Specialised Therapeutics Alim Pty Ltd
Regulatory activities for this sponsor.
Loading...
Sponsor content
21 result(s) found, displaying 11 to 20
-
ARTGAustralian Register of Therapeutic Goods (ARTG) information for PEMAZYRE pemigatinib 13.5 mg tablet blister pack.
-
ARTGAustralian Register of Therapeutic Goods (ARTG) information for PEMAZYRE pemigatinib 9 mg tablet blister pack.
-
Australian Public Assessment Report (AusPAR)AusPAR for Pemazyre (pemigatinib) for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic therapy.
-
Prescription medicine decision summaryWe have approved Minjuvi (tafasitamab) to treat diffuse large B-cell lymphoma (DLBCL).
-
Prescription medicine registrationActive ingredients: tafasitamab.
-
Prescription medicine decision summaryTGA decision: Pemazyre (pemigatinib) is approved to treat cancer
-
Prescription medicine registrationActive ingredients: pemigatinib.
-
Designation or determinationProvisional determination
-
Designation or determinationOrphan drug
-
ARTGAustralian Register of Therapeutic Goods (ARTG) information for ILUVIEN fluocinolone acetonide 190 mcg intravitreal implant in applicator.