SmPC - Ivabradine Accord 5mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Ivabradine Accord 5mg Film-coated Tablets)
Last updated on this site: 28 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.
SmPC sections updated: 2. 5.2, 6.4 & 10.
Last updated on this site: 28 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.
SmPC sections updated: 2. 5.2, 6.4 & 10.
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Changes: (Updated: 28 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.
SmPC sections updated: 2. 5.2, 6.4 & 10.
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Changes: (Updated: 02 Nov 2023)
Description of update: New product launch. Launch date: 05/10/2023.
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Changes: (Updated: 27 Jan 2023)
Website administration update.