Galathenal [Galanas]

Medicinal product

(Invented) name

Galathenal [Galanas]

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

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2021-04-29

Date of renewal

Documents

4735 Galathenal 0,5_50 RPP 2025 03 14.docx

4735 Pakuotės lapelis 2025 03 14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LV/H/0196/001/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
106387	92488	1092488	buteliukas	10 ml (su dozavimo pompa) N1		Nereceptinis	LT/1/21/4735/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-29	Registruotas