Ambroxol Siromed

Medicinal product

(Invented) name

Ambroxol Siromed

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

2016-02-09

Date of renewal

2020-11-20

Documents

3813 Pakuotės lapelis 2025 03 04.docx

3813 Ambroxol Siromed sirupas RPP 2025 03 04.docx

Ambroxol_Siromed_sir_AR.pdf

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
62534	76944	1076944	buteliukas	100 ml (stiklinis) ir matavimo šaukštas N1		Nereceptinis	LT/1/15/3813/003	Netiekiama	-	-	No	-	-
65065	79561	1079561	buteliukas	100 ml (plastikinis) ir matavimo šaukštas N1		Nereceptinis	LT/1/15/3813/004	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2020-11-20	Perregistruotas
2016-02-09	Registruotas