Metronidazole VIOSER

Medicinal product

(Invented) name

Metronidazole VIOSER

Active substance (s)

Metronidazolas

Strength

500 mg/100 ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01XD01, Metronidazole

Marketing authorisation holder

VIOSER S.A. Parenteral Solutions Industry, Graikija

Date of authorisation

2017-04-06

Date of renewal

2021-12-07

Documents

Metronidazole Vioser_LT_117_DC_ PAR_summary+scient disc+LT apzvalga_170406.pdf

4065 Pakuotės lapelis 2023 04 06.docx

4065 Metronidazole VIOSER PCS PL 2023 04 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0117/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

100 ml tirpalo yra:	100 ml
Metronidazolas	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
64359	78841	1078841	talpyklė	100 ml N1		Receptinis	LT/1/17/4065/001	Netiekiama	-	-	No	-	-	Download
68078	82641	1082641	talpyklė	100 ml N10		Receptinis	LT/1/17/4065/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-07	Perregistruotas
2017-04-06	Registruotas