Cinacalcet Viatris [Cinacalcet Mylan]

Medicinal product

(Invented) name

Cinacalcet Viatris [Cinacalcet Mylan]

Active substance (s)

Cinakalcetas

Strength

30 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	30 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
64600	79084	1079084	lizdinė plokštelė	N28		Receptinis	EU/1/15/1054/001	Netiekiama	-	-	No	-	-
64601	79085	1079085	buteliukas	N100		Receptinis	EU/1/15/1054/002	Netiekiama	-	-	No	-	-
64602	79086	1079086	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/15/1054/003	Netiekiama	-	-	No	-	-
64603	79087	1079087	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/15/1054/004	Netiekiama	-	-	No	-	-
102872	88973	1088973	dalomoji lizdinė plokštelė	N84x1		Receptinis	EU/1/15/1054/011	Netiekiama	-	-	No	-	-
105435	91535	1091535	buteliukas	N100		Receptinis	EU/1/15/1054/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-19	Registruotas