BOTOX

Medicinal product

(Invented) name

BOTOX

Active substance (s)

Botulino toksinas A tipo (Clostridium botulinum)

Strength

50 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/0113/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Botulino toksinas A tipo (Clostridium botulinum)	50 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
61476	75796	1075796	flakonas	N1		Receptinis	LT/1/15/3824/001	Netiekiama	-	-	No	-	-
64093	78540	1078540	flakonas	N2		Receptinis	LT/1/15/3824/002	Netiekiama	-	-	No	-	-
64094	78541	1078541	flakonas	N3		Receptinis	LT/1/15/3824/003	Netiekiama	-	-	No	-	-
64095	78542	1078542	flakonas	N6		Receptinis	LT/1/15/3824/004	Netiekiama	-	-	No	-	-
64096	78543	1078543	flakonas	N10		Receptinis	LT/1/15/3824/005	Netiekiama	-	-	No	-	-

Stadijos

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