Sinomist

Medicinal product

(Invented) name

Sinomist

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

WICK Pharma, Vokietija

Date of authorisation

2014-10-10

Date of renewal

2019-09-12

Documents

3634 Sinomist PCS PL 2023 06 19.docx

3634 Pakuotės lapelis 2023 06 19.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/3870/002/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
55832	69884	1069884	buteliukas	10 ml N1		Nereceptinis	LT/1/14/3634/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-10-31	Išregistruotas
2019-09-12	Perregistruotas
2014-10-10	Registruotas