Parsabiv

Medicinal product

(Invented) name

Parsabiv

Active substance (s)

Etelkalcetidas

Strength

10 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H05BX04, Etelcalcetide

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2016-11-11

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	2 ml
Etelkalcetidas	10 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
67074	81617	1081617	flakonas	2 ml N1		Receptinis	EU/1/16/1142/009	Netiekiama	-	-	No	-	-
67075	81618	1081618	flakonas	2 ml N6		Receptinis	EU/1/16/1142/010	Netiekiama	-	-	No	-	-
67076	81619	1081619	flakonas	2 ml N12		Receptinis	EU/1/16/1142/011	Netiekiama	-	-	No	-	-
67077	81620	1081620	flakonas	2 ml N42		Receptinis	EU/1/16/1142/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-11	Registruotas