CINACALCET ACCORD
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1667538
Name of medicinal product:
CINACALCET ACCORD
Active substances:
Cinacalcet
Estonian
,
English
,
Latin
ATC code:
H05BX01
Dosage form:
film-coated tablet
Route of administration:
oral use
Strengh:
30mg
Amount in package:
28TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
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
Summary of product characteristics (SPC):
(last updated 03 March 2021)
Package information leaflet (PIL):
EST
(last updated 21 May 2020)
Labelling:
(last updated 20 March 2019)
Last imported to Estonia:
11 March 2022
Marketing authorization
Marketing authorization holder:
Accord Healthcare B.V.
Marketing authorization number:
892315
Marketing authorization issued on:
11 November 2015
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Reimbursements
Percent
Valid from
Valid until
Valid
Diagnosis
Doctor's speciality
Primary
Age
Other
100
01/07/2023
01/10/2023
Yes
N18-N18
Nefroloog, Pediaater
No
hemo- või peritoneaaldialüüsil olevatele patsientidele, kelle ravi vitamiin D analoogidega on ebaõnnestunud (seerumi parathormooni taseme eesmärkväärtust <=300 pg/ml ei saavutata) või kellele on vitamiin D analoogid vastunäidustatud
50
01/07/2023
01/10/2023
Yes
No
100
01/07/2023
01/10/2023
Yes
No
until 4 years
100
01/07/2023
01/10/2023
Yes
N18-N18
Pediaater, Nefroloog
No
until 4 years
hemo- või peritoneaaldialüüsil olevatele patsientidele, kelle ravi vitamiin D analoogidega on ebaõnnestunud (seerumi parathormooni taseme eesmärkväärtust <=300 pg/ml ei saavutata) või kellele on vitamiin D analoogid vastunäidustatud
Prices
Reference price:
85.40 EUR
Under reference price:
No
Reference price of daily dose:
6.10 EUR
Entry/Changing date: 03 March 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription