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PIL - Prednisolone 2.5mg, 5mg, 10mg, 20mg, 25mg, 30mg Tablets: Change history

  • Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.8, 4.9 of the SmPC in line with the reference product Prednisolone Pfizer 2.5, 5, 10mg tablets (MA numbers: 10059, 8822, 10060; MAH: PfizerAB). Consequently, the PIL has been updated. Additionally, minor editorial changes have also been made to the SmPC and PIL.

    PIL sections updated: 2, 3, 4, 5 and 6.

    • Changes: (Updated: 29 Jan 2024)

      Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.8, 4.9 of the SmPC in line with the reference product Prednisolone Pfizer 2.5, 5, 10mg tablets (MA numbers: 10059, 8822, 10060; MAH: PfizerAB). Consequently, the PIL has been updated. Additionally, minor editorial changes have also been made to the SmPC and PIL.

      PIL sections updated: 2, 3, 4, 5 and 6.

    • Changes: (Updated: 24 Mar 2023)

      Variation Description: To update section 2 of the SmPC in line with the MHRA request to add lactose as an excipient of known effect. The PIL has been updated to correct a typographical error in the wording about use in children and adolescents, as well as other minor editorial updates.

      PIL sections updated – 2, 5 and 6.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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