Brontex

Medicinal product

(Invented) name

Brontex

Active substance (s)

Ambroksolio hidrochloridas

Strength

7,5 mg/ml

Pharmaceutical form

geriamieji lašai (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

ratiopharm GmbH, Vokietija

Date of authorisation

1995-11-22

Date of renewal

2009-07-21

Documents

1616 Brontex geriam lasai PCS PL 2021 08 02.docx

1616 Pakuotės lapelis geriam lasai 2021 08 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo (14 lašų) yra:	1 ml
Ambroksolio hidrochloridas	7,5 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
1792	7473	1007473	buteliukas	100 ml ir matavimo taurelė N1		Nereceptinis	LT/1/95/1616/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2009-07-21	Perregistruotas
1995-11-22	Registruotas