Instanyl

Medicinal product

(Invented) name

Instanyl

Active substance (s)

Fentanilis

Strength

50 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	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
47487	61304	1061304	talpyklė	N2		Receptinis	EU/1/09/531/010	Netiekiama	-	-	No	-	-
47488	61305	1061305	talpyklė	N6		Receptinis	EU/1/09/531/011	Netiekiama	-	-	No	-	-
47489	61306	1061306	talpyklė	N8		Receptinis	EU/1/09/531/012	Netiekiama	-	-	No	-	-
47490	61307	1061307	talpyklė	N10		Receptinis	EU/1/09/531/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-07-20	Registruotas