Nomex [Xylometazolin ICN Polfa]

Medicinal product

(Invented) name

Nomex [Xylometazolin ICN Polfa]

Active substance (s)

Ksilometazolinas

Strength

0,5 mg/ml

Pharmaceutical form

nosies lašai (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

SIA Meda Pharma, Latvija

Date of authorisation

1994-06-22

Date of renewal

2009-12-17

Documents

1807_1 Pakuotės lapelis 180927.docx

1807_1 Nomex 0.5mg_ml RPP 180927.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Ksilometazolinas	0,5 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
5111	10412	1010412	buteliukas	10 ml N1		Nereceptinis	LT/1/94/1807/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-02-06	Išregistruotas
2009-12-17	Perregistruotas
1994-06-22	Registruotas