SINZYL

Medicinal product

(Invented) name

SINZYL

Active substance (s)

Ksilometazolino hidrochloridas

Strength

0,5 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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2017-07-10

Date of renewal

2022-03-02

Documents

4104 Pakuotės lapelis 2025 01 03.docx

4104 SINZYL II PL 2025 01 03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/4485/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Ksilometazolino hidrochloridas	0,5 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
62434	76842	1076842	buteliukas	10 ml N1		Nereceptinis	LT/1/17/4104/001	Netiekiama	-	-	No	-	-
68796	83379	1083379	buteliukas	15 ml N1		Nereceptinis	LT/1/17/4104/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2022-03-02	Perregistruotas
2017-07-10	Registruotas