Cinacalcet Accord

Medicinal product

(Invented) name

Cinacalcet Accord

Active substance (s)

Cinakalcetas

Strength

60 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H05BX01, Cinacalcet

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2016-01-04

Date of renewal

2021-06-29

Documents

3863 Cinacalcet Accord_perr2021-06-29.docx

3863 pakuotes lapelis 2021-06-29.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/0869/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Cinakalcetas	60 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
60499	74777	1074777	lizdinė plokštelė	N14		Receptinis	LT/1/16/3863/004	Netiekiama	-	-	No	-	-
64700	79187	1079187	lizdinė plokštelė	N28		Receptinis	LT/1/16/3863/005	Netiekiama	2024-11-12	2025-03-14	No	-	-
64701	79188	1079188	lizdinė plokštelė	N84		Receptinis	LT/1/16/3863/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-28	Išregistruotas
2021-06-29	Perregistruotas
2016-01-04	Registruotas