Septolete plus

Medicinal product

(Invented) name

Septolete plus

Active substance (s)

Benzokainas/Cetilpiridinio chloridas

Strength

10 mg/2 mg/ml

Pharmaceutical form

burnos gleivinės purškalas

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R02AA06, Cetylpyridinium

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2010-11-10

Date of renewal

2015-07-21

Documents

2217_5 Septolete_plus_atn-0721.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kiekviename mililitre burnos gleivinės purškalo yra	1 ml
Benzokainas	10 mg
Cetilpiridinio chloridas	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
36509	38841	1038841	purškalo talpyklė	30 ml ir mechaninis purkštukas N1		Nereceptinis	LT/1/96/2217/005	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-11-28	Išregistruotas
2015-07-21	Perregistruotas
2010-11-10	Registruotas