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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 (81)
Prescription medicine registration (64)
Australian Public Assessment Report (AusPAR) (33)
Designation or determination (31)
Prescription medicine evaluation (7)
Prescription medicine decision summary (3)

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Sponsor content

358 result(s) found, displaying 81 to 90

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
AusPAR: Welireg

13 September 2023

Australian Public Assessment Report (AusPAR)

WELIREG (belzutifan) is indicated for treatment of patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system haemangioblastomas, or pancreatic neuroendocrine tumours, not requiring immediate surgery.

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