Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1433304
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Name of medicinal product:
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AFINITOR
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Active substances:
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ATC code:
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L01EG02
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Dosage form:
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tablet
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Route of administration:
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oral use
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Strengh:
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5mg
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Amount in package:
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90TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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|
Additional information:
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Indication:
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Hormone receptor-positive advanced breast cancer
Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Neuroendocrine tumours of pancreatic origin
Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
Neuroendocrine tumours of gastrointestinal or lung origin
Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1).
Renal cell carcinoma
Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
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Safety features:
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Yes
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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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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Novartis Europharm Limited
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Marketing authorization number:
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EU/1/09/538
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Marketing authorization issued on:
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August 3, 2009
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Entry/Changing date:
April 4, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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