Midazolam Baxter

Medicinal product

(Invented) name

Midazolam Baxter

Active substance (s)

Midazolamas

Strength

5 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05CD08, Midazolam

Marketing authorisation holder

Baxter Holding B.V. , Nyderlandai

Date of authorisation

2019-06-10

Date of renewal

Documents

4399_1-8 Midazolam Baxter5_DC.docx

4399_01-08 pakuotes lapelis_2019-06-10.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4275/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml yra	1 ml
Midazolamas	5 mg

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
101858	87960	1087960	ampulė	1 ml N5		Receptinis	LT/1/19/4399/001	Netiekiama	-	-	No	-	-
101859	87961	1087961	ampulė	1 ml N10		Receptinis	LT/1/19/4399/002	Netiekiama	-	-	No	-	-
101860	87962	1087962	ampulė	1 ml N25		Receptinis	LT/1/19/4399/003	Netiekiama	-	-	No	-	-
101861	87963	1087963	ampulė	3 ml N5		Receptinis	LT/1/19/4399/004	Netiekiama	-	-	No	-	-
101862	87964	1087964	ampulė	3 ml N10		Receptinis	LT/1/19/4399/005	Netiekiama	-	-	No	-	-
101863	87965	1087965	ampulė	3 ml N25		Receptinis	LT/1/19/4399/006	Netiekiama	-	-	No	-	-
101864	87966	1087966	ampulė	10 ml N5		Receptinis	LT/1/19/4399/007	Netiekiama	-	-	No	-	-
101865	87967	1087967	ampulė	10 ml N10		Receptinis	LT/1/19/4399/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-28	Išregistruotas
2019-06-10	Registruotas