Trebexen

Medicinal product

(Invented) name

Trebexen

Active substance (s)

Naproksenas

Strength

100 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)

M02AA12, Naproxen

Marketing authorisation holder

STADA Arzneimittel AG, Vokietija

Date of authorisation

2016-12-20

Date of renewal

2021-08-27

Documents

4021 Trebexen gelis PL 2023 05 11.docx

Trebexen gel_AR.pdf

4021 Pakuotės lapelis 2023 05 11.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

LT/H/0115/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g gelio yra:	1 g
Naproksenas	100 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
63626	78067	1078067	tūbelė	55 g N1		Nereceptinis	LT/1/16/4021/001	Netiekiama	-	-	No	-	-	Download
67285	81832	1081832	tūbelė	100 g N1		Nereceptinis	LT/1/16/4021/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-28	Išregistruotas
2021-08-27	Perregistruotas
2016-12-20	Registruotas