SmPC- Dabigatran etexilate Accord 110 mg hard capsules: Change history
View Summary of Product Characteristics (SmPC- Dabigatran etexilate Accord 110 mg hard capsules)
Last updated on this site: 07 Aug 2024
To update SmPC sections 4.1, 4.2, 4.8, and 5.2 and section 3 of PIL in-line with the information of reference product (Pradaxa 75 mg/110 mg/ 150 mg hard capsules; EU Procedure number with outcome - EMEA/H/C/000829/II/0147/G; MAH: Boehringer Ingelheim International GmbH., Germany). In addition, editorial updates have been made in section 3, 4.2, 4.4, 4.8, 5.1, 5.2 and section 2 and 3 of PIL in line with information of reference product.
Last updated on this site: 07 Aug 2024
To update SmPC sections 4.1, 4.2, 4.8, and 5.2 and section 3 of PIL in-line with the information of reference product (Pradaxa 75 mg/110 mg/ 150 mg hard capsules; EU Procedure number with outcome - EMEA/H/C/000829/II/0147/G; MAH: Boehringer Ingelheim International GmbH., Germany). In addition, editorial updates have been made in section 3, 4.2, 4.4, 4.8, 5.1, 5.2 and section 2 and 3 of PIL in line with information of reference product.
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Changes: (Updated: 07 Aug 2024)
To update SmPC sections 4.1, 4.2, 4.8, and 5.2 and section 3 of PIL in-line with the information of reference product (Pradaxa 75 mg/110 mg/ 150 mg hard capsules; EU Procedure number with outcome - EMEA/H/C/000829/II/0147/G; MAH: Boehringer Ingelheim International GmbH., Germany). In addition, editorial updates have been made in section 3, 4.2, 4.4, 4.8, 5.1, 5.2 and section 2 and 3 of PIL in line with information of reference product.
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Changes: (Updated: 12 Jan 2024)
New product launch. Launch date: 08/01/2024.