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2019-12-03
Bayer submits application of rivaroxaban for venous thromboembolism in children to European Medicines Agency


  • This new treatment application is for children with venous thromboembolism (including cerebral venous sinus thrombosis) from birth to 17 years of age. It is used to treat venous thromboembolism and prevent recurrence.
  • The application is based on the results of a phase III clinical EINSTEIN-Jr. Study, which shows that rivaroxaban shows convincing effectiveness and safety in venous thromboembolism in children.
  • Newly developed a rivaroxaban oral liquid dosage form that does not require injection and routine monitoring and is suitable for pediatric use.
  • Once the application process is completed, the drug's patent period in Europe is extended by 6 months.

Bayer submitted to the European Medicines Agency the marketing authorization to expand rivaroxaban for children with venous thromboembolism (including cerebral venous sinus thrombosis) from birth to 17 years of age. This application is based on the positive results of the Phase III clinical EINSTEIN-Jr. Trial for the treatment of venous thromboembolism and prevention of relapse.

This is the largest study to date on venous thromboembolism in children, compared with standard treatments--heparin alone or bridging oral vitamin K antagonists (such as warfarin)-in children with rivaroxaban The incidence of thromboembolism is low. 临床试验中,儿童患者服用利伐沙班片剂或者新研制的口服混悬液。 In the EINSTEIN-Jr. Clinical trial, pediatric patients were treated with rivaroxaban tablets or newly developed oral suspensions.

Once the European Medicines Agency completes the review and updates the EU product information, Bayer will apply for a six-month patent extension, and Xarelto's patent period in Europe will be extended to April 2024.

Dr. Joerg Moeller, member of the executive committee and director of research and development at Bayer Prescription Drugs, said: "This application represents an important step forward in allowing us to provide new treatment options to children with venous thromboembolism who are at risk of relapse. These children currently have limited treatment options. We look forward to working with the European Medicines Agency to provide patients with this treatment as soon as possible. "

Medical advances have allowed children with life-threatening diseases to live longer and healthier lives, but hospital stays have been lengthened accordingly, leading to an increased risk of venous thromboembolism. There is too much uncertainty in the treatment of pediatric venous thromboembolism at present, because the treatment plan is usually inferred from clinical trials or observational data in adults. Moreover, there is currently a lack of treatments that require long-term subcutaneous or intravenous injections, as well as regular monitoring, and long-term injections are a particularly heavy burden for infants and children. Oral liquid preparations are treatments that do not require injection and do not require regular monitoring. They are essential for pediatric clinical practice.

Venous thromboembolism includes cerebral venous sinus thrombosis (thrombosis in the brain), pulmonary embolism (thrombosis to the lungs), and deep vein thrombosis that usually occurs in the deep veins of the legs. Venous thromboembolism is an increasingly common complication among hospitalized children, and venous catheters are the most common risk factor for venous thromboembolism. The currently recommended therapies include unfractionated heparin, low molecular weight heparin, fondaparinux sodium, and bridged / unbridged vitamin K antagonists. To date, no non-vitamin antagonist oral anticoagulants have been approved for this situation (venous thromboembolism in children).

About EINSTEIN-Jr. Research

磺达肝葵钠,桥接/不桥接维生素拮抗剂的标准疗法。 The EINSTEIN-Jr. Study is a randomized, open-label phase III clinical study that included 500 children who were diagnosed with acute venous thromboembolism from birth to 17 years of age and started receiving heparin treatment. Weight-adjusted rivaroxaban tablets or suspensions equivalent to a daily therapeutic dose of 20 mg, or standard heparin, low-molecular-weight heparin, or fondaparinux sodium bridged / unbridged vitamin antagonists. The duration of treatment is 3 months, but the course of treatment for patients with catheter-related venous thromboembolism under two years of age is 1 month. Review the imaging examination at the end of the treatment period. The results were interpreted with reference to a study of rivaroxaban in adults with venous thromboembolism.

Revenge of venous thromboembolism occurred in 4 (1.2%) of 335 children taking rivaroxaban, and recurrence in 5 (3.0%) of 165 children receiving standard therapy (HR = 0.40; 95% CI: 0.11 -1.41). Re-examination image examination showed that rivaroxaban was superior to standard therapy in improving thrombus load (P = 0.012). There were 10 cases of clinically relevant bleeding in the rivaroxaban group (3%, no major bleeding events), and 3 cases in the standard treatment group (1.9%, two major bleedings, and 1 non-major bleeding).

Rivaroxaban (Xarelto® )

Rivaroxaban is the world's most widely used non-vitamin K antagonist oral anticoagulant and has been marketed under the trade name Xarelto®. Compared to other new oral anticoagulants, rivaroxaban is approved globally to protect more patients with venous and arterial thromboembolism:

  • For nonvalvular atrial fibrillation (AF) adults with one or more risk factors to prevent stroke and systemic embolism
  • Treatment of pulmonary embolism (PE) in adults
  • Treatment of adult deep vein thrombosis (DVT)
  • Prevention of DVT and PE recurrence in adults
  • Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement
  • In adults with elevated cardiac biomarkers following acute coronary syndrome, a combination of aspirin alone or aspirin + clopidogrel / ticlopidine is used to prevent atherosclerotic thrombotic events.
  • It is used in adults with high ischemic risk of coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) to prevent atherosclerotic thrombotic events.

The indications approved by countries may vary, but from the perspective of all indications, rivaroxaban has been approved in more than 130 countries. Rivaroxaban was discovered by Bayer and is currently being developed in conjunction with Janssen R & D. 由拜耳公司在美国以外上市,由杨森制药公司在美国上市。 Xarelto® is marketed outside the United States by Bayer and in the United States by Janssen Pharmaceuticals.

Forward-looking statements

This press release includes forward-looking statements made by Bayer Group management based on current assumptions and forecasts. Various known and unknown risks, uncertainties and other factors may cause the company's actual future operating results, financial condition, development or performance to differ materially from the estimates made in the forward-looking statements. These factors include Bayer reports published on the official Bayer website at http://www.bayer.com/. The company assumes no responsibility to update these forward-looking statements or to make them consistent with future events or developments.

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Last updated: 2019-12-17
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