Cinacalcet Sandoz

Medicinal product

(Invented) name

Cinacalcet Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2016-01-04

Date of renewal

Documents

3864_1_9 Pakuotės lapelis 190522.docx

3864_1_9 Cinacalcet Sandoz PL 190522.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2470/002/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
60493	74771	1074771	lizdinė plokštelė	N14		Receptinis	LT/1/16/3864/004	Netiekiama	-	-	No	-	-
64706	79193	1079193	lizdinė plokštelė	N28		Receptinis	LT/1/16/3864/005	Netiekiama	-	-	No	-	-
64707	79194	1079194	lizdinė plokštelė	N84		Receptinis	LT/1/16/3864/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-08-05	Išregistruotas
2016-01-04	Registruotas