Parsabiv

Medicinal product

(Invented) name

Parsabiv

Active substance (s)

Etelkalcetidas

Strength

5 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	1 ml
Etelkalcetidas	5 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
67070	81613	1081613	flakonas	1 ml N1		Receptinis	EU/1/16/1142/005	Netiekiama	-	-	No	-	-
67071	81614	1081614	flakonas	1 ml N6		Receptinis	EU/1/16/1142/006	Netiekiama	-	-	No	-	-
67072	81615	1081615	flakonas	1 ml N12		Receptinis	EU/1/16/1142/007	Netiekiama	-	-	No	-	-
67073	81616	1081616	flakonas	1 ml N42		Receptinis	EU/1/16/1142/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-11	Registruotas