Dabigatran Etexilate Leon Farma
Authorised
This medicine is authorised for use in the European Union
dabigatran etexilate
MedicineHumanAuthorised
Overview
Dabigatran etexilate Leon Farma is an anticoagulant medicine (a medicine that prevents blood clotting) 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 blood clot in a blood vessel supplying the lungs) in adults, and preventing these conditions from occurring again;
- treating blood clots in veins in children and preventing them from occurring again.
Dabigatran etexilate Leon Farma contains the active substance dabigatran etexilate.
Dabigatran etexilate Leon Farma is a ‘generic medicine’. This means that Dabigatran etexilate Leon Farma 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 Leon Farma is Pradaxa. For more information on generic medicines, see the question-and-answer document here.
Dabigatran etexilate Leon Farma can only be obtained with a prescription. The medicine is taken by mouth and is available in different forms depending on the patient’s age. The dose and duration of treatment depend on the condition the medicine is being used to treat, the patient’s age and kidney function, and other medicines the patient is taking. For children the dose also depends on their weight.
All patients at increased risk of bleeding should be monitored closely and the doctor may reduce the dose of Dabigatran etexilate Leon Farma. 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 Leon Farma 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 in patients whose kidney function is mildly to moderately reduced or who are over 75 years old.
For more information about using Dabigatran etexilate Leon Farma, see the package leaflet or contact your doctor or pharmacist.
The active substance in Dabigatran etexilate Leon Farma, 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 plays an important role in 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 Leon Farma.
As for every medicine, the company provided studies on the quality of Dabigatran etexilate Leon Farma. The company also carried out two studies 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 Leon Farma 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 Leon Farma, see the package leaflet.
The European Medicines Agency concluded that, in accordance with EU requirements, Dabigatran etexilate Leon Farma 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 Leon Farma 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 Leon Farma have been included in the summary of product characteristics and the package leaflet.
Any additional measures in place for Pradaxa, such as a patient card with key safety information, also apply to Dabigatran etexilate Leon Farma where appropriate.
As for all medicines, data on the use of Dabigatran etexilate Leon Farma are continuously monitored. Suspected side effects reported with Dabigatran etexilate Leon Farma are carefully evaluated and any necessary action taken to protect patients.
Dabigatran etexilate Leon Farma received a marketing authorisation valid throughout the EU on 19 February 2024.
Product information
Latest procedure affecting product information: N/0001
16/04/2024
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).
Product details
- Name of medicine
- Dabigatran Etexilate Leon Farma
- 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
Pharmacotherapeutic group
Antithrombotic agentsTherapeutic indication
Dabigatran etexilate Leon Farma 75 mg
Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age.
Dabigatran etexilate Leon Farma 110 mg
Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent
DVT and PE in adults.
Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than
18 years of age.
Dabigatran etexilate Leon Farma 150 mg
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults
Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age.
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