Dabigatran Etexilate Leon Farma

Dabigatran etexilate Leon Farma received a marketing authorisation valid throughout the EU on 19 February 2024.

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.

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.

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.

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.

Dabigatran etexilate Teva 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 Teva.

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 Teva 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 Teva, see the package leaflet or contact your doctor or pharmacist.

The active substance in Dabigatran etexilate Teva, 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 Teva.

As for every medicine, the company provided studies on the quality of Dabigatran etexilate Teva. 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 Teva 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 Teva, see the package leaflet.

The European Medicines Agency concluded that, in accordance with EU requirements, Dabigatran etexilate Teva 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 Teva outweigh the identified risks and it can be authorised for use in the EU.

Dabigatran etexilate Leon Farma received a marketing authorisation valid throughout the EU on 19 February 2024.

The name of the medicine was changed to Dabigatran etexilate Teva on 19 August 2024.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dabigatran etexilate Teva 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 Teva where appropriate.

As for all medicines, data on the use of Dabigatran etexilate Teva are continuously monitored. Suspected side effects reported with Dabigatran etexilate Teva are carefully evaluated and any necessary action taken to protect patients.