SmPC - Prednisolone 25mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Prednisolone 25mg Tablets)
Last updated on this site: 12 Aug 2026
Description of update: To update sections 4.3, 4.4, 4.5, and 4.8 of the SmPC in line with the reference products Prednisolone Pfizer 2.5 mg, 5 mg, and 10 mg tablets (MAH: Pfizer AB, MA Number: 10059, 8822, 10060). The PIL has also been updated accordingly. In addition, the following updates have been included: Editorial and formatting updates to the PIL; Update to lactose excipient information in the PIL to align with EC Excipient Guidelines; QRD update to SmPC section 4.4 and the PIL.
Date of approval: 11/08/2026
SmPC sections updated: 4.3, 4.4, 4.5, 4.8 and 10
Last updated on this site: 12 Aug 2026
Description of update: To update sections 4.3, 4.4, 4.5, and 4.8 of the SmPC in line with the reference products Prednisolone Pfizer 2.5 mg, 5 mg, and 10 mg tablets (MAH: Pfizer AB, MA Number: 10059, 8822, 10060). The PIL has also been updated accordingly. In addition, the following updates have been included: Editorial and formatting updates to the PIL; Update to lactose excipient information in the PIL to align with EC Excipient Guidelines; QRD update to SmPC section 4.4 and the PIL.
Date of approval: 11/08/2026
SmPC sections updated: 4.3, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 12 Aug 2026)
Description of update: To update sections 4.3, 4.4, 4.5, and 4.8 of the SmPC in line with the reference products Prednisolone Pfizer 2.5 mg, 5 mg, and 10 mg tablets (MAH: Pfizer AB, MA Number: 10059, 8822, 10060). The PIL has also been updated accordingly. In addition, the following updates have been included: Editorial and formatting updates to the PIL; Update to lactose excipient information in the PIL to align with EC Excipient Guidelines; QRD update to SmPC section 4.4 and the PIL.
Date of approval: 11/08/2026
SmPC sections updated: 4.3, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 08 Jul 2025)
Renewal. Renewal approval 03/07/2025
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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.
SmPC Sections updated: 4.3, 4.4, 4.5, 4.6, 4.8, 4.9 and 10.
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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.
SmPC sections updated – 2 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload