Coldistan

Medicinal product

(Invented) name

Coldistan

Active substance (s)

Difenhidraminas/Nafazolinas

Strength

140 µg/70 µg/dozėje

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)

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

Viename nosies purškalo išpurškime (dozėje) (0,14 ml) yra	0.14 ml
Difenhidraminas	140 µg
Nafazolinas	70 µg

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
7621	12565	1012565	buteliukas	10 ml su purškalo pompa N1		Nereceptinis	LT/1/97/3396/002	Netiekiama	-	-	No	-	-

Stadijos

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