Coldargan

Medicinal product

(Invented) name

Coldargan

Active substance (s)

Sidabro proteinatas/Efedrino levulinatas/Kalcio levulinatas

Strength

25 mg/20 mg/2,2 mg/ml

Pharmaceutical form

nosies lašai (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

1 ml tirpalo yra	1 ml
Sidabro proteinatas	25 mg
Efedrino levulinatas	20 mg
Kalcio levulinatas	2,2 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
7610	12554	1012554	buteliukas	10 ml ir aplikatorius su pipete N1		Receptinis	LT/1/97/2975/001	Netiekiama	-	-	No	-	-

Stadijos

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