Xylometazoline/Dexpanthenol Teva

Medicinal product

(Invented) name

Xylometazoline/Dexpanthenol Teva

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

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R01AB06, Xylometazoline

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2021-03-18

Date of renewal

2025-07-18

Documents

4705-06_pakuotes lapelis_2025-07-18.doc

4705-06_Xylom_Dexp_Teva_perr2025-07-18.doc

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/5884/001/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
106149	92250	1092250	buteliukas	10 ml (90 įpurškimų) N1		Nereceptinis	LT/1/21/4705/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-18	Perregistruotas
2021-03-18	Registruotas