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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

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Search

Sponsor content

348 result(s) found, displaying 61 to 70

STEGLATRO 5 ertugliflozin 5 mg film-coated tablet blister pack 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) 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

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