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- Pfizer Australia Pty Ltd (8)
- Merck Sharp & Dohme (Australia) Pty Ltd (5)
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- UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia (2)
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Application types:
- Application type A: applications for a 'new medicine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia
- Application type B: applications for a 'new combination', where two or more already approved medicines are combined into a single product
- Application type C: applications for a 'new indication', or additional therapeutic use, for an already approved medicine.
For more information visit Prescription medicines: applications under evaluation.
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101 result(s) found, displaying 26 to 50
- TBC UCB Australia Pty Ltd T/A UCB Pharma Division of UCB AustraliaJul-2023Prescription medicine evaluationActive ingredient: zilucoplan.
- Ultomiris Alexion Pharmaceuticals Australasia Pty LtdJul-2023Prescription medicine evaluationActive ingredient: ravulizumab.
- ARCATUS Arctic Vision Australia Pty LtdJun-2023Prescription medicine evaluationActive ingredient: Triamcinolone acetonide.
- DYMISTA 125/50 & DYLASTINE 125/50 Viatris Pty LtdJun-2023Prescription medicine evaluationActive ingredient: azelastine hydrochloride, fluticasone propionate.
- KEYTRUDA Merck Sharp & Dohme (Australia) Pty LtdJun-2023Prescription medicine evaluationActive ingredient: pembrolizumab.
- Leqembi Eisai Australia Pty LtdJun-2023Prescription medicine evaluationActive ingredient: lecanemab.
- REXULTI Lundbeck Australia Pty LtdJun-2023Prescription medicine evaluationActive ingredient: brexpiprazole.
- TAKHZYRO Takeda Pharmaceuticals Australia Pty LtdJun-2023Prescription medicine evaluationActive ingredient: lanadelumab.
- TALVEY Janssen-Cilag Pty LtdJun-2023Prescription medicine evaluationActive ingredient: talquetamab.
- Teriparatide Sun/Teriparatide RBX/Prosteo Sun Pharma ANZ Pty LtdJun-2023Prescription medicine evaluationActive ingredient: Teriparatide.
- ABRYSVO Pfizer Australia Pty LtdMay-2023Prescription medicine evaluationActive ingredient: recombinant respiratory syncytial virus pre-fusion F protein, water for injections.
- EBGLYSS Eli Lilly Australia Pty LtdMay-2023Prescription medicine evaluationActive ingredient: lebrikizumab.
- ELREXFIO Pfizer Australia Pty LtdMay-2023Prescription medicine evaluationActive ingredient: elranatamab.
- HEPCLUDEX Gilead Sciences Pty LtdMay-2023Prescription medicine evaluationActive ingredient: bulevirtide acetate.
- KEYTRUDA Merck Sharp & Dohme (Australia) Pty LtdMay-2023Prescription medicine evaluationActive ingredient: pembrolizumab.
- KEYTRUDA Merck Sharp & Dohme (Australia) Pty LtdMay-2023Prescription medicine evaluationActive ingredient: pembrolizumab.
- Pascomer Cream AFT Pharmaceuticals Pty LtdMay-2023Prescription medicine evaluationActive ingredient: Sirolimus.
- PENBRAYA Pfizer Australia Pty LtdMay-2023Prescription medicine evaluationActive ingredient: Meningococcal polysaccharide Group Y, Meningococcal polysaccharide group A, Meningococcal polysaccharide group C, Meningococcal polysaccharide group W135, Neisseria meningitidis serogroup B recombinant lipidated- factor H binding protein subfamily A, Neisseria meningitidis serogroup B recombinant lipidated- factor H binding protein subfamily B
- Talzenna Pfizer Australia Pty LtdMay-2023Prescription medicine evaluationActive ingredient: talazoparib tosilate.
- TRADENAME AstraZeneca Pty LtdMay-2023Prescription medicine evaluationActive ingredient: capivasertib.
- TRADENAME Novo Nordisk Pharmaceuticals Pty LtdMay-2023Prescription medicine evaluationActive ingredient: insulin icodec.
- VOXZOGO BioMarin Pharmaceutical Australia Pty LtdMay-2023Prescription medicine evaluationActive ingredient: vosoritide.
- SIDAPVIA 10/100 AstraZeneca Pty LtdApr-2023Prescription medicine evaluationActive ingredient: dapagliflozin propanediol monohydrate, sitagliptin phosphate monohydrate.
- Belfidess Galderma Australia Pty LtdMar-2023Prescription medicine evaluationActive ingredient: relabotulinumtoxinA.