Fenistil

Medicinal product

(Invented) name

Fenistil

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

Haleon Hungary Kft. , Vengrija

Date of authorisation

1995-10-04

Date of renewal

2007-11-30

Documents

0933 Fenistil gelis II PL 2024 09 30.docx

0933 Pakuotės lapelis 2024 09 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė 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
3391	8855	1008855	tūbelė	30 g, N1		Nereceptinis	LT/1/95/0933/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2007-11-30	Perregistruotas
1995-10-04	Registruotas