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Prescription medicine determinations and designations
Find out more about Prescription medicines determination and designation notices
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273 result(s) found, displaying 1 to 25
- Designation or determinationNotice for etranacogene dezaparvovec (CSL Behring Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for sirolimus/rapamycin (AFT Pharmaceuticals Pty Ltd)Orphan drug
- Designation or determinationNotice for vosoritide (BioMarin Pharmaceutical Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for sacituzumab govitecan (Gilead Sciences Pty Ltd)Priority review
- Designation or determinationNotice for talquetamab (Janssen-Cilag Pty Ltd)Provisional determination
- Designation or determinationNotice for tozinameran and famtozinameran (Pfizer Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for elexacaftor/tezacaftor/ivacaftor (Vertex Pharmaceuticals Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for tozinameran & famtozinameran (COMIRNATY BIVALENT BA.4/BA.5 COVID-19 VACCINE) (Pfizer Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for tucatinib (Merck Sharp & Dohme (Australia) Pty Ltd)Provisional determination
- Designation or determinationNotice for vedolizumab (Takeda Pharmaceuticals Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for S1-RBD-sFc and Th/CTL peptides (Graythan Regulatory Services Pty Ltd)Provisional determination
- 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 etranacogene dezaparvovec (CSL Behring Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for sabizabulin (Adjutor Healthcare Pty Ltd)Provisional determination
- Designation or determinationNotice for Elasomeran/Elasomeran 0-omicron (Moderna Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for SARS-CoV-2-rS (NVX-CoV2373) (Biocelect Pty Ltd)Provisional determination
- Designation or determinationNotice for tocilizumab (ACTEMRA) (Roche Products Pty Ltd)Provisional determination
- Designation or determinationNotice for Recombinant CoV-2-S-?TM protein with Advax-CpG55.2 (active ingredient name and tradename to be confirmed) (Vaxine Pty Ltd)Provisional determination