SmPC - Hydralazine 25mg Tablets BP: Change history
View Summary of Product Characteristics (SmPC - Hydralazine 25mg Tablets BP)
Last updated on this site: 20 May 2024
Description of update:
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC and PIL in line with reference product, Apresoline 25 mg Tablets, PL 20072/0026, MAH: Amdipharm UK Limited, SPC updated 13/03/2024. In addition, editorial update has been made to section 4.2 of the SmPC to amend the dosing for the 25mg strength which was incorrectly updated with the 50mg fragment during variation approval for PL 00142/0499 - 0048. Moreover, section 2 of PIL in line with the excipient guideline (SANTE-2017-11668) dated 22 November 2019 and section 4 of PIL has been updated to remove an ADR not listed in the SmPC or reference PI (enlargement of the spleen).
SmPC Sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10.
Last updated on this site: 20 May 2024
Description of update:
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC and PIL in line with reference product, Apresoline 25 mg Tablets, PL 20072/0026, MAH: Amdipharm UK Limited, SPC updated 13/03/2024. In addition, editorial update has been made to section 4.2 of the SmPC to amend the dosing for the 25mg strength which was incorrectly updated with the 50mg fragment during variation approval for PL 00142/0499 - 0048. Moreover, section 2 of PIL in line with the excipient guideline (SANTE-2017-11668) dated 22 November 2019 and section 4 of PIL has been updated to remove an ADR not listed in the SmPC or reference PI (enlargement of the spleen).
SmPC Sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10.
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Changes: (Updated: 20 May 2024)
Description of update:
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC and PIL in line with reference product, Apresoline 25 mg Tablets, PL 20072/0026, MAH: Amdipharm UK Limited, SPC updated 13/03/2024. In addition, editorial update has been made to section 4.2 of the SmPC to amend the dosing for the 25mg strength which was incorrectly updated with the 50mg fragment during variation approval for PL 00142/0499 - 0048. Moreover, section 2 of PIL in line with the excipient guideline (SANTE-2017-11668) dated 22 November 2019 and section 4 of PIL has been updated to remove an ADR not listed in the SmPC or reference PI (enlargement of the spleen).
SmPC Sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload