Lotemax

Medicinal product

(Invented) name

Lotemax

Active substance (s)

Loteprednolis

Strength

5 mg/ml

Pharmaceutical form

akių lašai (suspensija)

Route (s) of administration

vartoti į akis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01BA14, Loteprednol

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2025-12-22

Date of renewal

Documents

3100_Lotemax 0,5mg-ml_akiu lasai_PZ_2025-12-22.docx

3100_Lotemax 0,5mg-ml_akiu lasai_PL_2025-12-22.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

1 ml suspensijos yra:	1 ml
Loteprednolis	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
119548	105654	1105654	buteliukas	5 ml N1		Receptinis	LT/L/25/3100/001	Netiekiama	-	2026-02-23	No	-	-	Download

Stadijos

Data	Stadija
2025-12-22	Registruotas