Prescription medicine determinations and designations
Find out more about Prescription medicines determination and designation notices
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280 result(s) found, displaying 1 to 25
- Designation or determinationNotice for irinotecan (as sucrosofate) (Servier Laboratories (Aust) Pty Ltd)Orphan drug
- Designation or determinationNotice for irinotecan (as sucrosofate) (Servier Laboratories (Aust) Pty Ltd)Priority review
- Designation or determinationNotice for iptacopan (Novartis Pharmaceuticals Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for penpulimab (Specialised Therapeutics Pharma Pty Ltd)Orphan drug
- Designation or determinationNotice for elranatamab (Pfizer Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for valoctocogene roxaparvovec (BioMarin Pharmaceuticals Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for mRNA-1345 (for Respiratory Syncytial Virus (RSV) pre-fusion F protein (Moderna Australia Pty Ltd)Priority review
- Designation or determinationNotice for pembrolizumab (Merck Sharp & Dohme (Australia) Pty Ltd)Orphan drug
- Designation or determinationNotice for tepotinib (as hydrochloride monohydrate) (Merck Healthcare Pty Ltd)Orphan drug
- Designation or determinationNotice for tozinameran and famtozinameran (Pfizer Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for lanadelumab (Takeda Pharmaceuticals Australia Pty Ltd)Orphan drug
- Designation or determinationNotice for dostarlimab (GlaxoSmithKline Australia Pty Ltd)Priority review
- Designation or determinationNotice for vosoritide (BioMarin Pharmaceutical Australia Pty Ltd)Priority review
- 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 etranacogene dezaparvovec (CSL Behring Australia Pty Ltd)Provisional determination
- Designation or determinationNotice for sacituzumab govitecan (Gilead Sciences Pty Ltd)Priority review