Tracrium

Medicinal product

(Invented) name

Tracrium

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

Aspen Pharma Trading Limited, Airija

Date of authorisation

1994-11-11

Date of renewal

2011-06-15

Documents

2526 Pakuotės lapelis 2023 11 22.docx

2526 Tracrium RPP 2023 11 22.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė 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
1393	7143	1007143	ampulė	2,5 ml N5		Receptinis	LT/1/94/2526/001	Netiekiama	-	-	No	-	-	Download
47149	60964	1060964	ampulė	5 ml N5		Receptinis	LT/1/94/2526/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-30	Išregistruotas
2011-06-15	Perregistruotas
1994-11-11	Registruotas