Moflaxa

Medicinal product

(Invented) name

Moflaxa

Active substance (s)

Moksifloksacinas

Strength

400 mg/250 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)

J01MA14, Moxifloxacin

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2016-02-24

Date of renewal

2019-10-11

Documents

3566 Moflaxa inf PCS PL 2025 02 06.docx

3566 Pakuotės lapelis inf 2025 02 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SI/H/0149/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename 250 ml infuzinio tirpalo buteliuke yra	250 ml
Moksifloksacinas	400 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
60677	74966	1074966	buteliukas	250 ml N1		Receptinis	LT/1/14/3566/013	Netiekiama	-	-	No	-	-
65168	79666	1079666	buteliukas	250 ml N5		Receptinis	LT/1/14/3566/014	Netiekiama	-	-	No	-	-
65169	79667	1079667	buteliukas	250 ml N10		Receptinis	LT/1/14/3566/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-10-11	Perregistruotas
2016-02-24	Registruotas