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Merck Sharp & Dohme (Australia) Pty Ltd

Regulatory activities for this sponsor.

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Type

Cancellation by sponsor (138)
ARTG (79)
Prescription medicine registration (61)
Australian public assessment report (AusPar) (33)
Designation or determination (31)
Prescription medicine evaluation (4)
Prescription medicine decision summary (2)

Date

2025 (35)
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2011 (4)
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1997 (5)
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Search

Sponsor content

348 result(s) found, displaying 181 to 190

SINEMET 250/25 levodopa/carbidopa 250mg/25mg tablet bottle Cancelled under Section 30(1)(c) of the Act

15 June 2020

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
ELOCON mometasone furoate 1mg/g cream tube Cancelled under Section 30(1)(c) of the Act

5 June 2020

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
NOVASONE mometasone furoate 1mg/g cream tube Cancelled under Section 30(1)(c) of the Act

5 June 2020

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
Notice for pembrolizumab (Merck Sharp & Dohme (Australia) Pty Ltd)

2 June 2020

Designation or determination

Provisional approval
Notice for pembrolizumab (Merck Sharp & Dohme (Australia) Pty Ltd)

2 June 2020

Designation or determination

Orphan drug
Notice for pembrolizumab (Merck Sharp & Dohme (Australia) Pty Ltd)

2 June 2020

Designation or determination

Provisional approval
KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)

2 June 2020

Prescription medicine registration

Active ingredients: pembrolizumab.
Merck Sharp & Dohme Australia Pty Ltd - Peg-Intron Redipen Heist - Syringe, hypodermic, cartridge, recessed-needle Section 41GL(d) of the Act

28 April 2020

Cancellation by sponsor

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

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