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Servier Laboratories Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

Cancellation by sponsor (27)
Prescription medicine registration (3)
Designation or determination (2)

Date

2022 (3)
2020 (22)
2019 (2)
2018 (1)
2017 (4)

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32 result(s) found, displaying 1 to 10

VALDOXAN, DOMION, NORTIM and ARDIX AGOMELATINE (Servier Laboratories Australia Pty Ltd)

12 May 2022

Prescription medicine registration

Active ingredients: Agomelatine.
Notice for ivosidenib (Servier Laboratories Australia Pty Ltd)

29 April 2022

Designation or determination

Priority review
Notice for ivosidenib (Servier Laboratories Australia Pty Ltd)

29 April 2022

Designation or determination

Orphan drug
ARDIX GLICLAZIDE MR gliclazide 30mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

4 December 2020

Cancellation by sponsor

Requested by Servier Laboratories Australia Pty Ltd
FLAMIPAX 5/5 perindopril arginine 5mg/ amlodipine (as besilate) 5mg tablet bottle Cancelled under Section 30(1)(c) of the Act

4 December 2020

Cancellation by sponsor

Requested by Servier Laboratories Australia Pty Ltd
FLAMIPAX 5/10 perindopril arginine 5mg/ amlodipine (as besilate) 10mg tablet bottle Cancelled under Section 30(1)(c) of the Act

4 December 2020

Cancellation by sponsor

Requested by Servier Laboratories Australia Pty Ltd
FLAMIPAX 10/5 perindopril arginine 10mg/ amlodipine (as besilate) 5mg tablet bottle Cancelled under Section 30(1)(c) of the Act

4 December 2020

Cancellation by sponsor

Requested by Servier Laboratories Australia Pty Ltd
FLAMIPAX 10/10 perindopril arginine 10mg/ amlodipine (as besilate) 10mg tablet bottle Cancelled under Section 30(1)(c) of the Act

4 December 2020

Cancellation by sponsor

Requested by Servier Laboratories Australia Pty Ltd
IDAPREX ARG 2.5 perindopril arginine 2.5 mg film-coated tablet bottle Cancelled under Section 30(1)(c) of the Act

4 December 2020

Cancellation by sponsor

Requested by Servier Laboratories Australia Pty Ltd
IDAPREX ARG 5 perindopril arginine 5 mg film-coated tablet bottle Cancelled under Section 30(1)(c) of the Act

4 December 2020

Cancellation by sponsor

Requested by Servier Laboratories Australia Pty Ltd

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