Product Dossier
RANEXA
Product Dossier for RANEXA (ranolazine, A Menarini). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: A Menarini
- Active ingredient: ranolazine
- Therapeutic area: Cardiology
- Same area: ATOZET
- Same area: OPSUMIT
What it is
Ranexa is a modified-release tablet containing ranolazine, available in three strengths: 375 mg, 500 mg, and 750 mg.
Approved indications
— Add-on therapy for the symptomatic treatment of stable angina pectoris in adults taking maximum tolerated doses of a beta-blocker or a calcium channel blocker with inadequate symptom control.
Dosing overview
Specific dosing information for Ranexa is not provided in the available source documents.
Key safety warnings
Key safety warnings for Ranexa are not detailed in the available source documents.
Contraindications
Contraindications for Ranexa are not detailed in the available source documents.
PBS listing
Ranexa was recommended by the PBAC in March 2018 for listing as Section 85 Authority Required (Telephone) for the symptomatic treatment of stable angina pectoris, with a risk sharing arrangement necessary. This recommendation was withdrawn by the PBAC in July 2021 with support from the sponsor. Ranexa is not currently listed on the PBS.
Regulatory history
Ranexa received TGA approval on 12 May 2016. Quality issues from the previous submission, including control of the genotoxic impurity 2,6-dimethylanaline, were adequately addressed by the sponsor. Ranexa was first registered on the ARTG on 13 October 2017, with all three strengths (375 mg, 500 mg, and 750 mg) listed simultaneously. The PBAC recommended listing in March 2018 under Section 85 Authority Required with a risk sharing arrangement. The PBAC withdrew this recommendation in July 2021 with sponsor support.