SmPC- Clarithromycin 250mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Clarithromycin 250mg Film-coated Tablets)
Last updated on this site: 23 Dec 2024
To update section 5.1 of the SmPC in line with the EMA request to add new text regarding EUCAST breakpoint data.
Last updated on this site: 23 Dec 2024
To update section 5.1 of the SmPC in line with the EMA request to add new text regarding EUCAST breakpoint data.
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Changes: (Updated: 23 Dec 2024)
To update section 5.1 of the SmPC in line with the EMA request to add new text regarding EUCAST breakpoint data.
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Changes: (Updated: 11 Jul 2024)
To update sections 4.3, 4.4, 4.5, 4.8, 5.1 of the SmPC and the PIL in line with the reference product Klaricid 250mg Tablets (PL 46302/0016; MAH: Mylan Products Ltd.) dated 15th March 2024. Additionally, editorial updates have been made to the PIL.
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Changes: (Updated: 13 Mar 2024)
Description of update: Update to SPC sections 4.3, 4.4, and 4.5, and PIL in line with PSUSA/00000788/202304, for concomitant use of hydroxychloroquine, chloroquines, edoxaban, ivabradine and systemic or inhaled corticosteroids. Additional editorial and QRD updates have been made in the PIL.
SmPC Sections updated: 4.3, 4.4, 4.5 and 10.
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Changes: (Updated: 30 Jan 2024)
Description of update: To update sections 4.3, 4.4 and 4.5 of the SmPC to bring in line with the MHRA recommendation to include information regarding the contraindicated use of clarithromycin with ivabradine. Consequently, the PIL has been updated. Additional editorial updates have been made to the PIL.
SmPC Sections updated: 4.3, 4.4, 4.5 and 10.
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Changes: (Updated: 30 Jan 2024)
Description of update: To implement the outcome of PSUSA/00001519/202301: Update section 4.4 of the SmPC with a general warning regarding SCARs. Update of section 4.8 of the SmPC under SOC Skin and subcutaneous tissue disorders to add the adverse reaction AGEP with a frequency Not known. Consequential PIL updates.
SmPC Sections updated: 4.4, 4.8 and 10.
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Changes: (Updated: 07 Nov 2023)
Description of update:
To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 7 and 9 in line with the conclusions of the Commission on Human Medicines' Pharmacovigilance Expert Advisory Group on the cardiovascular safety of the concomitant use of hydroxychloroquine, chloroquine, and macrolide antibiotics. Additionally, minor corrections and inconsistencies have been corrected on both the PIL and SPC. Consequently, the PIL has been updated.
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 7, 9 and 10.
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Changes: (Updated: 28 Sep 2023)
Description of update: To update section 6.1 of SmPC to remove printing ink
components inadvertently mentioned for Clarithromycin 250mg/ 500mg film coated tablets.
SmPC sections updated: 6.1, 10.
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Changes: (Updated: 23 Aug 2023)
Website administration update only- no change to file
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Changes: (Updated: 21 Sep 2022)
Initial upload