Flavamed

Medicinal product

(Invented) name

Flavamed

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

Berlin-Chemie AG (Menarini Group), Vokietija

Date of authorisation

2013-06-27

Date of renewal

2018-04-12

Documents

3327_1 Flavamed_15mg_5ml geriam tirp RPP 181025.docx

3327_1 Pakuotės lapelis 181025.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/3590/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

5 ml geriamojo tirpalo (1 matavimo šaukšte) 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
51784	65681	1065681	buteliukas	100 ml ir matavimo šaukštas N1		Nereceptinis	LT/1/13/3327/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-04-12	Perregistruotas
2013-06-27	Registruotas