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CINACALCET ACCORD
General data
Product class:
Medicinal product with marketing authorization
Medicinal product class:
Human medicine
Name of medicinal product:
CINACALCET ACCORD
Active substances:
Cinacalcet
Estonian
,
English
,
Latin
ATC code:
H05BX01
Dosage form:
film-coated tablet
Strength:
30mg
Legal status for supply*:
Subject to medicinal prescription
Summary of product characteristics (SPC):
(last updated March 3, 2021)
Package information leaflet (PIL):
EST
(last updated May 21, 2020)
Labelling:
(last updated March 20, 2019)
Indication:
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 3years 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).
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.
Safety features:
Yes
Marketing authorization
Marketing authorization holder:
Accord Healthcare B.V.
Marketing authorization number:
892315
Marketing authorization issued on:
November 11, 2015
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Assessment report:
(last updated November 18, 2015)
Packages approved by this marketing authorization
Package code
Name of medicinal product
Dosage form
Package
Legal status
Reimbursements
Reference price
Last imported
PƤritolumaa
Additional information
1667527
CINACALCET ACCORD
film-coated tablet
30mg 14TK
Prescription
1667538
CINACALCET ACCORD
film-coated tablet
30mg 28TK
Prescription
100% 50%
85,40
11.03.2022
1667549
CINACALCET ACCORD
film-coated tablet
30mg 84TK
Prescription
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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