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Merck Sharp & Dohme (Australia) Pty Ltd

Regulatory activities for this sponsor.

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Type

Prescription medicine registration (11)
Cancellation by sponsor (9)
ARTG (3)
Designation or determination (3)
Prescription medicine decision summary (2)
Australian public assessment report (AusPar) (1)

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2022

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Sponsor content

29 result(s) found, displaying 11 to 20

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

19 August 2022

Prescription medicine registration

Active ingredients: pembrolizumab.
DELSTRIGO doravirine 100 mg lamivudine 300 mg tenofovir disoproxil fumarate 300 mg film-coated tablet bottle Cancelled under Section 30(1)(c) of the Act

20 July 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
ZINPLAVA bezlotoxumab (rch) 1000 mg/40 mL concentrated injection vial Cancelled under Section 30(1)(c) of the Act

29 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
Merck Sharp & Dohme Australia Pty Ltd - Medicine administration kit, oral Cancelled under Section 41GL(d) of the Act

22 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
Merck Sharp & Dohme Australia Pty Ltd - Medicine administration kit, oral Cancelled under Section 41GL(d) of the Act

22 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
DIFICID fidaxomicin 200 mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

22 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
EMEND aprepitant 80mg & 125mg tri-pack capsule blister pack Cancelled under Section 30(1)(c) of the Act

22 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
EMEND aprepitant 125mg capsule blister pack Cancelled under Section 30(1)(c) of the Act

22 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
KEYTRUDA pembrolizumab (rch) 50 mg powder for injection vial Cancelled under Section 30(1)(c) of the Act

16 June 2022

Cancellation by sponsor

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

11 May 2022

Prescription medicine registration

Active ingredients: pembrolizumab.

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