FOI release

FOI Request - PL 05448/0023 – Paracetamol 10mg/ml solution for infusion

Case reference FOI2025/01174

Received 10 November 2025

Published 12 December 2025

Request

Please can you provide us with the latest Clinical Overview, Non-clinical overview, assessment reports and Risk Management Plan for PL 05448/0023 – Paracetamol 10mg/ml solution for infusion by Instituto Biochimico Italiano Giovanni Lorenzini SPA

Response

See attached

Documents

• clinical-overview redacted.pdf (1.2 MB)
• FOI2025_01174 (redacted).pdf (1.0 MB)
• nonclinical-overview redacted.pdf (502.2 KB)
• risk-management-system redacted.pdf (512.6 KB)

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