTOVI encorafenib 75 mg capsule blister pack (295441)

3 January 2019

ARTG

Australian Register of Therapeutic Goods (ARTG) information for BRAFTOVI encorafenib 75 mg capsule blister pack.
MEKTOVI binimetinib 15 mg film-coated tablet blister pack (295440)

3 January 2019

ARTG

Australian Register of Therapeutic Goods (ARTG) information for MEKTOVI binimetinib 15 mg film-coated tablet blister pack.
Notice for encorafenib (Pierre Fabre Australia Pty Ltd)

10 July 2020

Designation or determination

Priority review
Eau Thermale Avene Sunscreen Spray SPF 50+ (296376)

16 November 2017

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Eau Thermale Avene Sunscreen Spray SPF 50+.

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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.