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Intended for UK patients and members of the public

Dabigatran etexilate Accord 110 mg hard capsules
Active Ingredients

Product Documentation

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

Dabigatran etexilate Accord 110 mg hard capsules

PL Number:
PLGB 20075/1416
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

  • 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

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