Fenistil

Medicinal product

(Invented) name

Fenistil

Active substance (s)

Dimetindenas

Strength

1 mg/ml

Pharmaceutical form

geriamieji lašai (tirpalas)

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R06AB03, Dimetindene

Marketing authorisation holder

GlaxoSmithKline Dungarvan Limited, Airija

Date of authorisation

1995-10-04

Date of renewal

2008-06-02

Documents

0933_2 Pakuotės lapelis 190401.docx

0933_2 Fenistil geriam lasai II PL 190401.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Dimetindenas	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
3392	8856	1008856	buteliukas	20 ml N1		Nereceptinis	LT/1/95/0933/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-27	Išregistruotas
2008-06-02	Perregistruotas
1995-10-04	Registruotas