GULER

Medicinal product

(Invented) name

GULER

Active substance (s)

Diklofenako natrio druska

Strength

50 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M02AA15, Diclofenac

Marketing authorisation holder

UAB TBS Pharma, Lietuva

Date of authorisation

2025-09-26

Date of renewal

Documents

5864 GULER_corr.docx

5864 pakuotes lapelis_2025-09-26.docx

GULER 50 mgg gelis_NP_viešas_AR.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g gelio yra	1 g
Diklofenako natrio druska	50 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
118751	104857	1104857	tūbelė	50 g N1		Nereceptinis	LT/1/25/5864/001	Netiekiama	-	-	No	-	-
118752	104858	1104858	slėginė talpyklė	50 g N1		Nereceptinis	LT/1/25/5864/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-09-26	Registruotas