Instanyl

Medicinal product

(Invented) name

Instanyl

Active substance (s)

Fentanilis

Strength

200 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	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
47495	61312	1061312	talpyklė	N2		Receptinis	EU/1/09/531/018	Netiekiama	-	-	No	-	-
47496	61313	1061313	talpyklė	N6		Receptinis	EU/1/09/531/019	Netiekiama	-	-	No	-	-
47497	61314	1061314	talpyklė	N8		Receptinis	EU/1/09/531/020	Netiekiama	-	-	No	-	-
47498	61315	1061315	talpyklė	N10		Receptinis	EU/1/09/531/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-07-20	Registruotas