Coldargan

Medicinal product

(Invented) name

Coldargan

Active substance (s)

Sidabro proteinatas/Efedrino levulinatas/Kalcio levulinatas

Strength

3,5 mg/2,8 mg/0,31 mg/išpurškime

Pharmaceutical form

nosies purškalas (tirpalas)

Route (s) of administration

vartoti į burną ir ryklę, vartoti į nosį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R01AX30, Combinations

Marketing authorisation holder

Sigmapharm Arzneimittel GmbH & Co KG, Austrija

Date of authorisation

1997-07-02

Date of renewal

2012-06-15

Documents

2975-01-02 Coldargan_atn-06-15.doc

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Viename išpurškime (0,14 ml) yra	0.14 ml
Sidabro proteinatas	3,5 mg
Efedrino levulinatas	2,8 mg
Kalcio levulinatas	0,31 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
7616	12560	1012560	buteliukas	10 ml su mechaniniu purkštuku N1		Receptinis	LT/1/97/2975/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-19	Išregistruotas
2012-06-15	Perregistruotas
1997-07-02	Registruotas