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Class 4 Medicines Defect Notification: Sandoz Limited, Co-Amoxiclav powder for oral suspension 250/62.5 mg/mL, EL(26)A/46

🇬🇧 MHRA · Thu 05 Nov 2026

Sandoz Limited has notified the MHRA of errors in the dosing table of the SmPC for Co-amoxiclav 250/62.5 mg/5 mL Powder for Oral Suspension (Class 4 defect, EL(26)A/46). Class 4 indicates no risk to patients or the product itself, but prescribers and pharmacists should be aware that the SmPC dosing table is inaccurate, as this could lead to dosing errors if relied upon, and the SmPC will need correcting.

Official source: MHRA ↗

Summary written by VigiEye from the official notice. AI-assisted; check the source before acting.

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