Kadmon Oceania Pty Ltd

Regulatory activities for this sponsor.

5 result(s) found, displaying 1 to 5

AusPAR: Belumosudil

5 May 2022

Australian Public Assessment Report (AusPAR)

New AusPAR for Rholistiq (belumosudil) for the treatment of patients with chronic graft-versus-host disease aged 12 years and older.
Rholistiq

26 November 2021

Prescription medicine decision summary

TGA decision: Rholistiq (belumosudil mesilate) is approved to treat chronic graft-versus-host disease (GVHD)
RHOLISTIQ (Kadmon Oceania Pty Ltd)

11 November 2021

Prescription medicine registration

Active ingredients: belumosudil mesilate.
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