Ekara

Medicinal product

(Invented) name

Ekara

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

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2017-09-28

Date of renewal

Documents

4133 Pakuotės lapelis 2022 01 21.docx

4133 Ekara RPP 2022 01 21.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PL/H/0413/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename tirpalo ml 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
97918	84014	1084014	buteliukas	5 ml N1		Receptinis	LT/1/17/4133/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2017-09-28	Registruotas