Prescription medicine determinations and designations
Find out more about Prescription medicines determination and designation notices
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257 result(s) found, displaying 1 to 25
- Designation or determinationNotice for elasomeran and davesomeran (SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-BA.5) (Moderna Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for S1-RBD-sFc and Th/CTL peptides (Graythan Regulatory Services Pty Ltd)Provisional determination
- Designation or determinationNotice for vedolizumab (Takeda Pharmaceuticals Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for etranacogene dezaparvovec (CSL Behring Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for sabizabulin (Adjutor Healthcare Pty Ltd)Provisional determination
- Designation or determinationNotice for crisantaspase (Jazz Pharmaceuticals ANZ Pty Ltd)Orphan drug
- Designation or determinationNotice for concizumab (Novo Nordisk Pharmaceuticals Pty Ltd)Orphan drug
- Designation or determinationNotice for SARS-CoV-2 rS(MVC-COV1901) (Grand Pacific CRO Australia)Provisional determination
- Designation or determinationNotice for concizumab (Novo Nordisk Pharmaceuticals Pty Ltd)Priority review
- Designation or determinationNotice for riltozinameran (Pfizer Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for tozinameran and riltozinameran (Pfizer Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for tozinameran (Pfizer Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for olipudase alfa (Sanofi-Aventis Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for lumacaftor/ivacaftor (Vertex Pharmaceuticals Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for trastuzumab deruxtecan (AstraZeneca Pty Ltd)Priority review
- Designation or determinationNotice for imlifidase (Hansa Biopharma (Australia) Pty Ltd)Orphan drug
- Designation or determinationNotice for imlifidase (Hansa Biopharma (Australia) Pty Ltd)Provisional determination
- Designation or determinationNotice for ivosidenib (Servier Laboratories Australia Pty Ltd)Priority review
- Designation or determinationNotice for ivosidenib (Servier Laboratories Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for Elasomeran/Elasomeran 0-omicron (Moderna Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for glofitamab (Roche Products Pty Limited)Provisional determination