SmPC - Paracetamol Accord 10mg/ml solution for infusion: Change history
View Summary of Product Characteristics (SmPC - Paracetamol Accord 10mg/ml solution for infusion)
Last updated on this site: 13 May 2024
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).
SmPC Sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3 and 10.
Last updated on this site: 13 May 2024
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).
SmPC Sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3 and 10.
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Changes: (Updated: 13 May 2024)
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).
SmPC Sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3 and 10.
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Changes: (Updated: 12 Sep 2023)
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 -
Changes: (Updated: 21 Sep 2022)
Initial upload