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

Rx vaistinė, Lietuva

Date of authorisation

2024-02-01

Date of renewal

Documents

2065_Dexmedetomidine-Kalceks PL_2025-08-21_K.docx

2065 Dexmedetomidine Kalceks PZ_2025-08-21_K.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
112683	98803	1098803	ampulė	2 ml N5	ASPĮ	Receptinis	LT/L/24/2065/001	Tiekiama	-	-	No	-	-	Download
112684	98804	1098804	ampulė	2 ml N25	ASPĮ	Receptinis	LT/L/24/2065/002	Netiekiama	-	-	No	-	-	Download
112685	98805	1098805	ampulė	4 ml N4	ASPĮ	Receptinis	LT/L/24/2065/003	Netiekiama	2025-07-01	2025-08-31	No	-	-	Download
112686	98806	1098806	ampulė	10 ml N4	ASPĮ	Receptinis	LT/L/24/2065/004	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-02-01	Registruotas