Linezolid Krka

Medicinal product

(Invented) name

Linezolid Krka

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2016-12-08

Date of renewal

2021-09-22

Documents

4014 Linezolid Krka inf RPP 2025 05 30.docx

4014 Pakuotės lapelis 2025 05 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0639/001/DC

Marketing authorisation procedure

Decentralizuota 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
63288	77705	1077705	maišelis	300 ml N1		Receptinis	LT/1/16/4014/001	Netiekiama	-	-	No	-	-
67244	81790	1081790	maišelis	300 ml N10		Receptinis	LT/1/16/4014/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-09-22	Perregistruotas
2016-12-08	Registruotas