Coldistan

Medicinal product

(Invented) name

Coldistan

Active substance (s)

Difenhidraminas/Fenilefrinas/Kalcio levulinatas/Cetilpiridinio chloridas/Pantenolis/Vaistinių šalavijų (Salvia officinalis) eterinis aliejus

Strength

2 mg/2 mg/2,5 mg/0,5 mg/20 mg/30 mg/g

Pharmaceutical form

nosies tepalas

Route (s) of administration

vartoti į nosį

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

ATC code (s)

R01AB02, Naphazoline

Marketing authorisation holder

SIGMAPHARM Arzneimittel GmbH, Austrija

Date of authorisation

1997-07-02

Date of renewal

2013-10-18

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g tepalo yra	1 g
Difenhidraminas	2 mg
Fenilefrinas	2 mg
Kalcio levulinatas	2,5 mg
Cetilpiridinio chloridas	0,5 mg
Pantenolis	20 mg
Vaistinių šalavijų (Salvia officinalis) eterinis aliejus	30 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
7606	12550	1012550	tūbelė	8 g N1		Nereceptinis	LT/1/97/3396/003	Netiekiama	-	-	No	-	-

Stadijos