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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

2025 (35)
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Sponsor content

348 result(s) found, displaying 131 to 140

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

24 September 2021

Prescription medicine registration

Active ingredients: pembrolizumab.
KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)

16 September 2021

Prescription medicine registration

Active ingredients: pembrolizumab.
KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)

16 September 2021

Prescription medicine registration

Active ingredients: pembrolizumab.
Notice for pembrolizumab (Merck Sharp & Dohme (Australia) Pty Ltd)

14 September 2021

Designation or determination

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

14 September 2021

Designation or determination

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

13 September 2021

Prescription medicine registration

Active ingredients: pembrolizumab.
KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)

13 September 2021

Prescription medicine registration

Active ingredients: pembrolizumab.
Notice for pembrolizumab (Merck Sharp & Dohme (Australia) Pty Ltd)

8 September 2021

Designation or determination

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

8 September 2021

Designation or determination

Orphan drug
Notice for molnupiravir (Merck Sharp & Dohme (Australia) Pty Ltd)

9 August 2021

Designation or determination

Provisional approval

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