Midazolam Kalceks

Medicinal product

(Invented) name

Midazolam Kalceks

Active substance (s)

Midazolamas

Strength

1 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, vartoti į tiesiąją žarną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05CD08, Midazolam

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2021-10-26

Date of renewal

Documents

4240, 4841 Pakuotės lapelis 2024 10 01.docx

4240, 4841 Midazolam Kalceks PL 2024 10 01, VRA rastas 17041.docx

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10(1)

Procedure number

EE/H/0252/002/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
107464	93569	1093569	ampulė	5 ml N5		Receptinis	LT/1/21/4841/001	Netiekiama	-	-	No	-	-
107465	93570	1093570	ampulė	5 ml N10		Receptinis	LT/1/21/4841/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-10-26	Registruotas