Dexmedetomidine EVER Pharma

Medicinal product

(Invented) name

Dexmedetomidine EVER Pharma

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 Niromed, Lietuva

Date of authorisation

2025-05-14

Date of renewal

Documents

2571_Dexmedetomidine_Ever_pharma_PIL.docx

2571_Dexmedetomidine_Ever_pharma_PZ.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
117631	103734	1103734	ampulė	2 ml N25		Receptinis	LT/L/25/2571/001	Netiekiama	-	-	No	-	-
117632	103735	1103735	ampulė	2 ml N5		Receptinis	LT/L/25/2571/002	Netiekiama	-	-	No	-	-	Download
117633	103736	1103736	ampulė	4 ml N4		Receptinis	LT/L/25/2571/003	Netiekiama	-	-	No	-	-
117635	103738	1103738	ampulė	10 ml N4		Receptinis	LT/L/25/2571/004	Netiekiama	-	-	No	-	-
117636	103739	1103739	flakonas	4 ml N4		Receptinis	LT/L/25/2571/005	Netiekiama	-	-	No	-	-
117637	103740	1103740	flakonas	10 ml N4		Receptinis	LT/L/25/2571/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-05-14	Registruotas