Instanyl

Medicinal product

(Invented) name

Instanyl

Active substance (s)

Fentanilis

Strength

100 µg/dozėje

Pharmaceutical form

nosies purškalas (tirpalas)

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
36982	50594	1050594	buteliukas	1,8 ml N1 (10 dozių)		Receptinis	EU/1/09/531/004	Netiekiama	-	-	No	-	-
36983	50595	1050595	buteliukas	2,9 ml N1 (20 dozių)		Receptinis	EU/1/09/531/005	Netiekiama	-	-	No	-	-
36984	50596	1050596	buteliukas	5 ml N1 (40 dozių)		Receptinis	EU/1/09/531/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-07-20	Registruotas