Ambroxol Sandoz

Medicinal product

(Invented) name

Ambroxol Sandoz

Active substance (s)

Ambroksolio hidrochloridas

Strength

15 mg/5 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

Sandoz d.d., Slovėnija

Date of authorisation

1997-01-03

Date of renewal

2009-01-23

Documents

1421_3 Amroxol Sandoz syrup_RPP 160318 taisy.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

5 ml sirupo yra	5 ml
Ambroksolio hidrochloridas	15 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
4887	10213	1010213	buteliukas	100 ml ir dozavimo šaukštelis (5 ml) N1		Nereceptinis	LT/1/97/1421/003	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-09-11	Išregistruotas
2009-01-23	Perregistruotas
1997-01-03	Registruotas