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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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1703843
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Name of medicinal product:
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CINACALCET MYLAN
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Active substances:
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ATC code:
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H05BX01
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Dosage form:
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film-coated tablet
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Route of administration:
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oral use
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Strengh:
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30mg
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Amount in package:
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28TK
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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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Secondary hyperparathyroidism
Adults
Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease
(ESRD) on maintenance dialysis therapy.
Paediatric population
Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage
renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately
controlled with standard of care therapy (see section 4.4).
Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or
vitamin D sterols, as appropriate (see section 5.1).
Parathyroid carcinoma and primary hyperparathyroidism in adults
Reduction of hypercalcaemia in adult patients with:
- parathyroid carcinoma.
- primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium
levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not
clinically appropriate or is contraindicated.
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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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Mylan Pharmaceuticals Limited
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Marketing authorization number:
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EU/1/15/1054
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Marketing authorization issued on:
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November 23, 2015
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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:
October 26, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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