Frest

Medicinal product

(Invented) name

Frest

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

AS Grindeks, Latvija

Date of authorisation

2022-05-16

Date of renewal

Documents

4952 Frest PL 2024 10 16, VRA_19535.docx

4952 Pakuotės lapelis 2024 10 16, VRA_19535.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PT/H/2621/001/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
108661	94766	1094766	tūbelė	30 g N1		Nereceptinis	LT/1/22/4952/001	Tiekiama	-	-	No	-	-	Download
108662	94767	1094767	tūbelė	50 g N1		Nereceptinis	LT/1/22/4952/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-16	Registruotas