Vigamox

Medicinal product

(Invented) name

Vigamox

Active substance (s)

Moksifloksacinas

Strength

5 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01AE07, Moxifloxacin

Marketing authorisation holder

SIA Novartis Baltics, Latvija

Date of authorisation

2009-07-27

Date of renewal

2014-11-10

Documents

1655 Vigamox II PL 2024 11 29.docx

1655 Pakuotės lapelis 2024 11 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/1588/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Moksifloksacinas	5 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
28539	31060	1031060	buteliukas	5 ml N1		Receptinis	LT/1/09/1655/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2014-11-10	Perregistruotas
2009-07-27	Registruotas