Regulatory update
Cardevia 10 mg · hepatic monitoring safety language · demonstration workflow
Step 6 · Review differences
Compare the current published leaflet against the proposed language before approval.
Version comparison
Cardevia v4.2 (published) → v4.3 (proposed)
Removed language
- Your doctor may check your liver function occasionally during treatment.
- Tell your doctor if you feel unusually tired.
Added language
- Your doctor will check your liver function before treatment and monthly for the first three months.
- Tell your doctor immediately if you feel unusually tired, notice yellowing of the skin or eyes, or have dark urine.
Approval notes
Wording mirrors the CHMP opinion of 09 Jul 2026 and the BfArM circular 2026/114. German affiliate requested a plain-language variant for the patient companion, approved by medical review.
Regulatory approval checklist
- Complete
- Complete
- Outstanding
- Outstanding
- Outstanding