Product Dossier
LIVALO
Product Dossier for LIVALO (pitavastatin, Advantage Medical Products Consulting). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Advantage Medical Products Consulting
- Active ingredient: pitavastatin
- Therapeutic area: Cardiology
- Same area: ATOZET
- Same area: OPSUMIT
What it is
Livalo is a film-coated tablet containing pitavastatin, available in strengths of 1 mg, 2 mg, and 4 mg.
Approved indications
— Primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, as an adjunct to diet in adult patients when response to diet and other non-pharmacological measures is inadequate.
Key safety warnings
The TGA's approval was based on a positive risk-benefit assessment with satisfactory findings in quality, nonclinical, and clinical evaluations.
Regulatory history
Livalo (pitavastatin) received TGA approval on 25 November 2011 for the treatment of primary hypercholesterolaemia. The three registered tablet strengths (1 mg, 2 mg, and 4 mg film-coated tablets) were first listed on the ARTG on 27 August 2013.