Septanest

Medicinal product

(Invented) name

Septanest

Active substance (s)

Artikaino hidrochloridas/Adrenalinas

Strength

40 mg/5 µg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti aplink nervus, vartoti ant dantų arba į juos, infiltracija

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01BB58, Articaine, combinations

Marketing authorisation holder

Septodont, Prancūzija

Date of authorisation

2001-05-16

Date of renewal

2021-03-05

Documents

3247_3248 Septanest, Septanest Forte RPP 2022 05 06.docx

3247_3248 Pakuotės lapelis 2022 05 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

SE/H/0325/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Artikaino hidrochloridas	40 mg
Adrenalinas	5 µg

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
8233	12965	1012965	užtaisas	1,7 ml N50		Receptinis	LT/1/01/3247/001	Tiekiama	-	-	No	-	-	Download
103354	89456	1089456	užtaisas	1,7 ml N50 (savisiurbis)		Receptinis	LT/1/01/3247/002	Netiekiama	-	-	No	-	-
103355	89457	1089457	užtaisas	1,7 ml N4×50		Receptinis	LT/1/01/3247/003	Netiekiama	-	-	No	-	-
103356	89458	1089458	užtaisas	1,7 ml N8×50		Receptinis	LT/1/01/3247/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-05	Perregistruotas
2001-05-16	Registruotas