Linezolid Medana

Medicinal product

(Invented) name

Linezolid Medana

Active substance (s)

Linezolidas

Strength

2 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01XX08, Linezolid

Marketing authorisation holder

Medana Pharma SA, Lenkija

Date of authorisation

2015-08-06

Date of renewal

Documents

3782_1_2 Linezolid Medana inf II PL 171020.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2781/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Linezolidas	2 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
60912	75219	1075219	maišelis	300 ml N1		Receptinis	LT/1/15/3782/001	Netiekiama	-	-	No	-	-
63388	77826	1077826	maišelis	300 ml N10		Receptinis	LT/1/15/3782/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-01-10	Išregistruotas
2015-08-06	Registruotas