Cisatracurium Accord

Medicinal product

(Invented) name

Cisatracurium Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2014-12-11

Date of renewal

Documents

3659_1_10 Cisatracurium Accord II PL 190517.docx

3659_1_10 Pakuotės lapelis 190517.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4778/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml 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
58210	72336	1072336	flakonas	2,5 ml N1 (5 mg/2,5 ml)		Receptinis	LT/1/14/3659/001	Netiekiama	-	-	No	-	-
60838	75128	1075128	flakonas	2,5 ml N5 (5 mg/2,5 ml)		Receptinis	LT/1/14/3659/002	Netiekiama	-	-	No	-	-
60839	75129	1075129	flakonas	5 ml N1 (10 mg/5 ml)		Receptinis	LT/1/14/3659/003	Netiekiama	-	-	No	-	-
60840	75130	1075130	flakonas	5 ml N5 (10 mg/5 ml)		Receptinis	LT/1/14/3659/004	Netiekiama	-	-	No	-	-
60841	75131	1075131	flakonas	10 ml N1 (20 mg/10 ml)		Receptinis	LT/1/14/3659/005	Netiekiama	-	-	No	-	-
60842	75132	1075132	flakonas	10 ml N5 (20 mg/10 ml)		Receptinis	LT/1/14/3659/006	Netiekiama	-	-	No	-	-
60843	75133	1075133	flakonas	25 ml N1 (50 mg/25 ml)		Receptinis	LT/1/14/3659/007	Netiekiama	-	-	No	-	-
60844	75134	1075134	flakonas	25 ml N2 (50 mg/25 ml)		Receptinis	LT/1/14/3659/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-27	Išregistruotas
2014-12-11	Registruotas