Otrinazil

Medicinal product

(Invented) name

Otrinazil

Active substance (s)

Ksilometazolino hidrochloridas/Dekspantenolis

Strength

1 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

Haleon Hungary Kft. , Vengrija

Date of authorisation

2018-06-08

Date of renewal

2023-11-22

Documents

4233 Pakuotės lapelis 2024 07 31.docx

4233 Otrinazil PCS II PL 2024 07 31.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PT/H/1800/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Ksilometazolino hidrochloridas	1 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
99633	85741	1085741	buteliukas	10 ml N1		Nereceptinis	LT/1/18/4233/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-22	Perregistruotas
2018-06-08	Registruotas