The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Specialised Therapeutics Alim Pty Ltd
Regulatory activities for this sponsor.
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Sponsor content
21 result(s) found, displaying 1 to 10
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Designation or determinationOrphan drug
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Designation or determinationPriority review
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Designation or determinationPriority review
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Designation or determinationOrphan drug
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Designation or determinationOrphan drug
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Designation or determinationOrphan Drug
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Australian Public Assessment Report (AusPAR)Minjuvi (tafasitamab) is provisionally approved for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplants.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for MINJUVI tafasitamab 200 mg powder for solution for infusion 1 vial per carton.
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Designation or determinationOrphan drug
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for PEMAZYRE pemigatinib 4.5 mg tablet blister pack.