Cinacalcet Viatris [Cinacalcet Mylan]

Medicinal product

(Invented) name

Cinacalcet Viatris [Cinacalcet Mylan]

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

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	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
64604	79088	1079088	lizdinė plokštelė	N28		Receptinis	EU/1/15/1054/005	Netiekiama	-	-	No	-	-
64605	79089	1079089	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/15/1054/006	Netiekiama	-	-	No	-	-
64606	79090	1079090	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/15/1054/007	Netiekiama	-	-	No	-	-
102873	88974	1088974	dalomoji lizdinė plokštelė	N84x1		Receptinis	EU/1/15/1054/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-19	Registruotas