Metamizole sodium Kalceks

Medicinal product

(Invented) name

Metamizole sodium Kalceks

Active substance (s)

Metamizolo natrio druska monohidratas

Strength

500 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02BB02, Metamizole sodium

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2017-07-10

Date of renewal

2022-04-22

Documents

4098 Metamizole sodium Kalceks PL 2024 10 01, VRA_17041.docx

4098 Pakuotės lapelis 2024 10 01.docx

Metamizolas_laiškas gydytojams_LT 2024-11-27.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0701/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Metamizolo natrio druska monohidratas	500 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
68750	83333	1083333	ampulė	2 ml N5		Receptinis	LT/1/17/4098/001	Netiekiama	-	-	No	-	-
68751	83334	1083334	ampulė	2 ml N10		Receptinis	LT/1/17/4098/002	Tiekiama	-	-	No	-	-	Download
68752	83335	1083335	ampulė	2 ml N100		Receptinis	LT/1/17/4098/003	Netiekiama	-	-	No	-	-
68753	83336	1083336	ampulė	5 ml N5		Receptinis	LT/1/17/4098/004	Netiekiama	-	-	No	-	-
68754	83337	1083337	ampulė	5 ml N10		Receptinis	LT/1/17/4098/005	Tiekiama	-	-	No	-	-
68755	83338	1083338	ampulė	5 ml N100		Receptinis	LT/1/17/4098/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-22	Perregistruotas
2017-07-10	Registruotas