NEXODAL

Medicinal product

(Invented) name

NEXODAL

Active substance (s)

Naloksonas

Strength

0,4 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V03AB15, Naloxone

Marketing authorisation holder

OrPha-Devel Handels und Vertriebs GmbH, Austrija

Date of authorisation

2008-07-03

Date of renewal

2011-10-25

Documents

1182_1 NEXODAL inj_inf PCS PL 170731.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1024/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Ampulėje (1 ml) yra	1 ml
Naloksonas	0,4 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
24257	26921	1026921	ampulė	1 ml N10		Receptinis	LT/1/08/1182/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-05	Išregistruotas
2011-10-25	Perregistruotas
2008-07-03	Registruotas