Cinacalcet Viatris [Cinacalcet Mylan]

Medicinal product

(Invented) name

Cinacalcet Viatris [Cinacalcet Mylan]

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

Viatris Limited, Airija

Date of authorisation

2015-11-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	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
64607	79091	1079091	lizdinė plokštelė	N28		Receptinis	EU/1/15/1054/008	Netiekiama	-	-	No	-	-
64608	79092	1079092	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/15/1054/009	Netiekiama	-	-	No	-	-
64609	79093	1079093	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/15/1054/010	Netiekiama	-	-	No	-	-
102874	88975	1088975	dalomoji lizdinė plokštelė	N84x1		Receptinis	EU/1/15/1054/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-19	Registruotas