Vancomycin Mylan

Medicinal product

(Invented) name

Vancomycin Mylan

Active substance (s)

Vankomicinas

Strength

500 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01XA01, Vancomycin

Marketing authorisation holder

Mylan S.A.S., Prancūzija

Date of authorisation

2013-02-08

Date of renewal

2018-11-08

Documents

3204_1_2 Vancomycin Mylan milt inf konc PCS PL 210128.docx

3204_1_2 Pakuotės lapelis 210128.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

SE/H/1158/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Kiekviename flakone yra	1 vnt.
Vankomicinas	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
52844	66780	1066780	flakonas	N1		Receptinis	LT/1/13/3204/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-27	Išregistruotas
2018-11-08	Perregistruotas
2013-02-08	Registruotas