Amolytin

Medicinal product

(Invented) name

Amolytin

Active substance (s)

Ambroksolio hidrochloridas

Strength

30 mg

Pharmaceutical form

tabletės

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

2024-01-05

Date of renewal

2025-07-31

Documents

5321_Amolytin_perr2025-07-31.docx

5321_pakuotes lapelis_2025-07-31.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

LV/H/0202/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
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
112495	98615	1098615	lizdinė plokštelė	N20		Nereceptinis	LT/1/24/5321/001	Tiekiama	2025-01-01	-	No	-	-
112496	98616	1098616	lizdinė plokštelė	N30		Nereceptinis	LT/1/24/5321/002	Netiekiama	-	-	No	-	-
112497	98617	1098617	lizdinė plokštelė	N50		Nereceptinis	LT/1/24/5321/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-31	Perregistruotas
2024-01-05	Registruotas