Cisatracurium Kalceks

Medicinal product

(Invented) name

Cisatracurium Kalceks

Active substance (s)

Cisatrakuris

Strength

2 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M03AC11, Cisatracurium

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2019-08-07

Date of renewal

2024-02-14

Documents

4433 Pakuotės lapelis 2024 10 01.docx

4433 Cisatracurium Kalceks PL 2024 10 01, VRA rastas 17041.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0165/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Cisatrakuris	2 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
102232	88332	1088332	ampulė	2,5 ml N5		Receptinis	LT/1/19/4433/001	Netiekiama	-	-	No	-	-
102233	88333	1088333	ampulė	5 ml N5		Receptinis	LT/1/19/4433/002	Netiekiama	-	-	No	-	-
102234	88334	1088334	ampulė	10 ml N5		Receptinis	LT/1/19/4433/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-14	Perregistruotas
2019-08-07	Registruotas