BOTOX

Medicinal product

(Invented) name

BOTOX

Active substance (s)

Botulino toksinas A tipo (Clostridium botulinum)

Strength

200 Allergan V

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti į raumenis, leisti į odą

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

2015-11-03

Date of renewal

2021-04-07

Documents

3824 Pakuotės lapelis 2025 07 25.docx

3824 BOTOX II PL 2025 07 25.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

IE/H/0113/003/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Botulino toksinas A tipo (Clostridium botulinum)	200 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
61477	75797	1075797	flakonas	N1		Receptinis	LT/1/15/3824/011	Tiekiama	-	-	No	-	-	Download
64101	78548	1078548	flakonas	N2		Receptinis	LT/1/15/3824/012	Netiekiama	-	-	No	-	-
64102	78549	1078549	flakonas	N3		Receptinis	LT/1/15/3824/013	Netiekiama	-	-	No	-	-
64103	78550	1078550	flakonas	N6		Receptinis	LT/1/15/3824/014	Netiekiama	-	-	No	-	-
113551	99670	1099670	flakonas	N10		Receptinis	LT/1/15/3824/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-07	Perregistruotas
2015-11-03	Registruotas