Cinacalcet Accordpharma

Medicinal product

(Invented) name

Cinacalcet Accordpharma

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2020-04-03

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
103769	89871	1089871	lizdinė plokštelė	N14		Receptinis	EU/1/20/1429/009	Netiekiama	-	-	No	-	-
103770	89872	1089872	lizdinė plokštelė	N28		Receptinis	EU/1/20/1429/010	Netiekiama	2025-01-01	2025-12-31	Yes	2025-01-01	2025-12-31
103771	89873	1089873	lizdinė plokštelė	N84		Receptinis	EU/1/20/1429/011	Netiekiama	-	-	No	-	-
103772	89874	1089874	buteliukas	N30		Receptinis	EU/1/20/1429/012	Netiekiama	-	-	No	-	-
104971	91073	1091073	dalomoji lizdinė plokštelė	N14×1		Receptinis	EU/1/20/1429/019	Netiekiama	-	-	No	-	-
104972	91074	1091074	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/20/1429/020	Netiekiama	-	-	No	-	-
104973	91075	1091075	dalomoji lizdinė plokštelė	N84×1		Receptinis	EU/1/20/1429/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-03	Registruotas