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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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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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Strength:
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30mg
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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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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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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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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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1703843
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CINACALCET MYLAN
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film-coated tablet
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30mg 28TK
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Prescription
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1703854
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CINACALCET MYLAN
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film-coated tablet
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30mg 30TK
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Prescription
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1703865
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CINACALCET MYLAN
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film-coated tablet
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30mg 100TK
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Prescription
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1820797
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CINACALCET MYLAN
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film-coated tablet
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30mg 84TK
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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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