Dexmedetomidine Kalceks

Medicinal product

(Invented) name

Dexmedetomidine Kalceks

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

AS Kalceks, Latvija

Date of authorisation

2019-03-04

Date of renewal

2024-11-11

Documents

4334 Pakuotės lapelis 2025 06 13.docx

4334 Dexmedetomidine Kalceks PL 2025 06 13.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2891/001/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
101002	87113	1087113	ampulė	2 ml N5		Receptinis	LT/1/19/4334/001	Netiekiama	-	-	No	-	-
101003	87114	1087114	ampulė	2 ml N25		Receptinis	LT/1/19/4334/002	Tiekiama	-	-	No	-	-
104502	90604	1090604	flakonas	4 ml N1		Receptinis	LT/1/19/4334/003	Netiekiama	-	-	No	-	-
104503	90605	1090605	flakonas	4 ml N4		Receptinis	LT/1/19/4334/004	Tiekiama	-	-	No	-	-	Download
104504	90606	1090606	flakonas	10 ml N1		Receptinis	LT/1/19/4334/005	Netiekiama	-	-	No	-	-
104505	90607	1090607	flakonas	10 ml N4		Receptinis	LT/1/19/4334/006	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-11-11	Perregistruotas
2019-03-04	Registruotas