Benzydamine hydrochloride Zentiva

Medicinal product

(Invented) name

Benzydamine hydrochloride Zentiva

Active substance (s)

Benzidamino hidrochloridas

Strength

1,5 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

Zentiva k.s., Čekija

Date of authorisation

2022-07-27

Date of renewal

Documents

4989_4990_Benzydamine HCl Zentiva.docx

4989_pakuotes lapelis_2022-07-27.docx

Benzydamine HCl Zentiva_PAR_Summ+LT apzvalga.pdf

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

RO/H/0215/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Benzidamino hidrochloridas	1,5 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
109036	95142	1095142	buteliukas	15 ml N1 (su dozavimo pompa)		Nereceptinis	LT/1/22/4989/001	Netiekiama	-	-	No	-	-
109037	95143	1095143	buteliukas	30 ml N1 (su dozavimo pompa)		Nereceptinis	LT/1/22/4989/002	Netiekiama	-	-	No	-	-
109038	95144	1095144	buteliukas	60 ml N1 (su dozavimo pompa)		Nereceptinis	LT/1/22/4989/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Išregistruotas
2022-07-27	Registruotas