![]() Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh.Stakeholder submission form – form to be used by stakeholders to submit data (if applicable).healthcare professionals, patient organisations, individual patients) (if applicable) List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g.List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s).Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion.List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified.Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable).Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure.Overview - lay-language summary of the stage of the procedure.Please note that some of the listed documents apply only to certain procedures. The European Commission issued a decision on this opinion on. The Committee also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions), 4.5 (interaction with other medicinal products and other forms of interaction), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use of machines) and 4.8 (undesirable effects). A table with dosing recommendations in this group was included.Ī contraindication that existed in some EU member states for use in patients with severe kidney impairment was removed. This section was also updated to reflect that outside its approved use in haemodialysis Lovenox is not recommended in patients with end stage kidney disease. The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and of the risk of bleeding. Patients at higher risk should be given 100 IU/kg (1 mg/kg) twice daily. ![]() ![]() to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.Ĥ.2 Posology and method of administrationįor the treatment of deep vein thrombosis and pulmonary embolism, the CHMP also clarified that the dose regimen of 150 IU/kg (1.5 mg/kg) given once daily should only be used only in uncomplicated patients who have a low risk of a further venous thromboembolism.to treat certain types of myocardial infarction (heart attack).to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart).to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg) or pulmonary embolism (clot in a blood vessel supplying the lung).to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they have reduced mobility due to illness.The CHMP agreed that Lovenox can be used for the following uses: The CHMP agreed that the strength of the active substance enoxaparin will now be expressed both in international units (IU) and in milligram (mg) throughout the product information. The CHMP, in light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
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