Colistimethate sodium Accord

Medicinal product

(Invented) name

Active substance (s)

Kolistimetato natrio druska

Strength

1000000 TV

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną, leisti į smegenų skilvelius, leisti į povoratinklinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J01XB01, Colistin

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2024-05-21

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5448/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Kolistimetato natrio druska	1000000 TV

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
113694	99813	1099813	flakonas	N1		Receptinis	LT/1/24/5445/001	Netiekiama	-	-	No	-	-
113695	99814	1099814	flakonas	N10		Receptinis	LT/1/24/5445/002	Netiekiama	-	2025-09-30	No	-	-

Stadijos

Data	Stadija
2024-05-21	Registruotas