Ambrotusin

Medicinal product

(Invented) name

Ambrotusin

Active substance (s)

Ambroksolio hidrochloridas

Strength

3 mg/ml

Pharmaceutical form

sirupas

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_3mg-ml sirup_AR.pdf

3703 Pakuotės lapelis 2024 03 07.docx

3703 Ambrotusin sirupas RPP 2024 03 07.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 sirupo 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
59621	73852	1073852	buteliukas	100 ml ir matavimo šaukštas N1		Nereceptinis	LT/1/15/3703/003	Tiekiama	-	-	No	-	-	Download

Stadijos

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