Halixol

Medicinal product

(Invented) name

Halixol

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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

1998-12-23

Date of renewal

2007-10-15

Documents

0826 Halixol sirupas PCS 2024 01 02.docx

0826 Pakuotės lapelis sirupas 2022 10 12.docx

Stage

Perregistruotas

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
6661	11727	1011727	buteliukas	100 ml, N1		Nereceptinis	LT/1/98/0826/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2007-10-15	Perregistruotas
1998-12-23	Registruotas