規制動向

FDA、EMA、TGA および世界の規制動向

#Patient Information Leaflet ×

2026年9月23日•1分で読めます

B. Braun reports PIL errors in Meropenem 1000 mg infusion product

B. Braun Melsungen AG has informed the MHRA of patient information leaflet errors in certain Meropenem 1000 mg powder and solvent batches.

2026年8月23日•1分で読めます

Omega Pharma Recalls Napralief 250mg Tablets Over Missing PIL Text

Omega Pharma Ltd is recalling specific batches of Napralief 250mg gastro‑resistant tablets because sections of the patient information leaflet and carton labeling are missing.

2026年8月23日•1分で読めます

Milpharm Limited reports discrepancy in PIL for Loperamide 2 mg Orodispersible Tablets

Milpharm Limited has found a discrepancy in the approved Patient Information Leaflet for its 2 mg Loperamide hydrochloride orodispersible tablets.

2026年8月23日•1分で読めます

Brancaster Pharma reports outdated PIL on notified batches

Brancaster Pharma informed the MHRA that cartons for the listed batches were supplied with an outdated Patient Information Leaflet.

2026年8月23日•1分で読めます

Flamingo Pharma UK Ltd recalls Flucloxacillin 500mg capsules due to incorrect PIL

Flamingo Pharma UK Ltd notified the MHRA that some packs of Flucloxacillin Capsules BP 500 mg were supplied with the Patient Information Leaflet for Amoxicillin 500 mg, prompting a recall.