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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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ABATIXENT
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Active substances:
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ATC code:
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B01AF02
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Dosage form:
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film-coated tablet
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Strength:
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2,5mg
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Legal status for supply*:
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Subject to medicinal prescription
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Summary of product characteristics (SPC):
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 (last updated September 15, 2021)
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Package information leaflet (PIL):
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EST (last updated November 16, 2021)
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Labelling:
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(last updated September 15, 2021)
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Indication:
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Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or 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 ischaemic attack (TIA); age >= 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class >= II).
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
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Safety features:
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Yes
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Marketing authorization holder:
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Sandoz Pharmaceuticals d.d.
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Marketing authorization number:
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1037621
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Marketing authorization issued on:
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September 15, 2021
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Marketing authorization expires on:
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September 15, 2026
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Marketing authorization procedure type:
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Decentralised
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Assessment report:
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1804722
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ABATIXENT
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film-coated tablet
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2,5mg 10TK
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Prescription
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1804733
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ABATIXENT
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film-coated tablet
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2,5mg 12TK
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Prescription
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1804744
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ABATIXENT
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film-coated tablet
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2,5mg 14TK
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Prescription
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1804755
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ABATIXENT
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film-coated tablet
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2,5mg 20TK
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Prescription
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1804766
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ABATIXENT
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film-coated tablet
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2,5mg 28TK
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Prescription
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1804777
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ABATIXENT
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film-coated tablet
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2,5mg 30TK
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Prescription
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1804788
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ABATIXENT
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film-coated tablet
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2,5mg 56TK
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Prescription
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1804799
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ABATIXENT
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film-coated tablet
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2,5mg 60TK
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Prescription
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1804801
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ABATIXENT
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film-coated tablet
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2,5mg 100TK
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Prescription
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1804812
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ABATIXENT
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film-coated tablet
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2,5mg 168TK
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Prescription
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1804823
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ABATIXENT
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film-coated tablet
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2,5mg 180TK
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Prescription
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1804834
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ABATIXENT
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film-coated tablet
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2,5mg 200TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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