Cinacalcet Sandoz

Medicinal product

(Invented) name

Cinacalcet Sandoz

Active substance (s)

Cinakalcetas

Strength

90 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/2470/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Cinakalcetas	90 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
60494	74772	1074772	lizdinė plokštelė	N14		Receptinis	LT/1/16/3864/007	Netiekiama	-	-	No	-	-
64708	79195	1079195	lizdinė plokštelė	N28		Receptinis	LT/1/16/3864/008	Netiekiama	-	-	No	-	-
64709	79196	1079196	lizdinė plokštelė	N84		Receptinis	LT/1/16/3864/009	Netiekiama	-	-	No	-	-

Stadijos

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