PIL - Paracetamol 10mg/ml solution for infusion: Change history

Description of update: To update the SmPC and relevant sections of the PIL in line with the reference product PERFALGAN 10 mg/ml, solution pour perfusion (Procedure number: FR/H/197/001; MAH: Bristol-Myers Squibb Pharmaceuticals limited).

PIL sections updated: 2, 3, 4, 6 and HCP section.

C.I.3.z. - IB - Safety, efficacy, pharmacovigilance changes. Human and veterinary medicinal products. Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of human medicinal products intended to implement the outcome of a procedure concerning PSUR or PASS, or the outcome of the assessment done by the competent authority under Articles 45 or 46 of Regulation 1901/2006. Other variation.:
PSUSA/00002311/202105 published on EC