Specialised Therapeutics PM Pty Ltd

Regulatory activities for this sponsor.

4 result(s) found, displaying 1 to 4

QINLOCK ripretinib 50 mg tablet bottle (327899)

13 July 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for QINLOCK ripretinib 50 mg tablet bottle.
NERLYNX neratinib (as maleate) 40 mg film coated tablets (301129)

15 March 2019

ARTG

Australian Register of Therapeutic Goods (ARTG) information for NERLYNX neratinib (as maleate) 40 mg film coated tablets.
AusPAR: Neratinib (as maleate)

12 May 2020

Australian Public Assessment Report (AusPAR)

Australian Public Assessment Report for Neratinib (as maleate)
NERLYNX (Specialised Therapeutics PM Pty Ltd)

14 March 2019

Prescription medicine registration

Active ingredients: neratinib maleate.