Septanazal

Medicinal product

(Invented) name

Septanazal

Active substance (s)

Ksilometazolino hidrochloridas/Dekspantenolis

Strength

0,5 mg/50 mg/ml

Pharmaceutical form

nosies purškalas (tirpalas)

Route (s) of administration

vartoti į nosį

Purpose for use

vaikams

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R01AB06, Xylometazoline

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2013-09-24

Date of renewal

2019-02-08

Documents

3376 Septanazal 0,5mg PCS 2023 06 01.docx

3376 Pakuotės lapelis 0,5mg 2023 01 31.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

CZ/H/0170/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Ksilometazolino hidrochloridas	0,5 mg
Dekspantenolis	50 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
53077	67018	1067018	purškalo talpyklė	10 ml N1		Nereceptinis	LT/1/13/3376/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-02-08	Perregistruotas
2013-09-24	Registruotas