Gardyxon

Medicinal product

(Invented) name

Gardyxon

Active substance (s)

Dimetindeno maleatas

Strength

1 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)

D04AA13, Dimetindene

Marketing authorisation holder

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2025-02-20

Date of renewal

Documents

5710_pakuotes lapelis_2025-02-20.docx

5710_Gardyxon.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

HU/H/0841/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g gelio yra:	1 g
Dimetindeno maleatas	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
116695	102796	1102796	tūbelė	30 g N1		Nereceptinis	LT/1/25/5710/001	Netiekiama	-	2026-02-28	No	-	-
116696	102797	1102797	tūbelė	50 g N1		Nereceptinis	LT/1/25/5710/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-20	Registruotas