Dabigatran Etexilate Accord

dabigatran etexilate

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Dabigatran Etexilate Accord is an anticoagulant medicine used for:

preventing the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee;
preventing stroke (caused by a blood clot in the brain) and systemic embolism (a blood clot in another organ) in adults who have an abnormal heartbeat called ‘non-valvular atrial fibrillation’ and are considered to be at risk of stroke;
treating deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (PE, a clot in a blood vessel supplying the lungs) in adults, and preventing these conditions from occurring again.
treating blood clots in veins and preventing them from occurring again in children.

Dabigatran Etexilate Accord is a ‘generic medicine’. This means that Dabigatran Etexilate Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Dabigatran Etexilate Accord is Pradaxa. For more information on generic medicines, see the question-and-answer document here.

Dabigatran Etexilate Accord contains the active substance dabigatran etexilate.

: Dabigatran Etexilate Accord is available as capsules for adults and children above 8 years of age. The medicine is to be taken by the mouth once or twice a day, and the duration of treatment and the dose depend on the condition the medicine is being used to treat or prevent and other medicines the patient is taking.
In all patients, kidney function should be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected. When Dabigatran Etexilate Accord is used long term in patients with non-valvular atrial fibrillation, or when it is used in patients with DVT or PE, kidney function should be assessed at least once a year if their kidney function is mildly to moderately reduced or if they are over 75 years old.
The medicine can only be obtained with a prescription.
For more information about using Dabigatran Etexilate Accord, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Dabigatran Etexilate Accord, dabigatran etexilate, is a ‘prodrug’ of dabigatran. This means that it is converted into dabigatran in the body. Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating (clotting). It blocks a substance called thrombin, which is central to the process of blood clotting.

: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Pradaxa, and do not need to be repeated for Dabigatran Etexilate Accord.
As for every medicine, the company provided studies on the quality of Dabigatran Etexilate Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

: Because Dabigatran Etexilate Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
For the list of side effects and restrictions with Dabigatran Etexilate Accord, see the package leaflet.

: The European Medicines Agency concluded that, in accordance with EU requirements, Dabigatran Etexilate Accord has been shown to have comparable quality and to be bioequivalent to Pradaxa. Therefore, the Agency’s view was that, as for Pradaxa, the benefits of Dabigatran Etexilate Accord outweigh the identified risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dabigatran Etexilate Accord have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Dabigatran Etexilate Accord are continuously monitored. Suspected side effects reported with Dabigatran Etexilate Accord are carefully evaluated and any necessary action taken to protect patients.

: Dabigatran Etexilate Accord received a marketing authorisation valid throughout the EU on 26 May 2023.

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Dabigatran Etexilate Accord : EPAR - Medicine Overview (PDF/110.69 KB)

First published: 31/05/2023
EMA/162570/2023
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Dabigatran Etexilate Accord : EPAR - Risk management plan summary (PDF/116.71 KB)

First published: 31/05/2023

This EPAR was last updated on 31/05/2023

Authorisation details

Product details
Name	Dabigatran Etexilate Accord
Agency product number	EMEA/H/C/005639
Active substance	Dabigatran etexilate mesilate
International non-proprietary name (INN) or common name	dabigatran etexilate
Therapeutic area (MeSH)	Venous Thromboembolism Arthroplasty, Replacement
Anatomical therapeutic chemical (ATC) code	B01AE07
Generic	This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder	Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union	26/05/2023
Contact address	Accord Healthcare S.L.U. Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona SPAIN

Product information

Dabigatran Etexilate Accord - EMEA/H/C/005639 -

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Dabigatran Etexilate Accord : EPAR - Product Information (PDF/1.98 MB)

First published: 31/05/2023
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  (PDF/2.51 MB)
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Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Dabigatran Etexilate Accord : EPAR - All authorised presentations (PDF/119.47 KB)

First published: 31/05/2023
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  (PDF/205.53 KB)
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- Slovak
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- Spanish
  (PDF/125.93 KB)
- Swedish
  (PDF/122.38 KB)

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Prevention of venous thromboembolic events

Assessment history

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023

31/03/2023

Dabigatran Etexilate Accord

Table of contents

Overview