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SmPC- Paracetamol 500mg Tablets: Change history

  • To update sections 4.4, 4.5, 4.8 of the SmPC and the PIL in line with the PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis.

    • Changes: (Updated: 08 May 2025)

      To update sections 4.4, 4.5, 4.8 of the SmPC and the PIL in line with the PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis.

    • Changes: (Updated: 23 Mar 2023)

      Website administration update

    • Changes: (Updated: 14 Mar 2023)

      New product (launched 08/03/2023)

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