Roqurum

Medicinal product

(Invented) name

Roqurum

Active substance (s)

Rokuronio bromidas

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)

M03AC09, Rocuronium bromide

Marketing authorisation holder

Bausch Health Ireland Limited, Airija

Date of authorisation

2010-12-20

Date of renewal

2016-05-23

Documents

2251_1_3 Pakuotės lapelis 201103.docx

2251_1_3 Roqurum inj_inf RPP 201103.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Rokuronio bromidas	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
36731	50342	1050342	flakonas	2,5 ml N10		Receptinis	LT/1/10/2251/001	Netiekiama	-	-	No	-	-
36732	50343	1050343	flakonas	5 ml N10		Receptinis	LT/1/10/2251/002	Netiekiama	-	-	No	-	-	Download
36733	50344	1050344	flakonas	10 ml N10		Receptinis	LT/1/10/2251/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-23	Perregistruotas
2010-12-20	Registruotas