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Dabigatran (Pradaxa) and risk of bleeding: Information for health professionals - safety alert

Official notice

25 May 2026

Last checked

25 May 2026

Risk not stated by sourceTGA

An official TGA notice concerns Dabigatran (Pradaxa) and risk of bleeding: Information for health professionals - safety alert. An official TGA notice concerns Dabigatran (Pradaxa) and risk of bleeding: Information for health professionals. The notice reports a potential product safety risk. Follow the official notice for consumer instructions. Published 2026-05-25. Published 2026-05-25.

What to do now

The source does not provide specific consumer instructions. Follow the official TGA notice for next steps.

Recall number

283797

Official notice

2026-05-25

The hazard

An official TGA notice concerns Dabigatran (Pradaxa) and risk of bleeding: Information for health professionals. The notice reports a potential product safety risk. Follow the official notice for consumer instructions. Published 2026-05-25.

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Affected products

Product 1

Dabigatran (Pradaxa) and risk of bleeding: Information for health professionals

Risk / hazard

An official TGA notice concerns Dabigatran (Pradaxa) and risk of bleeding: Information for health professionals. The notice reports a potential product safety risk. Follow the official notice for consumer instructions. Published 2026-05-25.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Contact: Therapeutic Goods Administration (TGA).

Source & status

Source

Tier

beta

Category

HEALTH

App estimate

unspecified

Recall details

Recall number

283797

Event id

283797

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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