Dentocaine

Medicinal product

(Invented) name

Dentocaine

Active substance (s)

Artikainas/Epinefrinas

Strength

40 mg/0,01 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

vartoti ant burnos gleivinės

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01BB58, Articaine, combinations

Marketing authorisation holder

Laboratorios Inibsa, S.A., Ispanija

Date of authorisation

2009-10-20

Date of renewal

2021-11-24

Documents

1745 DENTOCAINE 40mg_0,01mg RPP 2024 09 04.docx

1745 Pakuotės lapelis 40mg_0,01mg 2024 09 04.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

NL/H/1492/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Artikainas	40 mg
Epinefrinas	0,01 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
30399	32861	1032861	užtaisas	1,8 ml N50		Receptinis	LT/1/09/1745/003	Tiekiama	-	-	No	-	-	Download
37319	50958	1050958	užtaisas	1,8 ml N100		Receptinis	LT/1/09/1745/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-24	Perregistruotas
2009-10-20	Registruotas