Dabigatran

Evidence Level: N/A

Predicted Indications: 0

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Table of Contents

1. Dabigatran
   1. Pharmacist Assessment Report
   2. Dabigatran: Known uses and market status in Australia
   3. Summary
   4. Quick overview
   5. Known uses recorded for this drug
      1. Approved (supported by a licence or label)
      2. Related to an approved indication (same disease category)
      3. Relations recorded in the knowledge graph (no approval found)
   6. Australia Market Information
   7. Safety Considerations
   8. Disclaimer

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Pharmacist Assessment Report

Dabigatran: Known uses and market status in Australia

Summary

The TxGNN model has no candidate with a score of 0.99 or higher for Dabigatran, so there is currently no new predicted indication. The drug’s recorded uses are listed below. They are the drug’s own recorded uses, not model candidates.

Quick overview

Item	Content
New predicted indications	None (no model candidate scored 0.99 or higher)
Known uses recorded for this drug	2
Evidence level	Not applicable
Australia Market Status	Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items	1 (valid: 1)

Known uses recorded for this drug

Approved (supported by a licence or label)

Indication	Source
arrhythmia	licence in another country
thrombosis	licence in another country

Related to an approved indication (same disease category)

Indication	Approved category
none	none

Relations recorded in the knowledge graph (no approval found)

Indication
none

Australia Market Information

Licence	Product	Dosage form	Status
13489Y	Pradaxa	Capsule 150 mg (as mesilate)	Valid

Safety Considerations

Safety data (warnings, contraindications and drug interactions) were not available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for safety information.

Relevant points from the literature:

• Bleeding risk is the main concern with any anticoagulant, particularly when combined with antiplatelet therapy.
• A possible increase in MI risk with dabigatran has been reported in some trial meta-analyses, although larger and real-world analyses have generally not confirmed it.
• In mechanical heart valves, dabigatran showed harm (the RE-ALIGN experience), so it should not be extrapolated to other thrombotic settings.

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Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.

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