Dexmedetomidine Kabi

Medicinal product

(Invented) name

Dexmedetomidine Kabi

Active substance (s)

Deksmedetomidinas

Strength

100 µg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05CM18, Dexmedetomidine

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2021-10-22

Date of renewal

Documents

4838 Dexmedetomidine Kabi PCS PL 2022 10 19.docx

4838 Pakuotės lapelis 2022 10 19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/6834/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Deksmedetomidinas	100 µg

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
107452	93557	1093557	flakonas	2 ml N10		Receptinis	LT/1/21/4838/001	Netiekiama	-	-	No	-	-	Download
107453	93558	1093558	flakonas	2 ml N25		Receptinis	LT/1/21/4838/002	Netiekiama	-	-	No	-	-
107454	93559	1093559	flakonas	4 ml N1		Receptinis	LT/1/21/4838/003	Netiekiama	-	-	No	-	-
107455	93560	1093560	flakonas	4 ml N4		Receptinis	LT/1/21/4838/004	Netiekiama	-	-	No	-	-
107456	93561	1093561	flakonas	4 ml N10		Receptinis	LT/1/21/4838/005	Netiekiama	-	-	No	-	-
107457	93562	1093562	flakonas	10 ml N4		Receptinis	LT/1/21/4838/006	Netiekiama	-	-	No	-	-
107458	93563	1093563	flakonas	10 ml N10		Receptinis	LT/1/21/4838/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-22	Registruotas