Kapruvia

Medicinal product

(Invented) name

Kapruvia

Active substance (s)

Difelikefalinas

Strength

50 µg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

V03AX04, difelikefalin

Marketing authorisation holder

Vifor Fresenius Medical Care Renal Pharma France, Prancūzija

Date of authorisation

2022-04-25

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1 ml
Difelikefalinas	50 µg

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
108532	94636	1094636	flakonas	1 ml N3		Receptinis	EU/1/22/1643/001	Netiekiama	-	-	No	-	-
108533	94637	1094637	flakonas	1 ml N12		Receptinis	EU/1/22/1643/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-25	Registruotas