Instanyl (DoseGuard)

Medicinal product

(Invented) name

Instanyl (DoseGuard)

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
66685	81221	1081221	buteliukas	20 dozių (3,2 ml) N1		Receptinis	EU/1/09/531/031	Netiekiama	-	-	No	-	-
66686	81222	1081222	buteliukas	30 dozių (4,3 ml) N1		Receptinis	EU/1/09/531/032	Netiekiama	-	-	No	-	-
66687	81223	1081223	buteliukas	40 dozių (5,3 ml) N1		Receptinis	EU/1/09/531/033	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-07-20	Registruotas