Midazolam Baxter

Medicinal product

(Invented) name

Midazolam Baxter

Active substance (s)

Midazolamas

Strength

1 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

4398_01-03 pakuotes lapelis_2019-06-10.docx

4398_1-3 Midazolam Baxter1_DC.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4275/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Midazolamas	1 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
101855	87957	1087957	ampulė	5 ml N5		Receptinis	LT/1/19/4398/001	Netiekiama	-	-	No	-	-
101856	87958	1087958	ampulė	5 ml N10		Receptinis	LT/1/19/4398/002	Netiekiama	-	-	No	-	-
101857	87959	1087959	ampulė	5 ml N25		Receptinis	LT/1/19/4398/003	Netiekiama	-	-	No	-	-

Stadijos

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