Olydex

Medicinal product

(Invented) name

Olydex

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

McNeil Healthcare (Ireland) Limited, Airija

Date of authorisation

2019-04-30

Date of renewal

2022-12-29

Documents

4376 Olydex 0,5mg RPP 2023 08 22.docx

4376 Pakuotės lapelis 2023 08 22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LV/H/0148/001/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
101586	87690	1087690	buteliukas	10 ml N1		Nereceptinis	LT/1/19/4376/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Perregistruotas
2019-04-30	Registruotas