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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 (75)
Prescription medicine registration (64)
Australian Public Assessment Report (AusPAR) (34)
Designation or determination (31)
Prescription medicine evaluation (7)
Prescription medicine decision summary (3)

Date

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Sponsor content

353 result(s) found, displaying 81 to 90

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
MSD-ERTUGLIFLOZIN-METFORMIN 7.5/1000 ertugliflozin/metformin hydrochloride 7.5 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-SITAGLIPTIN 15/100 ertugliflozin/sitagliptin (as phosphate monohydrate) 15 mg/100 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 15 ertugliflozin 15 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-SITAGLIPTIN 5/100 ertugliflozin/sitagliptin (as phosphate monohydrate) 5 mg/100 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 5 ertugliflozin 5 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
Notice for sotatercept (Merck Sharp & Dohme (Australia) Pty Ltd)

3 October 2023

Designation or determination

Priority review
Notice for sotatercept (Merck Sharp & Dohme (Australia) Pty Ltd)

19 September 2023

Designation or determination

Orphan drug

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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.