Brontex [Ambroxol hydrochloride ratiopharm]

Medicinal product

(Invented) name

Brontex [Ambroxol hydrochloride ratiopharm]

Active substance (s)

Ambroksolio hidrochloridas

Strength

60 mg

Pharmaceutical form

šnypščiosios tabletės

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

ratiopharm GmbH, Vokietija

Date of authorisation

2022-08-08

Date of renewal

Documents

4999 Pakuotės lapelis 2022 10 29.docx

4999 Brontex 60mg snypsc tab RPP 2022 10 29.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3254/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Ambroksolio hidrochloridas	60 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
109106	95212	1095212	tūbelė	N10		Nereceptinis	LT/1/22/4999/001	Tiekiama	-	-	No	-	-	Download
109107	95213	1095213	tūbelė	N20		Nereceptinis	LT/1/22/4999/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-08	Registruotas