Linezolid Norameda

Medicinal product

(Invented) name

Linezolid Norameda

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

UAB Norameda, Lietuva

Date of authorisation

2018-04-12

Date of renewal

2022-08-01

Documents

4211_Linezolid Norameda_perr2022-08-01.docx

4211_pakuotes lapelis_2022-08-01.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0242/001/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
99265	85371	1085371	maišelis	300 ml N5		Receptinis	LT/1/18/4211/001	Netiekiama	-	-	No	-	-
99266	85372	1085372	maišelis	300 ml N30		Receptinis	LT/1/18/4211/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-28	Išregistruotas
2022-08-01	Perregistruotas
2018-04-12	Registruotas