Rocuronium bromide Kalceks

Medicinal product

(Invented) name

Rocuronium bromide Kalceks

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

AS Kalceks, Latvija

Date of authorisation

2019-02-08

Date of renewal

2023-06-21

Documents

4331 Pakuotės lapelis 2024 10 01.docx

4331 Rocuronium bromide Kalceks PL 2024 10 01, VRA_17041.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0253/001/DC

Marketing authorisation procedure

Decentralizuota 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
100932	87043	1087043	flakonas	5 ml N10		Receptinis	LT/1/19/4331/001	Tiekiama	2025-10-24	-	No	-	-

Stadijos

Data	Stadija
2023-06-21	Perregistruotas
2019-02-08	Registruotas