Alposan

Medicinal product

(Invented) name

Alposan

Active substance (s)

Ambroksolio hidrochloridas

Strength

15 mg/5 ml

Pharmaceutical form

geriamasis tirpalas

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

Rivopharm Ltd., Airija

Date of authorisation

2015-07-28

Date of renewal

2019-10-25

Documents

3770_1_4 Pakuotės lapelis 200120.docx

3770_1_4 Alposan geria tirp RPP 200120.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0275/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

5 ml geriamojo tirpalo 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
58486	72651	1072651	buteliukas	100 ml ir geriamasis švirkštas N1		Nereceptinis	LT/1/15/3770/001	Netiekiama	-	-	No	-	-
63177	77592	1077592	buteliukas	200 ml ir geriamasis švirkštas N1		Nereceptinis	LT/1/15/3770/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-31	Išregistruotas
2019-10-25	Perregistruotas
2015-07-28	Registruotas