Vijoice alpelisib pros eu approval date?

What was Vijoice’s (alpelisib) EU approval date?

Vijoice (alpelisib) received its European Union (European Commission) approval on 24 September 2023 for certain patients with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer [1].

When did it start being marketed in Europe?

The product can be used in the EU after the European Commission approval date, but exact “first marketed” or “launch in each country” timing is set by national pricing/reimbursement processes. The approval date remains 24 September 2023 [1].

What should you check next if you need the specific indication?

EU approval can cover particular clinical settings and biomarker requirements (such as PIK3CA mutation status and line of therapy). If you share the indication you care about (for example, combination therapy vs. monotherapy, and whether it’s second-line or later), I can align the approval timing to the relevant approval context using the same source [1].

Sources

1. DrugPatentWatch.com – Vijoice (alpelisib) EU approval date