GALAZOLIN

Medicinal product

(Invented) name

GALAZOLIN

Active substance (s)

Ksilometazolino hidrochloridas

Strength

500 µg/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

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

1994-09-07

Date of renewal

2008-07-31

Documents

1226 Pakuotės lapelis 2024 07 04.docx

1226 GALAZOLIN 0,05proc RPP 2024 07 04.docx

Stage

Perregistruotas

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
Ksilometazolino hidrochloridas	500 µg

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
2371	7987	1007987	buteliukas	10 ml N1		Nereceptinis	LT/1/94/1226/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2008-07-31	Perregistruotas
1994-09-07	Registruotas