MUNIX [Ambroxol Sopharma]

Medicinal product

(Invented) name

MUNIX [Ambroxol Sopharma]

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

SOPHARMA AD, Bulgarija

Date of authorisation

2014-07-23

Date of renewal

2019-04-15

Documents

3595 Pakuotės lapelis 2025 02 24.docx

3595 MUNIX PCS PL 2025 02 24.docx

Ambroxol VVB_AR.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

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
57734	71854	1071854	buteliukas	100 ml ir matavimo taurelė N1		Nereceptinis	LT/1/14/3595/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-04-15	Perregistruotas
2014-07-23	Registruotas