Vancomycin Kabi

Medicinal product

(Invented) name

Vancomycin Kabi

Active substance (s)

Vankomicino hidrochloridas

Strength

500 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną, vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A07AA09, Vancomycin

J01XA01, Vancomycin

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2011-06-06

Date of renewal

2015-11-26

Documents

2505 Pakuotės lapelis 500mg, 1000mg 2021 01 18.docx

2505 Vancomycin Kabi 500mg PCS PL 2021 01 18.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2179/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Vankomicino hidrochloridas	500 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
35237	37573	1037573	flakonas	N1		Receptinis	LT/1/11/2505/001	Netiekiama	-	-	No	-	-
55833	69886	1069886	flakonas	N10		Receptinis	LT/1/11/2505/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-26	Perregistruotas
2011-06-06	Registruotas