Dexmedetomidine B. Braun

Medicinal product

(Invented) name

Dexmedetomidine B. Braun

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

B.Braun Melsungen AG, Vokietija

Date of authorisation

2020-09-30

Date of renewal

Documents

4624 Pakuotės lapelis 2024 10 10.docx

4624 Dexmedetomidine B_Braun PCS PL 2024 10 10.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

ES/H/0754/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato 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
105126	91228	1091228	ampulė	2 ml N5		Receptinis	LT/1/20/4624/001	Netiekiama	-	-	No	-	-
105127	91229	1091229	ampulė	2 ml N10		Receptinis	LT/1/20/4624/002	Netiekiama	-	-	No	-	-	Download
105128	91230	1091230	ampulė	2 ml N25		Receptinis	LT/1/20/4624/003	Netiekiama	-	-	No	-	-
105129	91231	1091231	ampulė	4 ml N4		Receptinis	LT/1/20/4624/004	Netiekiama	-	-	No	-	-
105130	91232	1091232	ampulė	4 ml N10		Receptinis	LT/1/20/4624/005	Netiekiama	-	-	No	-	-
105131	91233	1091233	ampulė	10 ml N4		Receptinis	LT/1/20/4624/006	Netiekiama	-	-	No	-	-
105132	91234	1091234	ampulė	10 ml N10		Receptinis	LT/1/20/4624/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-28	Išregistruotas
2020-09-30	Registruotas