Sinomist [Xylometazoline/Dexpanthenol Teva]

Medicinal product

(Invented) name

Sinomist [Xylometazoline/Dexpanthenol Teva]

Active substance (s)

Ksilometazolinas/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

WICK Pharma, Vokietija

Date of authorisation

2014-10-10

Date of renewal

Documents

3634_1_2 Sinomist PCS PZ 180502.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/3870/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Ksilometazolinas	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
55831	69883	1069883	buteliukas	10 ml N1		Nereceptinis	LT/1/14/3634/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-08-02	Išregistruotas
2014-10-10	Registruotas