SmPC - Diltiazem hydrochloride Tablets 60mg: Change history
View Summary of Product Characteristics (SmPC - Diltiazem hydrochloride Tablets 60mg)
Last updated on this site: 02 May 2024
Description of update: To update section 4.9 of the SmPC and section 3 of PIL in line with the reference product Tildiem 60mg Modified release Tablets (PL 04425/0640; MAH: Aventis Pharma Limited) dated 4th December 2023.
SmPC Sections updated: 4.9 and 10.
Last updated on this site: 02 May 2024
Description of update: To update section 4.9 of the SmPC and section 3 of PIL in line with the reference product Tildiem 60mg Modified release Tablets (PL 04425/0640; MAH: Aventis Pharma Limited) dated 4th December 2023.
SmPC Sections updated: 4.9 and 10.
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Changes: (Updated: 02 May 2024)
Description of update: To update section 4.9 of the SmPC and section 3 of PIL in line with the reference product Tildiem 60mg Modified release Tablets (PL 04425/0640; MAH: Aventis Pharma Limited) dated 4th December 2023.
SmPC Sections updated: 4.9 and 10.
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Changes: (Updated: 16 Aug 2023)
Description of update: To update sections 4.4, 4.5 and 4.8 of the SmPC and sections 2, 3 and 4 of the PIL for Diltiazem Hydrochloride Tablets 60mg in line with the PRAC recommendation for diltiazem (lupus-like syndrome; drug-drug interaction with lomitapide; renal failure; acute kidney injury with overdose) - PSUSA/00001084/202205.
SmPC sections updated: 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload