Metamizole sodium Bausch Health

Medicinal product

(Invented) name

Metamizole sodium Bausch Health

Active substance (s)

Metamizolo natrio druska

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

Bausch Health Ireland Limited, Airija

Date of authorisation

2023-09-27

Date of renewal

Documents

5243 Pakuotės lapelis 2024 12 27.docx

5243 Metamizole Na Bausch Health RPP 2024 12 27.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

BG/H/0124/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Metamizolo natrio druska	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
111716	97830	1097830	ampulė	2 ml N5		Receptinis	LT/1/23/5243/001	Netiekiama	-	-	No	-	-
111717	97831	1097831	ampulė	5 ml N5		Receptinis	LT/1/23/5243/002	Netiekiama	-	-	No	-	-
111718	97832	1097832	ampulė	2 ml N10		Receptinis	LT/1/23/5243/003	Netiekiama	-	-	No	-	-
111719	97833	1097833	ampulė	5 ml N10		Receptinis	LT/1/23/5243/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-27	Registruotas