Dexmedetomidine Teva

Medicinal product

(Invented) name

Dexmedetomidine Teva

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

Teva B.V., Nyderlandai

Date of authorisation

2020-12-22

Date of renewal

2022-01-17

Documents

4649 Dexmedetomidine Teva PCS PL 2022 09 16.docx

4649 Pakuotės lapelis 2022 09 16.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0655/001/E/002

Marketing authorisation procedure

Kartotinė procedūra

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
105487	91587	1091587	flakonas	2 ml N1		Receptinis	LT/1/20/4649/001	Netiekiama	-	-	No	-	-
105488	91588	1091588	flakonas	2 ml N5		Receptinis	LT/1/20/4649/002	Netiekiama	-	-	No	-	-	Download
105489	91589	1091589	flakonas	2 ml N25		Receptinis	LT/1/20/4649/003	Netiekiama	-	-	No	-	-
105490	91590	1091590	flakonas	4 ml N4		Receptinis	LT/1/20/4649/004	Netiekiama	-	-	No	-	-
105491	91591	1091591	flakonas	10 ml N4		Receptinis	LT/1/20/4649/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-30	Išregistruotas
2022-01-17	Perregistruotas
2020-12-22	Registruotas