Linezolid Krka

Medicinal product

(Invented) name

Linezolid Krka

Active substance (s)

Linezolidas

Strength

600 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

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

2015-11-18

Date of renewal

2020-03-27

Documents

3838 Linezolid Krka tab RPP 2025 05 30.docx

3838 Pakuotės lapelis 2025 05 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0620/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Linezolidas	600 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
61426	75745	1075745	lizdinė plokštelė	N10		Receptinis	LT/1/15/3838/001	Tiekiama	-	-	No	-	-
64253	78713	1078713	lizdinė plokštelė	N20		Receptinis	LT/1/15/3838/002	Netiekiama	-	-	No	-	-
64254	78714	1078714	lizdinė plokštelė	N30		Receptinis	LT/1/15/3838/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-03-27	Perregistruotas
2015-11-18	Registruotas