Atracurium besilate Kalceks

Medicinal product

(Invented) name

Atracurium besilate Kalceks

Active substance (s)

Atrakurio besilatas

Strength

10 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)

M03AC04, Atracurium

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2017-12-12

Date of renewal

2022-09-16

Documents

4168 Pakuotės lapelis 2024 10 01.docx

4168 Atracurium besilate Kalceks PL 2024 10 01, VRA_17041.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0726/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Atrakurio besilatas	10 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
98524	84627	1084627	ampulė	2,5 ml N1		Receptinis	LT/1/17/4168/001	Netiekiama	-	-	No	-	-
98525	84628	1084628	ampulė	2,5 ml N5		Receptinis	LT/1/17/4168/002	Tiekiama	-	-	No	-	-	Download
98526	84629	1084629	ampulė	5 ml N1		Receptinis	LT/1/17/4168/003	Netiekiama	-	-	No	-	-
98527	84630	1084630	ampulė	5 ml N5		Receptinis	LT/1/17/4168/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-16	Perregistruotas
2017-12-12	Registruotas