Otrivin

Medicinal product

(Invented) name

Otrivin

Active substance (s)

Ksilometazolino hidrochloridas

Strength

1 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)

R01AA07, Xylometazoline

Marketing authorisation holder

Haleon Hungary Kft. , Vengrija

Date of authorisation

1998-10-22

Date of renewal

2011-04-13

Documents

0102 Otrivin nosies pursk RPP 2025 09 02.docx

0102 Pakuotės lapelis 2025 09 02.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	1 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
11104	15614	1015614	buteliukas	(10 ml) ir dviem pirštais vertikaliai spaudžiama pompa, N1		Nereceptinis	LT/1/95/0102/001	Tiekiama	-	-	No	-	-	Download
118534	104637	1104637	buteliukas	(10 ml) ir nykščiu spaudžiama pompa, N1		Nereceptinis	LT/1/95/0102/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-04-13	Perregistruotas
1998-10-22	Registruotas