Xymelin Menthol

Medicinal product

(Invented) name

Xymelin Menthol

Active substance (s)

Ksilometazolino hidrochloridas

Strength

1 mg/ml

Pharmaceutical form

nosies purškalas (tirpalas)

Route (s) of administration

vartoti į nosį

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R01AA07, Xylometazoline

Marketing authorisation holder

Orifarm Healthcare A/S, Danija

Date of authorisation

2004-04-13

Date of renewal

2013-10-18

Documents

0002 Pakuotės lapelis Menthol 2022 02 01.docx

0002 Xymelin Menthol nosies pusk RPP 2022 02 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Ksilometazolino hidrochloridas	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
11804	16241	1016241	buteliukas	10 ml (su purškalo pompa) N1		Nereceptinis	LT/1/04/0002/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2013-10-18	Perregistruotas
2004-04-13	Registruotas