Linezolid Kalceks

Medicinal product

(Invented) name

Linezolid Kalceks

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

AS Kalceks, Latvija

Date of authorisation

2025-04-24

Date of renewal

Documents

5767_Linezolid Kalceks.docx

5767_pakuotes lapelis_2025-04-24.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2285/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml infuzinio 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
117317	103417	1103417	maišelis	N1		Receptinis	LT/1/25/5767/001	Netiekiama	-	-	No	-	-
117318	103418	1103418	maišelis	N10		Receptinis	LT/1/25/5767/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-24	Registruotas