Stability of repackaged dabigatran etexilate capsules in dose administration aids

Author:

Robertson Sherryl G,Glass Beverley D

Publisher

BMJ

Subject

General Pharmacology, Toxicology and Pharmaceutics

Reference21 articles.

1. Dabigatran Etexilate

2. European Medicines Agency. CHMP assessment report for pradaxa EMEA/174363/2008. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/000829/WC500041062.pdf (accessed 2 Feb 2017).

3. Nagadeep J , Kamaraj P , Arthanareeswari M . Gradient RP-HPLC method for the determination of potential impurities in dabigatran etexilate in bulk drug and capsule formulations. Arab J Chem (Published Online First: 9 Oct 2015).doi:10.1016/j.arabjc.2015.09.006

4. US Food & Drug Administration. FDA drug safety communication: special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules. http://www.fda.gov/Drugs/DrugSafety/ucm248746.htm#sa (accessed 2 Feb 2017).

5. Australian Government Therapeutic Goods Administration. Dabigatran (Pradaxa) safety update: information for consumers. https://www.tga.gov.au/alert/dabigatran-pradaxa-safety-update-information-consumers (accessed 2 Feb 2017).

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