- Active Ingredients
Product Documentation
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View RMM (RMM- Patient Alert Card - Dabigatran)
Last updated on this site: 15 Jan 2024
New products launched. UK launch date: 08/01/2024.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintDabigatran etexilate Accord 110 mg hard capsules
- PL Number:
- PLGB 20075/1416
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
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POM
- Product Status:
- Active
Product Documentation
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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.
View Patient Information Leaflet (PIL- 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.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaint
For any further assistance, please get in touch.