Midazolam Kalceks

Medicinal product

(Invented) name

Midazolam Kalceks

Active substance (s)

Midazolamas

Strength

5 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

2018-07-12

Date of renewal

2023-03-24

Documents

4240, 4841 Pakuotės lapelis 2024 10 01.docx

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

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10(1)

Procedure number

EE/H/0252/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo 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
99752	85860	1085860	ampulė	1 ml N5		Receptinis	LT/1/18/4240/001	Netiekiama	-	-	No	-	-
99753	85861	1085861	ampulė	1 ml N10		Receptinis	LT/1/18/4240/002	Tiekiama	-	-	No	-	-
99754	85862	1085862	ampulė	3 ml N5		Receptinis	LT/1/18/4240/003	Netiekiama	-	-	No	-	-
99755	85863	1085863	ampulė	3 ml N10		Receptinis	LT/1/18/4240/004	Netiekiama	-	-	No	-	-
102162	88263	1088263	ampulė	10 ml N5		Receptinis	LT/1/18/4240/005	Netiekiama	-	-	No	-	-
102163	88264	1088264	ampulė	10 ml N10		Receptinis	LT/1/18/4240/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-24	Perregistruotas
2018-07-12	Registruotas