Cisatracurium Kabi

Medicinal product

(Invented) name

Cisatracurium Kabi

Active substance (s)

Cisatrakuris

Strength

5 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

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2013-03-27

Date of renewal

2016-07-22

Documents

2605 Pakuotės lapelis 5mg_ml 2021 08 20.docx

2605 Cisatracurium Kabi 5mg_ml PCS PL 2021 08 20.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/2771/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml injekcinio/infuzinio tirpalo yra	1 ml
Cisatrakuris	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
49262	63130	1063130	flakonas	30 ml N1		Receptinis	LT/1/11/2605/013	Netiekiama	-	-	No	-	-
55743	69794	1069794	flakonas	30 ml N5		Receptinis	LT/1/11/2605/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-07	Išregistruotas
2016-07-22	Perregistruotas
2013-03-27	Registruotas