Coldistan

Medicinal product

(Invented) name

Coldistan

Active substance (s)

Difenhidraminas/Nafazolinas

Strength

1 mg/0,5 mg/ml

Pharmaceutical form

nosies lašai (tirpalas)

Route (s) of administration

vartoti į nosį

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

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

3396_1_2 Coldistan lasai_pursk RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml nosies lašų yra	1 ml
Difenhidraminas	1 mg
Nafazolinas	0,5 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
7620	12564	1012564	buteliukas	10 ml ir aplikatorius su pipete N1		Nereceptinis	LT/1/97/3396/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-04-05	Išregistruotas
2013-10-18	Perregistruotas
1997-07-02	Registruotas