BROXIVAN

Medicinal product

(Invented) name

BROXIVAN

Active substance (s)

Ambroksolio hidrochloridas

Strength

3 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05CB06, Ambroxol

Marketing authorisation holder

Medochemie Ltd., Kipras

Date of authorisation

2021-09-22

Date of renewal

Documents

4811 Pakuotės lapelis 2021 11 24.docx

4811 BROXIVAN 3mg_ml RPP 2021 11 24.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2469/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Ambroksolio hidrochloridas	3 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
107261	93365	1093365	buteliukas	100 ml ir matavimo taurelė N1		Nereceptinis	LT/1/21/4811/001	Netiekiama	-	-	No	-	-
107262	93366	1093366	buteliukas	125 ml ir matavimo taurelė N1		Nereceptinis	LT/1/21/4811/002	Netiekiama	-	-	No	-	-
107263	93367	1093367	buteliukas	150 ml ir matavimo taurelė N1		Nereceptinis	LT/1/21/4811/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-12-31	Išregistruotas
2021-09-22	Registruotas