VISTABEL

Medicinal product

(Invented) name

VISTABEL

Active substance (s)

Botulino toksinas A tipo, injekcinis

Strength

4 Allergan V/0,1 ml

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M03AX01, Botulinum toxin

Marketing authorisation holder

AbbVie SIA, Latvija

Date of authorisation

2005-05-04

Date of renewal

2008-10-15

Documents

0211 VISTABEL II PL 2025 07 25.docx

0211 Pakuotės lapelis 2025 07 25.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0230/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

0,1 ml paruošto tirpalo yra	0.1 ml
Botulino toksinas A tipo, injekcinis	4 Allergan V

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
13003	17350	1017350	flakonas	50 vienetų, N1		Receptinis	LT/1/05/0211/001	Tiekiama	-	-	No	-	-	Download
17341	21234	1021234	flakonas	50 vienetų, N2		Receptinis	LT/1/05/0211/002	Netiekiama	-	-	No	-	-
100310	86419	1086419	flakonas	100 vienetų, N1		Receptinis	LT/1/05/0211/003	Tiekiama	-	-	No	-	-
100311	86420	1086420	flakonas	100 vienetų, N2		Receptinis	LT/1/05/0211/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-10-15	Perregistruotas
2005-05-04	Registruotas