|
Boehringer Ingelheim recently announced，The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review opinion，Recommended for approval of the oral anticoagulant Pradaxa (dabigatran etexilate)，Dabigatran ester，For pediatric patients from birth to under 18 years of age，Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE。
If the proposed indication is approved by the European Commission (EC), pediatric patients and healthcare professionals in Europe will be able to treat this oral anticoagulant, the risk benefit of which has been fully evaluated by the regulatory authorities。
Currently, there are no approved treatments to treat or prevent VTE in children。The current standard of care (SOC) is associated with a range of limitations, including the need for frequent monitoring of anticoagulant levels or the burden of daily injections。
This regimen can be taken orally, does not require routine laboratory monitoring or dose-titration, and formulations for specific age groups, including younger patients, are available。
(Information source: BioValley)(Source: China News Service) | 
