Amrex

Medicinal product

(Invented) name

Amrex

Active substance (s)

Ambroksolio hidrochloridas

Strength

30 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

SOPHARMA AD, Bulgarija

Date of authorisation

2023-12-22

Date of renewal

2025-03-13

Documents

5307_Amrex_perr2025-03-13.docx

5307_pakuotes lapelis_2025-03-13.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

LV/H/0199/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

5 ml sirupo yra:	5 ml
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
112386	98501	1098501	buteliukas	120 ml + matavimo taurelė N1		Nereceptinis	LT/1/23/5307/001	Tiekiama	2026-01-01	-	No	-	-
112387	98502	1098502	buteliukas	200 ml + matavimo taurelė N1		Nereceptinis	LT/1/23/5307/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-13	Perregistruotas
2023-12-22	Registruotas