Septabene

Medicinal product

(Invented) name

Septabene

Active substance (s)

Benzidamino hidrochloridas/Cetilpiridinio chloridas

Strength

1,5 mg/5 mg/ml

Pharmaceutical form

burnos gleivinės purškalas (tirpalas)

Route (s) of administration

vartoti ant burnos gleivinės

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R02AX03, Benzydamine

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2015-08-06

Date of renewal

2020-12-22

Documents

3784 Septabene pursk RPP 2020 12 22, PZ 2023 11 21.docx

3784 pakuotes lapelis 2020-12-22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

CZ/H/0508/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename tirpalo mililitre yra	1 ml
Benzidamino hidrochloridas	1,5 mg
Cetilpiridinio chloridas	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
58864	73081	1073081	purškalo talpyklė	30 ml N1		Nereceptinis	LT/1/15/3784/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2020-12-22	Perregistruotas
2015-08-06	Registruotas