SmPC - Prednisolone 2.5mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Prednisolone 2.5mg Tablets)
Last updated on this site: 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.
Last updated on this site: 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.
-
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.
-
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.
-
Changes: (Updated: 21 Sep 2022)
Initial upload