FORVEL

Medicinal product

(Invented) name

FORVEL

Active substance (s)

Naloksono hidrochloridas

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

Medochemie Ltd., Kipras

Date of authorisation

2017-09-05

Date of renewal

2023-01-31

Documents

4125 FORVEL PCS PL 2025 03 30.docx

4125 Pakuotės lapelis 2025 03 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2605/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekvienoje 1 ml ampulėje yra	1 ml
Naloksono hidrochloridas	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
97674	83769	1083769	ampulė	1 ml N5		Receptinis	LT/1/17/4125/001	Netiekiama	-	-	No	-	-
97675	83770	1083770	ampulė	1 ml N10		Receptinis	LT/1/17/4125/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-01-31	Perregistruotas
2017-09-05	Registruotas