Instanyl (DoseGuard)

Medicinal product

(Invented) name

Instanyl (DoseGuard)

Active substance (s)

Fentanilis

Strength

50 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	50 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
66677	81213	1081213	buteliukas	20 dozių (3,2 ml) N1		Receptinis	EU/1/09/531/023	Netiekiama	-	-	No	-	-
66678	81214	1081214	buteliukas	30 dozių (4,3 ml) N1		Receptinis	EU/1/09/531/024	Netiekiama	-	-	No	-	-
66679	81215	1081215	buteliukas	40 dozių (5,3 ml) N1		Receptinis	EU/1/09/531/025	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-07-20	Registruotas