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

UAB Rx pharma, Lietuva

Date of authorisation

2024-05-23

Date of renewal

Documents

2153_Dexmedetomidine Kalceks 100mcg-ml_konc_inf_tirp_PZPL_2024-05-23.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
113709	99828	1099828	ampulė	2 ml N5	ASPĮ	Receptinis	LT/L/24/2153/001	Netiekiama	-	-	No	-	-	Download
113710	99829	1099829	ampulė	2 ml N25	ASPĮ	Receptinis	LT/L/24/2153/002	Netiekiama	-	-	No	-	-	Download
113711	99830	1099830	ampulė	4 ml N4	ASPĮ	Receptinis	LT/L/24/2153/003	Netiekiama	-	-	No	-	-	Download
113712	99831	1099831	ampulė	10 ml N4	ASPĮ	Receptinis	LT/L/24/2153/004	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-05-23	Registruotas