Dexdor

Medicinal product

(Invented) name

Dexdor

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

Orion Corporation, Suomija

Date of authorisation

2011-09-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	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
49115	62981	1062981	ampulė	2 ml N5		Receptinis	EU/1/11/718/001	Netiekiama	-	-	No	-	-
49116	62982	1062982	ampulė	2 ml N25		Receptinis	EU/1/11/718/002	Tiekiama	-	-	No	-	-
49118	62984	1062984	flakonas	4 ml N4 (omniflex plus)		Receptinis	EU/1/11/718/004	Tiekiama	-	-	No	-	-
49120	62986	1062986	flakonas	10 ml N4 (omniflex plus)		Receptinis	EU/1/11/718/006	Netiekiama	-	-	No	-	-
58758	72972	1072972	flakonas	2 ml N5		Receptinis	EU/1/11/718/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-09-16	Registruotas