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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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ABECMA
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Active substances:
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ATC code:
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L01XL07
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Dosage form:
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dispersion for infusion
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Strength:
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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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Package information leaflet (PIL):
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EST
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Labelling:
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Indication:
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Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma
who have received at least three prior therapies, including an immunomodulatory agent, a proteasome
inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
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Safety features:
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Yes
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 :
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This medicinal product is subject to additional monitoring. This will allow quick identification of
new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
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Marketing authorization holder:
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Bristol-Myers Squibb Pharma EEIG
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Marketing authorization number:
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EU/1/21/1539
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Marketing authorization issued on:
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August 18, 2021
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Marketing authorization expires on:
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August 19, 2024
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Marketing authorization procedure type:
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Centralised
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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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1860140
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ABECMA
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dispersion for infusion
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1TK
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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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