Ambrotusin

Medicinal product

(Invented) name

Ambrotusin

Active substance (s)

Ambroksolio hidrochloridas

Strength

30 mg

Pharmaceutical form

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

UAB Eletis Pharma, Lietuva

Date of authorisation

2015-04-13

Date of renewal

2020-06-17

Documents

Ambrotusin_30 mg tab_AR.pdf

3703 Ambrotusin tab RPP 2025 03 05.docx

3703 Pakuotės lapelis 2025 03 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ambroksolio hidrochloridas	30 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
59622	73853	1073853	lizdinė plokštelė	N20		Nereceptinis	LT/1/15/3703/001	Tiekiama	-	-	No	-	-	Download
61769	76125	1076125	lizdinė plokštelė	N30		Nereceptinis	LT/1/15/3703/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-06-17	Perregistruotas
2015-04-13	Registruotas