What is authorized?
Manufacture and sale are permitted, but use may be restricted to qualified institutions, physicians and patients, with mandatory post-marketing surveillance.
What remains uncertain?
Efficacy may be inferred rather than confirmed, often from small studies. Additional effectiveness and long-term safety data must be collected before the deadline and submitted for renewed review.
Approval is not reimbursement
Regulatory approval concerns whether the product may be marketed; insurance listing concerns public reimbursement. Reimbursement does not by itself prove long-term efficacy.