Linezolid Accord

Medicinal product

(Invented) name

Linezolid Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2018-01-24

Date of renewal

2021-06-29

Documents

4185 Pakuotės lapelis inf 2023 01 20.docx

4185 Linezolid Accord inf PCS 2023 04 20.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/1195/001/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
98787	84891	1084891	maišelis	300 ml N10		Receptinis	LT/1/18/4185/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-29	Perregistruotas
2018-01-24	Registruotas