Instanyl

Medicinal product

(Invented) name

Instanyl

Active substance (s)

Fentanilis

Strength

100 µg

Pharmaceutical form

nosies purškalas (tirpalas vienadozėje talpyklėje)

Route (s) of administration

vartoti į nosį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AB03, Fentanyl

Marketing authorisation holder

Istituto Gentili S.r.l., Italija

Date of authorisation

2009-07-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Nasal spray, solution	1 dozėje
Fentanilis	100 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
47491	61308	1061308	talpyklė	N2		Receptinis	EU/1/09/531/014	Netiekiama	-	-	No	-	-
47492	61309	1061309	talpyklė	N6		Receptinis	EU/1/09/531/015	Netiekiama	-	-	No	-	-
47493	61310	1061310	talpyklė	N8		Receptinis	EU/1/09/531/016	Netiekiama	-	-	No	-	-
47494	61311	1061311	talpyklė	N10		Receptinis	EU/1/09/531/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-07-20	Registruotas