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Merck Sharp & Dohme (Australia) Pty Ltd

Regulatory activities for this sponsor.

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Type

Cancellation by sponsor (139)
ARTG (81)
Prescription medicine registration (64)
Australian Public Assessment Report (AusPAR) (33)
Designation or determination (31)
Prescription medicine evaluation (7)
Prescription medicine decision summary (3)

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Search

Sponsor content

358 result(s) found, displaying 201 to 210

REMERON SOLTAB mirtazapine 30mg orally disintegrating tablet blister pack Section 30(1)(c) of the Act

31 March 2020

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
ZERBAXA (Merck Sharp & Dohme (Australia) Pty Ltd)

31 March 2020

Prescription medicine registration

Active ingredients: ceftolozane sulfate; tazobactam sodium.
AusPAR: Doravirine and doravirine/ lamivudine/ tenofovir disoproxil fumarate

16 March 2020

Australian Public Assessment Report (AusPAR)

Australian Public Assessment Report for Doravirine and doravirine/lamivudine/tenofovir disoproxil fumarate
Notice for pembrolizumab (Merck Sharp & Dohme (Australia) Pty Ltd)

11 February 2020

Designation or determination

Provisional approval
AusPAR: Daptomycin

19 December 2019

Australian Public Assessment Report (AusPAR)

Australian Public Assessment Report for Daptomycin
REMERON SOLTAB mirtazapine 15mg orally disintegrating tablet blister pack Cancelled under Section 30(1)(c) of the Act

16 December 2019

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
ESMERON (Merck Sharp & Dohme (Australia) Pty Ltd)

12 December 2019

Prescription medicine registration

Active ingredients: rocuronium bromide.
INTRON A Interferon alfa-2b (HSA-free) 18 million IU/3mL injection Cancelled under Section 30(1)(c) of the Act

25 November 2019

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
INTRON A Interferon alfa-2b (HSA-free) 25 million IU/2.5mL injection Cancelled under Section 30(1)(c) of the Act

25 November 2019

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
INTRON A Interferon alfa-2b ( HSA-free ) 10 million IU/1mL Injection vial Cancelled under Section 30(1)(c) of the Act

25 November 2019

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd

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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.