Parsabiv

Medicinal product

(Invented) name

Parsabiv

Active substance (s)

Etelkalcetidas

Strength

2,5 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	0.5 ml
Etelkalcetidas	2,5 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
67066	81609	1081609	flakonas	0,5 ml N1		Receptinis	EU/1/16/1142/001	Netiekiama	-	-	No	-	-
67067	81610	1081610	flakonas	0,5 ml N6		Receptinis	EU/1/16/1142/002	Netiekiama	-	-	No	-	-
67068	81611	1081611	flakonas	0,5 ml N12		Receptinis	EU/1/16/1142/003	Netiekiama	-	-	No	-	-
67069	81612	1081612	flakonas	0,5 ml N42		Receptinis	EU/1/16/1142/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-11	Registruotas