The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
You are here Home Guidance and resources Sponsors Kadmon Oceania Pty Ltd Regulatory activities for this sponsor. Listen Print Share Loading... Type Designation or determination (2) (-) Designation or determination (2) Prescription medicine decision summary (1) (-) Prescription medicine decision summary (1) Australian Public Assessment Report (AusPAR) (1) Australian Public Assessment Report (AusPAR) (1) Prescription medicine registration (1) Prescription medicine registration (1) Date 2021 (1) 2021 (1) 2020 (2) 2020 (2) Search Filters applied:Prescription medicine decision summaryDesignation or determinationClear all Sponsor content3 result(s) found, displaying 1 to 3 Rholistiq 26 November 2021 Prescription medicine decision summary TGA decision: Rholistiq (belumosudil mesilate) is approved to treat chronic graft-versus-host disease (GVHD) Notice for belumosudil (Kadmon Oceania Pty Ltd) 15 September 2020 Designation or determination Priority review Notice for belumosudil (Kadmon Oceania Pty Ltd) 4 September 2020 Designation or determination Orphan drug
Rholistiq 26 November 2021 Prescription medicine decision summary TGA decision: Rholistiq (belumosudil mesilate) is approved to treat chronic graft-versus-host disease (GVHD)
Notice for belumosudil (Kadmon Oceania Pty Ltd) 15 September 2020 Designation or determination Priority review
Notice for belumosudil (Kadmon Oceania Pty Ltd) 4 September 2020 Designation or determination Orphan drug