Product Dossier
EZALO Composite Pack
Product Dossier for EZALO Composite Pack (ezetimibe, rosuvastatin, Organon Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Organon Pharma
- Active ingredient: ezetimibe, rosuvastatin
- Therapeutic area: Cardiology
- Related brand: ATOZET
- Related brand: APO-EZETIMIBE/SIMVASTATIN
- Related brand: ZETEZE
- Same area: OPSUMIT
- Same area: TARKA
What it is
EZALO Composite Pack contains ezetimibe and rosuvastatin (as calcium) . Each EZETROL tablet contains 10 mg ezetimibe . OGN ROSUVASTATIN tablets are available in strengths of 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin (as calcium) .
Dosing overview
EZALO Composite Pack is available in four formulations: 10 mg ezetimibe with 10 mg rosuvastatin, 10 mg ezetimibe with 40 mg rosuvastatin, 10 mg ezetimibe with 20 mg rosuvastatin, and 10 mg ezetimibe with 5 mg rosuvastatin .
Regulatory history
EZALO Composite Pack was first listed on the Australian Register of Therapeutic Goods on 26 November 2013, with four registered variants covering the different rosuvastatin strength combinations .