Flarex

Medicinal product

(Invented) name

Flarex

Active substance (s)

Fluorometolonas

Strength

1 mg/ml

Pharmaceutical form

akių lašai (suspensija)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01BA07, Fluorometholone

Marketing authorisation holder

Immedica Pharma AB, Švedija

Date of authorisation

2003-05-20

Date of renewal

2013-07-31

Documents

3348 Flarex PCS PL 2025 09 02.docx

3348 Pakuotės lapelis 2025 09 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml akių lašų yra	1 ml
Fluorometolonas	1 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
7649	12590	1012590	buteliukas	5 ml su lašintuvu N1		Receptinis	LT/1/03/3348/001	Netiekiama	2025-07-14	2025-10-01	Yes	2025-07-09	2025-10-01	Download

Stadijos

Data	Stadija
2013-07-31	Perregistruotas
2003-05-20	Registruotas