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Guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation

We have adopted this International Scientific Guideline - EMA/CHMP/341363/2014.

Last updated

About this guideline

Overseas effective date: 26 December 2014

Categories: Clinical efficacy and safety | Cardiovascular system | Arrythmias

TGA annotations:

Section 8.1:

The collection of plasma/serum samples for the measurement of drug level and/or anticoagulant effect at the time of outcome events (e.g. bleeding, SEE, stroke) is recommended.

The dossier must include specific discussion regarding non-specific and specific reversal agents and/or antidotes.

The dossier must include a discussion regarding the utility of routine and/or ad hoc laboratory monitoring (drug levels or measures of anticoagulant effect) for the safe and efficacious use of the product. The availability of the laboratory tests mentioned should be included in the discussion.

Section 6.2 (3):

Where a study includes outcomes from 'VKA-naïve patients' meeting the definition provided in this guidance, a sensitivity analysis must be conducted with results from patients with no previous VKA exposure.

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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For more information see International scientific guidelines adopted in Australia.

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