Dexmedetomidine Accord

Medicinal product

(Invented) name

Dexmedetomidine Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2020-02-13

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

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
103312	89414	1089414	flakonas	2 ml N1		Receptinis	EU/1/19/1418/001	Netiekiama	-	-	No	-	-
103313	89415	1089415	flakonas	2 ml N4		Receptinis	EU/1/19/1418/002	Netiekiama	-	-	No	-	-
103314	89416	1089416	flakonas	2 ml N5		Receptinis	EU/1/19/1418/003	Netiekiama	-	-	No	-	-
103315	89417	1089417	flakonas	2 ml N25		Receptinis	EU/1/19/1418/004	Netiekiama	-	-	No	-	-
103316	89418	1089418	flakonas	4 ml N1		Receptinis	EU/1/19/1418/005	Netiekiama	-	-	No	-	-
103317	89419	1089419	flakonas	4 ml N4		Receptinis	EU/1/19/1418/006	Netiekiama	-	-	No	-	-
103318	89420	1089420	flakonas	4 ml N5		Receptinis	EU/1/19/1418/007	Netiekiama	-	-	No	-	-
103319	89421	1089421	flakonas	10 ml N1		Receptinis	EU/1/19/1418/008	Netiekiama	-	-	No	-	-
103320	89422	1089422	flakonas	10 ml N4		Receptinis	EU/1/19/1418/009	Netiekiama	-	-	No	-	-
103321	89423	1089423	flakonas	10 ml N5		Receptinis	EU/1/19/1418/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2020-02-13	Registruotas