Instanyl

Medicinal product

(Invented) name

Instanyl

Active substance (s)

Fentanilis

Strength

200 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	200 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
36985	50597	1050597	buteliukas	1,8 ml N1 (10 dozių)		Receptinis	EU/1/09/531/007	Netiekiama	-	-	No	-	-
36986	50598	1050598	buteliukas	2,9 ml N1 (20 dozių)		Receptinis	EU/1/09/531/008	Netiekiama	-	-	No	-	-
36987	50599	1050599	buteliukas	5 ml N1 (40 dozių)		Receptinis	EU/1/09/531/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-07-20	Registruotas