Ubistesin

Medicinal product

(Invented) name

Ubistesin

Active substance (s)

Artikainas/Epinefrinas

Strength

40 mg/5 µg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti aplink nervus

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01BB58, Articaine, combinations

Marketing authorisation holder

Pierrel S.p.A., Italija

Date of authorisation

1999-03-05

Date of renewal

2013-10-18

Documents

0457 Ubistesin 40_5 II PL 2025 08 01.docx

0457 Pakuotės lapelis 40mg_5mcg 2025 08 01.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
Artikainas	40 mg
Epinefrinas	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
11730	16169	1016169	užtaisas	1,7 ml N50		Receptinis	LT/1/99/0457/001	Tiekiama	2026-01-06	-	No	-	-

Stadijos

Data	Stadija
2013-10-18	Perregistruotas
1999-03-05	Registruotas