Dabigatran Etexilate Accord (dabigatran etexilate)
Generic
- Region
- 🇪🇺 EU
- Active substance
- dabigatran etexilate
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Venous Thromboembolism; Arthroplasty, Replacement
- CHMP opinion
- Thu 30 Mar 2023
- EU approval
- Fri 26 May 2023
- Designations
- Generic
- Application
- EMEA/H/C/005639
- ATC
- B01AE07
- Official record
- www.ema.europa.eu
Indication
Prevention of venous thromboembolic events
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Pradaxa Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma) Authorised · Teva GmbH
- 🇪🇺 Dabigatran etexilate Teva Application withdrawn · Teva GmbH
Follow Dabigatran Etexilate Accord
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.