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Merck Sharp & Dohme (Australia) Pty Ltd

Regulatory activities for this sponsor.

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Cancellation by sponsor (139)
ARTG (79)
Prescription medicine registration (64)
Australian public assessment report (AusPar) (33)
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Sponsor content

356 result(s) found, displaying 71 to 80

INTEGRILIN eptifibatide (as acetate) 75mg/100mL injection vial Cancelled under Section 30(1)(c) of the Act

23 April 2024

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
INTEGRILIN eptifibatide (as acetate) 20mg/10mL injection vial Cancelled under Section 30(1)(c) of the Act

23 April 2024

Cancellation by sponsor

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

22 February 2024

Prescription medicine registration

Active ingredients: pembrolizumab.
WELIREG belzutifan 40 mg film-coated tablet bottle (355338)

22 December 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for WELIREG belzutifan 40 mg film-coated tablet bottle.
TUKYSA (Merck Sharp & Dohme (Australia) Pty Ltd)

17 November 2023

Prescription medicine registration

Active ingredients: tucatinib.
SILUMBRA suvorexant 15mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

10 October 2023

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
SILUMBRA suvorexant 20mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

10 October 2023

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
MSD-ERTUGLIFLOZIN-METFORMIN 7.5/500 ertugliflozin/metformin hydrochloride 7.5 mg/500 mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

5 October 2023

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
MSD-ERTUGLIFLOZIN-METFORMIN 2.5/1000 ertugliflozin/metformin hydrochloride 2.5 mg/1000 mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

5 October 2023

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
MSD-ERTUGLIFLOZIN-METFORMIN 2.5/500 ertugliflozin/metformin hydrochloride 2.5 mg/500 mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

5 October 2023

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd

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