Fluanxol Depot

Medicinal product

(Invented) name

Fluanxol Depot

Active substance (s)

Flupentiksolio dekanoatas

Strength

20 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AF01, Flupentixol

Marketing authorisation holder

H.Lundbeck A/S, Danija

Date of authorisation

1998-06-02

Date of renewal

2011-02-09

Documents

0086_3 Pakuotės lapelis 2020 02 11.docx

0086_3_Fluanxol Depot 20 mg ml_inj_tirp_RPP_200211.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Flupentiksolio dekanoatas	20 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
6862	3021	1003021	ampulė	1 ml N1		Receptinis	LT/1/98/0086/003	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2011-02-09	Perregistruotas
1998-06-02	Registruotas