PIL - Ivabradine Accord 5mg, 7.5mg Film-coated Tablets (PLGB 20075/1284, 1285): Change history
View Patient Information Leaflet (PIL - Ivabradine Accord 5mg, 7.5mg Film-coated Tablets (PLGB 20075/1284, 1285))
Last updated on this site: 29 May 2025
1) To introduce a manufacturer of drug substance (Alembic Pharmaceuticals Ltd., India) supported by ASMF Applicant’s Part version: IVA-EU-AP-2017-00. Restricted Part version: IVA-EU-RP-2017-00 Linked to MFD-40420-2-05780-0001.
2) To change the storage conditions from 'This medicinal product does not require any special storage conditions' to 'Store below 30 °C' for the 5 mg strength of the finished product.
3) To delete Wessling Hungary Kft. Anonymus u. 6., Budapest, 1045, Hungary as batch release site for finished product.
PIL sections updated: 5 & 6.
Last updated on this site: 29 May 2025
1) To introduce a manufacturer of drug substance (Alembic Pharmaceuticals Ltd., India) supported by ASMF Applicant’s Part version: IVA-EU-AP-2017-00. Restricted Part version: IVA-EU-RP-2017-00 Linked to MFD-40420-2-05780-0001.
2) To change the storage conditions from 'This medicinal product does not require any special storage conditions' to 'Store below 30 °C' for the 5 mg strength of the finished product.
3) To delete Wessling Hungary Kft. Anonymus u. 6., Budapest, 1045, Hungary as batch release site for finished product.
PIL sections updated: 5 & 6.
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Changes: (Updated: 29 May 2025)
1) To introduce a manufacturer of drug substance (Alembic Pharmaceuticals Ltd., India) supported by ASMF Applicant’s Part version: IVA-EU-AP-2017-00. Restricted Part version: IVA-EU-RP-2017-00 Linked to MFD-40420-2-05780-0001.
2) To change the storage conditions from 'This medicinal product does not require any special storage conditions' to 'Store below 30 °C' for the 5 mg strength of the finished product.
3) To delete Wessling Hungary Kft. Anonymus u. 6., Budapest, 1045, Hungary as batch release site for finished product.
PIL sections updated: 5 & 6.
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Changes: (Updated: 02 Nov 2023)
Description of update: New product launch: Ivabradine Accord 5mg Film-coated Tablets. Launch date: 05/10/2023.
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Changes: (Updated: 27 Jan 2023)
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